{"id":204040,"date":"2023-12-11T09:52:00","date_gmt":"2023-12-11T01:52:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=204040"},"modified":"2023-12-11T09:52:00","modified_gmt":"2023-12-11T01:52:00","slug":"menarini-group-%e6%96%bc-sabcs-2023-%e4%b8%8a%e7%99%bc%e4%bd%88-orserdu-elacestrant-%e5%9c%a8%e6%b2%bb%e7%99%82-esr1-%e7%aa%81%e8%ae%8a%e7%9a%84-er%e3%80%81her2-%e8%bd%89%e7%a7%bb%e6%80%a7","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=204040","title":{"rendered":"Menarini Group \u65bc SABCS 2023 \u4e0a\u767c\u4f48 ORSERDU\u00ae (Elacestrant) \u5728\u6cbb\u7642 ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\u81e8\u5e8a\u76f8\u95dc\u4e9e\u7d44\u65b9\u9762 EMERALD \u81e8\u5e8a\u7814\u7a76\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u7684\u65b0\u6578\u64da"},"content":{"rendered":"<div>\n<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><i>EMERALD <\/i><i>\u7b2c<\/i><i> 3 <\/i><i>\u671f\u8a66\u9a57\u7684\u65b0\u4e8b\u4ef6\u5f8c\u5206\u6790\u8a55\u4f30\u3001<\/i><i> elacestrant <\/i><i>\u5728\u5167\u5206\u6ccc\u654f\u611f\u65cf\u7fa4\uff08<\/i><i>CDK4\/6 <\/i><i>\u6291\u5236\u5291\u7642\u7a0b\u81f3\u5c11<\/i><i> 12 <\/i><i>\u500b\u6708\uff09\u4e2d\u7684\u61c9\u7528\u60c5\u6cc1\uff0c\u9019\u4e9b\u65cf\u7fa4\u6240\u60a3\u7684\u816b\u7624\u5747\u5e36\u6709<\/i><i> ESR1 <\/i><i>\u7a81\u8b8a\u3002<\/i>\u00a0<\/li>\n<li><i>\u8a72\u5206\u6790\u986f\u793a\uff0c\u5728\u53c3\u8207\u7814\u7a76\u7684\u5404\u4e9e\u7d44\u4e2d\uff0c\u5305\u62ec\u9aa8\u3001\u809d\u53ca<\/i><i>\/<\/i><i>\u6216\u80ba\u8f49\u79fb\u60a3\u8005\u3001\u4f34\u6709\u5e38\u898b\u7a81\u8b8a\uff08\u5982<\/i><i> PIK3CA <\/i><i>\u548c<\/i><i> TP53<\/i><i>\uff09\u7684\u60a3\u8005\u4ee5\u53ca<\/i><i> HER2 <\/i><i>\u4f4e\u8868\u9054\u60a3\u8005\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u90fd\u6709\u5177\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002<\/i>\u00a0<\/li>\n<li><i>\u4e0a\u8ff0\u7d50\u679c\u986f\u793a\uff0c\u7576<\/i><i> ESR1 <\/i><i>\u7a81\u8b8a\u7684\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0c<\/i><i>ER <\/i><i>\u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\u3002<\/i>\u00a0<\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">\u610f\u5927\u5229\u4f5b\u7f85\u502b\u65af\u548c\u7d10\u7d04<\/span><span class=\"legendSpanClass\">2023\u5e7412\u670811\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212; \u570b\u969b\u9818\u5148\u7684\u88fd\u85e5\u548c\u8a3a\u65b7\u516c\u53f8 Menarini Group\uff08\u300cMenarini\u300d\uff09\u8207\u5176\u81f4\u529b\u65bc\u70ba\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u8f49\u5316\u816b\u7624\u6cbb\u7642\u7684\u5168\u8cc7\u5b50\u516c\u53f8 Stemline Therapeutics, Inc. (\u300cStemline\u300d\uff09\u4eca\u5929\u516c\u4f48\u4e86\u91dd\u5c0d\u95dc\u9375 EMERALD \u81e8\u5e8a\u7814\u7a76\u958b\u5c55\u7684\u4e00\u9805\u65b0\u7684\u4e8b\u5f8c\u5206\u6790\u7d50\u679c\uff0c\u7d50\u679c\u8868\u660e\uff0c\u5728\u6240\u6709\u76f8\u95dc\u4e9e\u7d44\u4e2d\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u90fd\u5f97\u5230\u4e86\u5177\u6709\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002 \u6578\u64da\u986f\u793a\uff0c\u91dd\u5c0d\u5185\u5206\u6ccc\u654f\u611f\u4e14\u643a\u5e36\u00a0<i>ESR1<\/i> \u7a81\u8b8a\u816b\u7624\u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\uff0c\u5982\u679c\u5148\u524d\u4f7f\u7528 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\uff0c\u5247 ORSERDU\u00ae (elacestrant) \u55ae\u85e5\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u512a\u65bc\u6a19\u6e96\u6cbb\u7642 (SOC)\u3002 \u9019\u4e9b\u6578\u64da\u5c07\u5728 2023 \u5e74 12 \u6708 5 \u65e5\u81f3 12 \u6708 9 \u65e5\u8209\u884c\u7684 2023 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u764c\u7814\u8a0e\u6703 (SABCS) \u4e2d\u516c\u4f48\u3002\u00a0<\/p>\n<p>EMERALD \u662f\u4e00\u9805\u7b2c 3 \u671f\u8a3b\u518a\u8a66\u9a57\uff0c\u8868\u660e\u8207\u6a19\u6e96\u6cbb\u7642\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\uff08\u6c1f\u7dad\u53f8\u7fa4\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766\uff09\u76f8\u6bd4\uff0cORSERDU \u6cbb\u7642\u5177\u6709\u5728\u7d71\u8a08\u5b78\u4e0a\u66f4\u52a0\u986f\u8457\u7684 PFS\u3002\u6839\u64da\u4e0a\u8ff0\u7d50\u679c\uff0cFDA \u65bc 2023 \u5e74 1 \u6708 27 \u65e5\u6838\u51c6 ORSERDU \u7528\u65bc\u6cbb\u7642\u60a3\u6709 ER+\u3001HER2-\u3001<i>ESR1<\/i> \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\uff0c\u4e14\u9019\u4e9b\u60a3\u8005\u9700\u5728\u81f3\u5c11\u4e00\u7a2e\u5167\u5206\u6ccc\u7642\u6cd5\u5f8c\u75be\u75c5\u51fa\u73fe\u60e1\u5316\u3002\u9ad8\u9054 40% \u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u5b58\u5728 <i>ESR1<\/i> \u7a81\u8b8a\u3002\u00a0\u9019\u7a2e\u7a81\u8b8a\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u51fa\u73fe\u6297\u85e5\u6027\u7684\u5df2\u77e5\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u4e14\u5230\u76ee\u524d\u70ba\u6b62\uff0c\u5177\u6709\u9019\u985e\u7a81\u8b8a\u7684\u816b\u7624\u6cbb\u7642\u96e3\u5ea6\u66f4\u5927\u3002 \u00a0<\/p>\n<p>\u91cd\u9ede\u662f\uff0c\u5728 2022 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u817a\u764c\u7814\u8a0e\u6703 (SABCS) \u4e0a\u958b\u5c55\u95dc\u65bc EMERALD PFS \u7d50\u679c\u4e9e\u7d44\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 ORSERDU \u5f8c\u7684 PFS \u5ef6\u9577\u5448\u6b63\u9762\u76f8\u95dc\u59d3\uff0c\u4f46\u5728\u6a19\u6e96\u6cbb\u7642 (SOC) \u4e0a\u4e26\u7121\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD \u96a8\u6a5f\u5206\u7d44\u524d\u63a5\u53d7 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u00a0<i>ESR1<\/i> \u7a81\u8b8a\u60a3\u8005\uff0c\u63a1\u7528 ORSERDU \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 8.6 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u51fa\u73fe\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e 59% (\u98a8\u96aa\u6bd4\u7387 (HR)=0.41 95% \u7f6e\u4fe1\u5340\u9593: 0.26-0.63)\u3002<sup>[1]<\/sup><\/p>\n<p>\u5728\u9019\u9805\u66f4\u65b0\u5f8c\u7684\u5206\u6790\u4e2d\uff0cMenarini Stemline \u8a55\u4f30\u55ae\u85e5 ORSERDU \u70ba\u9ad8\u767c\u81e8\u5e8a\u548c\u95dc\u9375\u751f\u7269\u6a19\u8a18\u4e9e\u7d44\u5e36\u4f86\u7684\u76ca\u8655\uff0c\u5305\u62ec\u60a3\u6709\u9aa8\u3001\u809d\u548c\/\u6216\u80ba\u8f49\u79fb\u7684\u60a3\u8005\uff1b\u6709\u5e38\u898b\u4f75\u767c PIK3CA \u6216 TP53 \u7a81\u8b8a\u7684\u60a3\u8005\uff1b\u6216 HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u00a0<\/p>\n<p>\u300c\u9019\u4e9b\u6700\u65b0\u7814\u7a76\u7d50\u679c\u9032\u4e00\u6b65\u8b49\u5be6\uff0c\u5c0d\u65bc\u816b\u7624\u651c\u5e36\u00a0<i>ESR1<\/i> \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u4f86\u8aaa\uff0cORSERDU \u55ae\u85e5\u6cbb\u7642\u662f\u4e00\u7a2e\u5f88\u6709\u524d\u666f\u7684\u4e8c\u7dda\u6cbb\u7642\u9078\u64c7\uff0c\u300dUT Health San Antonio \u548c MD Anderson \u764c\u75c7\u4e2d\u5fc3\u4e73\u623f\u816b\u7624\u5c08\u5bb6\u3001\u91ab\u5b78\u6559\u6388\u3001\u91ab\u5b78\u535a\u58eb\u3001\u00a0\u79d1\u5b78\u535a\u58ebVirginia Kaklamani \u8aaa\uff0c\u300c\u6211\u5011\u767c\u73fe\uff0c\u5c0d\u65bc\u5148\u524d\u63a5\u53d7 CDK 4\/6 \u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u60a3\u8005\uff0c\u4f7f\u7528 elacestrant \u55ae\u85e5\u6cbb\u7642\u8207\u6a19\u6e96\u6cbb\u7642\u76f8\u6bd4\uff0c\u5728\u8a31\u591a\u91cd\u8981\u4e9e\u7d44\u7684\u75be\u75c5\u7121\u60e1\u5316\u751f\u5b58\u671f\u65b9\u9762\u90fd\u6709\u6301\u7e8c\u6539\u5584\u3002\u00a0\u6211\u5011\u89c0\u5bdf\u5230\u7684\u9019\u4e9b\u7d50\u679c\u4e0d\u50c5\u9069\u7528\u65bc\u9aa8\u8f49\u79fb\u60a3\u8005\uff0c\u540c\u6a23\u9069\u7528\u65bc\u809d\u81df\u548c\/\u6216\u80ba\u90e8\u8f49\u79fb\u60a3\u8005\uff0c\u4e5f\u9069\u7528\u65bc PIK3CA \u548c TP53 \u7b49\u5e38\u898b\u5171\u7a81\u8b8a\u60a3\u8005\uff0c\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u300d\u00a0<\/p>\n<p>\u8207 SOC \u5167\u5206\u6ccc\u55ae\u85e5\u6cbb\u7642 (\u6cd5\u6d1b\u5fb7\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766) \u76f8\u6bd4\uff0cORSERDU \u5728\u9019\u4e9b\u4e9e\u7d44\u4e2d\u986f\u793a\u51fa\u6709\u81e8\u5e8a\u610f\u7fa9\u7684 PFS \u6539\u5584\u3002\u7576\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u6642\u9593\u81f3\u5c11\u70ba 12 \u500b\u6708\u6642\uff0cORSERDU \u7684 PFS \u660e\u986f\u66f4\u9577\uff0c\u9019\u8868\u660e\u7576 <i>ESR1<\/i> \u7a81\u8b8a\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u8207\u8f49\u79fb\u90e8\u4f4d\u3001\u00a0\u4f34\u96a8\u7684 PIK3CA \u6216 TP53 \u7a81\u8b8a\u6216 HER2 \u4f4e\u8868\u9054\u5747\u7121\u95dc\u3002\u8acb\u65bc<a href=\"https:\/\/sabcs2023.eventscribe.net\/fsPopup.asp?Mode=posterinfo&amp;PosterID=623727\" target=\"_blank\" rel=\"nofollow noopener\">\u6b64\u8655<\/a>\u67e5\u770b\u5b8c\u6574\u6458\u8981\u3002<\/p>\n<p>Menarini Group \u884c\u653f\u7e3d\u88c1 <span class=\"xn-person\">Elcin Barker Ergun<\/span> \u8868\u793a\uff1a\u300c\u9019\u4e9b\u5728 SABCS 2023 \u5927\u6703\u4e0a\u516c\u4f48\u7684\u6578\u64da\u5efa\u7acb\u5728\u6211\u5011\u5c0d\u65bc ORSERDU \u53ca\u5176\u4f5c\u70ba\u91dd\u5c0d\u00a0<i>ESR1<\/i> \u7a81\u8b8a\u816b\u7624\u7684\u55ae\u85e5\u7642\u6cd5\u6f5b\u529b\u7684\u8a8d\u77e5\u57fa\u790e\u4e4b\u4e0a\u3002\u300d\u00a0\u4ed6\u88dc\u5145\u9053\uff1a\u300cMenarini Stemline \u7684\u76ee\u6a19\u662f\u63d0\u4f9b\u8b8a\u9769\u6027\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u5e6b\u52a9\u5ef6\u9577\u548c\u6539\u5584\u764c\u75c7\u60a3\u8005\u7684\u751f\u547d\u3002\u00a0\u6211\u5011\u5f88\u81ea\u8c6a\u80fd\u70ba\u773e\u591a\u5408\u9069\u7684\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u63d0\u4f9b\u4e00\u7a2e\u6025\u9700\u7684\u5167\u5206\u6ccc\u6cbb\u7642\u9078\u64c7\uff0c\u800c\u4e14\u9019\u7a2e\u9078\u64c7\u7684\u5b89\u5168\u6027\u4e5f\u662f\u53ef\u63a7\u7684\u3002\u300d\u00a0<\/p>\n<p>\u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u808c\u9aa8\u75db\u3001\u5641\u5fc3\uff0c\u4e09\u9178\u7518\u6cb9\u916f\u5347\u9ad8\uff0c\u81bd\u56fa\u9187\u5347\u9ad8\uff0c\u5614\u5410\uff0c\u75b2\u52de\uff0c\u6d88\u5316\u4e0d\u826f\uff0c\u8179\u7009\uff0c\u9223\u964d\u4f4e\uff0c\u80cc\u75db\uff0c\u808c\u9178\u9150\u5347\u9ad8\uff0c\u95dc\u7bc0\u75db\uff0c\u9209\u964d\u4f4e\uff0c\u4fbf\u79d8\uff0c\u982d\u75db\uff0c\u6f6e\u71b1\uff0c\u8179\u75db\uff0c\u8ca7\u8840\uff0c\u9240\u964d\u4f4e\u548c\u4e19\u6c28\u9178\u8f49\u6c28\u9176\u5347\u9ad8\u3002 ORSERDU \u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002\u00a0<\/p>\n<p>\u8acb\u65bc<a href=\"https:\/\/www.menarini.com\/en-us\/news\/news-detail\/menarini-group-announces-new-data-on-orserdu174-elacestrant-at-the-2023-san-antonio-breast-cancer-symposium-and-on-elzonris174-tagraxofusp-erzs-at-the-65th-american-society-of-hematology\" target=\"_blank\" rel=\"nofollow noopener\">\u6b64\u8655<\/a>\u67e5\u95b1\u6709\u95dc Menarini Group \/Stemline Therapeutics \u5728 SABCS 2023 \u4e0a\u7684\u5168\u7cfb\u5217\u4ecb\u7d39\u986f\u793a\u7684\u8a73\u7d30\u8cc7\u8a0a\u3002<\/p>\n<p><b>EMERALD <\/b><b>\u7b2c<\/b><b> 3 <\/b><b>\u671f\u7814\u7a76<\/b><b> (NCT03778931) <\/b><b>\u7c21\u4ecb<\/b>\u00a0<br \/>EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u662f\u4e00\u9805\u96a8\u6a5f\u3001\u958b\u653e\u5f0f\u3001\u4e3b\u52d5\u5c0d\u7167\u7684\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2- \u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u00a0\u8a72\u7814\u7a76\u62db\u52df 478 \u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5 (\u5305\u62ec CDK4\/6 \u6291\u5236\u5291) \u7684\u60a3\u8005\u3002\u00a0\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7\u00a0elacestrant \u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u8a72\u7814\u7a76\u7684\u4e3b\u8981\u81e8\u5e8a\u7d42\u9ede\u662f\u8a55\u91cf\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u548c\u96cc\u6fc0\u7d20\u53d7\u9ad4 1 \u57fa\u56e0 (<i>ESR1<\/i>) \u7a81\u8b8a\u60a3\u8005\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS)\u3002\u00a0\u5728\u816b\u7624\u5177\u6709\u00a0<i>ESR1<\/i> \u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 3.8 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS \u98a8\u96aa\u6bd4\u7387 (HR)=0.55, 95% \u7f6e\u4fe1\u5340\u9593: 0.39, 0.77)\u3002<\/p>\n<p><b>ORSERDU (elacestrant) <\/b><b>\u7c21\u4ecb<\/b>\u00a0<br \/><b>\u7f8e\u570b\u9069\u61c9\u75c7\uff1a<\/b>ORSERDU (elacestrant) \uff0c\u6bcf\u9320 345 \u6beb\u514b\uff0c\u9069\u7528\u65bc\u6cbb\u7642\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001<i>ESR1<\/i> \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u81f3\u5c11\u63a5\u53d7\u904e\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75be\u75c5\u6709\u60e1\u5316\u9032\u5c55\u7684\u60a3\u8005\u3002<\/p>\n<p>\u6b32\u4e86\u89e3\u7f8e\u570b\u7684\u5b8c\u6574\u8655\u65b9\u8cc7\u8a0a\u53ef\u4ee5\u700f\u89bd\u00a0<a href=\"http:\/\/www.orserdu.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.orserdu.com<\/a>\u3002<\/p>\n<p><b>\u91cd\u8981\u5b89\u5168\u8cc7\u8a0a<\/b> <br \/><i>\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9805<\/i><\/p>\n<p><i>\u8840\u8102\u7570\u5e38<\/i>\uff1a\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c30% \u51fa\u73fe\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\uff0c27% \u51fa\u73fe\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u30023 \u7d1a\u548c 4 \u7d1a\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\u548c\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u7684\u767c\u751f\u7387\u5206\u5225\u70ba 0.9% \u548c 2.2%\u3002\u5728\u958b\u59cb ORSERDU \u6cbb\u7642\u524d\u4ee5\u53ca\u6cbb\u7642\u671f\u9593\u9808\u5b9a\u671f\u76e3\u6e2c\u8840\u8102\u60c5\u6cc1\u3002 <br \/><i>\u80da\u80ce<\/i><i>&#8211;<\/i><i>\u80ce\u5152\u6bd2\u6027<\/i>\uff1a\u6839\u64da\u52d5\u7269\u7814\u7a76\u4e2d\u7684\u767c\u73fe\u53ca\u5176\u4f5c\u7528\u6a5f\u5236\uff0c\u5411\u5b55\u5a66\u8655\u65b9 ORSERDU \u7d66\u85e5\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u00a0\u8acb\u5411\u5b55\u5a66\u548c\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u544a\u77e5\u53ef\u80fd\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u7684\u98a8\u96aa\u3002\u00a0\u5efa\u8b70\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u670d\u7528\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002\u5c0d\u65bc\u64c1\u6709\u5177\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u4f34\u4fb6\u7684\u7537\u6027\u60a3\u8005\uff0c\u5efa\u8b70\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\uff0c\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002<\/p>\n<p><i>\u4e0d\u826f\u53cd\u61c9<\/i><\/p>\n<p><i>\u5728\u63a5\u53d7<\/i><i> ORSERDU <\/i><i>\u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c<\/i><i>12% <\/i><i>\u7684\u60a3\u8005\u51fa\u73fe\u56b4\u91cd\u7684\u4e0d\u826f\u53cd\u61c9<\/i>\u3002\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c\u767c\u751f\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u7684\u60a3\u8005\u6bd4\u4f8b\u8d85\u904e 1%\uff0c\u9019\u4e9b\u53cd\u61c9\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (1.7%) \u548c\u5641\u5fc3 (1.3%)\u30021.7% \u7684\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u51fa\u73fe\u4e86\u81f4\u547d\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u5305\u62ec\u5fc3\u81df\u9a5f\u505c\u3001\u6557\u8840\u6027\u4f11\u514b\u3001\u61a9\u5ba4\u708e\uff0c\u4ee5\u53ca\u539f\u56e0\u672a\u660e\u7684\u75c5\u75c7(\u5404\u4e00\u4f8b)\u3002<br \/><i>ORSERDU <\/i><i>\u7684\u6700\u5e38\u898b\u4e0d\u826f\u53cd\u61c9<\/i><i> (<u>&gt;<\/u>10%) <\/i>\uff0c\u5305\u62ec\u5be6\u9a57\u5ba4\u6aa2\u6e2c\u7d50\u679c\u7570\u5e38\uff0c\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (41%) \u3001\u5641\u5fc3 (35%) \u3001\u81bd\u56fa\u9187\u589e\u9ad8 (30%) \u3001\u8c37\u8349\u8f49\u6c28\u9176 (AST) \u589e\u9ad8 (29%) \u3001\u4e09\u9178\u7518\u6cb9\u8102\u589e\u9ad8 (27%) \u3001\u75b2\u52de (26%) \u3001\u8840\u7d05\u86cb\u767d\u964d\u4f4e (26%) \u3001\u5614\u5410 (19%) \u3001\u7a40\u4e19\u8f49\u6c28\u9176 (ALT) \u6c34\u5e73\u589e\u9ad8 (17%) \u3001\u9209\u964d\u4f4e (16%) \u3001\u808c\u9178\u9150\u589e\u9ad8 (16%) \u3001\u98df\u617e\u964d\u4f4e (15%) \u3001\u8179\u7009 (13%) \u3001\u982d\u75db (12%) \u3001\u4fbf\u79d8 (12%) \u3001\u8179\u75db (11%) \u3001\u6f6e\u7d05 (11%) \u548c\u6d88\u5316\u4e0d\u826f (10%)\u3002<\/p>\n<p><i>\u85e5\u7269\u76f8\u4e92\u4f5c\u7528<\/i>\u00a0<\/p>\n<p><i>\u8207<\/i><i> CYP3A4 <\/i><i>\u8a98\u5c0e\u5291\u53ca<\/i><i>\/<\/i><i>\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528<\/i>\uff1a\u00a0\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u6291\u5236\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u8a98\u5c0e\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002<\/p>\n<p><i>\u4f7f\u7528\u65bc\u7279\u5b9a\u4eba\u7fa4\u7684\u6ce8\u610f\u4e8b\u9805<\/i><\/p>\n<p><i>\u54fa\u4e73\u671f<\/i>\uff1a\u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u5230\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4e0d\u8981\u54fa\u4e73\u3002<br \/><i>\u809d\u529f\u80fd\u53d7\u640d<\/i>\uff1a\u907f\u514d\u5c0d\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C) \u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002\u4e2d\u5ea6\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh B) \u7684\u60a3\u8005\u8981\u6e1b\u5c11 ORSERDU \u7684\u5291\u91cf\u3002 <br \/>ORSERDU \u5728\u5152\u79d1\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u5b9a\u3002<\/p>\n<p>\u82e5\u8981\u5831\u544a\u53ef\u7591\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61 Stemline Therapeutics, Inc.\uff0c\u96fb\u8a71\u865f\u78bc\u70ba 1-877-332-7961\uff0c\u6216\u8005\u81f4\u96fb 1-800-FDA-1088 \u806f\u7d61 FDA\uff0c\u6216\u700f\u89bd\u00a0<a href=\"http:\/\/www.fda.gov\/medwatch\" target=\"_blank\" rel=\"nofollow noopener\">www.fda.gov\/medwatch<\/a>\u3002<\/p>\n<p><b>\u95dc\u65bc<\/b><b> Elacestrant <\/b><b>\u81e8\u5e8a\u958b\u767c\u8a08\u5283<\/b>\u00a0<br \/>Elacestrant \u9084\u5728\u6578\u500b\u8f49\u79fb\u6027\u4e73\u764c\u75be\u75c5\u7684\u81e8\u5e8a\u8a66\u9a57\u4e2d\u9032\u884c\u7814\u7a76\uff0c\u55ae\u7368\u6216\u662f\u7d50\u5408\u5176\u4ed6\u7642\u6cd5\uff1aELEVATE\uff08<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05563220\" target=\"_blank\" rel=\"nofollow noopener\">NCT05563220<\/a>\uff09\u662f\u4e00\u9805\u7b2c <span class=\"xn-money\">1b<\/span>\/2 \u671f\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c07\u8a55\u4f30 elacestrant \u5408\u4f75\u4f7f\u7528 alpelisib\u3001everolimus\u3001palbociclib\u3001abemaciclib \u548c ribociclib \u7642\u6cd5\u7684\u5b89\u5168\u6027\u548c\u7642\u6548\u3002ELECTRA\uff08<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05386108\" target=\"_blank\" rel=\"nofollow noopener\">NCT05386108<\/a>\uff09\u662f\u4e00\u9805 <span class=\"xn-money\">1b<\/span>\/2 \u671f\u958b\u653e\u6a19\u7c64\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u806f\u5408 abemaciclib \u6cbb\u7642 ER+\u3001HER2- \u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u7b2c 2 \u671f\u7814\u7a76\u8a55\u4f30\u6b64\u6cbb\u7642\u65b9\u6848\u5728\u8166\u8f49\u79fb\u60a3\u8005\u4e2d\u7684\u61c9\u7528\u3002 ELCIN\uff08<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05596409\" target=\"_blank\" rel=\"nofollow noopener\">NCT05596409<\/a>\uff09\u662f\u4e00\u9805\u7b2c 2 \u671f\u8a66\u9a57\uff0c\u8a55\u4f30 elacestrant \u5c0d\u96cc\u6fc0\u7d20\u53d7\u9ad4\u967d\u6027 (ER+)\/\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4-2 \u9670\u6027\uff08HER2-\uff09\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005 (mBC) \u7684\u7642\u6548\uff0c\u9019\u4e9b\u60a3\u8005\u5148\u524d\u63a5\u53d7\u904e 1 \u6b21\u6216 2 \u6b21\u8377\u723e\u8499\u7642\u6cd5\uff0c\u4e14\u5148\u524d\u672a\u4f7f\u7528\u904e\u7d30\u80de\u9031\u671f\u86cb\u767d\u4f9d\u8cf4\u6027\u6fc0\u9176\u6a19\u9776\u9176 CDK4 \u548c CDK6 \u6291\u5236\u5291\uff08CDK4\/6i\uff09\u3002Elacestrant \u4e5f\u5c07\u65bc\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002\u00a0<\/p>\n<p><b>Menarini Group <\/b><b>\u7c21\u4ecb<\/b>\u00a0<br \/>Menarini Group \u662f\u4e00\u5bb6\u9818\u5148\u696d\u754c\u7684\u570b\u969b\u88fd\u85e5\u548c\u8a3a\u7642\u516c\u53f8\uff0c\u5e74\u71df\u696d\u984d\u8d85\u904e 44 \u5104\u7f8e\u5143\uff0c\u54e1\u5de5\u8d85\u904e 17,000 \u4eba\u3002Menarini \u5c08\u6ce8\u65bc\u6cbb\u7642\u9700\u6c42\u9ad8\u5ea6\u672a\u6eff\u8db3\u7684\u9818\u57df\uff0c\u5176\u7522\u54c1\u6db5\u84cb\u5fc3\u81df\u75c5\u5b78\u3001\u816b\u7624\u5b78\u3001\u547c\u5438\u75c5\u5b78\u3001\u80c3\u8178\u75c5\u5b78\u3001\u50b3\u67d3\u75c5\u5b78\u3001\u7cd6\u5c3f\u75c5\u5b78\u3001\u708e\u75c7\u548c\u93ae\u75db\u7b49\u9818\u57df\u3002Menarini \u64c1\u6709 18 \u500b\u751f\u7522\u57fa\u5730\u548c 9 \u500b\u7814\u767c\u4e2d\u5fc3\uff0c\u7522\u54c1\u92b7\u5f80\u5168\u7403 140 \u500b\u570b\u5bb6\/\u5730\u5340\u3002\u00a0\u6b32\u4e86\u89e3\u66f4\u591a\u76f8\u95dc\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd\u00a0<a href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.menarini.com&amp;esheet=53558844&amp;newsitemid=20230920907427&amp;lan=en-US&amp;anchor=www.menarini.com&amp;index=5&amp;md5=7682feaaefe280a649c9a9d8a9e54a2c\" target=\"_blank\" rel=\"nofollow noopener\">www.menarini.com<\/a>\u3002<\/p>\n<p><b>Stemline Therapeutics Inc. <\/b><b>\u7c21\u4ecb<\/b><br \/>Stemline Therapeutics, Inc. (\u300cStemline\u300d) \u662f Menarini Group \u7684\u5168\u8cc7\u5b50\u516c\u53f8\uff0c\u662f\u4e00\u5bb6\u5546\u696d\u5316\u968e\u6bb5\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u65b0\u578b\u816b\u7624\u5b78\u6cbb\u7642\u85e5\u7269\u7684\u958b\u767c\u548c\u5546\u696d\u5316\u3002Stemline \u5c07\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u5546\u696d\u5316 ORSERDU\u00ae (elacestrant) \uff0c\u9019\u662f\u4e00\u7a2e\u53e3\u670d\u5167\u5206\u6ccc\u6cbb\u7642\u85e5\u7269\uff0c\u9069\u7528\u65bc\u60a3\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\uff0c\u4e14\u5728\u63a5\u53d7\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u3002Stemline \u9084\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u63a8\u51fa\u4e86 ELZONRIS\u00ae (tagraxofusp-erzs) \uff0c\u9019\u662f\u4e00\u7a2e\u91dd\u5c0d CD123 \u7684\u5275\u65b0\u6a19\u9776\u6cbb\u7642\uff0c\u7528\u65bc\u6cbb\u7642\u7206\u767c\u6027\u6f3f\u7d30\u80de\u6a39\u7a81\u7d30\u80de\u816b\u7624 (BPDCN)\uff08\u4e00\u7a2e\u4fb5\u8972\u6027\u8840\u6db2\u764c\u75c7\uff09\u60a3\u8005\uff0c\u4e5f\u662f\u7f8e\u570b\u548c\u6b50\u76df\u8fc4\u4eca\u552f\u4e00\u7372\u6279\u7684 BPDCN \u6cbb\u7642\u65b9\u6848\u3002Stemline \u4ea6\u5c07\u5728\u6b50\u6d32\u5546\u696d\u5316 NEXPOVIO\u00ae (selinexor) \uff0c\u4e00\u7a2e\u7528\u65bc\u6cbb\u7642\u591a\u767c\u6027\u9aa8\u9ad3\u7624\u7684 XPO1 \u6291\u5236\u5291\u3002\u00a0\u6b64\u5916\uff0cStemline \u9084\u64c1\u6709\u5ee3\u6cdb\u7684\u5c0f\u5206\u5b50\u548c\u751f\u7269\u88fd\u5291\u81e8\u5e8a\u7522\u54c1\u7ba1\u9053\uff0c\u9019\u4e9b\u7522\u54c1\u8655\u65bc\u4e0d\u540c\u7684\u958b\u767c\u968e\u6bb5\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u591a\u7a2e\u5be6\u9ad4\u764c\u548c\u8840\u764c\u3002\u00a0<\/p>\n<p>[1] Bardia \u7b49\u4eba EMERALD \u7684 elacestrant 3 \u671f\u8a66\u9a57\u5c0d\u6bd4\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\/HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u6548\u679c\uff1a\u00a0\u5728\u764c\u75c7\u75c5\u7076\u8f49\u79fb\u7684\u60c5\u6cc1\u4e0b\uff0c\u65e2\u5f80 CDK4\/6i \u6301\u7e8c\u6642\u9577\u7684\u7d50\u679c\u66f4\u65b0\u3002 SABCS 2022\u3002GS3-01<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>EMERALD \u7b2c 3 \u671f\u8a66\u9a57&#8230;<\/p>\n","protected":false},"author":16,"featured_media":204041,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[40567],"tags":[],"class_list":["post-204040","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-40567"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Menarini Group \u65bc SABCS 2023 \u4e0a\u767c\u4f48 ORSERDU\u00ae (Elacestrant) \u5728\u6cbb\u7642 ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\u81e8\u5e8a\u76f8\u95dc\u4e9e\u7d44\u65b9\u9762 EMERALD \u81e8\u5e8a\u7814\u7a76\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u7684\u65b0\u6578\u64da - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831<\/title>\n<meta name=\"description\" content=\"EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u7684\u65b0\u4e8b\u4ef6\u5f8c\u5206\u6790\u8a55\u4f30\u3001 elacestrant \u5728\u5167\u5206\u6ccc\u654f\u611f\u65cf\u7fa4\uff08CDK4\/6 \u6291\u5236\u5291\u7642\u7a0b\u81f3\u5c11 12 \u500b\u6708\uff09\u4e2d\u7684\u61c9\u7528\u60c5\u6cc1\uff0c\u9019\u4e9b\u65cf\u7fa4\u6240\u60a3\u7684\u816b\u7624\u5747\u5e36\u6709 ESR1 \u7a81\u8b8a\u3002\u00a0  \u8a72\u5206\u6790\u986f\u793a\uff0c\u5728\u53c3\u8207\u7814\u7a76\u7684\u5404\u4e9e\u7d44\u4e2d\uff0c\u5305\u62ec\u9aa8\u3001\u809d\u53ca\/\u6216\u80ba\u8f49\u79fb\u60a3\u8005\u3001\u4f34\u6709\u5e38\u898b\u7a81\u8b8a\uff08\u5982 PIK3CA \u548c TP53\uff09\u7684\u60a3\u8005\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u60a3\u8005\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u90fd\u6709\u5177\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002\u00a0  \u4e0a\u8ff0\u7d50\u679c\u986f\u793a\uff0c\u7576 ESR1 \u7a81\u8b8a\u7684\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\u3002\u00a0 \u610f\u5927\u5229\u4f5b\u7f85\u502b\u65af\u548c\u7d10\u7d042023\u5e7412\u670811\u65e5 \/\u7f8e\u901a\u793e\/ -- \u570b\u969b\u9818\u5148\u7684\u88fd\u85e5\u548c\u8a3a\u65b7\u516c\u53f8 Menarini Group\uff08\u300cMenarini\u300d\uff09\u8207\u5176\u81f4\u529b\u65bc\u70ba\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u8f49\u5316\u816b\u7624\u6cbb\u7642\u7684\u5168\u8cc7\u5b50\u516c\u53f8 Stemline Therapeutics, Inc. (\u300cStemline\u300d\uff09\u4eca\u5929\u516c\u4f48\u4e86\u91dd\u5c0d\u95dc\u9375 EMERALD \u81e8\u5e8a\u7814\u7a76\u958b\u5c55\u7684\u4e00\u9805\u65b0\u7684\u4e8b\u5f8c\u5206\u6790\u7d50\u679c\uff0c\u7d50\u679c\u8868\u660e\uff0c\u5728\u6240\u6709\u76f8\u95dc\u4e9e\u7d44\u4e2d\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u90fd\u5f97\u5230\u4e86\u5177\u6709\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002 \u6578\u64da\u986f\u793a\uff0c\u91dd\u5c0d\u5185\u5206\u6ccc\u654f\u611f\u4e14\u643a\u5e36\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\uff0c\u5982\u679c\u5148\u524d\u4f7f\u7528 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\uff0c\u5247 ORSERDU\u00ae (elacestrant) \u55ae\u85e5\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u512a\u65bc\u6a19\u6e96\u6cbb\u7642 (SOC)\u3002 \u9019\u4e9b\u6578\u64da\u5c07\u5728 2023 \u5e74 12 \u6708 5 \u65e5\u81f3 12 \u6708 9 \u65e5\u8209\u884c\u7684 2023 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u764c\u7814\u8a0e\u6703 (SABCS) \u4e2d\u516c\u4f48\u3002\u00a0 EMERALD \u662f\u4e00\u9805\u7b2c 3 \u671f\u8a3b\u518a\u8a66\u9a57\uff0c\u8868\u660e\u8207\u6a19\u6e96\u6cbb\u7642\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\uff08\u6c1f\u7dad\u53f8\u7fa4\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766\uff09\u76f8\u6bd4\uff0cORSERDU \u6cbb\u7642\u5177\u6709\u5728\u7d71\u8a08\u5b78\u4e0a\u66f4\u52a0\u986f\u8457\u7684 PFS\u3002\u6839\u64da\u4e0a\u8ff0\u7d50\u679c\uff0cFDA \u65bc 2023 \u5e74 1 \u6708 27 \u65e5\u6838\u51c6 ORSERDU \u7528\u65bc\u6cbb\u7642\u60a3\u6709 ER+\u3001HER2-\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\uff0c\u4e14\u9019\u4e9b\u60a3\u8005\u9700\u5728\u81f3\u5c11\u4e00\u7a2e\u5167\u5206\u6ccc\u7642\u6cd5\u5f8c\u75be\u75c5\u51fa\u73fe\u60e1\u5316\u3002\u9ad8\u9054 40% \u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u5b58\u5728 ESR1 \u7a81\u8b8a\u3002\u00a0\u9019\u7a2e\u7a81\u8b8a\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u51fa\u73fe\u6297\u85e5\u6027\u7684\u5df2\u77e5\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u4e14\u5230\u76ee\u524d\u70ba\u6b62\uff0c\u5177\u6709\u9019\u985e\u7a81\u8b8a\u7684\u816b\u7624\u6cbb\u7642\u96e3\u5ea6\u66f4\u5927\u3002 \u00a0 \u91cd\u9ede\u662f\uff0c\u5728 2022 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u817a\u764c\u7814\u8a0e\u6703 (SABCS) \u4e0a\u958b\u5c55\u95dc\u65bc EMERALD PFS \u7d50\u679c\u4e9e\u7d44\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 ORSERDU \u5f8c\u7684 PFS \u5ef6\u9577\u5448\u6b63\u9762\u76f8\u95dc\u59d3\uff0c\u4f46\u5728\u6a19\u6e96\u6cbb\u7642 (SOC) \u4e0a\u4e26\u7121\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD \u96a8\u6a5f\u5206\u7d44\u524d\u63a5\u53d7 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u00a0ESR1 \u7a81\u8b8a\u60a3\u8005\uff0c\u63a1\u7528 ORSERDU \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 8.6 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u51fa\u73fe\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e 59% (\u98a8\u96aa\u6bd4\u7387 (HR)=0.41 95% \u7f6e\u4fe1\u5340\u9593: 0.26-0.63)\u3002 \u5728\u9019\u9805\u66f4\u65b0\u5f8c\u7684\u5206\u6790\u4e2d\uff0cMenarini Stemline \u8a55\u4f30\u55ae\u85e5 ORSERDU \u70ba\u9ad8\u767c\u81e8\u5e8a\u548c\u95dc\u9375\u751f\u7269\u6a19\u8a18\u4e9e\u7d44\u5e36\u4f86\u7684\u76ca\u8655\uff0c\u5305\u62ec\u60a3\u6709\u9aa8\u3001\u809d\u548c\/\u6216\u80ba\u8f49\u79fb\u7684\u60a3\u8005\uff1b\u6709\u5e38\u898b\u4f75\u767c PIK3CA \u6216 TP53 \u7a81\u8b8a\u7684\u60a3\u8005\uff1b\u6216 HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u00a0 \u300c\u9019\u4e9b\u6700\u65b0\u7814\u7a76\u7d50\u679c\u9032\u4e00\u6b65\u8b49\u5be6\uff0c\u5c0d\u65bc\u816b\u7624\u651c\u5e36\u00a0ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u4f86\u8aaa\uff0cORSERDU \u55ae\u85e5\u6cbb\u7642\u662f\u4e00\u7a2e\u5f88\u6709\u524d\u666f\u7684\u4e8c\u7dda\u6cbb\u7642\u9078\u64c7\uff0c\u300dUT Health San Antonio \u548c MD Anderson \u764c\u75c7\u4e2d\u5fc3\u4e73\u623f\u816b\u7624\u5c08\u5bb6\u3001\u91ab\u5b78\u6559\u6388\u3001\u91ab\u5b78\u535a\u58eb\u3001\u00a0\u79d1\u5b78\u535a\u58ebVirginia Kaklamani \u8aaa\uff0c\u300c\u6211\u5011\u767c\u73fe\uff0c\u5c0d\u65bc\u5148\u524d\u63a5\u53d7 CDK 4\/6 \u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u60a3\u8005\uff0c\u4f7f\u7528 elacestrant \u55ae\u85e5\u6cbb\u7642\u8207\u6a19\u6e96\u6cbb\u7642\u76f8\u6bd4\uff0c\u5728\u8a31\u591a\u91cd\u8981\u4e9e\u7d44\u7684\u75be\u75c5\u7121\u60e1\u5316\u751f\u5b58\u671f\u65b9\u9762\u90fd\u6709\u6301\u7e8c\u6539\u5584\u3002\u00a0\u6211\u5011\u89c0\u5bdf\u5230\u7684\u9019\u4e9b\u7d50\u679c\u4e0d\u50c5\u9069\u7528\u65bc\u9aa8\u8f49\u79fb\u60a3\u8005\uff0c\u540c\u6a23\u9069\u7528\u65bc\u809d\u81df\u548c\/\u6216\u80ba\u90e8\u8f49\u79fb\u60a3\u8005\uff0c\u4e5f\u9069\u7528\u65bc PIK3CA \u548c TP53 \u7b49\u5e38\u898b\u5171\u7a81\u8b8a\u60a3\u8005\uff0c\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u300d\u00a0 \u8207 SOC \u5167\u5206\u6ccc\u55ae\u85e5\u6cbb\u7642 (\u6cd5\u6d1b\u5fb7\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766) \u76f8\u6bd4\uff0cORSERDU \u5728\u9019\u4e9b\u4e9e\u7d44\u4e2d\u986f\u793a\u51fa\u6709\u81e8\u5e8a\u610f\u7fa9\u7684 PFS \u6539\u5584\u3002\u7576\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u6642\u9593\u81f3\u5c11\u70ba 12 \u500b\u6708\u6642\uff0cORSERDU \u7684 PFS \u660e\u986f\u66f4\u9577\uff0c\u9019\u8868\u660e\u7576 ESR1 \u7a81\u8b8a\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u8207\u8f49\u79fb\u90e8\u4f4d\u3001\u00a0\u4f34\u96a8\u7684 PIK3CA \u6216 TP53 \u7a81\u8b8a\u6216 HER2 \u4f4e\u8868\u9054\u5747\u7121\u95dc\u3002\u8acb\u65bc\u6b64\u8655\u67e5\u770b\u5b8c\u6574\u6458\u8981\u3002 Menarini Group \u884c\u653f\u7e3d\u88c1 Elcin Barker Ergun \u8868\u793a\uff1a\u300c\u9019\u4e9b\u5728 SABCS 2023 \u5927\u6703\u4e0a\u516c\u4f48\u7684\u6578\u64da\u5efa\u7acb\u5728\u6211\u5011\u5c0d\u65bc ORSERDU \u53ca\u5176\u4f5c\u70ba\u91dd\u5c0d\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684\u55ae\u85e5\u7642\u6cd5\u6f5b\u529b\u7684\u8a8d\u77e5\u57fa\u790e\u4e4b\u4e0a\u3002\u300d\u00a0\u4ed6\u88dc\u5145\u9053\uff1a\u300cMenarini Stemline \u7684\u76ee\u6a19\u662f\u63d0\u4f9b\u8b8a\u9769\u6027\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u5e6b\u52a9\u5ef6\u9577\u548c\u6539\u5584\u764c\u75c7\u60a3\u8005\u7684\u751f\u547d\u3002\u00a0\u6211\u5011\u5f88\u81ea\u8c6a\u80fd\u70ba\u773e\u591a\u5408\u9069\u7684\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u63d0\u4f9b\u4e00\u7a2e\u6025\u9700\u7684\u5167\u5206\u6ccc\u6cbb\u7642\u9078\u64c7\uff0c\u800c\u4e14\u9019\u7a2e\u9078\u64c7\u7684\u5b89\u5168\u6027\u4e5f\u662f\u53ef\u63a7\u7684\u3002\u300d\u00a0 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u808c\u9aa8\u75db\u3001\u5641\u5fc3\uff0c\u4e09\u9178\u7518\u6cb9\u916f\u5347\u9ad8\uff0c\u81bd\u56fa\u9187\u5347\u9ad8\uff0c\u5614\u5410\uff0c\u75b2\u52de\uff0c\u6d88\u5316\u4e0d\u826f\uff0c\u8179\u7009\uff0c\u9223\u964d\u4f4e\uff0c\u80cc\u75db\uff0c\u808c\u9178\u9150\u5347\u9ad8\uff0c\u95dc\u7bc0\u75db\uff0c\u9209\u964d\u4f4e\uff0c\u4fbf\u79d8\uff0c\u982d\u75db\uff0c\u6f6e\u71b1\uff0c\u8179\u75db\uff0c\u8ca7\u8840\uff0c\u9240\u964d\u4f4e\u548c\u4e19\u6c28\u9178\u8f49\u6c28\u9176\u5347\u9ad8\u3002 ORSERDU \u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002\u00a0 \u8acb\u65bc\u6b64\u8655\u67e5\u95b1\u6709\u95dc Menarini Group \/Stemline Therapeutics \u5728 SABCS 2023 \u4e0a\u7684\u5168\u7cfb\u5217\u4ecb\u7d39\u986f\u793a\u7684\u8a73\u7d30\u8cc7\u8a0a\u3002 EMERALD \u7b2c 3 \u671f\u7814\u7a76 (NCT03778931) \u7c21\u4ecb\u00a0EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u662f\u4e00\u9805\u96a8\u6a5f\u3001\u958b\u653e\u5f0f\u3001\u4e3b\u52d5\u5c0d\u7167\u7684\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2- \u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u00a0\u8a72\u7814\u7a76\u62db\u52df 478 \u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5 (\u5305\u62ec CDK4\/6 \u6291\u5236\u5291) \u7684\u60a3\u8005\u3002\u00a0\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7\u00a0elacestrant \u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u8a72\u7814\u7a76\u7684\u4e3b\u8981\u81e8\u5e8a\u7d42\u9ede\u662f\u8a55\u91cf\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u548c\u96cc\u6fc0\u7d20\u53d7\u9ad4 1 \u57fa\u56e0 (ESR1) \u7a81\u8b8a\u60a3\u8005\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS)\u3002\u00a0\u5728\u816b\u7624\u5177\u6709\u00a0ESR1 \u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 3.8 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS \u98a8\u96aa\u6bd4\u7387 (HR)=0.55, 95% \u7f6e\u4fe1\u5340\u9593: 0.39, 0.77)\u3002 ORSERDU (elacestrant) \u7c21\u4ecb\u00a0\u7f8e\u570b\u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \uff0c\u6bcf\u9320 345 \u6beb\u514b\uff0c\u9069\u7528\u65bc\u6cbb\u7642\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u81f3\u5c11\u63a5\u53d7\u904e\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75be\u75c5\u6709\u60e1\u5316\u9032\u5c55\u7684\u60a3\u8005\u3002 \u6b32\u4e86\u89e3\u7f8e\u570b\u7684\u5b8c\u6574\u8655\u65b9\u8cc7\u8a0a\u53ef\u4ee5\u700f\u89bd\u00a0www.orserdu.com\u3002 \u91cd\u8981\u5b89\u5168\u8cc7\u8a0a \u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9805 \u8840\u8102\u7570\u5e38\uff1a\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c30% \u51fa\u73fe\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\uff0c27% \u51fa\u73fe\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u30023 \u7d1a\u548c 4 \u7d1a\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\u548c\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u7684\u767c\u751f\u7387\u5206\u5225\u70ba 0.9% \u548c 2.2%\u3002\u5728\u958b\u59cb ORSERDU \u6cbb\u7642\u524d\u4ee5\u53ca\u6cbb\u7642\u671f\u9593\u9808\u5b9a\u671f\u76e3\u6e2c\u8840\u8102\u60c5\u6cc1\u3002 \u80da\u80ce-\u80ce\u5152\u6bd2\u6027\uff1a\u6839\u64da\u52d5\u7269\u7814\u7a76\u4e2d\u7684\u767c\u73fe\u53ca\u5176\u4f5c\u7528\u6a5f\u5236\uff0c\u5411\u5b55\u5a66\u8655\u65b9 ORSERDU \u7d66\u85e5\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u00a0\u8acb\u5411\u5b55\u5a66\u548c\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u544a\u77e5\u53ef\u80fd\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u7684\u98a8\u96aa\u3002\u00a0\u5efa\u8b70\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u670d\u7528\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002\u5c0d\u65bc\u64c1\u6709\u5177\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u4f34\u4fb6\u7684\u7537\u6027\u60a3\u8005\uff0c\u5efa\u8b70\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\uff0c\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002 \u4e0d\u826f\u53cd\u61c9 \u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c12% \u7684\u60a3\u8005\u51fa\u73fe\u56b4\u91cd\u7684\u4e0d\u826f\u53cd\u61c9\u3002\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c\u767c\u751f\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u7684\u60a3\u8005\u6bd4\u4f8b\u8d85\u904e 1%\uff0c\u9019\u4e9b\u53cd\u61c9\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (1.7%) \u548c\u5641\u5fc3 (1.3%)\u30021.7% \u7684\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u51fa\u73fe\u4e86\u81f4\u547d\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u5305\u62ec\u5fc3\u81df\u9a5f\u505c\u3001\u6557\u8840\u6027\u4f11\u514b\u3001\u61a9\u5ba4\u708e\uff0c\u4ee5\u53ca\u539f\u56e0\u672a\u660e\u7684\u75c5\u75c7(\u5404\u4e00\u4f8b)\u3002ORSERDU \u7684\u6700\u5e38\u898b\u4e0d\u826f\u53cd\u61c9 (&gt;10%) \uff0c\u5305\u62ec\u5be6\u9a57\u5ba4\u6aa2\u6e2c\u7d50\u679c\u7570\u5e38\uff0c\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (41%) \u3001\u5641\u5fc3 (35%) \u3001\u81bd\u56fa\u9187\u589e\u9ad8 (30%) \u3001\u8c37\u8349\u8f49\u6c28\u9176 (AST) \u589e\u9ad8 (29%) \u3001\u4e09\u9178\u7518\u6cb9\u8102\u589e\u9ad8 (27%) \u3001\u75b2\u52de (26%) \u3001\u8840\u7d05\u86cb\u767d\u964d\u4f4e (26%) \u3001\u5614\u5410 (19%) \u3001\u7a40\u4e19\u8f49\u6c28\u9176 (ALT) \u6c34\u5e73\u589e\u9ad8 (17%) \u3001\u9209\u964d\u4f4e (16%) \u3001\u808c\u9178\u9150\u589e\u9ad8 (16%) \u3001\u98df\u617e\u964d\u4f4e (15%) \u3001\u8179\u7009 (13%) \u3001\u982d\u75db (12%) \u3001\u4fbf\u79d8 (12%) \u3001\u8179\u75db (11%) \u3001\u6f6e\u7d05 (11%) \u548c\u6d88\u5316\u4e0d\u826f (10%)\u3002 \u85e5\u7269\u76f8\u4e92\u4f5c\u7528\u00a0 \u8207 CYP3A4 \u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a\u00a0\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u6291\u5236\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u8a98\u5c0e\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002 \u4f7f\u7528\u65bc\u7279\u5b9a\u4eba\u7fa4\u7684\u6ce8\u610f\u4e8b\u9805 \u54fa\u4e73\u671f\uff1a\u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u5230\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4e0d\u8981\u54fa\u4e73\u3002\u809d\u529f\u80fd\u53d7\u640d\uff1a\u907f\u514d\u5c0d\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C) \u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002\u4e2d\u5ea6\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh B) \u7684\u60a3\u8005\u8981\u6e1b\u5c11 ORSERDU \u7684\u5291\u91cf\u3002 ORSERDU \u5728\u5152\u79d1\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u5b9a\u3002 \u82e5\u8981\u5831\u544a\u53ef\u7591\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61 Stemline Therapeutics, Inc.\uff0c\u96fb\u8a71\u865f\u78bc\u70ba 1-877-332-7961\uff0c\u6216\u8005\u81f4\u96fb 1-800-FDA-1088 \u806f\u7d61 FDA\uff0c\u6216\u700f\u89bd\u00a0www.fda.gov\/medwatch\u3002 \u95dc\u65bc Elacestrant \u81e8\u5e8a\u958b\u767c\u8a08\u5283\u00a0Elacestrant \u9084\u5728\u6578\u500b\u8f49\u79fb\u6027\u4e73\u764c\u75be\u75c5\u7684\u81e8\u5e8a\u8a66\u9a57\u4e2d\u9032\u884c\u7814\u7a76\uff0c\u55ae\u7368\u6216\u662f\u7d50\u5408\u5176\u4ed6\u7642\u6cd5\uff1aELEVATE\uff08NCT05563220\uff09\u662f\u4e00\u9805\u7b2c 1b\/2 \u671f\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c07\u8a55\u4f30 elacestrant \u5408\u4f75\u4f7f\u7528 alpelisib\u3001everolimus\u3001palbociclib\u3001abemaciclib \u548c ribociclib \u7642\u6cd5\u7684\u5b89\u5168\u6027\u548c\u7642\u6548\u3002ELECTRA\uff08NCT05386108\uff09\u662f\u4e00\u9805 1b\/2 \u671f\u958b\u653e\u6a19\u7c64\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u806f\u5408 abemaciclib \u6cbb\u7642 ER+\u3001HER2- \u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u7b2c 2 \u671f\u7814\u7a76\u8a55\u4f30\u6b64\u6cbb\u7642\u65b9\u6848\u5728\u8166\u8f49\u79fb\u60a3\u8005\u4e2d\u7684\u61c9\u7528\u3002 ELCIN\uff08NCT05596409\uff09\u662f\u4e00\u9805\u7b2c 2 \u671f\u8a66\u9a57\uff0c\u8a55\u4f30 elacestrant \u5c0d\u96cc\u6fc0\u7d20\u53d7\u9ad4\u967d\u6027 (ER+)\/\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4-2 \u9670\u6027\uff08HER2-\uff09\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005 (mBC) \u7684\u7642\u6548\uff0c\u9019\u4e9b\u60a3\u8005\u5148\u524d\u63a5\u53d7\u904e 1 \u6b21\u6216 2 \u6b21\u8377\u723e\u8499\u7642\u6cd5\uff0c\u4e14\u5148\u524d\u672a\u4f7f\u7528\u904e\u7d30\u80de\u9031\u671f\u86cb\u767d\u4f9d\u8cf4\u6027\u6fc0\u9176\u6a19\u9776\u9176 CDK4 \u548c CDK6 \u6291\u5236\u5291\uff08CDK4\/6i\uff09\u3002Elacestrant \u4e5f\u5c07\u65bc\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002\u00a0 Menarini Group \u7c21\u4ecb\u00a0Menarini Group \u662f\u4e00\u5bb6\u9818\u5148\u696d\u754c\u7684\u570b\u969b\u88fd\u85e5\u548c\u8a3a\u7642\u516c\u53f8\uff0c\u5e74\u71df\u696d\u984d\u8d85\u904e 44 \u5104\u7f8e\u5143\uff0c\u54e1\u5de5\u8d85\u904e 17,000 \u4eba\u3002Menarini \u5c08\u6ce8\u65bc\u6cbb\u7642\u9700\u6c42\u9ad8\u5ea6\u672a\u6eff\u8db3\u7684\u9818\u57df\uff0c\u5176\u7522\u54c1\u6db5\u84cb\u5fc3\u81df\u75c5\u5b78\u3001\u816b\u7624\u5b78\u3001\u547c\u5438\u75c5\u5b78\u3001\u80c3\u8178\u75c5\u5b78\u3001\u50b3\u67d3\u75c5\u5b78\u3001\u7cd6\u5c3f\u75c5\u5b78\u3001\u708e\u75c7\u548c\u93ae\u75db\u7b49\u9818\u57df\u3002Menarini \u64c1\u6709 18 \u500b\u751f\u7522\u57fa\u5730\u548c 9 \u500b\u7814\u767c\u4e2d\u5fc3\uff0c\u7522\u54c1\u92b7\u5f80\u5168\u7403 140 \u500b\u570b\u5bb6\/\u5730\u5340\u3002\u00a0\u6b32\u4e86\u89e3\u66f4\u591a\u76f8\u95dc\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd\u00a0www.menarini.com\u3002 Stemline Therapeutics Inc. \u7c21\u4ecbStemline Therapeutics, Inc. (\u300cStemline\u300d) \u662f Menarini Group \u7684\u5168\u8cc7\u5b50\u516c\u53f8\uff0c\u662f\u4e00\u5bb6\u5546\u696d\u5316\u968e\u6bb5\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u65b0\u578b\u816b\u7624\u5b78\u6cbb\u7642\u85e5\u7269\u7684\u958b\u767c\u548c\u5546\u696d\u5316\u3002Stemline \u5c07\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u5546\u696d\u5316 ORSERDU\u00ae (elacestrant) \uff0c\u9019\u662f\u4e00\u7a2e\u53e3\u670d\u5167\u5206\u6ccc\u6cbb\u7642\u85e5\u7269\uff0c\u9069\u7528\u65bc\u60a3\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\uff0c\u4e14\u5728\u63a5\u53d7\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u3002Stemline \u9084\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u63a8\u51fa\u4e86 ELZONRIS\u00ae (tagraxofusp-erzs) \uff0c\u9019\u662f\u4e00\u7a2e\u91dd\u5c0d CD123 \u7684\u5275\u65b0\u6a19\u9776\u6cbb\u7642\uff0c\u7528\u65bc\u6cbb\u7642\u7206\u767c\u6027\u6f3f\u7d30\u80de\u6a39\u7a81\u7d30\u80de\u816b\u7624 (BPDCN)\uff08\u4e00\u7a2e\u4fb5\u8972\u6027\u8840\u6db2\u764c\u75c7\uff09\u60a3\u8005\uff0c\u4e5f\u662f\u7f8e\u570b\u548c\u6b50\u76df\u8fc4\u4eca\u552f\u4e00\u7372\u6279\u7684 BPDCN \u6cbb\u7642\u65b9\u6848\u3002Stemline \u4ea6\u5c07\u5728\u6b50\u6d32\u5546\u696d\u5316 NEXPOVIO\u00ae (selinexor) \uff0c\u4e00\u7a2e\u7528\u65bc\u6cbb\u7642\u591a\u767c\u6027\u9aa8\u9ad3\u7624\u7684 XPO1 \u6291\u5236\u5291\u3002\u00a0\u6b64\u5916\uff0cStemline \u9084\u64c1\u6709\u5ee3\u6cdb\u7684\u5c0f\u5206\u5b50\u548c\u751f\u7269\u88fd\u5291\u81e8\u5e8a\u7522\u54c1\u7ba1\u9053\uff0c\u9019\u4e9b\u7522\u54c1\u8655\u65bc\u4e0d\u540c\u7684\u958b\u767c\u968e\u6bb5\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u591a\u7a2e\u5be6\u9ad4\u764c\u548c\u8840\u764c\u3002\u00a0  Bardia \u7b49\u4eba EMERALD \u7684 elacestrant 3 \u671f\u8a66\u9a57\u5c0d\u6bd4\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\/HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u6548\u679c\uff1a\u00a0\u5728\u764c\u75c7\u75c5\u7076\u8f49\u79fb\u7684\u60c5\u6cc1\u4e0b\uff0c\u65e2\u5f80 CDK4\/6i \u6301\u7e8c\u6642\u9577\u7684\u7d50\u679c\u66f4\u65b0\u3002 SABCS 2022\u3002GS3-01\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pingtungtimes.com.tw\/?p=204040\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Menarini Group \u65bc SABCS 2023 \u4e0a\u767c\u4f48 ORSERDU\u00ae (Elacestrant) \u5728\u6cbb\u7642 ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\u81e8\u5e8a\u76f8\u95dc\u4e9e\u7d44\u65b9\u9762 EMERALD \u81e8\u5e8a\u7814\u7a76\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u7684\u65b0\u6578\u64da - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" content=\"EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u7684\u65b0\u4e8b\u4ef6\u5f8c\u5206\u6790\u8a55\u4f30\u3001 elacestrant \u5728\u5167\u5206\u6ccc\u654f\u611f\u65cf\u7fa4\uff08CDK4\/6 \u6291\u5236\u5291\u7642\u7a0b\u81f3\u5c11 12 \u500b\u6708\uff09\u4e2d\u7684\u61c9\u7528\u60c5\u6cc1\uff0c\u9019\u4e9b\u65cf\u7fa4\u6240\u60a3\u7684\u816b\u7624\u5747\u5e36\u6709 ESR1 \u7a81\u8b8a\u3002\u00a0  \u8a72\u5206\u6790\u986f\u793a\uff0c\u5728\u53c3\u8207\u7814\u7a76\u7684\u5404\u4e9e\u7d44\u4e2d\uff0c\u5305\u62ec\u9aa8\u3001\u809d\u53ca\/\u6216\u80ba\u8f49\u79fb\u60a3\u8005\u3001\u4f34\u6709\u5e38\u898b\u7a81\u8b8a\uff08\u5982 PIK3CA \u548c TP53\uff09\u7684\u60a3\u8005\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u60a3\u8005\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u90fd\u6709\u5177\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002\u00a0  \u4e0a\u8ff0\u7d50\u679c\u986f\u793a\uff0c\u7576 ESR1 \u7a81\u8b8a\u7684\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\u3002\u00a0 \u610f\u5927\u5229\u4f5b\u7f85\u502b\u65af\u548c\u7d10\u7d042023\u5e7412\u670811\u65e5 \/\u7f8e\u901a\u793e\/ -- \u570b\u969b\u9818\u5148\u7684\u88fd\u85e5\u548c\u8a3a\u65b7\u516c\u53f8 Menarini Group\uff08\u300cMenarini\u300d\uff09\u8207\u5176\u81f4\u529b\u65bc\u70ba\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u8f49\u5316\u816b\u7624\u6cbb\u7642\u7684\u5168\u8cc7\u5b50\u516c\u53f8 Stemline Therapeutics, Inc. (\u300cStemline\u300d\uff09\u4eca\u5929\u516c\u4f48\u4e86\u91dd\u5c0d\u95dc\u9375 EMERALD \u81e8\u5e8a\u7814\u7a76\u958b\u5c55\u7684\u4e00\u9805\u65b0\u7684\u4e8b\u5f8c\u5206\u6790\u7d50\u679c\uff0c\u7d50\u679c\u8868\u660e\uff0c\u5728\u6240\u6709\u76f8\u95dc\u4e9e\u7d44\u4e2d\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u90fd\u5f97\u5230\u4e86\u5177\u6709\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002 \u6578\u64da\u986f\u793a\uff0c\u91dd\u5c0d\u5185\u5206\u6ccc\u654f\u611f\u4e14\u643a\u5e36\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\uff0c\u5982\u679c\u5148\u524d\u4f7f\u7528 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\uff0c\u5247 ORSERDU\u00ae (elacestrant) \u55ae\u85e5\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u512a\u65bc\u6a19\u6e96\u6cbb\u7642 (SOC)\u3002 \u9019\u4e9b\u6578\u64da\u5c07\u5728 2023 \u5e74 12 \u6708 5 \u65e5\u81f3 12 \u6708 9 \u65e5\u8209\u884c\u7684 2023 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u764c\u7814\u8a0e\u6703 (SABCS) \u4e2d\u516c\u4f48\u3002\u00a0 EMERALD \u662f\u4e00\u9805\u7b2c 3 \u671f\u8a3b\u518a\u8a66\u9a57\uff0c\u8868\u660e\u8207\u6a19\u6e96\u6cbb\u7642\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\uff08\u6c1f\u7dad\u53f8\u7fa4\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766\uff09\u76f8\u6bd4\uff0cORSERDU \u6cbb\u7642\u5177\u6709\u5728\u7d71\u8a08\u5b78\u4e0a\u66f4\u52a0\u986f\u8457\u7684 PFS\u3002\u6839\u64da\u4e0a\u8ff0\u7d50\u679c\uff0cFDA \u65bc 2023 \u5e74 1 \u6708 27 \u65e5\u6838\u51c6 ORSERDU \u7528\u65bc\u6cbb\u7642\u60a3\u6709 ER+\u3001HER2-\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\uff0c\u4e14\u9019\u4e9b\u60a3\u8005\u9700\u5728\u81f3\u5c11\u4e00\u7a2e\u5167\u5206\u6ccc\u7642\u6cd5\u5f8c\u75be\u75c5\u51fa\u73fe\u60e1\u5316\u3002\u9ad8\u9054 40% \u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u5b58\u5728 ESR1 \u7a81\u8b8a\u3002\u00a0\u9019\u7a2e\u7a81\u8b8a\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u51fa\u73fe\u6297\u85e5\u6027\u7684\u5df2\u77e5\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u4e14\u5230\u76ee\u524d\u70ba\u6b62\uff0c\u5177\u6709\u9019\u985e\u7a81\u8b8a\u7684\u816b\u7624\u6cbb\u7642\u96e3\u5ea6\u66f4\u5927\u3002 \u00a0 \u91cd\u9ede\u662f\uff0c\u5728 2022 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u817a\u764c\u7814\u8a0e\u6703 (SABCS) \u4e0a\u958b\u5c55\u95dc\u65bc EMERALD PFS \u7d50\u679c\u4e9e\u7d44\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 ORSERDU \u5f8c\u7684 PFS \u5ef6\u9577\u5448\u6b63\u9762\u76f8\u95dc\u59d3\uff0c\u4f46\u5728\u6a19\u6e96\u6cbb\u7642 (SOC) \u4e0a\u4e26\u7121\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD \u96a8\u6a5f\u5206\u7d44\u524d\u63a5\u53d7 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u00a0ESR1 \u7a81\u8b8a\u60a3\u8005\uff0c\u63a1\u7528 ORSERDU \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 8.6 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u51fa\u73fe\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e 59% (\u98a8\u96aa\u6bd4\u7387 (HR)=0.41 95% \u7f6e\u4fe1\u5340\u9593: 0.26-0.63)\u3002 \u5728\u9019\u9805\u66f4\u65b0\u5f8c\u7684\u5206\u6790\u4e2d\uff0cMenarini Stemline \u8a55\u4f30\u55ae\u85e5 ORSERDU \u70ba\u9ad8\u767c\u81e8\u5e8a\u548c\u95dc\u9375\u751f\u7269\u6a19\u8a18\u4e9e\u7d44\u5e36\u4f86\u7684\u76ca\u8655\uff0c\u5305\u62ec\u60a3\u6709\u9aa8\u3001\u809d\u548c\/\u6216\u80ba\u8f49\u79fb\u7684\u60a3\u8005\uff1b\u6709\u5e38\u898b\u4f75\u767c PIK3CA \u6216 TP53 \u7a81\u8b8a\u7684\u60a3\u8005\uff1b\u6216 HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u00a0 \u300c\u9019\u4e9b\u6700\u65b0\u7814\u7a76\u7d50\u679c\u9032\u4e00\u6b65\u8b49\u5be6\uff0c\u5c0d\u65bc\u816b\u7624\u651c\u5e36\u00a0ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u4f86\u8aaa\uff0cORSERDU \u55ae\u85e5\u6cbb\u7642\u662f\u4e00\u7a2e\u5f88\u6709\u524d\u666f\u7684\u4e8c\u7dda\u6cbb\u7642\u9078\u64c7\uff0c\u300dUT Health San Antonio \u548c MD Anderson \u764c\u75c7\u4e2d\u5fc3\u4e73\u623f\u816b\u7624\u5c08\u5bb6\u3001\u91ab\u5b78\u6559\u6388\u3001\u91ab\u5b78\u535a\u58eb\u3001\u00a0\u79d1\u5b78\u535a\u58ebVirginia Kaklamani \u8aaa\uff0c\u300c\u6211\u5011\u767c\u73fe\uff0c\u5c0d\u65bc\u5148\u524d\u63a5\u53d7 CDK 4\/6 \u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u60a3\u8005\uff0c\u4f7f\u7528 elacestrant \u55ae\u85e5\u6cbb\u7642\u8207\u6a19\u6e96\u6cbb\u7642\u76f8\u6bd4\uff0c\u5728\u8a31\u591a\u91cd\u8981\u4e9e\u7d44\u7684\u75be\u75c5\u7121\u60e1\u5316\u751f\u5b58\u671f\u65b9\u9762\u90fd\u6709\u6301\u7e8c\u6539\u5584\u3002\u00a0\u6211\u5011\u89c0\u5bdf\u5230\u7684\u9019\u4e9b\u7d50\u679c\u4e0d\u50c5\u9069\u7528\u65bc\u9aa8\u8f49\u79fb\u60a3\u8005\uff0c\u540c\u6a23\u9069\u7528\u65bc\u809d\u81df\u548c\/\u6216\u80ba\u90e8\u8f49\u79fb\u60a3\u8005\uff0c\u4e5f\u9069\u7528\u65bc PIK3CA \u548c TP53 \u7b49\u5e38\u898b\u5171\u7a81\u8b8a\u60a3\u8005\uff0c\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u300d\u00a0 \u8207 SOC \u5167\u5206\u6ccc\u55ae\u85e5\u6cbb\u7642 (\u6cd5\u6d1b\u5fb7\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766) \u76f8\u6bd4\uff0cORSERDU \u5728\u9019\u4e9b\u4e9e\u7d44\u4e2d\u986f\u793a\u51fa\u6709\u81e8\u5e8a\u610f\u7fa9\u7684 PFS \u6539\u5584\u3002\u7576\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u6642\u9593\u81f3\u5c11\u70ba 12 \u500b\u6708\u6642\uff0cORSERDU \u7684 PFS \u660e\u986f\u66f4\u9577\uff0c\u9019\u8868\u660e\u7576 ESR1 \u7a81\u8b8a\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u8207\u8f49\u79fb\u90e8\u4f4d\u3001\u00a0\u4f34\u96a8\u7684 PIK3CA \u6216 TP53 \u7a81\u8b8a\u6216 HER2 \u4f4e\u8868\u9054\u5747\u7121\u95dc\u3002\u8acb\u65bc\u6b64\u8655\u67e5\u770b\u5b8c\u6574\u6458\u8981\u3002 Menarini Group \u884c\u653f\u7e3d\u88c1 Elcin Barker Ergun \u8868\u793a\uff1a\u300c\u9019\u4e9b\u5728 SABCS 2023 \u5927\u6703\u4e0a\u516c\u4f48\u7684\u6578\u64da\u5efa\u7acb\u5728\u6211\u5011\u5c0d\u65bc ORSERDU \u53ca\u5176\u4f5c\u70ba\u91dd\u5c0d\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684\u55ae\u85e5\u7642\u6cd5\u6f5b\u529b\u7684\u8a8d\u77e5\u57fa\u790e\u4e4b\u4e0a\u3002\u300d\u00a0\u4ed6\u88dc\u5145\u9053\uff1a\u300cMenarini Stemline \u7684\u76ee\u6a19\u662f\u63d0\u4f9b\u8b8a\u9769\u6027\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u5e6b\u52a9\u5ef6\u9577\u548c\u6539\u5584\u764c\u75c7\u60a3\u8005\u7684\u751f\u547d\u3002\u00a0\u6211\u5011\u5f88\u81ea\u8c6a\u80fd\u70ba\u773e\u591a\u5408\u9069\u7684\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u63d0\u4f9b\u4e00\u7a2e\u6025\u9700\u7684\u5167\u5206\u6ccc\u6cbb\u7642\u9078\u64c7\uff0c\u800c\u4e14\u9019\u7a2e\u9078\u64c7\u7684\u5b89\u5168\u6027\u4e5f\u662f\u53ef\u63a7\u7684\u3002\u300d\u00a0 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u808c\u9aa8\u75db\u3001\u5641\u5fc3\uff0c\u4e09\u9178\u7518\u6cb9\u916f\u5347\u9ad8\uff0c\u81bd\u56fa\u9187\u5347\u9ad8\uff0c\u5614\u5410\uff0c\u75b2\u52de\uff0c\u6d88\u5316\u4e0d\u826f\uff0c\u8179\u7009\uff0c\u9223\u964d\u4f4e\uff0c\u80cc\u75db\uff0c\u808c\u9178\u9150\u5347\u9ad8\uff0c\u95dc\u7bc0\u75db\uff0c\u9209\u964d\u4f4e\uff0c\u4fbf\u79d8\uff0c\u982d\u75db\uff0c\u6f6e\u71b1\uff0c\u8179\u75db\uff0c\u8ca7\u8840\uff0c\u9240\u964d\u4f4e\u548c\u4e19\u6c28\u9178\u8f49\u6c28\u9176\u5347\u9ad8\u3002 ORSERDU \u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002\u00a0 \u8acb\u65bc\u6b64\u8655\u67e5\u95b1\u6709\u95dc Menarini Group \/Stemline Therapeutics \u5728 SABCS 2023 \u4e0a\u7684\u5168\u7cfb\u5217\u4ecb\u7d39\u986f\u793a\u7684\u8a73\u7d30\u8cc7\u8a0a\u3002 EMERALD \u7b2c 3 \u671f\u7814\u7a76 (NCT03778931) \u7c21\u4ecb\u00a0EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u662f\u4e00\u9805\u96a8\u6a5f\u3001\u958b\u653e\u5f0f\u3001\u4e3b\u52d5\u5c0d\u7167\u7684\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2- \u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u00a0\u8a72\u7814\u7a76\u62db\u52df 478 \u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5 (\u5305\u62ec CDK4\/6 \u6291\u5236\u5291) \u7684\u60a3\u8005\u3002\u00a0\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7\u00a0elacestrant \u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u8a72\u7814\u7a76\u7684\u4e3b\u8981\u81e8\u5e8a\u7d42\u9ede\u662f\u8a55\u91cf\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u548c\u96cc\u6fc0\u7d20\u53d7\u9ad4 1 \u57fa\u56e0 (ESR1) \u7a81\u8b8a\u60a3\u8005\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS)\u3002\u00a0\u5728\u816b\u7624\u5177\u6709\u00a0ESR1 \u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 3.8 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS \u98a8\u96aa\u6bd4\u7387 (HR)=0.55, 95% \u7f6e\u4fe1\u5340\u9593: 0.39, 0.77)\u3002 ORSERDU (elacestrant) \u7c21\u4ecb\u00a0\u7f8e\u570b\u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \uff0c\u6bcf\u9320 345 \u6beb\u514b\uff0c\u9069\u7528\u65bc\u6cbb\u7642\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u81f3\u5c11\u63a5\u53d7\u904e\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75be\u75c5\u6709\u60e1\u5316\u9032\u5c55\u7684\u60a3\u8005\u3002 \u6b32\u4e86\u89e3\u7f8e\u570b\u7684\u5b8c\u6574\u8655\u65b9\u8cc7\u8a0a\u53ef\u4ee5\u700f\u89bd\u00a0www.orserdu.com\u3002 \u91cd\u8981\u5b89\u5168\u8cc7\u8a0a \u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9805 \u8840\u8102\u7570\u5e38\uff1a\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c30% \u51fa\u73fe\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\uff0c27% \u51fa\u73fe\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u30023 \u7d1a\u548c 4 \u7d1a\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\u548c\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u7684\u767c\u751f\u7387\u5206\u5225\u70ba 0.9% \u548c 2.2%\u3002\u5728\u958b\u59cb ORSERDU \u6cbb\u7642\u524d\u4ee5\u53ca\u6cbb\u7642\u671f\u9593\u9808\u5b9a\u671f\u76e3\u6e2c\u8840\u8102\u60c5\u6cc1\u3002 \u80da\u80ce-\u80ce\u5152\u6bd2\u6027\uff1a\u6839\u64da\u52d5\u7269\u7814\u7a76\u4e2d\u7684\u767c\u73fe\u53ca\u5176\u4f5c\u7528\u6a5f\u5236\uff0c\u5411\u5b55\u5a66\u8655\u65b9 ORSERDU \u7d66\u85e5\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u00a0\u8acb\u5411\u5b55\u5a66\u548c\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u544a\u77e5\u53ef\u80fd\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u7684\u98a8\u96aa\u3002\u00a0\u5efa\u8b70\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u670d\u7528\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002\u5c0d\u65bc\u64c1\u6709\u5177\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u4f34\u4fb6\u7684\u7537\u6027\u60a3\u8005\uff0c\u5efa\u8b70\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\uff0c\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002 \u4e0d\u826f\u53cd\u61c9 \u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c12% \u7684\u60a3\u8005\u51fa\u73fe\u56b4\u91cd\u7684\u4e0d\u826f\u53cd\u61c9\u3002\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c\u767c\u751f\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u7684\u60a3\u8005\u6bd4\u4f8b\u8d85\u904e 1%\uff0c\u9019\u4e9b\u53cd\u61c9\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (1.7%) \u548c\u5641\u5fc3 (1.3%)\u30021.7% \u7684\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u51fa\u73fe\u4e86\u81f4\u547d\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u5305\u62ec\u5fc3\u81df\u9a5f\u505c\u3001\u6557\u8840\u6027\u4f11\u514b\u3001\u61a9\u5ba4\u708e\uff0c\u4ee5\u53ca\u539f\u56e0\u672a\u660e\u7684\u75c5\u75c7(\u5404\u4e00\u4f8b)\u3002ORSERDU \u7684\u6700\u5e38\u898b\u4e0d\u826f\u53cd\u61c9 (&gt;10%) \uff0c\u5305\u62ec\u5be6\u9a57\u5ba4\u6aa2\u6e2c\u7d50\u679c\u7570\u5e38\uff0c\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (41%) \u3001\u5641\u5fc3 (35%) \u3001\u81bd\u56fa\u9187\u589e\u9ad8 (30%) \u3001\u8c37\u8349\u8f49\u6c28\u9176 (AST) \u589e\u9ad8 (29%) \u3001\u4e09\u9178\u7518\u6cb9\u8102\u589e\u9ad8 (27%) \u3001\u75b2\u52de (26%) \u3001\u8840\u7d05\u86cb\u767d\u964d\u4f4e (26%) \u3001\u5614\u5410 (19%) \u3001\u7a40\u4e19\u8f49\u6c28\u9176 (ALT) \u6c34\u5e73\u589e\u9ad8 (17%) \u3001\u9209\u964d\u4f4e (16%) \u3001\u808c\u9178\u9150\u589e\u9ad8 (16%) \u3001\u98df\u617e\u964d\u4f4e (15%) \u3001\u8179\u7009 (13%) \u3001\u982d\u75db (12%) \u3001\u4fbf\u79d8 (12%) \u3001\u8179\u75db (11%) \u3001\u6f6e\u7d05 (11%) \u548c\u6d88\u5316\u4e0d\u826f (10%)\u3002 \u85e5\u7269\u76f8\u4e92\u4f5c\u7528\u00a0 \u8207 CYP3A4 \u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a\u00a0\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u6291\u5236\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u8a98\u5c0e\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002 \u4f7f\u7528\u65bc\u7279\u5b9a\u4eba\u7fa4\u7684\u6ce8\u610f\u4e8b\u9805 \u54fa\u4e73\u671f\uff1a\u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u5230\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4e0d\u8981\u54fa\u4e73\u3002\u809d\u529f\u80fd\u53d7\u640d\uff1a\u907f\u514d\u5c0d\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C) \u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002\u4e2d\u5ea6\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh B) \u7684\u60a3\u8005\u8981\u6e1b\u5c11 ORSERDU \u7684\u5291\u91cf\u3002 ORSERDU \u5728\u5152\u79d1\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u5b9a\u3002 \u82e5\u8981\u5831\u544a\u53ef\u7591\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61 Stemline Therapeutics, Inc.\uff0c\u96fb\u8a71\u865f\u78bc\u70ba 1-877-332-7961\uff0c\u6216\u8005\u81f4\u96fb 1-800-FDA-1088 \u806f\u7d61 FDA\uff0c\u6216\u700f\u89bd\u00a0www.fda.gov\/medwatch\u3002 \u95dc\u65bc Elacestrant \u81e8\u5e8a\u958b\u767c\u8a08\u5283\u00a0Elacestrant \u9084\u5728\u6578\u500b\u8f49\u79fb\u6027\u4e73\u764c\u75be\u75c5\u7684\u81e8\u5e8a\u8a66\u9a57\u4e2d\u9032\u884c\u7814\u7a76\uff0c\u55ae\u7368\u6216\u662f\u7d50\u5408\u5176\u4ed6\u7642\u6cd5\uff1aELEVATE\uff08NCT05563220\uff09\u662f\u4e00\u9805\u7b2c 1b\/2 \u671f\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c07\u8a55\u4f30 elacestrant \u5408\u4f75\u4f7f\u7528 alpelisib\u3001everolimus\u3001palbociclib\u3001abemaciclib \u548c ribociclib \u7642\u6cd5\u7684\u5b89\u5168\u6027\u548c\u7642\u6548\u3002ELECTRA\uff08NCT05386108\uff09\u662f\u4e00\u9805 1b\/2 \u671f\u958b\u653e\u6a19\u7c64\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u806f\u5408 abemaciclib \u6cbb\u7642 ER+\u3001HER2- \u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u7b2c 2 \u671f\u7814\u7a76\u8a55\u4f30\u6b64\u6cbb\u7642\u65b9\u6848\u5728\u8166\u8f49\u79fb\u60a3\u8005\u4e2d\u7684\u61c9\u7528\u3002 ELCIN\uff08NCT05596409\uff09\u662f\u4e00\u9805\u7b2c 2 \u671f\u8a66\u9a57\uff0c\u8a55\u4f30 elacestrant \u5c0d\u96cc\u6fc0\u7d20\u53d7\u9ad4\u967d\u6027 (ER+)\/\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4-2 \u9670\u6027\uff08HER2-\uff09\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005 (mBC) \u7684\u7642\u6548\uff0c\u9019\u4e9b\u60a3\u8005\u5148\u524d\u63a5\u53d7\u904e 1 \u6b21\u6216 2 \u6b21\u8377\u723e\u8499\u7642\u6cd5\uff0c\u4e14\u5148\u524d\u672a\u4f7f\u7528\u904e\u7d30\u80de\u9031\u671f\u86cb\u767d\u4f9d\u8cf4\u6027\u6fc0\u9176\u6a19\u9776\u9176 CDK4 \u548c CDK6 \u6291\u5236\u5291\uff08CDK4\/6i\uff09\u3002Elacestrant \u4e5f\u5c07\u65bc\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002\u00a0 Menarini Group \u7c21\u4ecb\u00a0Menarini Group \u662f\u4e00\u5bb6\u9818\u5148\u696d\u754c\u7684\u570b\u969b\u88fd\u85e5\u548c\u8a3a\u7642\u516c\u53f8\uff0c\u5e74\u71df\u696d\u984d\u8d85\u904e 44 \u5104\u7f8e\u5143\uff0c\u54e1\u5de5\u8d85\u904e 17,000 \u4eba\u3002Menarini \u5c08\u6ce8\u65bc\u6cbb\u7642\u9700\u6c42\u9ad8\u5ea6\u672a\u6eff\u8db3\u7684\u9818\u57df\uff0c\u5176\u7522\u54c1\u6db5\u84cb\u5fc3\u81df\u75c5\u5b78\u3001\u816b\u7624\u5b78\u3001\u547c\u5438\u75c5\u5b78\u3001\u80c3\u8178\u75c5\u5b78\u3001\u50b3\u67d3\u75c5\u5b78\u3001\u7cd6\u5c3f\u75c5\u5b78\u3001\u708e\u75c7\u548c\u93ae\u75db\u7b49\u9818\u57df\u3002Menarini \u64c1\u6709 18 \u500b\u751f\u7522\u57fa\u5730\u548c 9 \u500b\u7814\u767c\u4e2d\u5fc3\uff0c\u7522\u54c1\u92b7\u5f80\u5168\u7403 140 \u500b\u570b\u5bb6\/\u5730\u5340\u3002\u00a0\u6b32\u4e86\u89e3\u66f4\u591a\u76f8\u95dc\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd\u00a0www.menarini.com\u3002 Stemline Therapeutics Inc. \u7c21\u4ecbStemline Therapeutics, Inc. (\u300cStemline\u300d) \u662f Menarini Group \u7684\u5168\u8cc7\u5b50\u516c\u53f8\uff0c\u662f\u4e00\u5bb6\u5546\u696d\u5316\u968e\u6bb5\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u65b0\u578b\u816b\u7624\u5b78\u6cbb\u7642\u85e5\u7269\u7684\u958b\u767c\u548c\u5546\u696d\u5316\u3002Stemline \u5c07\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u5546\u696d\u5316 ORSERDU\u00ae (elacestrant) \uff0c\u9019\u662f\u4e00\u7a2e\u53e3\u670d\u5167\u5206\u6ccc\u6cbb\u7642\u85e5\u7269\uff0c\u9069\u7528\u65bc\u60a3\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\uff0c\u4e14\u5728\u63a5\u53d7\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u3002Stemline \u9084\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u63a8\u51fa\u4e86 ELZONRIS\u00ae (tagraxofusp-erzs) \uff0c\u9019\u662f\u4e00\u7a2e\u91dd\u5c0d CD123 \u7684\u5275\u65b0\u6a19\u9776\u6cbb\u7642\uff0c\u7528\u65bc\u6cbb\u7642\u7206\u767c\u6027\u6f3f\u7d30\u80de\u6a39\u7a81\u7d30\u80de\u816b\u7624 (BPDCN)\uff08\u4e00\u7a2e\u4fb5\u8972\u6027\u8840\u6db2\u764c\u75c7\uff09\u60a3\u8005\uff0c\u4e5f\u662f\u7f8e\u570b\u548c\u6b50\u76df\u8fc4\u4eca\u552f\u4e00\u7372\u6279\u7684 BPDCN \u6cbb\u7642\u65b9\u6848\u3002Stemline \u4ea6\u5c07\u5728\u6b50\u6d32\u5546\u696d\u5316 NEXPOVIO\u00ae (selinexor) \uff0c\u4e00\u7a2e\u7528\u65bc\u6cbb\u7642\u591a\u767c\u6027\u9aa8\u9ad3\u7624\u7684 XPO1 \u6291\u5236\u5291\u3002\u00a0\u6b64\u5916\uff0cStemline \u9084\u64c1\u6709\u5ee3\u6cdb\u7684\u5c0f\u5206\u5b50\u548c\u751f\u7269\u88fd\u5291\u81e8\u5e8a\u7522\u54c1\u7ba1\u9053\uff0c\u9019\u4e9b\u7522\u54c1\u8655\u65bc\u4e0d\u540c\u7684\u958b\u767c\u968e\u6bb5\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u591a\u7a2e\u5be6\u9ad4\u764c\u548c\u8840\u764c\u3002\u00a0  Bardia \u7b49\u4eba EMERALD \u7684 elacestrant 3 \u671f\u8a66\u9a57\u5c0d\u6bd4\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\/HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u6548\u679c\uff1a\u00a0\u5728\u764c\u75c7\u75c5\u7076\u8f49\u79fb\u7684\u60c5\u6cc1\u4e0b\uff0c\u65e2\u5f80 CDK4\/6i \u6301\u7e8c\u6642\u9577\u7684\u7d50\u679c\u66f4\u65b0\u3002 SABCS 2022\u3002GS3-01\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pingtungtimes.com.tw\/?p=204040\" \/>\n<meta property=\"og:site_name\" content=\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/pingtungnews\" \/>\n<meta property=\"article:published_time\" content=\"2023-12-11T01:52:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/12\/Menarini_Industrie_Farmaceutiche_Riunite_Logo.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"400\" \/>\n\t<meta property=\"og:image:height\" content=\"121\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"\u7f8e\u901a\u793e\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005:\" \/>\n\t<meta name=\"twitter:data1\" content=\"\u7f8e\u901a\u793e\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9810\u4f30\u95b1\u8b80\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 \u5206\u9418\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"NewsArticle\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=204040#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=204040\"},\"author\":{\"name\":\"\u7f8e\u901a\u793e\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/person\\\/683b937f29ec1537972f6c41e22a2cf3\"},\"headline\":\"Menarini Group \u65bc SABCS 2023 \u4e0a\u767c\u4f48 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\u65bc SABCS 2023 \u4e0a\u767c\u4f48 ORSERDU\u00ae (Elacestrant) \u5728\u6cbb\u7642 ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\u81e8\u5e8a\u76f8\u95dc\u4e9e\u7d44\u65b9\u9762 EMERALD \u81e8\u5e8a\u7814\u7a76\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u7684\u65b0\u6578\u64da - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=204040#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=204040#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/12\\\/Menarini_Industrie_Farmaceutiche_Riunite_Logo.jpg\",\"datePublished\":\"2023-12-11T01:52:00+00:00\",\"description\":\"EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u7684\u65b0\u4e8b\u4ef6\u5f8c\u5206\u6790\u8a55\u4f30\u3001 elacestrant \u5728\u5167\u5206\u6ccc\u654f\u611f\u65cf\u7fa4\uff08CDK4\\\/6 \u6291\u5236\u5291\u7642\u7a0b\u81f3\u5c11 12 \u500b\u6708\uff09\u4e2d\u7684\u61c9\u7528\u60c5\u6cc1\uff0c\u9019\u4e9b\u65cf\u7fa4\u6240\u60a3\u7684\u816b\u7624\u5747\u5e36\u6709 ESR1 \u7a81\u8b8a\u3002\u00a0 \u8a72\u5206\u6790\u986f\u793a\uff0c\u5728\u53c3\u8207\u7814\u7a76\u7684\u5404\u4e9e\u7d44\u4e2d\uff0c\u5305\u62ec\u9aa8\u3001\u809d\u53ca\\\/\u6216\u80ba\u8f49\u79fb\u60a3\u8005\u3001\u4f34\u6709\u5e38\u898b\u7a81\u8b8a\uff08\u5982 PIK3CA \u548c TP53\uff09\u7684\u60a3\u8005\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u60a3\u8005\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u90fd\u6709\u5177\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002\u00a0 \u4e0a\u8ff0\u7d50\u679c\u986f\u793a\uff0c\u7576 ESR1 \u7a81\u8b8a\u7684\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\u3002\u00a0 \u610f\u5927\u5229\u4f5b\u7f85\u502b\u65af\u548c\u7d10\u7d042023\u5e7412\u670811\u65e5 \\\/\u7f8e\u901a\u793e\\\/ -- \u570b\u969b\u9818\u5148\u7684\u88fd\u85e5\u548c\u8a3a\u65b7\u516c\u53f8 Menarini Group\uff08\u300cMenarini\u300d\uff09\u8207\u5176\u81f4\u529b\u65bc\u70ba\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u8f49\u5316\u816b\u7624\u6cbb\u7642\u7684\u5168\u8cc7\u5b50\u516c\u53f8 Stemline Therapeutics, Inc. (\u300cStemline\u300d\uff09\u4eca\u5929\u516c\u4f48\u4e86\u91dd\u5c0d\u95dc\u9375 EMERALD \u81e8\u5e8a\u7814\u7a76\u958b\u5c55\u7684\u4e00\u9805\u65b0\u7684\u4e8b\u5f8c\u5206\u6790\u7d50\u679c\uff0c\u7d50\u679c\u8868\u660e\uff0c\u5728\u6240\u6709\u76f8\u95dc\u4e9e\u7d44\u4e2d\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u90fd\u5f97\u5230\u4e86\u5177\u6709\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002 \u6578\u64da\u986f\u793a\uff0c\u91dd\u5c0d\u5185\u5206\u6ccc\u654f\u611f\u4e14\u643a\u5e36\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\uff0c\u5982\u679c\u5148\u524d\u4f7f\u7528 CDK4\\\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\uff0c\u5247 ORSERDU\u00ae (elacestrant) \u55ae\u85e5\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u512a\u65bc\u6a19\u6e96\u6cbb\u7642 (SOC)\u3002 \u9019\u4e9b\u6578\u64da\u5c07\u5728 2023 \u5e74 12 \u6708 5 \u65e5\u81f3 12 \u6708 9 \u65e5\u8209\u884c\u7684 2023 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u764c\u7814\u8a0e\u6703 (SABCS) \u4e2d\u516c\u4f48\u3002\u00a0 EMERALD \u662f\u4e00\u9805\u7b2c 3 \u671f\u8a3b\u518a\u8a66\u9a57\uff0c\u8868\u660e\u8207\u6a19\u6e96\u6cbb\u7642\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\uff08\u6c1f\u7dad\u53f8\u7fa4\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766\uff09\u76f8\u6bd4\uff0cORSERDU \u6cbb\u7642\u5177\u6709\u5728\u7d71\u8a08\u5b78\u4e0a\u66f4\u52a0\u986f\u8457\u7684 PFS\u3002\u6839\u64da\u4e0a\u8ff0\u7d50\u679c\uff0cFDA \u65bc 2023 \u5e74 1 \u6708 27 \u65e5\u6838\u51c6 ORSERDU \u7528\u65bc\u6cbb\u7642\u60a3\u6709 ER+\u3001HER2-\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\uff0c\u4e14\u9019\u4e9b\u60a3\u8005\u9700\u5728\u81f3\u5c11\u4e00\u7a2e\u5167\u5206\u6ccc\u7642\u6cd5\u5f8c\u75be\u75c5\u51fa\u73fe\u60e1\u5316\u3002\u9ad8\u9054 40% \u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u5b58\u5728 ESR1 \u7a81\u8b8a\u3002\u00a0\u9019\u7a2e\u7a81\u8b8a\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u51fa\u73fe\u6297\u85e5\u6027\u7684\u5df2\u77e5\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u4e14\u5230\u76ee\u524d\u70ba\u6b62\uff0c\u5177\u6709\u9019\u985e\u7a81\u8b8a\u7684\u816b\u7624\u6cbb\u7642\u96e3\u5ea6\u66f4\u5927\u3002 \u00a0 \u91cd\u9ede\u662f\uff0c\u5728 2022 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u817a\u764c\u7814\u8a0e\u6703 (SABCS) \u4e0a\u958b\u5c55\u95dc\u65bc EMERALD PFS \u7d50\u679c\u4e9e\u7d44\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\\\/6 \u6291\u5236\u5291\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 ORSERDU \u5f8c\u7684 PFS \u5ef6\u9577\u5448\u6b63\u9762\u76f8\u95dc\u59d3\uff0c\u4f46\u5728\u6a19\u6e96\u6cbb\u7642 (SOC) \u4e0a\u4e26\u7121\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD \u96a8\u6a5f\u5206\u7d44\u524d\u63a5\u53d7 CDK4\\\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u00a0ESR1 \u7a81\u8b8a\u60a3\u8005\uff0c\u63a1\u7528 ORSERDU \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 8.6 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u51fa\u73fe\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e 59% (\u98a8\u96aa\u6bd4\u7387 (HR)=0.41 95% \u7f6e\u4fe1\u5340\u9593: 0.26-0.63)\u3002 \u5728\u9019\u9805\u66f4\u65b0\u5f8c\u7684\u5206\u6790\u4e2d\uff0cMenarini Stemline \u8a55\u4f30\u55ae\u85e5 ORSERDU \u70ba\u9ad8\u767c\u81e8\u5e8a\u548c\u95dc\u9375\u751f\u7269\u6a19\u8a18\u4e9e\u7d44\u5e36\u4f86\u7684\u76ca\u8655\uff0c\u5305\u62ec\u60a3\u6709\u9aa8\u3001\u809d\u548c\\\/\u6216\u80ba\u8f49\u79fb\u7684\u60a3\u8005\uff1b\u6709\u5e38\u898b\u4f75\u767c PIK3CA \u6216 TP53 \u7a81\u8b8a\u7684\u60a3\u8005\uff1b\u6216 HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u00a0 \u300c\u9019\u4e9b\u6700\u65b0\u7814\u7a76\u7d50\u679c\u9032\u4e00\u6b65\u8b49\u5be6\uff0c\u5c0d\u65bc\u816b\u7624\u651c\u5e36\u00a0ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u4f86\u8aaa\uff0cORSERDU \u55ae\u85e5\u6cbb\u7642\u662f\u4e00\u7a2e\u5f88\u6709\u524d\u666f\u7684\u4e8c\u7dda\u6cbb\u7642\u9078\u64c7\uff0c\u300dUT Health San Antonio \u548c MD Anderson \u764c\u75c7\u4e2d\u5fc3\u4e73\u623f\u816b\u7624\u5c08\u5bb6\u3001\u91ab\u5b78\u6559\u6388\u3001\u91ab\u5b78\u535a\u58eb\u3001\u00a0\u79d1\u5b78\u535a\u58ebVirginia Kaklamani \u8aaa\uff0c\u300c\u6211\u5011\u767c\u73fe\uff0c\u5c0d\u65bc\u5148\u524d\u63a5\u53d7 CDK 4\\\/6 \u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u60a3\u8005\uff0c\u4f7f\u7528 elacestrant \u55ae\u85e5\u6cbb\u7642\u8207\u6a19\u6e96\u6cbb\u7642\u76f8\u6bd4\uff0c\u5728\u8a31\u591a\u91cd\u8981\u4e9e\u7d44\u7684\u75be\u75c5\u7121\u60e1\u5316\u751f\u5b58\u671f\u65b9\u9762\u90fd\u6709\u6301\u7e8c\u6539\u5584\u3002\u00a0\u6211\u5011\u89c0\u5bdf\u5230\u7684\u9019\u4e9b\u7d50\u679c\u4e0d\u50c5\u9069\u7528\u65bc\u9aa8\u8f49\u79fb\u60a3\u8005\uff0c\u540c\u6a23\u9069\u7528\u65bc\u809d\u81df\u548c\\\/\u6216\u80ba\u90e8\u8f49\u79fb\u60a3\u8005\uff0c\u4e5f\u9069\u7528\u65bc PIK3CA \u548c TP53 \u7b49\u5e38\u898b\u5171\u7a81\u8b8a\u60a3\u8005\uff0c\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u300d\u00a0 \u8207 SOC \u5167\u5206\u6ccc\u55ae\u85e5\u6cbb\u7642 (\u6cd5\u6d1b\u5fb7\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766) \u76f8\u6bd4\uff0cORSERDU \u5728\u9019\u4e9b\u4e9e\u7d44\u4e2d\u986f\u793a\u51fa\u6709\u81e8\u5e8a\u610f\u7fa9\u7684 PFS \u6539\u5584\u3002\u7576\u5148\u524d CDK4\\\/6 \u6291\u5236\u5291\u6cbb\u7642\u6642\u9593\u81f3\u5c11\u70ba 12 \u500b\u6708\u6642\uff0cORSERDU \u7684 PFS \u660e\u986f\u66f4\u9577\uff0c\u9019\u8868\u660e\u7576 ESR1 \u7a81\u8b8a\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u8207\u8f49\u79fb\u90e8\u4f4d\u3001\u00a0\u4f34\u96a8\u7684 PIK3CA \u6216 TP53 \u7a81\u8b8a\u6216 HER2 \u4f4e\u8868\u9054\u5747\u7121\u95dc\u3002\u8acb\u65bc\u6b64\u8655\u67e5\u770b\u5b8c\u6574\u6458\u8981\u3002 Menarini Group \u884c\u653f\u7e3d\u88c1 Elcin Barker Ergun \u8868\u793a\uff1a\u300c\u9019\u4e9b\u5728 SABCS 2023 \u5927\u6703\u4e0a\u516c\u4f48\u7684\u6578\u64da\u5efa\u7acb\u5728\u6211\u5011\u5c0d\u65bc ORSERDU \u53ca\u5176\u4f5c\u70ba\u91dd\u5c0d\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684\u55ae\u85e5\u7642\u6cd5\u6f5b\u529b\u7684\u8a8d\u77e5\u57fa\u790e\u4e4b\u4e0a\u3002\u300d\u00a0\u4ed6\u88dc\u5145\u9053\uff1a\u300cMenarini Stemline \u7684\u76ee\u6a19\u662f\u63d0\u4f9b\u8b8a\u9769\u6027\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u5e6b\u52a9\u5ef6\u9577\u548c\u6539\u5584\u764c\u75c7\u60a3\u8005\u7684\u751f\u547d\u3002\u00a0\u6211\u5011\u5f88\u81ea\u8c6a\u80fd\u70ba\u773e\u591a\u5408\u9069\u7684\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u63d0\u4f9b\u4e00\u7a2e\u6025\u9700\u7684\u5167\u5206\u6ccc\u6cbb\u7642\u9078\u64c7\uff0c\u800c\u4e14\u9019\u7a2e\u9078\u64c7\u7684\u5b89\u5168\u6027\u4e5f\u662f\u53ef\u63a7\u7684\u3002\u300d\u00a0 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u808c\u9aa8\u75db\u3001\u5641\u5fc3\uff0c\u4e09\u9178\u7518\u6cb9\u916f\u5347\u9ad8\uff0c\u81bd\u56fa\u9187\u5347\u9ad8\uff0c\u5614\u5410\uff0c\u75b2\u52de\uff0c\u6d88\u5316\u4e0d\u826f\uff0c\u8179\u7009\uff0c\u9223\u964d\u4f4e\uff0c\u80cc\u75db\uff0c\u808c\u9178\u9150\u5347\u9ad8\uff0c\u95dc\u7bc0\u75db\uff0c\u9209\u964d\u4f4e\uff0c\u4fbf\u79d8\uff0c\u982d\u75db\uff0c\u6f6e\u71b1\uff0c\u8179\u75db\uff0c\u8ca7\u8840\uff0c\u9240\u964d\u4f4e\u548c\u4e19\u6c28\u9178\u8f49\u6c28\u9176\u5347\u9ad8\u3002 ORSERDU \u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002\u00a0 \u8acb\u65bc\u6b64\u8655\u67e5\u95b1\u6709\u95dc Menarini Group \\\/Stemline Therapeutics \u5728 SABCS 2023 \u4e0a\u7684\u5168\u7cfb\u5217\u4ecb\u7d39\u986f\u793a\u7684\u8a73\u7d30\u8cc7\u8a0a\u3002 EMERALD \u7b2c 3 \u671f\u7814\u7a76 (NCT03778931) \u7c21\u4ecb\u00a0EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u662f\u4e00\u9805\u96a8\u6a5f\u3001\u958b\u653e\u5f0f\u3001\u4e3b\u52d5\u5c0d\u7167\u7684\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2- \u665a\u671f\\\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u00a0\u8a72\u7814\u7a76\u62db\u52df 478 \u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5 (\u5305\u62ec CDK4\\\/6 \u6291\u5236\u5291) \u7684\u60a3\u8005\u3002\u00a0\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7\u00a0elacestrant \u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u8a72\u7814\u7a76\u7684\u4e3b\u8981\u81e8\u5e8a\u7d42\u9ede\u662f\u8a55\u91cf\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u548c\u96cc\u6fc0\u7d20\u53d7\u9ad4 1 \u57fa\u56e0 (ESR1) \u7a81\u8b8a\u60a3\u8005\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS)\u3002\u00a0\u5728\u816b\u7624\u5177\u6709\u00a0ESR1 \u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 3.8 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS \u98a8\u96aa\u6bd4\u7387 (HR)=0.55, 95% \u7f6e\u4fe1\u5340\u9593: 0.39, 0.77)\u3002 ORSERDU (elacestrant) \u7c21\u4ecb\u00a0\u7f8e\u570b\u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \uff0c\u6bcf\u9320 345 \u6beb\u514b\uff0c\u9069\u7528\u65bc\u6cbb\u7642\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u81f3\u5c11\u63a5\u53d7\u904e\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75be\u75c5\u6709\u60e1\u5316\u9032\u5c55\u7684\u60a3\u8005\u3002 \u6b32\u4e86\u89e3\u7f8e\u570b\u7684\u5b8c\u6574\u8655\u65b9\u8cc7\u8a0a\u53ef\u4ee5\u700f\u89bd\u00a0www.orserdu.com\u3002 \u91cd\u8981\u5b89\u5168\u8cc7\u8a0a \u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9805 \u8840\u8102\u7570\u5e38\uff1a\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c30% \u51fa\u73fe\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\uff0c27% \u51fa\u73fe\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u30023 \u7d1a\u548c 4 \u7d1a\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\u548c\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u7684\u767c\u751f\u7387\u5206\u5225\u70ba 0.9% \u548c 2.2%\u3002\u5728\u958b\u59cb ORSERDU \u6cbb\u7642\u524d\u4ee5\u53ca\u6cbb\u7642\u671f\u9593\u9808\u5b9a\u671f\u76e3\u6e2c\u8840\u8102\u60c5\u6cc1\u3002 \u80da\u80ce-\u80ce\u5152\u6bd2\u6027\uff1a\u6839\u64da\u52d5\u7269\u7814\u7a76\u4e2d\u7684\u767c\u73fe\u53ca\u5176\u4f5c\u7528\u6a5f\u5236\uff0c\u5411\u5b55\u5a66\u8655\u65b9 ORSERDU \u7d66\u85e5\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u00a0\u8acb\u5411\u5b55\u5a66\u548c\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u544a\u77e5\u53ef\u80fd\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u7684\u98a8\u96aa\u3002\u00a0\u5efa\u8b70\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u670d\u7528\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002\u5c0d\u65bc\u64c1\u6709\u5177\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u4f34\u4fb6\u7684\u7537\u6027\u60a3\u8005\uff0c\u5efa\u8b70\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\uff0c\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002 \u4e0d\u826f\u53cd\u61c9 \u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c12% \u7684\u60a3\u8005\u51fa\u73fe\u56b4\u91cd\u7684\u4e0d\u826f\u53cd\u61c9\u3002\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c\u767c\u751f\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u7684\u60a3\u8005\u6bd4\u4f8b\u8d85\u904e 1%\uff0c\u9019\u4e9b\u53cd\u61c9\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (1.7%) \u548c\u5641\u5fc3 (1.3%)\u30021.7% \u7684\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u51fa\u73fe\u4e86\u81f4\u547d\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u5305\u62ec\u5fc3\u81df\u9a5f\u505c\u3001\u6557\u8840\u6027\u4f11\u514b\u3001\u61a9\u5ba4\u708e\uff0c\u4ee5\u53ca\u539f\u56e0\u672a\u660e\u7684\u75c5\u75c7(\u5404\u4e00\u4f8b)\u3002ORSERDU \u7684\u6700\u5e38\u898b\u4e0d\u826f\u53cd\u61c9 (&gt;10%) \uff0c\u5305\u62ec\u5be6\u9a57\u5ba4\u6aa2\u6e2c\u7d50\u679c\u7570\u5e38\uff0c\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (41%) \u3001\u5641\u5fc3 (35%) \u3001\u81bd\u56fa\u9187\u589e\u9ad8 (30%) \u3001\u8c37\u8349\u8f49\u6c28\u9176 (AST) \u589e\u9ad8 (29%) \u3001\u4e09\u9178\u7518\u6cb9\u8102\u589e\u9ad8 (27%) \u3001\u75b2\u52de (26%) \u3001\u8840\u7d05\u86cb\u767d\u964d\u4f4e (26%) \u3001\u5614\u5410 (19%) \u3001\u7a40\u4e19\u8f49\u6c28\u9176 (ALT) \u6c34\u5e73\u589e\u9ad8 (17%) \u3001\u9209\u964d\u4f4e (16%) \u3001\u808c\u9178\u9150\u589e\u9ad8 (16%) \u3001\u98df\u617e\u964d\u4f4e (15%) \u3001\u8179\u7009 (13%) \u3001\u982d\u75db (12%) \u3001\u4fbf\u79d8 (12%) \u3001\u8179\u75db (11%) \u3001\u6f6e\u7d05 (11%) \u548c\u6d88\u5316\u4e0d\u826f (10%)\u3002 \u85e5\u7269\u76f8\u4e92\u4f5c\u7528\u00a0 \u8207 CYP3A4 \u8a98\u5c0e\u5291\u53ca\\\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a\u00a0\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u6291\u5236\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u8a98\u5c0e\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002 \u4f7f\u7528\u65bc\u7279\u5b9a\u4eba\u7fa4\u7684\u6ce8\u610f\u4e8b\u9805 \u54fa\u4e73\u671f\uff1a\u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u5230\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4e0d\u8981\u54fa\u4e73\u3002\u809d\u529f\u80fd\u53d7\u640d\uff1a\u907f\u514d\u5c0d\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C) \u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002\u4e2d\u5ea6\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh B) \u7684\u60a3\u8005\u8981\u6e1b\u5c11 ORSERDU \u7684\u5291\u91cf\u3002 ORSERDU \u5728\u5152\u79d1\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u5b9a\u3002 \u82e5\u8981\u5831\u544a\u53ef\u7591\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61 Stemline Therapeutics, Inc.\uff0c\u96fb\u8a71\u865f\u78bc\u70ba 1-877-332-7961\uff0c\u6216\u8005\u81f4\u96fb 1-800-FDA-1088 \u806f\u7d61 FDA\uff0c\u6216\u700f\u89bd\u00a0www.fda.gov\\\/medwatch\u3002 \u95dc\u65bc Elacestrant \u81e8\u5e8a\u958b\u767c\u8a08\u5283\u00a0Elacestrant \u9084\u5728\u6578\u500b\u8f49\u79fb\u6027\u4e73\u764c\u75be\u75c5\u7684\u81e8\u5e8a\u8a66\u9a57\u4e2d\u9032\u884c\u7814\u7a76\uff0c\u55ae\u7368\u6216\u662f\u7d50\u5408\u5176\u4ed6\u7642\u6cd5\uff1aELEVATE\uff08NCT05563220\uff09\u662f\u4e00\u9805\u7b2c 1b\\\/2 \u671f\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c07\u8a55\u4f30 elacestrant \u5408\u4f75\u4f7f\u7528 alpelisib\u3001everolimus\u3001palbociclib\u3001abemaciclib \u548c ribociclib \u7642\u6cd5\u7684\u5b89\u5168\u6027\u548c\u7642\u6548\u3002ELECTRA\uff08NCT05386108\uff09\u662f\u4e00\u9805 1b\\\/2 \u671f\u958b\u653e\u6a19\u7c64\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u806f\u5408 abemaciclib \u6cbb\u7642 ER+\u3001HER2- \u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u7b2c 2 \u671f\u7814\u7a76\u8a55\u4f30\u6b64\u6cbb\u7642\u65b9\u6848\u5728\u8166\u8f49\u79fb\u60a3\u8005\u4e2d\u7684\u61c9\u7528\u3002 ELCIN\uff08NCT05596409\uff09\u662f\u4e00\u9805\u7b2c 2 \u671f\u8a66\u9a57\uff0c\u8a55\u4f30 elacestrant \u5c0d\u96cc\u6fc0\u7d20\u53d7\u9ad4\u967d\u6027 (ER+)\\\/\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4-2 \u9670\u6027\uff08HER2-\uff09\u665a\u671f\\\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005 (mBC) \u7684\u7642\u6548\uff0c\u9019\u4e9b\u60a3\u8005\u5148\u524d\u63a5\u53d7\u904e 1 \u6b21\u6216 2 \u6b21\u8377\u723e\u8499\u7642\u6cd5\uff0c\u4e14\u5148\u524d\u672a\u4f7f\u7528\u904e\u7d30\u80de\u9031\u671f\u86cb\u767d\u4f9d\u8cf4\u6027\u6fc0\u9176\u6a19\u9776\u9176 CDK4 \u548c CDK6 \u6291\u5236\u5291\uff08CDK4\\\/6i\uff09\u3002Elacestrant \u4e5f\u5c07\u65bc\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002\u00a0 Menarini Group \u7c21\u4ecb\u00a0Menarini Group 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(\u300cStemline\u300d) \u662f Menarini Group \u7684\u5168\u8cc7\u5b50\u516c\u53f8\uff0c\u662f\u4e00\u5bb6\u5546\u696d\u5316\u968e\u6bb5\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u65b0\u578b\u816b\u7624\u5b78\u6cbb\u7642\u85e5\u7269\u7684\u958b\u767c\u548c\u5546\u696d\u5316\u3002Stemline \u5c07\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u5546\u696d\u5316 ORSERDU\u00ae (elacestrant) \uff0c\u9019\u662f\u4e00\u7a2e\u53e3\u670d\u5167\u5206\u6ccc\u6cbb\u7642\u85e5\u7269\uff0c\u9069\u7528\u65bc\u60a3\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\uff0c\u4e14\u5728\u63a5\u53d7\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u3002Stemline \u9084\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u63a8\u51fa\u4e86 ELZONRIS\u00ae 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\u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u5b58\u5728 ESR1 \u7a81\u8b8a\u3002\u00a0\u9019\u7a2e\u7a81\u8b8a\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u51fa\u73fe\u6297\u85e5\u6027\u7684\u5df2\u77e5\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u4e14\u5230\u76ee\u524d\u70ba\u6b62\uff0c\u5177\u6709\u9019\u985e\u7a81\u8b8a\u7684\u816b\u7624\u6cbb\u7642\u96e3\u5ea6\u66f4\u5927\u3002 \u00a0 \u91cd\u9ede\u662f\uff0c\u5728 2022 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u817a\u764c\u7814\u8a0e\u6703 (SABCS) \u4e0a\u958b\u5c55\u95dc\u65bc EMERALD PFS \u7d50\u679c\u4e9e\u7d44\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 ORSERDU \u5f8c\u7684 PFS \u5ef6\u9577\u5448\u6b63\u9762\u76f8\u95dc\u59d3\uff0c\u4f46\u5728\u6a19\u6e96\u6cbb\u7642 (SOC) \u4e0a\u4e26\u7121\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD \u96a8\u6a5f\u5206\u7d44\u524d\u63a5\u53d7 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u00a0ESR1 \u7a81\u8b8a\u60a3\u8005\uff0c\u63a1\u7528 ORSERDU \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 8.6 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u51fa\u73fe\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e 59% (\u98a8\u96aa\u6bd4\u7387 (HR)=0.41 95% \u7f6e\u4fe1\u5340\u9593: 0.26-0.63)\u3002 \u5728\u9019\u9805\u66f4\u65b0\u5f8c\u7684\u5206\u6790\u4e2d\uff0cMenarini Stemline \u8a55\u4f30\u55ae\u85e5 ORSERDU \u70ba\u9ad8\u767c\u81e8\u5e8a\u548c\u95dc\u9375\u751f\u7269\u6a19\u8a18\u4e9e\u7d44\u5e36\u4f86\u7684\u76ca\u8655\uff0c\u5305\u62ec\u60a3\u6709\u9aa8\u3001\u809d\u548c\/\u6216\u80ba\u8f49\u79fb\u7684\u60a3\u8005\uff1b\u6709\u5e38\u898b\u4f75\u767c PIK3CA \u6216 TP53 \u7a81\u8b8a\u7684\u60a3\u8005\uff1b\u6216 HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u00a0 \u300c\u9019\u4e9b\u6700\u65b0\u7814\u7a76\u7d50\u679c\u9032\u4e00\u6b65\u8b49\u5be6\uff0c\u5c0d\u65bc\u816b\u7624\u651c\u5e36\u00a0ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u4f86\u8aaa\uff0cORSERDU \u55ae\u85e5\u6cbb\u7642\u662f\u4e00\u7a2e\u5f88\u6709\u524d\u666f\u7684\u4e8c\u7dda\u6cbb\u7642\u9078\u64c7\uff0c\u300dUT Health San Antonio \u548c MD Anderson \u764c\u75c7\u4e2d\u5fc3\u4e73\u623f\u816b\u7624\u5c08\u5bb6\u3001\u91ab\u5b78\u6559\u6388\u3001\u91ab\u5b78\u535a\u58eb\u3001\u00a0\u79d1\u5b78\u535a\u58ebVirginia Kaklamani \u8aaa\uff0c\u300c\u6211\u5011\u767c\u73fe\uff0c\u5c0d\u65bc\u5148\u524d\u63a5\u53d7 CDK 4\/6 \u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u60a3\u8005\uff0c\u4f7f\u7528 elacestrant \u55ae\u85e5\u6cbb\u7642\u8207\u6a19\u6e96\u6cbb\u7642\u76f8\u6bd4\uff0c\u5728\u8a31\u591a\u91cd\u8981\u4e9e\u7d44\u7684\u75be\u75c5\u7121\u60e1\u5316\u751f\u5b58\u671f\u65b9\u9762\u90fd\u6709\u6301\u7e8c\u6539\u5584\u3002\u00a0\u6211\u5011\u89c0\u5bdf\u5230\u7684\u9019\u4e9b\u7d50\u679c\u4e0d\u50c5\u9069\u7528\u65bc\u9aa8\u8f49\u79fb\u60a3\u8005\uff0c\u540c\u6a23\u9069\u7528\u65bc\u809d\u81df\u548c\/\u6216\u80ba\u90e8\u8f49\u79fb\u60a3\u8005\uff0c\u4e5f\u9069\u7528\u65bc PIK3CA \u548c TP53 \u7b49\u5e38\u898b\u5171\u7a81\u8b8a\u60a3\u8005\uff0c\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u300d\u00a0 \u8207 SOC \u5167\u5206\u6ccc\u55ae\u85e5\u6cbb\u7642 (\u6cd5\u6d1b\u5fb7\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766) \u76f8\u6bd4\uff0cORSERDU \u5728\u9019\u4e9b\u4e9e\u7d44\u4e2d\u986f\u793a\u51fa\u6709\u81e8\u5e8a\u610f\u7fa9\u7684 PFS \u6539\u5584\u3002\u7576\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u6642\u9593\u81f3\u5c11\u70ba 12 \u500b\u6708\u6642\uff0cORSERDU \u7684 PFS \u660e\u986f\u66f4\u9577\uff0c\u9019\u8868\u660e\u7576 ESR1 \u7a81\u8b8a\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u8207\u8f49\u79fb\u90e8\u4f4d\u3001\u00a0\u4f34\u96a8\u7684 PIK3CA \u6216 TP53 \u7a81\u8b8a\u6216 HER2 \u4f4e\u8868\u9054\u5747\u7121\u95dc\u3002\u8acb\u65bc\u6b64\u8655\u67e5\u770b\u5b8c\u6574\u6458\u8981\u3002 Menarini Group \u884c\u653f\u7e3d\u88c1 Elcin Barker Ergun \u8868\u793a\uff1a\u300c\u9019\u4e9b\u5728 SABCS 2023 \u5927\u6703\u4e0a\u516c\u4f48\u7684\u6578\u64da\u5efa\u7acb\u5728\u6211\u5011\u5c0d\u65bc ORSERDU \u53ca\u5176\u4f5c\u70ba\u91dd\u5c0d\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684\u55ae\u85e5\u7642\u6cd5\u6f5b\u529b\u7684\u8a8d\u77e5\u57fa\u790e\u4e4b\u4e0a\u3002\u300d\u00a0\u4ed6\u88dc\u5145\u9053\uff1a\u300cMenarini Stemline \u7684\u76ee\u6a19\u662f\u63d0\u4f9b\u8b8a\u9769\u6027\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u5e6b\u52a9\u5ef6\u9577\u548c\u6539\u5584\u764c\u75c7\u60a3\u8005\u7684\u751f\u547d\u3002\u00a0\u6211\u5011\u5f88\u81ea\u8c6a\u80fd\u70ba\u773e\u591a\u5408\u9069\u7684\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u63d0\u4f9b\u4e00\u7a2e\u6025\u9700\u7684\u5167\u5206\u6ccc\u6cbb\u7642\u9078\u64c7\uff0c\u800c\u4e14\u9019\u7a2e\u9078\u64c7\u7684\u5b89\u5168\u6027\u4e5f\u662f\u53ef\u63a7\u7684\u3002\u300d\u00a0 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u808c\u9aa8\u75db\u3001\u5641\u5fc3\uff0c\u4e09\u9178\u7518\u6cb9\u916f\u5347\u9ad8\uff0c\u81bd\u56fa\u9187\u5347\u9ad8\uff0c\u5614\u5410\uff0c\u75b2\u52de\uff0c\u6d88\u5316\u4e0d\u826f\uff0c\u8179\u7009\uff0c\u9223\u964d\u4f4e\uff0c\u80cc\u75db\uff0c\u808c\u9178\u9150\u5347\u9ad8\uff0c\u95dc\u7bc0\u75db\uff0c\u9209\u964d\u4f4e\uff0c\u4fbf\u79d8\uff0c\u982d\u75db\uff0c\u6f6e\u71b1\uff0c\u8179\u75db\uff0c\u8ca7\u8840\uff0c\u9240\u964d\u4f4e\u548c\u4e19\u6c28\u9178\u8f49\u6c28\u9176\u5347\u9ad8\u3002 ORSERDU \u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002\u00a0 \u8acb\u65bc\u6b64\u8655\u67e5\u95b1\u6709\u95dc Menarini Group \/Stemline Therapeutics \u5728 SABCS 2023 \u4e0a\u7684\u5168\u7cfb\u5217\u4ecb\u7d39\u986f\u793a\u7684\u8a73\u7d30\u8cc7\u8a0a\u3002 EMERALD \u7b2c 3 \u671f\u7814\u7a76 (NCT03778931) \u7c21\u4ecb\u00a0EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u662f\u4e00\u9805\u96a8\u6a5f\u3001\u958b\u653e\u5f0f\u3001\u4e3b\u52d5\u5c0d\u7167\u7684\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2- \u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u00a0\u8a72\u7814\u7a76\u62db\u52df 478 \u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5 (\u5305\u62ec CDK4\/6 \u6291\u5236\u5291) \u7684\u60a3\u8005\u3002\u00a0\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7\u00a0elacestrant \u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u8a72\u7814\u7a76\u7684\u4e3b\u8981\u81e8\u5e8a\u7d42\u9ede\u662f\u8a55\u91cf\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u548c\u96cc\u6fc0\u7d20\u53d7\u9ad4 1 \u57fa\u56e0 (ESR1) \u7a81\u8b8a\u60a3\u8005\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS)\u3002\u00a0\u5728\u816b\u7624\u5177\u6709\u00a0ESR1 \u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 3.8 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS \u98a8\u96aa\u6bd4\u7387 (HR)=0.55, 95% \u7f6e\u4fe1\u5340\u9593: 0.39, 0.77)\u3002 ORSERDU (elacestrant) \u7c21\u4ecb\u00a0\u7f8e\u570b\u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \uff0c\u6bcf\u9320 345 \u6beb\u514b\uff0c\u9069\u7528\u65bc\u6cbb\u7642\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u81f3\u5c11\u63a5\u53d7\u904e\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75be\u75c5\u6709\u60e1\u5316\u9032\u5c55\u7684\u60a3\u8005\u3002 \u6b32\u4e86\u89e3\u7f8e\u570b\u7684\u5b8c\u6574\u8655\u65b9\u8cc7\u8a0a\u53ef\u4ee5\u700f\u89bd\u00a0www.orserdu.com\u3002 \u91cd\u8981\u5b89\u5168\u8cc7\u8a0a \u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9805 \u8840\u8102\u7570\u5e38\uff1a\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c30% \u51fa\u73fe\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\uff0c27% \u51fa\u73fe\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u30023 \u7d1a\u548c 4 \u7d1a\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\u548c\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u7684\u767c\u751f\u7387\u5206\u5225\u70ba 0.9% \u548c 2.2%\u3002\u5728\u958b\u59cb ORSERDU \u6cbb\u7642\u524d\u4ee5\u53ca\u6cbb\u7642\u671f\u9593\u9808\u5b9a\u671f\u76e3\u6e2c\u8840\u8102\u60c5\u6cc1\u3002 \u80da\u80ce-\u80ce\u5152\u6bd2\u6027\uff1a\u6839\u64da\u52d5\u7269\u7814\u7a76\u4e2d\u7684\u767c\u73fe\u53ca\u5176\u4f5c\u7528\u6a5f\u5236\uff0c\u5411\u5b55\u5a66\u8655\u65b9 ORSERDU \u7d66\u85e5\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u00a0\u8acb\u5411\u5b55\u5a66\u548c\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u544a\u77e5\u53ef\u80fd\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u7684\u98a8\u96aa\u3002\u00a0\u5efa\u8b70\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u670d\u7528\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002\u5c0d\u65bc\u64c1\u6709\u5177\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u4f34\u4fb6\u7684\u7537\u6027\u60a3\u8005\uff0c\u5efa\u8b70\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\uff0c\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002 \u4e0d\u826f\u53cd\u61c9 \u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c12% \u7684\u60a3\u8005\u51fa\u73fe\u56b4\u91cd\u7684\u4e0d\u826f\u53cd\u61c9\u3002\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c\u767c\u751f\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u7684\u60a3\u8005\u6bd4\u4f8b\u8d85\u904e 1%\uff0c\u9019\u4e9b\u53cd\u61c9\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (1.7%) \u548c\u5641\u5fc3 (1.3%)\u30021.7% \u7684\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u51fa\u73fe\u4e86\u81f4\u547d\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u5305\u62ec\u5fc3\u81df\u9a5f\u505c\u3001\u6557\u8840\u6027\u4f11\u514b\u3001\u61a9\u5ba4\u708e\uff0c\u4ee5\u53ca\u539f\u56e0\u672a\u660e\u7684\u75c5\u75c7(\u5404\u4e00\u4f8b)\u3002ORSERDU \u7684\u6700\u5e38\u898b\u4e0d\u826f\u53cd\u61c9 (&gt;10%) \uff0c\u5305\u62ec\u5be6\u9a57\u5ba4\u6aa2\u6e2c\u7d50\u679c\u7570\u5e38\uff0c\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (41%) \u3001\u5641\u5fc3 (35%) \u3001\u81bd\u56fa\u9187\u589e\u9ad8 (30%) \u3001\u8c37\u8349\u8f49\u6c28\u9176 (AST) \u589e\u9ad8 (29%) \u3001\u4e09\u9178\u7518\u6cb9\u8102\u589e\u9ad8 (27%) \u3001\u75b2\u52de (26%) \u3001\u8840\u7d05\u86cb\u767d\u964d\u4f4e (26%) \u3001\u5614\u5410 (19%) \u3001\u7a40\u4e19\u8f49\u6c28\u9176 (ALT) \u6c34\u5e73\u589e\u9ad8 (17%) \u3001\u9209\u964d\u4f4e (16%) \u3001\u808c\u9178\u9150\u589e\u9ad8 (16%) \u3001\u98df\u617e\u964d\u4f4e (15%) \u3001\u8179\u7009 (13%) \u3001\u982d\u75db (12%) \u3001\u4fbf\u79d8 (12%) \u3001\u8179\u75db (11%) \u3001\u6f6e\u7d05 (11%) \u548c\u6d88\u5316\u4e0d\u826f (10%)\u3002 \u85e5\u7269\u76f8\u4e92\u4f5c\u7528\u00a0 \u8207 CYP3A4 \u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a\u00a0\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u6291\u5236\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u8a98\u5c0e\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002 \u4f7f\u7528\u65bc\u7279\u5b9a\u4eba\u7fa4\u7684\u6ce8\u610f\u4e8b\u9805 \u54fa\u4e73\u671f\uff1a\u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u5230\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4e0d\u8981\u54fa\u4e73\u3002\u809d\u529f\u80fd\u53d7\u640d\uff1a\u907f\u514d\u5c0d\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C) \u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002\u4e2d\u5ea6\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh B) \u7684\u60a3\u8005\u8981\u6e1b\u5c11 ORSERDU \u7684\u5291\u91cf\u3002 ORSERDU \u5728\u5152\u79d1\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u5b9a\u3002 \u82e5\u8981\u5831\u544a\u53ef\u7591\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61 Stemline Therapeutics, Inc.\uff0c\u96fb\u8a71\u865f\u78bc\u70ba 1-877-332-7961\uff0c\u6216\u8005\u81f4\u96fb 1-800-FDA-1088 \u806f\u7d61 FDA\uff0c\u6216\u700f\u89bd\u00a0www.fda.gov\/medwatch\u3002 \u95dc\u65bc Elacestrant \u81e8\u5e8a\u958b\u767c\u8a08\u5283\u00a0Elacestrant \u9084\u5728\u6578\u500b\u8f49\u79fb\u6027\u4e73\u764c\u75be\u75c5\u7684\u81e8\u5e8a\u8a66\u9a57\u4e2d\u9032\u884c\u7814\u7a76\uff0c\u55ae\u7368\u6216\u662f\u7d50\u5408\u5176\u4ed6\u7642\u6cd5\uff1aELEVATE\uff08NCT05563220\uff09\u662f\u4e00\u9805\u7b2c 1b\/2 \u671f\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c07\u8a55\u4f30 elacestrant \u5408\u4f75\u4f7f\u7528 alpelisib\u3001everolimus\u3001palbociclib\u3001abemaciclib \u548c ribociclib \u7642\u6cd5\u7684\u5b89\u5168\u6027\u548c\u7642\u6548\u3002ELECTRA\uff08NCT05386108\uff09\u662f\u4e00\u9805 1b\/2 \u671f\u958b\u653e\u6a19\u7c64\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u806f\u5408 abemaciclib \u6cbb\u7642 ER+\u3001HER2- \u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u7b2c 2 \u671f\u7814\u7a76\u8a55\u4f30\u6b64\u6cbb\u7642\u65b9\u6848\u5728\u8166\u8f49\u79fb\u60a3\u8005\u4e2d\u7684\u61c9\u7528\u3002 ELCIN\uff08NCT05596409\uff09\u662f\u4e00\u9805\u7b2c 2 \u671f\u8a66\u9a57\uff0c\u8a55\u4f30 elacestrant \u5c0d\u96cc\u6fc0\u7d20\u53d7\u9ad4\u967d\u6027 (ER+)\/\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4-2 \u9670\u6027\uff08HER2-\uff09\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005 (mBC) \u7684\u7642\u6548\uff0c\u9019\u4e9b\u60a3\u8005\u5148\u524d\u63a5\u53d7\u904e 1 \u6b21\u6216 2 \u6b21\u8377\u723e\u8499\u7642\u6cd5\uff0c\u4e14\u5148\u524d\u672a\u4f7f\u7528\u904e\u7d30\u80de\u9031\u671f\u86cb\u767d\u4f9d\u8cf4\u6027\u6fc0\u9176\u6a19\u9776\u9176 CDK4 \u548c CDK6 \u6291\u5236\u5291\uff08CDK4\/6i\uff09\u3002Elacestrant \u4e5f\u5c07\u65bc\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002\u00a0 Menarini Group \u7c21\u4ecb\u00a0Menarini Group \u662f\u4e00\u5bb6\u9818\u5148\u696d\u754c\u7684\u570b\u969b\u88fd\u85e5\u548c\u8a3a\u7642\u516c\u53f8\uff0c\u5e74\u71df\u696d\u984d\u8d85\u904e 44 \u5104\u7f8e\u5143\uff0c\u54e1\u5de5\u8d85\u904e 17,000 \u4eba\u3002Menarini \u5c08\u6ce8\u65bc\u6cbb\u7642\u9700\u6c42\u9ad8\u5ea6\u672a\u6eff\u8db3\u7684\u9818\u57df\uff0c\u5176\u7522\u54c1\u6db5\u84cb\u5fc3\u81df\u75c5\u5b78\u3001\u816b\u7624\u5b78\u3001\u547c\u5438\u75c5\u5b78\u3001\u80c3\u8178\u75c5\u5b78\u3001\u50b3\u67d3\u75c5\u5b78\u3001\u7cd6\u5c3f\u75c5\u5b78\u3001\u708e\u75c7\u548c\u93ae\u75db\u7b49\u9818\u57df\u3002Menarini \u64c1\u6709 18 \u500b\u751f\u7522\u57fa\u5730\u548c 9 \u500b\u7814\u767c\u4e2d\u5fc3\uff0c\u7522\u54c1\u92b7\u5f80\u5168\u7403 140 \u500b\u570b\u5bb6\/\u5730\u5340\u3002\u00a0\u6b32\u4e86\u89e3\u66f4\u591a\u76f8\u95dc\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd\u00a0www.menarini.com\u3002 Stemline Therapeutics Inc. \u7c21\u4ecbStemline Therapeutics, Inc. (\u300cStemline\u300d) \u662f Menarini Group \u7684\u5168\u8cc7\u5b50\u516c\u53f8\uff0c\u662f\u4e00\u5bb6\u5546\u696d\u5316\u968e\u6bb5\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u65b0\u578b\u816b\u7624\u5b78\u6cbb\u7642\u85e5\u7269\u7684\u958b\u767c\u548c\u5546\u696d\u5316\u3002Stemline \u5c07\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u5546\u696d\u5316 ORSERDU\u00ae (elacestrant) \uff0c\u9019\u662f\u4e00\u7a2e\u53e3\u670d\u5167\u5206\u6ccc\u6cbb\u7642\u85e5\u7269\uff0c\u9069\u7528\u65bc\u60a3\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\uff0c\u4e14\u5728\u63a5\u53d7\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u3002Stemline \u9084\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u63a8\u51fa\u4e86 ELZONRIS\u00ae (tagraxofusp-erzs) \uff0c\u9019\u662f\u4e00\u7a2e\u91dd\u5c0d CD123 \u7684\u5275\u65b0\u6a19\u9776\u6cbb\u7642\uff0c\u7528\u65bc\u6cbb\u7642\u7206\u767c\u6027\u6f3f\u7d30\u80de\u6a39\u7a81\u7d30\u80de\u816b\u7624 (BPDCN)\uff08\u4e00\u7a2e\u4fb5\u8972\u6027\u8840\u6db2\u764c\u75c7\uff09\u60a3\u8005\uff0c\u4e5f\u662f\u7f8e\u570b\u548c\u6b50\u76df\u8fc4\u4eca\u552f\u4e00\u7372\u6279\u7684 BPDCN \u6cbb\u7642\u65b9\u6848\u3002Stemline \u4ea6\u5c07\u5728\u6b50\u6d32\u5546\u696d\u5316 NEXPOVIO\u00ae (selinexor) \uff0c\u4e00\u7a2e\u7528\u65bc\u6cbb\u7642\u591a\u767c\u6027\u9aa8\u9ad3\u7624\u7684 XPO1 \u6291\u5236\u5291\u3002\u00a0\u6b64\u5916\uff0cStemline \u9084\u64c1\u6709\u5ee3\u6cdb\u7684\u5c0f\u5206\u5b50\u548c\u751f\u7269\u88fd\u5291\u81e8\u5e8a\u7522\u54c1\u7ba1\u9053\uff0c\u9019\u4e9b\u7522\u54c1\u8655\u65bc\u4e0d\u540c\u7684\u958b\u767c\u968e\u6bb5\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u591a\u7a2e\u5be6\u9ad4\u764c\u548c\u8840\u764c\u3002\u00a0  Bardia \u7b49\u4eba EMERALD \u7684 elacestrant 3 \u671f\u8a66\u9a57\u5c0d\u6bd4\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\/HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u6548\u679c\uff1a\u00a0\u5728\u764c\u75c7\u75c5\u7076\u8f49\u79fb\u7684\u60c5\u6cc1\u4e0b\uff0c\u65e2\u5f80 CDK4\/6i \u6301\u7e8c\u6642\u9577\u7684\u7d50\u679c\u66f4\u65b0\u3002 SABCS 2022\u3002GS3-01","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/pingtungtimes.com.tw\/?p=204040","og_locale":"zh_TW","og_type":"article","og_title":"Menarini Group \u65bc SABCS 2023 \u4e0a\u767c\u4f48 ORSERDU\u00ae (Elacestrant) \u5728\u6cbb\u7642 ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\u81e8\u5e8a\u76f8\u95dc\u4e9e\u7d44\u65b9\u9762 EMERALD \u81e8\u5e8a\u7814\u7a76\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u7684\u65b0\u6578\u64da - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","og_description":"EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u7684\u65b0\u4e8b\u4ef6\u5f8c\u5206\u6790\u8a55\u4f30\u3001 elacestrant \u5728\u5167\u5206\u6ccc\u654f\u611f\u65cf\u7fa4\uff08CDK4\/6 \u6291\u5236\u5291\u7642\u7a0b\u81f3\u5c11 12 \u500b\u6708\uff09\u4e2d\u7684\u61c9\u7528\u60c5\u6cc1\uff0c\u9019\u4e9b\u65cf\u7fa4\u6240\u60a3\u7684\u816b\u7624\u5747\u5e36\u6709 ESR1 \u7a81\u8b8a\u3002\u00a0  \u8a72\u5206\u6790\u986f\u793a\uff0c\u5728\u53c3\u8207\u7814\u7a76\u7684\u5404\u4e9e\u7d44\u4e2d\uff0c\u5305\u62ec\u9aa8\u3001\u809d\u53ca\/\u6216\u80ba\u8f49\u79fb\u60a3\u8005\u3001\u4f34\u6709\u5e38\u898b\u7a81\u8b8a\uff08\u5982 PIK3CA \u548c TP53\uff09\u7684\u60a3\u8005\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u60a3\u8005\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u90fd\u6709\u5177\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002\u00a0  \u4e0a\u8ff0\u7d50\u679c\u986f\u793a\uff0c\u7576 ESR1 \u7a81\u8b8a\u7684\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\u3002\u00a0 \u610f\u5927\u5229\u4f5b\u7f85\u502b\u65af\u548c\u7d10\u7d042023\u5e7412\u670811\u65e5 \/\u7f8e\u901a\u793e\/ -- \u570b\u969b\u9818\u5148\u7684\u88fd\u85e5\u548c\u8a3a\u65b7\u516c\u53f8 Menarini Group\uff08\u300cMenarini\u300d\uff09\u8207\u5176\u81f4\u529b\u65bc\u70ba\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u8f49\u5316\u816b\u7624\u6cbb\u7642\u7684\u5168\u8cc7\u5b50\u516c\u53f8 Stemline Therapeutics, Inc. (\u300cStemline\u300d\uff09\u4eca\u5929\u516c\u4f48\u4e86\u91dd\u5c0d\u95dc\u9375 EMERALD \u81e8\u5e8a\u7814\u7a76\u958b\u5c55\u7684\u4e00\u9805\u65b0\u7684\u4e8b\u5f8c\u5206\u6790\u7d50\u679c\uff0c\u7d50\u679c\u8868\u660e\uff0c\u5728\u6240\u6709\u76f8\u95dc\u4e9e\u7d44\u4e2d\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u90fd\u5f97\u5230\u4e86\u5177\u6709\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002 \u6578\u64da\u986f\u793a\uff0c\u91dd\u5c0d\u5185\u5206\u6ccc\u654f\u611f\u4e14\u643a\u5e36\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\uff0c\u5982\u679c\u5148\u524d\u4f7f\u7528 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\uff0c\u5247 ORSERDU\u00ae (elacestrant) \u55ae\u85e5\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u512a\u65bc\u6a19\u6e96\u6cbb\u7642 (SOC)\u3002 \u9019\u4e9b\u6578\u64da\u5c07\u5728 2023 \u5e74 12 \u6708 5 \u65e5\u81f3 12 \u6708 9 \u65e5\u8209\u884c\u7684 2023 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u764c\u7814\u8a0e\u6703 (SABCS) \u4e2d\u516c\u4f48\u3002\u00a0 EMERALD \u662f\u4e00\u9805\u7b2c 3 \u671f\u8a3b\u518a\u8a66\u9a57\uff0c\u8868\u660e\u8207\u6a19\u6e96\u6cbb\u7642\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\uff08\u6c1f\u7dad\u53f8\u7fa4\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766\uff09\u76f8\u6bd4\uff0cORSERDU \u6cbb\u7642\u5177\u6709\u5728\u7d71\u8a08\u5b78\u4e0a\u66f4\u52a0\u986f\u8457\u7684 PFS\u3002\u6839\u64da\u4e0a\u8ff0\u7d50\u679c\uff0cFDA \u65bc 2023 \u5e74 1 \u6708 27 \u65e5\u6838\u51c6 ORSERDU \u7528\u65bc\u6cbb\u7642\u60a3\u6709 ER+\u3001HER2-\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\uff0c\u4e14\u9019\u4e9b\u60a3\u8005\u9700\u5728\u81f3\u5c11\u4e00\u7a2e\u5167\u5206\u6ccc\u7642\u6cd5\u5f8c\u75be\u75c5\u51fa\u73fe\u60e1\u5316\u3002\u9ad8\u9054 40% \u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u5b58\u5728 ESR1 \u7a81\u8b8a\u3002\u00a0\u9019\u7a2e\u7a81\u8b8a\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u51fa\u73fe\u6297\u85e5\u6027\u7684\u5df2\u77e5\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u4e14\u5230\u76ee\u524d\u70ba\u6b62\uff0c\u5177\u6709\u9019\u985e\u7a81\u8b8a\u7684\u816b\u7624\u6cbb\u7642\u96e3\u5ea6\u66f4\u5927\u3002 \u00a0 \u91cd\u9ede\u662f\uff0c\u5728 2022 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u817a\u764c\u7814\u8a0e\u6703 (SABCS) \u4e0a\u958b\u5c55\u95dc\u65bc EMERALD PFS \u7d50\u679c\u4e9e\u7d44\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 ORSERDU \u5f8c\u7684 PFS \u5ef6\u9577\u5448\u6b63\u9762\u76f8\u95dc\u59d3\uff0c\u4f46\u5728\u6a19\u6e96\u6cbb\u7642 (SOC) \u4e0a\u4e26\u7121\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD \u96a8\u6a5f\u5206\u7d44\u524d\u63a5\u53d7 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u00a0ESR1 \u7a81\u8b8a\u60a3\u8005\uff0c\u63a1\u7528 ORSERDU \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 8.6 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u51fa\u73fe\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e 59% (\u98a8\u96aa\u6bd4\u7387 (HR)=0.41 95% \u7f6e\u4fe1\u5340\u9593: 0.26-0.63)\u3002 \u5728\u9019\u9805\u66f4\u65b0\u5f8c\u7684\u5206\u6790\u4e2d\uff0cMenarini Stemline \u8a55\u4f30\u55ae\u85e5 ORSERDU \u70ba\u9ad8\u767c\u81e8\u5e8a\u548c\u95dc\u9375\u751f\u7269\u6a19\u8a18\u4e9e\u7d44\u5e36\u4f86\u7684\u76ca\u8655\uff0c\u5305\u62ec\u60a3\u6709\u9aa8\u3001\u809d\u548c\/\u6216\u80ba\u8f49\u79fb\u7684\u60a3\u8005\uff1b\u6709\u5e38\u898b\u4f75\u767c PIK3CA \u6216 TP53 \u7a81\u8b8a\u7684\u60a3\u8005\uff1b\u6216 HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u00a0 \u300c\u9019\u4e9b\u6700\u65b0\u7814\u7a76\u7d50\u679c\u9032\u4e00\u6b65\u8b49\u5be6\uff0c\u5c0d\u65bc\u816b\u7624\u651c\u5e36\u00a0ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u4f86\u8aaa\uff0cORSERDU \u55ae\u85e5\u6cbb\u7642\u662f\u4e00\u7a2e\u5f88\u6709\u524d\u666f\u7684\u4e8c\u7dda\u6cbb\u7642\u9078\u64c7\uff0c\u300dUT Health San Antonio \u548c MD Anderson \u764c\u75c7\u4e2d\u5fc3\u4e73\u623f\u816b\u7624\u5c08\u5bb6\u3001\u91ab\u5b78\u6559\u6388\u3001\u91ab\u5b78\u535a\u58eb\u3001\u00a0\u79d1\u5b78\u535a\u58ebVirginia Kaklamani \u8aaa\uff0c\u300c\u6211\u5011\u767c\u73fe\uff0c\u5c0d\u65bc\u5148\u524d\u63a5\u53d7 CDK 4\/6 \u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u60a3\u8005\uff0c\u4f7f\u7528 elacestrant \u55ae\u85e5\u6cbb\u7642\u8207\u6a19\u6e96\u6cbb\u7642\u76f8\u6bd4\uff0c\u5728\u8a31\u591a\u91cd\u8981\u4e9e\u7d44\u7684\u75be\u75c5\u7121\u60e1\u5316\u751f\u5b58\u671f\u65b9\u9762\u90fd\u6709\u6301\u7e8c\u6539\u5584\u3002\u00a0\u6211\u5011\u89c0\u5bdf\u5230\u7684\u9019\u4e9b\u7d50\u679c\u4e0d\u50c5\u9069\u7528\u65bc\u9aa8\u8f49\u79fb\u60a3\u8005\uff0c\u540c\u6a23\u9069\u7528\u65bc\u809d\u81df\u548c\/\u6216\u80ba\u90e8\u8f49\u79fb\u60a3\u8005\uff0c\u4e5f\u9069\u7528\u65bc PIK3CA \u548c TP53 \u7b49\u5e38\u898b\u5171\u7a81\u8b8a\u60a3\u8005\uff0c\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u300d\u00a0 \u8207 SOC \u5167\u5206\u6ccc\u55ae\u85e5\u6cbb\u7642 (\u6cd5\u6d1b\u5fb7\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766) \u76f8\u6bd4\uff0cORSERDU \u5728\u9019\u4e9b\u4e9e\u7d44\u4e2d\u986f\u793a\u51fa\u6709\u81e8\u5e8a\u610f\u7fa9\u7684 PFS \u6539\u5584\u3002\u7576\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u6642\u9593\u81f3\u5c11\u70ba 12 \u500b\u6708\u6642\uff0cORSERDU \u7684 PFS \u660e\u986f\u66f4\u9577\uff0c\u9019\u8868\u660e\u7576 ESR1 \u7a81\u8b8a\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u8207\u8f49\u79fb\u90e8\u4f4d\u3001\u00a0\u4f34\u96a8\u7684 PIK3CA \u6216 TP53 \u7a81\u8b8a\u6216 HER2 \u4f4e\u8868\u9054\u5747\u7121\u95dc\u3002\u8acb\u65bc\u6b64\u8655\u67e5\u770b\u5b8c\u6574\u6458\u8981\u3002 Menarini Group \u884c\u653f\u7e3d\u88c1 Elcin Barker Ergun \u8868\u793a\uff1a\u300c\u9019\u4e9b\u5728 SABCS 2023 \u5927\u6703\u4e0a\u516c\u4f48\u7684\u6578\u64da\u5efa\u7acb\u5728\u6211\u5011\u5c0d\u65bc ORSERDU \u53ca\u5176\u4f5c\u70ba\u91dd\u5c0d\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684\u55ae\u85e5\u7642\u6cd5\u6f5b\u529b\u7684\u8a8d\u77e5\u57fa\u790e\u4e4b\u4e0a\u3002\u300d\u00a0\u4ed6\u88dc\u5145\u9053\uff1a\u300cMenarini Stemline \u7684\u76ee\u6a19\u662f\u63d0\u4f9b\u8b8a\u9769\u6027\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u5e6b\u52a9\u5ef6\u9577\u548c\u6539\u5584\u764c\u75c7\u60a3\u8005\u7684\u751f\u547d\u3002\u00a0\u6211\u5011\u5f88\u81ea\u8c6a\u80fd\u70ba\u773e\u591a\u5408\u9069\u7684\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u63d0\u4f9b\u4e00\u7a2e\u6025\u9700\u7684\u5167\u5206\u6ccc\u6cbb\u7642\u9078\u64c7\uff0c\u800c\u4e14\u9019\u7a2e\u9078\u64c7\u7684\u5b89\u5168\u6027\u4e5f\u662f\u53ef\u63a7\u7684\u3002\u300d\u00a0 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u808c\u9aa8\u75db\u3001\u5641\u5fc3\uff0c\u4e09\u9178\u7518\u6cb9\u916f\u5347\u9ad8\uff0c\u81bd\u56fa\u9187\u5347\u9ad8\uff0c\u5614\u5410\uff0c\u75b2\u52de\uff0c\u6d88\u5316\u4e0d\u826f\uff0c\u8179\u7009\uff0c\u9223\u964d\u4f4e\uff0c\u80cc\u75db\uff0c\u808c\u9178\u9150\u5347\u9ad8\uff0c\u95dc\u7bc0\u75db\uff0c\u9209\u964d\u4f4e\uff0c\u4fbf\u79d8\uff0c\u982d\u75db\uff0c\u6f6e\u71b1\uff0c\u8179\u75db\uff0c\u8ca7\u8840\uff0c\u9240\u964d\u4f4e\u548c\u4e19\u6c28\u9178\u8f49\u6c28\u9176\u5347\u9ad8\u3002 ORSERDU \u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002\u00a0 \u8acb\u65bc\u6b64\u8655\u67e5\u95b1\u6709\u95dc Menarini Group \/Stemline Therapeutics \u5728 SABCS 2023 \u4e0a\u7684\u5168\u7cfb\u5217\u4ecb\u7d39\u986f\u793a\u7684\u8a73\u7d30\u8cc7\u8a0a\u3002 EMERALD \u7b2c 3 \u671f\u7814\u7a76 (NCT03778931) \u7c21\u4ecb\u00a0EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u662f\u4e00\u9805\u96a8\u6a5f\u3001\u958b\u653e\u5f0f\u3001\u4e3b\u52d5\u5c0d\u7167\u7684\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2- \u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u00a0\u8a72\u7814\u7a76\u62db\u52df 478 \u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5 (\u5305\u62ec CDK4\/6 \u6291\u5236\u5291) \u7684\u60a3\u8005\u3002\u00a0\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7\u00a0elacestrant \u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u8a72\u7814\u7a76\u7684\u4e3b\u8981\u81e8\u5e8a\u7d42\u9ede\u662f\u8a55\u91cf\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u548c\u96cc\u6fc0\u7d20\u53d7\u9ad4 1 \u57fa\u56e0 (ESR1) \u7a81\u8b8a\u60a3\u8005\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS)\u3002\u00a0\u5728\u816b\u7624\u5177\u6709\u00a0ESR1 \u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 3.8 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS \u98a8\u96aa\u6bd4\u7387 (HR)=0.55, 95% \u7f6e\u4fe1\u5340\u9593: 0.39, 0.77)\u3002 ORSERDU (elacestrant) \u7c21\u4ecb\u00a0\u7f8e\u570b\u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \uff0c\u6bcf\u9320 345 \u6beb\u514b\uff0c\u9069\u7528\u65bc\u6cbb\u7642\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u81f3\u5c11\u63a5\u53d7\u904e\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75be\u75c5\u6709\u60e1\u5316\u9032\u5c55\u7684\u60a3\u8005\u3002 \u6b32\u4e86\u89e3\u7f8e\u570b\u7684\u5b8c\u6574\u8655\u65b9\u8cc7\u8a0a\u53ef\u4ee5\u700f\u89bd\u00a0www.orserdu.com\u3002 \u91cd\u8981\u5b89\u5168\u8cc7\u8a0a \u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9805 \u8840\u8102\u7570\u5e38\uff1a\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c30% \u51fa\u73fe\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\uff0c27% \u51fa\u73fe\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u30023 \u7d1a\u548c 4 \u7d1a\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\u548c\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u7684\u767c\u751f\u7387\u5206\u5225\u70ba 0.9% \u548c 2.2%\u3002\u5728\u958b\u59cb ORSERDU \u6cbb\u7642\u524d\u4ee5\u53ca\u6cbb\u7642\u671f\u9593\u9808\u5b9a\u671f\u76e3\u6e2c\u8840\u8102\u60c5\u6cc1\u3002 \u80da\u80ce-\u80ce\u5152\u6bd2\u6027\uff1a\u6839\u64da\u52d5\u7269\u7814\u7a76\u4e2d\u7684\u767c\u73fe\u53ca\u5176\u4f5c\u7528\u6a5f\u5236\uff0c\u5411\u5b55\u5a66\u8655\u65b9 ORSERDU \u7d66\u85e5\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u00a0\u8acb\u5411\u5b55\u5a66\u548c\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u544a\u77e5\u53ef\u80fd\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u7684\u98a8\u96aa\u3002\u00a0\u5efa\u8b70\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u670d\u7528\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002\u5c0d\u65bc\u64c1\u6709\u5177\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u4f34\u4fb6\u7684\u7537\u6027\u60a3\u8005\uff0c\u5efa\u8b70\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\uff0c\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002 \u4e0d\u826f\u53cd\u61c9 \u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c12% \u7684\u60a3\u8005\u51fa\u73fe\u56b4\u91cd\u7684\u4e0d\u826f\u53cd\u61c9\u3002\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c\u767c\u751f\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u7684\u60a3\u8005\u6bd4\u4f8b\u8d85\u904e 1%\uff0c\u9019\u4e9b\u53cd\u61c9\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (1.7%) \u548c\u5641\u5fc3 (1.3%)\u30021.7% \u7684\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u51fa\u73fe\u4e86\u81f4\u547d\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u5305\u62ec\u5fc3\u81df\u9a5f\u505c\u3001\u6557\u8840\u6027\u4f11\u514b\u3001\u61a9\u5ba4\u708e\uff0c\u4ee5\u53ca\u539f\u56e0\u672a\u660e\u7684\u75c5\u75c7(\u5404\u4e00\u4f8b)\u3002ORSERDU \u7684\u6700\u5e38\u898b\u4e0d\u826f\u53cd\u61c9 (&gt;10%) \uff0c\u5305\u62ec\u5be6\u9a57\u5ba4\u6aa2\u6e2c\u7d50\u679c\u7570\u5e38\uff0c\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (41%) \u3001\u5641\u5fc3 (35%) \u3001\u81bd\u56fa\u9187\u589e\u9ad8 (30%) \u3001\u8c37\u8349\u8f49\u6c28\u9176 (AST) \u589e\u9ad8 (29%) \u3001\u4e09\u9178\u7518\u6cb9\u8102\u589e\u9ad8 (27%) \u3001\u75b2\u52de (26%) \u3001\u8840\u7d05\u86cb\u767d\u964d\u4f4e (26%) \u3001\u5614\u5410 (19%) \u3001\u7a40\u4e19\u8f49\u6c28\u9176 (ALT) \u6c34\u5e73\u589e\u9ad8 (17%) \u3001\u9209\u964d\u4f4e (16%) \u3001\u808c\u9178\u9150\u589e\u9ad8 (16%) \u3001\u98df\u617e\u964d\u4f4e (15%) \u3001\u8179\u7009 (13%) \u3001\u982d\u75db (12%) \u3001\u4fbf\u79d8 (12%) \u3001\u8179\u75db (11%) \u3001\u6f6e\u7d05 (11%) \u548c\u6d88\u5316\u4e0d\u826f (10%)\u3002 \u85e5\u7269\u76f8\u4e92\u4f5c\u7528\u00a0 \u8207 CYP3A4 \u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a\u00a0\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u6291\u5236\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u8a98\u5c0e\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002 \u4f7f\u7528\u65bc\u7279\u5b9a\u4eba\u7fa4\u7684\u6ce8\u610f\u4e8b\u9805 \u54fa\u4e73\u671f\uff1a\u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u5230\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4e0d\u8981\u54fa\u4e73\u3002\u809d\u529f\u80fd\u53d7\u640d\uff1a\u907f\u514d\u5c0d\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C) \u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002\u4e2d\u5ea6\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh B) \u7684\u60a3\u8005\u8981\u6e1b\u5c11 ORSERDU \u7684\u5291\u91cf\u3002 ORSERDU \u5728\u5152\u79d1\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u5b9a\u3002 \u82e5\u8981\u5831\u544a\u53ef\u7591\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61 Stemline Therapeutics, Inc.\uff0c\u96fb\u8a71\u865f\u78bc\u70ba 1-877-332-7961\uff0c\u6216\u8005\u81f4\u96fb 1-800-FDA-1088 \u806f\u7d61 FDA\uff0c\u6216\u700f\u89bd\u00a0www.fda.gov\/medwatch\u3002 \u95dc\u65bc Elacestrant \u81e8\u5e8a\u958b\u767c\u8a08\u5283\u00a0Elacestrant \u9084\u5728\u6578\u500b\u8f49\u79fb\u6027\u4e73\u764c\u75be\u75c5\u7684\u81e8\u5e8a\u8a66\u9a57\u4e2d\u9032\u884c\u7814\u7a76\uff0c\u55ae\u7368\u6216\u662f\u7d50\u5408\u5176\u4ed6\u7642\u6cd5\uff1aELEVATE\uff08NCT05563220\uff09\u662f\u4e00\u9805\u7b2c 1b\/2 \u671f\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c07\u8a55\u4f30 elacestrant \u5408\u4f75\u4f7f\u7528 alpelisib\u3001everolimus\u3001palbociclib\u3001abemaciclib \u548c ribociclib \u7642\u6cd5\u7684\u5b89\u5168\u6027\u548c\u7642\u6548\u3002ELECTRA\uff08NCT05386108\uff09\u662f\u4e00\u9805 1b\/2 \u671f\u958b\u653e\u6a19\u7c64\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u806f\u5408 abemaciclib \u6cbb\u7642 ER+\u3001HER2- \u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u7b2c 2 \u671f\u7814\u7a76\u8a55\u4f30\u6b64\u6cbb\u7642\u65b9\u6848\u5728\u8166\u8f49\u79fb\u60a3\u8005\u4e2d\u7684\u61c9\u7528\u3002 ELCIN\uff08NCT05596409\uff09\u662f\u4e00\u9805\u7b2c 2 \u671f\u8a66\u9a57\uff0c\u8a55\u4f30 elacestrant \u5c0d\u96cc\u6fc0\u7d20\u53d7\u9ad4\u967d\u6027 (ER+)\/\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4-2 \u9670\u6027\uff08HER2-\uff09\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005 (mBC) \u7684\u7642\u6548\uff0c\u9019\u4e9b\u60a3\u8005\u5148\u524d\u63a5\u53d7\u904e 1 \u6b21\u6216 2 \u6b21\u8377\u723e\u8499\u7642\u6cd5\uff0c\u4e14\u5148\u524d\u672a\u4f7f\u7528\u904e\u7d30\u80de\u9031\u671f\u86cb\u767d\u4f9d\u8cf4\u6027\u6fc0\u9176\u6a19\u9776\u9176 CDK4 \u548c CDK6 \u6291\u5236\u5291\uff08CDK4\/6i\uff09\u3002Elacestrant \u4e5f\u5c07\u65bc\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002\u00a0 Menarini Group \u7c21\u4ecb\u00a0Menarini Group \u662f\u4e00\u5bb6\u9818\u5148\u696d\u754c\u7684\u570b\u969b\u88fd\u85e5\u548c\u8a3a\u7642\u516c\u53f8\uff0c\u5e74\u71df\u696d\u984d\u8d85\u904e 44 \u5104\u7f8e\u5143\uff0c\u54e1\u5de5\u8d85\u904e 17,000 \u4eba\u3002Menarini \u5c08\u6ce8\u65bc\u6cbb\u7642\u9700\u6c42\u9ad8\u5ea6\u672a\u6eff\u8db3\u7684\u9818\u57df\uff0c\u5176\u7522\u54c1\u6db5\u84cb\u5fc3\u81df\u75c5\u5b78\u3001\u816b\u7624\u5b78\u3001\u547c\u5438\u75c5\u5b78\u3001\u80c3\u8178\u75c5\u5b78\u3001\u50b3\u67d3\u75c5\u5b78\u3001\u7cd6\u5c3f\u75c5\u5b78\u3001\u708e\u75c7\u548c\u93ae\u75db\u7b49\u9818\u57df\u3002Menarini \u64c1\u6709 18 \u500b\u751f\u7522\u57fa\u5730\u548c 9 \u500b\u7814\u767c\u4e2d\u5fc3\uff0c\u7522\u54c1\u92b7\u5f80\u5168\u7403 140 \u500b\u570b\u5bb6\/\u5730\u5340\u3002\u00a0\u6b32\u4e86\u89e3\u66f4\u591a\u76f8\u95dc\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd\u00a0www.menarini.com\u3002 Stemline Therapeutics Inc. \u7c21\u4ecbStemline Therapeutics, Inc. (\u300cStemline\u300d) \u662f Menarini Group \u7684\u5168\u8cc7\u5b50\u516c\u53f8\uff0c\u662f\u4e00\u5bb6\u5546\u696d\u5316\u968e\u6bb5\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u65b0\u578b\u816b\u7624\u5b78\u6cbb\u7642\u85e5\u7269\u7684\u958b\u767c\u548c\u5546\u696d\u5316\u3002Stemline \u5c07\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u5546\u696d\u5316 ORSERDU\u00ae (elacestrant) \uff0c\u9019\u662f\u4e00\u7a2e\u53e3\u670d\u5167\u5206\u6ccc\u6cbb\u7642\u85e5\u7269\uff0c\u9069\u7528\u65bc\u60a3\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\uff0c\u4e14\u5728\u63a5\u53d7\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u3002Stemline \u9084\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u63a8\u51fa\u4e86 ELZONRIS\u00ae (tagraxofusp-erzs) \uff0c\u9019\u662f\u4e00\u7a2e\u91dd\u5c0d CD123 \u7684\u5275\u65b0\u6a19\u9776\u6cbb\u7642\uff0c\u7528\u65bc\u6cbb\u7642\u7206\u767c\u6027\u6f3f\u7d30\u80de\u6a39\u7a81\u7d30\u80de\u816b\u7624 (BPDCN)\uff08\u4e00\u7a2e\u4fb5\u8972\u6027\u8840\u6db2\u764c\u75c7\uff09\u60a3\u8005\uff0c\u4e5f\u662f\u7f8e\u570b\u548c\u6b50\u76df\u8fc4\u4eca\u552f\u4e00\u7372\u6279\u7684 BPDCN \u6cbb\u7642\u65b9\u6848\u3002Stemline \u4ea6\u5c07\u5728\u6b50\u6d32\u5546\u696d\u5316 NEXPOVIO\u00ae (selinexor) \uff0c\u4e00\u7a2e\u7528\u65bc\u6cbb\u7642\u591a\u767c\u6027\u9aa8\u9ad3\u7624\u7684 XPO1 \u6291\u5236\u5291\u3002\u00a0\u6b64\u5916\uff0cStemline \u9084\u64c1\u6709\u5ee3\u6cdb\u7684\u5c0f\u5206\u5b50\u548c\u751f\u7269\u88fd\u5291\u81e8\u5e8a\u7522\u54c1\u7ba1\u9053\uff0c\u9019\u4e9b\u7522\u54c1\u8655\u65bc\u4e0d\u540c\u7684\u958b\u767c\u968e\u6bb5\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u591a\u7a2e\u5be6\u9ad4\u764c\u548c\u8840\u764c\u3002\u00a0  Bardia \u7b49\u4eba EMERALD \u7684 elacestrant 3 \u671f\u8a66\u9a57\u5c0d\u6bd4\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\/HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u6548\u679c\uff1a\u00a0\u5728\u764c\u75c7\u75c5\u7076\u8f49\u79fb\u7684\u60c5\u6cc1\u4e0b\uff0c\u65e2\u5f80 CDK4\/6i \u6301\u7e8c\u6642\u9577\u7684\u7d50\u679c\u66f4\u65b0\u3002 SABCS 2022\u3002GS3-01","og_url":"https:\/\/pingtungtimes.com.tw\/?p=204040","og_site_name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","article_publisher":"https:\/\/www.facebook.com\/pingtungnews","article_published_time":"2023-12-11T01:52:00+00:00","og_image":[{"width":400,"height":121,"url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/12\/Menarini_Industrie_Farmaceutiche_Riunite_Logo.jpg","type":"image\/jpeg"}],"author":"\u7f8e\u901a\u793e","twitter_card":"summary_large_image","twitter_misc":{"\u4f5c\u8005:":"\u7f8e\u901a\u793e","\u9810\u4f30\u95b1\u8b80\u6642\u9593":"1 \u5206\u9418"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"NewsArticle","@id":"https:\/\/pingtungtimes.com.tw\/?p=204040#article","isPartOf":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=204040"},"author":{"name":"\u7f8e\u901a\u793e","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/person\/683b937f29ec1537972f6c41e22a2cf3"},"headline":"Menarini Group \u65bc SABCS 2023 \u4e0a\u767c\u4f48 ORSERDU\u00ae (Elacestrant) \u5728\u6cbb\u7642 ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\u81e8\u5e8a\u76f8\u95dc\u4e9e\u7d44\u65b9\u9762 EMERALD \u81e8\u5e8a\u7814\u7a76\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u7684\u65b0\u6578\u64da","datePublished":"2023-12-11T01:52:00+00:00","mainEntityOfPage":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=204040"},"wordCount":276,"publisher":{"@id":"https:\/\/pingtungtimes.com.tw\/#organization"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=204040#primaryimage"},"thumbnailUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/12\/Menarini_Industrie_Farmaceutiche_Riunite_Logo.jpg","articleSection":["\u7f8e\u901a\u793e"],"inLanguage":"zh-TW"},{"@type":"WebPage","@id":"https:\/\/pingtungtimes.com.tw\/?p=204040","url":"https:\/\/pingtungtimes.com.tw\/?p=204040","name":"Menarini Group \u65bc SABCS 2023 \u4e0a\u767c\u4f48 ORSERDU\u00ae (Elacestrant) \u5728\u6cbb\u7642 ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\u81e8\u5e8a\u76f8\u95dc\u4e9e\u7d44\u65b9\u9762 EMERALD \u81e8\u5e8a\u7814\u7a76\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u7684\u65b0\u6578\u64da - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","isPartOf":{"@id":"https:\/\/pingtungtimes.com.tw\/#website"},"primaryImageOfPage":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=204040#primaryimage"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=204040#primaryimage"},"thumbnailUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/12\/Menarini_Industrie_Farmaceutiche_Riunite_Logo.jpg","datePublished":"2023-12-11T01:52:00+00:00","description":"EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u7684\u65b0\u4e8b\u4ef6\u5f8c\u5206\u6790\u8a55\u4f30\u3001 elacestrant \u5728\u5167\u5206\u6ccc\u654f\u611f\u65cf\u7fa4\uff08CDK4\/6 \u6291\u5236\u5291\u7642\u7a0b\u81f3\u5c11 12 \u500b\u6708\uff09\u4e2d\u7684\u61c9\u7528\u60c5\u6cc1\uff0c\u9019\u4e9b\u65cf\u7fa4\u6240\u60a3\u7684\u816b\u7624\u5747\u5e36\u6709 ESR1 \u7a81\u8b8a\u3002\u00a0 \u8a72\u5206\u6790\u986f\u793a\uff0c\u5728\u53c3\u8207\u7814\u7a76\u7684\u5404\u4e9e\u7d44\u4e2d\uff0c\u5305\u62ec\u9aa8\u3001\u809d\u53ca\/\u6216\u80ba\u8f49\u79fb\u60a3\u8005\u3001\u4f34\u6709\u5e38\u898b\u7a81\u8b8a\uff08\u5982 PIK3CA \u548c TP53\uff09\u7684\u60a3\u8005\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u60a3\u8005\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u90fd\u6709\u5177\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002\u00a0 \u4e0a\u8ff0\u7d50\u679c\u986f\u793a\uff0c\u7576 ESR1 \u7a81\u8b8a\u7684\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\u3002\u00a0 \u610f\u5927\u5229\u4f5b\u7f85\u502b\u65af\u548c\u7d10\u7d042023\u5e7412\u670811\u65e5 \/\u7f8e\u901a\u793e\/ -- \u570b\u969b\u9818\u5148\u7684\u88fd\u85e5\u548c\u8a3a\u65b7\u516c\u53f8 Menarini Group\uff08\u300cMenarini\u300d\uff09\u8207\u5176\u81f4\u529b\u65bc\u70ba\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u8f49\u5316\u816b\u7624\u6cbb\u7642\u7684\u5168\u8cc7\u5b50\u516c\u53f8 Stemline Therapeutics, Inc. (\u300cStemline\u300d\uff09\u4eca\u5929\u516c\u4f48\u4e86\u91dd\u5c0d\u95dc\u9375 EMERALD \u81e8\u5e8a\u7814\u7a76\u958b\u5c55\u7684\u4e00\u9805\u65b0\u7684\u4e8b\u5f8c\u5206\u6790\u7d50\u679c\uff0c\u7d50\u679c\u8868\u660e\uff0c\u5728\u6240\u6709\u76f8\u95dc\u4e9e\u7d44\u4e2d\uff0c\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u90fd\u5f97\u5230\u4e86\u5177\u6709\u81e8\u5e8a\u610f\u7fa9\u7684\u6539\u5584\u3002 \u6578\u64da\u986f\u793a\uff0c\u91dd\u5c0d\u5185\u5206\u6ccc\u654f\u611f\u4e14\u643a\u5e36\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u60a3\u8005\uff0c\u5982\u679c\u5148\u524d\u4f7f\u7528 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\uff0c\u5247 ORSERDU\u00ae (elacestrant) \u55ae\u85e5\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u512a\u65bc\u6a19\u6e96\u6cbb\u7642 (SOC)\u3002 \u9019\u4e9b\u6578\u64da\u5c07\u5728 2023 \u5e74 12 \u6708 5 \u65e5\u81f3 12 \u6708 9 \u65e5\u8209\u884c\u7684 2023 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u764c\u7814\u8a0e\u6703 (SABCS) \u4e2d\u516c\u4f48\u3002\u00a0 EMERALD \u662f\u4e00\u9805\u7b2c 3 \u671f\u8a3b\u518a\u8a66\u9a57\uff0c\u8868\u660e\u8207\u6a19\u6e96\u6cbb\u7642\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\uff08\u6c1f\u7dad\u53f8\u7fa4\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766\uff09\u76f8\u6bd4\uff0cORSERDU \u6cbb\u7642\u5177\u6709\u5728\u7d71\u8a08\u5b78\u4e0a\u66f4\u52a0\u986f\u8457\u7684 PFS\u3002\u6839\u64da\u4e0a\u8ff0\u7d50\u679c\uff0cFDA \u65bc 2023 \u5e74 1 \u6708 27 \u65e5\u6838\u51c6 ORSERDU \u7528\u65bc\u6cbb\u7642\u60a3\u6709 ER+\u3001HER2-\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u7684\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\uff0c\u4e14\u9019\u4e9b\u60a3\u8005\u9700\u5728\u81f3\u5c11\u4e00\u7a2e\u5167\u5206\u6ccc\u7642\u6cd5\u5f8c\u75be\u75c5\u51fa\u73fe\u60e1\u5316\u3002\u9ad8\u9054 40% \u7684 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u5b58\u5728 ESR1 \u7a81\u8b8a\u3002\u00a0\u9019\u7a2e\u7a81\u8b8a\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u51fa\u73fe\u6297\u85e5\u6027\u7684\u5df2\u77e5\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u4e14\u5230\u76ee\u524d\u70ba\u6b62\uff0c\u5177\u6709\u9019\u985e\u7a81\u8b8a\u7684\u816b\u7624\u6cbb\u7642\u96e3\u5ea6\u66f4\u5927\u3002 \u00a0 \u91cd\u9ede\u662f\uff0c\u5728 2022 \u5e74\u8056\u5b89\u6771\u5c3c\u5967\u4e73\u817a\u764c\u7814\u8a0e\u6703 (SABCS) \u4e0a\u958b\u5c55\u95dc\u65bc EMERALD PFS \u7d50\u679c\u4e9e\u7d44\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 ORSERDU \u5f8c\u7684 PFS \u5ef6\u9577\u5448\u6b63\u9762\u76f8\u95dc\u59d3\uff0c\u4f46\u5728\u6a19\u6e96\u6cbb\u7642 (SOC) \u4e0a\u4e26\u7121\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD \u96a8\u6a5f\u5206\u7d44\u524d\u63a5\u53d7 CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u00a0ESR1 \u7a81\u8b8a\u60a3\u8005\uff0c\u63a1\u7528 ORSERDU \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 8.6 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u51fa\u73fe\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e 59% (\u98a8\u96aa\u6bd4\u7387 (HR)=0.41 95% \u7f6e\u4fe1\u5340\u9593: 0.26-0.63)\u3002 \u5728\u9019\u9805\u66f4\u65b0\u5f8c\u7684\u5206\u6790\u4e2d\uff0cMenarini Stemline \u8a55\u4f30\u55ae\u85e5 ORSERDU \u70ba\u9ad8\u767c\u81e8\u5e8a\u548c\u95dc\u9375\u751f\u7269\u6a19\u8a18\u4e9e\u7d44\u5e36\u4f86\u7684\u76ca\u8655\uff0c\u5305\u62ec\u60a3\u6709\u9aa8\u3001\u809d\u548c\/\u6216\u80ba\u8f49\u79fb\u7684\u60a3\u8005\uff1b\u6709\u5e38\u898b\u4f75\u767c PIK3CA \u6216 TP53 \u7a81\u8b8a\u7684\u60a3\u8005\uff1b\u6216 HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u00a0 \u300c\u9019\u4e9b\u6700\u65b0\u7814\u7a76\u7d50\u679c\u9032\u4e00\u6b65\u8b49\u5be6\uff0c\u5c0d\u65bc\u816b\u7624\u651c\u5e36\u00a0ESR1 \u7a81\u8b8a\u7684 ER+\u3001HER2- \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u4f86\u8aaa\uff0cORSERDU \u55ae\u85e5\u6cbb\u7642\u662f\u4e00\u7a2e\u5f88\u6709\u524d\u666f\u7684\u4e8c\u7dda\u6cbb\u7642\u9078\u64c7\uff0c\u300dUT Health San Antonio \u548c MD Anderson \u764c\u75c7\u4e2d\u5fc3\u4e73\u623f\u816b\u7624\u5c08\u5bb6\u3001\u91ab\u5b78\u6559\u6388\u3001\u91ab\u5b78\u535a\u58eb\u3001\u00a0\u79d1\u5b78\u535a\u58ebVirginia Kaklamani \u8aaa\uff0c\u300c\u6211\u5011\u767c\u73fe\uff0c\u5c0d\u65bc\u5148\u524d\u63a5\u53d7 CDK 4\/6 \u6cbb\u7642\u81f3\u5c11 12 \u500b\u6708\u7684\u60a3\u8005\uff0c\u4f7f\u7528 elacestrant \u55ae\u85e5\u6cbb\u7642\u8207\u6a19\u6e96\u6cbb\u7642\u76f8\u6bd4\uff0c\u5728\u8a31\u591a\u91cd\u8981\u4e9e\u7d44\u7684\u75be\u75c5\u7121\u60e1\u5316\u751f\u5b58\u671f\u65b9\u9762\u90fd\u6709\u6301\u7e8c\u6539\u5584\u3002\u00a0\u6211\u5011\u89c0\u5bdf\u5230\u7684\u9019\u4e9b\u7d50\u679c\u4e0d\u50c5\u9069\u7528\u65bc\u9aa8\u8f49\u79fb\u60a3\u8005\uff0c\u540c\u6a23\u9069\u7528\u65bc\u809d\u81df\u548c\/\u6216\u80ba\u90e8\u8f49\u79fb\u60a3\u8005\uff0c\u4e5f\u9069\u7528\u65bc PIK3CA \u548c TP53 \u7b49\u5e38\u898b\u5171\u7a81\u8b8a\u60a3\u8005\uff0c\u4ee5\u53ca HER2 \u4f4e\u8868\u9054\u7684\u60a3\u8005\u3002\u300d\u00a0 \u8207 SOC \u5167\u5206\u6ccc\u55ae\u85e5\u6cbb\u7642 (\u6cd5\u6d1b\u5fb7\u3001\u4f86\u66f2\u5511\u3001\u963f\u90a3\u66f2\u5511\u3001\u4f9d\u897f\u7f8e\u5766) \u76f8\u6bd4\uff0cORSERDU \u5728\u9019\u4e9b\u4e9e\u7d44\u4e2d\u986f\u793a\u51fa\u6709\u81e8\u5e8a\u610f\u7fa9\u7684 PFS \u6539\u5584\u3002\u7576\u5148\u524d CDK4\/6 \u6291\u5236\u5291\u6cbb\u7642\u6642\u9593\u81f3\u5c11\u70ba 12 \u500b\u6708\u6642\uff0cORSERDU \u7684 PFS \u660e\u986f\u66f4\u9577\uff0c\u9019\u8868\u660e\u7576 ESR1 \u7a81\u8b8a\u816b\u7624\u5c0d\u5167\u5206\u6ccc\u4ecd\u7136\u654f\u611f\u6642\uff0cER \u8def\u5f91\u53ef\u80fd\u662f\u75be\u75c5\u7684\u95dc\u9375\u9a45\u52d5\u56e0\u7d20\uff0c\u800c\u8207\u8f49\u79fb\u90e8\u4f4d\u3001\u00a0\u4f34\u96a8\u7684 PIK3CA \u6216 TP53 \u7a81\u8b8a\u6216 HER2 \u4f4e\u8868\u9054\u5747\u7121\u95dc\u3002\u8acb\u65bc\u6b64\u8655\u67e5\u770b\u5b8c\u6574\u6458\u8981\u3002 Menarini Group \u884c\u653f\u7e3d\u88c1 Elcin Barker Ergun \u8868\u793a\uff1a\u300c\u9019\u4e9b\u5728 SABCS 2023 \u5927\u6703\u4e0a\u516c\u4f48\u7684\u6578\u64da\u5efa\u7acb\u5728\u6211\u5011\u5c0d\u65bc ORSERDU \u53ca\u5176\u4f5c\u70ba\u91dd\u5c0d\u00a0ESR1 \u7a81\u8b8a\u816b\u7624\u7684\u55ae\u85e5\u7642\u6cd5\u6f5b\u529b\u7684\u8a8d\u77e5\u57fa\u790e\u4e4b\u4e0a\u3002\u300d\u00a0\u4ed6\u88dc\u5145\u9053\uff1a\u300cMenarini Stemline \u7684\u76ee\u6a19\u662f\u63d0\u4f9b\u8b8a\u9769\u6027\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u5e6b\u52a9\u5ef6\u9577\u548c\u6539\u5584\u764c\u75c7\u60a3\u8005\u7684\u751f\u547d\u3002\u00a0\u6211\u5011\u5f88\u81ea\u8c6a\u80fd\u70ba\u773e\u591a\u5408\u9069\u7684\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u63d0\u4f9b\u4e00\u7a2e\u6025\u9700\u7684\u5167\u5206\u6ccc\u6cbb\u7642\u9078\u64c7\uff0c\u800c\u4e14\u9019\u7a2e\u9078\u64c7\u7684\u5b89\u5168\u6027\u4e5f\u662f\u53ef\u63a7\u7684\u3002\u300d\u00a0 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u808c\u9aa8\u75db\u3001\u5641\u5fc3\uff0c\u4e09\u9178\u7518\u6cb9\u916f\u5347\u9ad8\uff0c\u81bd\u56fa\u9187\u5347\u9ad8\uff0c\u5614\u5410\uff0c\u75b2\u52de\uff0c\u6d88\u5316\u4e0d\u826f\uff0c\u8179\u7009\uff0c\u9223\u964d\u4f4e\uff0c\u80cc\u75db\uff0c\u808c\u9178\u9150\u5347\u9ad8\uff0c\u95dc\u7bc0\u75db\uff0c\u9209\u964d\u4f4e\uff0c\u4fbf\u79d8\uff0c\u982d\u75db\uff0c\u6f6e\u71b1\uff0c\u8179\u75db\uff0c\u8ca7\u8840\uff0c\u9240\u964d\u4f4e\u548c\u4e19\u6c28\u9178\u8f49\u6c28\u9176\u5347\u9ad8\u3002 ORSERDU \u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002\u00a0 \u8acb\u65bc\u6b64\u8655\u67e5\u95b1\u6709\u95dc Menarini Group \/Stemline Therapeutics \u5728 SABCS 2023 \u4e0a\u7684\u5168\u7cfb\u5217\u4ecb\u7d39\u986f\u793a\u7684\u8a73\u7d30\u8cc7\u8a0a\u3002 EMERALD \u7b2c 3 \u671f\u7814\u7a76 (NCT03778931) \u7c21\u4ecb\u00a0EMERALD \u7b2c 3 \u671f\u8a66\u9a57\u662f\u4e00\u9805\u96a8\u6a5f\u3001\u958b\u653e\u5f0f\u3001\u4e3b\u52d5\u5c0d\u7167\u7684\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2- \u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u00a0\u8a72\u7814\u7a76\u62db\u52df 478 \u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5 (\u5305\u62ec CDK4\/6 \u6291\u5236\u5291) \u7684\u60a3\u8005\u3002\u00a0\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7\u00a0elacestrant \u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u8a72\u7814\u7a76\u7684\u4e3b\u8981\u81e8\u5e8a\u7d42\u9ede\u662f\u8a55\u91cf\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u548c\u96cc\u6fc0\u7d20\u53d7\u9ad4 1 \u57fa\u56e0 (ESR1) \u7a81\u8b8a\u60a3\u8005\u7684\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS)\u3002\u00a0\u5728\u816b\u7624\u5177\u6709\u00a0ESR1 \u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant \u6cbb\u7642\u7684\u4e2d\u4f4d PFS \u70ba 3.8 \u500b\u6708\uff0c\u800c\u63a1\u7528 SOC \u7684\u4e2d\u4f4d PFS \u70ba 1.9 \u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS \u98a8\u96aa\u6bd4\u7387 (HR)=0.55, 95% \u7f6e\u4fe1\u5340\u9593: 0.39, 0.77)\u3002 ORSERDU (elacestrant) \u7c21\u4ecb\u00a0\u7f8e\u570b\u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \uff0c\u6bcf\u9320 345 \u6beb\u514b\uff0c\u9069\u7528\u65bc\u6cbb\u7642\u7d55\u7d93\u5f8c\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u3001\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2 (HER2) \u9670\u6027\u3001ESR1 \u7a81\u8b8a\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u81f3\u5c11\u63a5\u53d7\u904e\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\u5f8c\u75be\u75c5\u6709\u60e1\u5316\u9032\u5c55\u7684\u60a3\u8005\u3002 \u6b32\u4e86\u89e3\u7f8e\u570b\u7684\u5b8c\u6574\u8655\u65b9\u8cc7\u8a0a\u53ef\u4ee5\u700f\u89bd\u00a0www.orserdu.com\u3002 \u91cd\u8981\u5b89\u5168\u8cc7\u8a0a \u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9805 \u8840\u8102\u7570\u5e38\uff1a\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c30% \u51fa\u73fe\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\uff0c27% \u51fa\u73fe\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u30023 \u7d1a\u548c 4 \u7d1a\u9ad8\u81bd\u56fa\u9187\u8840\u75c7\u548c\u9ad8\u4e09\u9178\u7518\u6cb9\u8102\u8840\u75c7\u7684\u767c\u751f\u7387\u5206\u5225\u70ba 0.9% \u548c 2.2%\u3002\u5728\u958b\u59cb ORSERDU \u6cbb\u7642\u524d\u4ee5\u53ca\u6cbb\u7642\u671f\u9593\u9808\u5b9a\u671f\u76e3\u6e2c\u8840\u8102\u60c5\u6cc1\u3002 \u80da\u80ce-\u80ce\u5152\u6bd2\u6027\uff1a\u6839\u64da\u52d5\u7269\u7814\u7a76\u4e2d\u7684\u767c\u73fe\u53ca\u5176\u4f5c\u7528\u6a5f\u5236\uff0c\u5411\u5b55\u5a66\u8655\u65b9 ORSERDU \u7d66\u85e5\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u00a0\u8acb\u5411\u5b55\u5a66\u548c\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u544a\u77e5\u53ef\u80fd\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u7684\u98a8\u96aa\u3002\u00a0\u5efa\u8b70\u5177\u6709\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u670d\u7528\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002\u5c0d\u65bc\u64c1\u6709\u5177\u751f\u80b2\u80fd\u529b\u7684\u5973\u6027\u4f34\u4fb6\u7684\u7537\u6027\u60a3\u8005\uff0c\u5efa\u8b70\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u81f3\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\uff0c\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u65b9\u6cd5\u3002 \u4e0d\u826f\u53cd\u61c9 \u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c12% \u7684\u60a3\u8005\u51fa\u73fe\u56b4\u91cd\u7684\u4e0d\u826f\u53cd\u61c9\u3002\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u4e2d\uff0c\u767c\u751f\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u7684\u60a3\u8005\u6bd4\u4f8b\u8d85\u904e 1%\uff0c\u9019\u4e9b\u53cd\u61c9\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (1.7%) \u548c\u5641\u5fc3 (1.3%)\u30021.7% \u7684\u63a5\u53d7 ORSERDU \u6cbb\u7642\u7684\u60a3\u8005\u51fa\u73fe\u4e86\u81f4\u547d\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u5305\u62ec\u5fc3\u81df\u9a5f\u505c\u3001\u6557\u8840\u6027\u4f11\u514b\u3001\u61a9\u5ba4\u708e\uff0c\u4ee5\u53ca\u539f\u56e0\u672a\u660e\u7684\u75c5\u75c7(\u5404\u4e00\u4f8b)\u3002ORSERDU \u7684\u6700\u5e38\u898b\u4e0d\u826f\u53cd\u61c9 (&gt;10%) \uff0c\u5305\u62ec\u5be6\u9a57\u5ba4\u6aa2\u6e2c\u7d50\u679c\u7570\u5e38\uff0c\u5305\u62ec\u808c\u8089\u9aa8\u9abc\u75bc\u75db (41%) \u3001\u5641\u5fc3 (35%) \u3001\u81bd\u56fa\u9187\u589e\u9ad8 (30%) \u3001\u8c37\u8349\u8f49\u6c28\u9176 (AST) \u589e\u9ad8 (29%) \u3001\u4e09\u9178\u7518\u6cb9\u8102\u589e\u9ad8 (27%) \u3001\u75b2\u52de (26%) \u3001\u8840\u7d05\u86cb\u767d\u964d\u4f4e (26%) \u3001\u5614\u5410 (19%) \u3001\u7a40\u4e19\u8f49\u6c28\u9176 (ALT) \u6c34\u5e73\u589e\u9ad8 (17%) \u3001\u9209\u964d\u4f4e (16%) \u3001\u808c\u9178\u9150\u589e\u9ad8 (16%) \u3001\u98df\u617e\u964d\u4f4e (15%) \u3001\u8179\u7009 (13%) \u3001\u982d\u75db (12%) \u3001\u4fbf\u79d8 (12%) \u3001\u8179\u75db (11%) \u3001\u6f6e\u7d05 (11%) \u548c\u6d88\u5316\u4e0d\u826f (10%)\u3002 \u85e5\u7269\u76f8\u4e92\u4f5c\u7528\u00a0 \u8207 CYP3A4 \u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a\u00a0\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u6291\u5236\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002\u907f\u514d\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4 \u8a98\u5c0e\u5291\u548c ORSERDU \u4e00\u8d77\u4f7f\u7528\u3002 \u4f7f\u7528\u65bc\u7279\u5b9a\u4eba\u7fa4\u7684\u6ce8\u610f\u4e8b\u9805 \u54fa\u4e73\u671f\uff1a\u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU \u6cbb\u7642\u671f\u9593\u76f4\u5230\u6700\u5f8c\u4e00\u5291\u5f8c\u7684 1 \u9031\u5167\u4e0d\u8981\u54fa\u4e73\u3002\u809d\u529f\u80fd\u53d7\u640d\uff1a\u907f\u514d\u5c0d\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C) \u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002\u4e2d\u5ea6\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh B) \u7684\u60a3\u8005\u8981\u6e1b\u5c11 ORSERDU \u7684\u5291\u91cf\u3002 ORSERDU \u5728\u5152\u79d1\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u5b9a\u3002 \u82e5\u8981\u5831\u544a\u53ef\u7591\u7684\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61 Stemline Therapeutics, Inc.\uff0c\u96fb\u8a71\u865f\u78bc\u70ba 1-877-332-7961\uff0c\u6216\u8005\u81f4\u96fb 1-800-FDA-1088 \u806f\u7d61 FDA\uff0c\u6216\u700f\u89bd\u00a0www.fda.gov\/medwatch\u3002 \u95dc\u65bc Elacestrant \u81e8\u5e8a\u958b\u767c\u8a08\u5283\u00a0Elacestrant \u9084\u5728\u6578\u500b\u8f49\u79fb\u6027\u4e73\u764c\u75be\u75c5\u7684\u81e8\u5e8a\u8a66\u9a57\u4e2d\u9032\u884c\u7814\u7a76\uff0c\u55ae\u7368\u6216\u662f\u7d50\u5408\u5176\u4ed6\u7642\u6cd5\uff1aELEVATE\uff08NCT05563220\uff09\u662f\u4e00\u9805\u7b2c 1b\/2 \u671f\u81e8\u5e8a\u8a66\u9a57\uff0c\u5c07\u8a55\u4f30 elacestrant \u5408\u4f75\u4f7f\u7528 alpelisib\u3001everolimus\u3001palbociclib\u3001abemaciclib \u548c ribociclib \u7642\u6cd5\u7684\u5b89\u5168\u6027\u548c\u7642\u6548\u3002ELECTRA\uff08NCT05386108\uff09\u662f\u4e00\u9805 1b\/2 \u671f\u958b\u653e\u6a19\u7c64\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30 elacestrant \u806f\u5408 abemaciclib \u6cbb\u7642 ER+\u3001HER2- \u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u7b2c 2 \u671f\u7814\u7a76\u8a55\u4f30\u6b64\u6cbb\u7642\u65b9\u6848\u5728\u8166\u8f49\u79fb\u60a3\u8005\u4e2d\u7684\u61c9\u7528\u3002 ELCIN\uff08NCT05596409\uff09\u662f\u4e00\u9805\u7b2c 2 \u671f\u8a66\u9a57\uff0c\u8a55\u4f30 elacestrant \u5c0d\u96cc\u6fc0\u7d20\u53d7\u9ad4\u967d\u6027 (ER+)\/\u4eba\u985e\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4-2 \u9670\u6027\uff08HER2-\uff09\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005 (mBC) \u7684\u7642\u6548\uff0c\u9019\u4e9b\u60a3\u8005\u5148\u524d\u63a5\u53d7\u904e 1 \u6b21\u6216 2 \u6b21\u8377\u723e\u8499\u7642\u6cd5\uff0c\u4e14\u5148\u524d\u672a\u4f7f\u7528\u904e\u7d30\u80de\u9031\u671f\u86cb\u767d\u4f9d\u8cf4\u6027\u6fc0\u9176\u6a19\u9776\u9176 CDK4 \u548c CDK6 \u6291\u5236\u5291\uff08CDK4\/6i\uff09\u3002Elacestrant \u4e5f\u5c07\u65bc\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002\u00a0 Menarini Group \u7c21\u4ecb\u00a0Menarini Group 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