{"id":179235,"date":"2023-09-22T21:49:00","date_gmt":"2023-09-22T13:49:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=179235"},"modified":"2023-09-22T21:49:00","modified_gmt":"2023-09-22T13:49:00","slug":"%e6%ad%90%e6%b4%b2%e5%a7%94%e5%93%a1%e6%9c%83%e6%a0%b8%e5%87%86-menarini-group-%e7%9a%84-orserdu-elacestrant-%e7%94%a8%e6%96%bc%e6%b2%bb%e7%99%82%e6%94%9c%e5%b8%b6%e6%b4%bb%e5%8c%96-esr1","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=179235","title":{"rendered":"\u6b50\u6d32\u59d4\u54e1\u6703\u6838\u51c6 Menarini Group \u7684 ORSERDU\u00ae (Elacestrant) \u7528\u65bc\u6cbb\u7642\u651c\u5e36\u6d3b\u5316 ESR1 \u7a81\u8b8a\u7684ER +\uff0cHER2- \u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u7684\u60a3\u8005"},"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>\u6bcf\u5e74\u5728\u6b50\u6d32\u6709\u8d85\u904e 550,000 \u540d\u60a3\u8005\u88ab\u8a3a\u65b7\u51fa\u60a3\u6709\u4e73\u764c\uff0c\u5176\u4e2d 70% \u7684\u60a3\u8005\u70ba\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u00b9\uff1b\u6bcf\u5e74\u6b50\u6d32\u6709\u8d85\u904e 147,000 \u540d\u4e73\u764c\u60a3\u8005\u6b7b\u65bc\u8a72\u75be\u75c5\u00b2\u3002<\/li>\n<li>ORSERDU \u662f\u9996\u6b3e\u5c08\u9580\u91dd\u5c0d ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u816b\u7624\u4e14\u651c\u5e36 ESR1 \u7a81\u8b8a\u7684\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u9019\u662f\u8fd1 20 \u5e74\u4f86\u5167\u5206\u6ccc\u6cbb\u7642\u9818\u57df\u7684\u9996\u6b21\u5275\u65b0<\/li>\n<li>ESR1 \u7a81\u8b8a\u5728 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u4e2d\u51fa\u73fe\u7684\u6bd4\u4f8b\u9ad8\u9054 40\uff05\uff0c\u4e14\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u7684\u5df2\u77e5\u8010\u85e5\u9a45\u52d5\u56e0\u7d20\uff0c\u4f7f\u5f97\u9019\u985e\u578b\u816b\u7624\u66f4\u52a0\u96e3\u4ee5\u6cbb\u7642<\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">\u610f\u5927\u5229\u4f5b\u7f85\u502b\u85a9\u53ca\u7d10\u7d04<\/span><span class=\"legendSpanClass\">\u00a02023\u5e749\u670822\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212; \u9818\u5148\u7684\u570b\u969b\u5236\u85e5\u548c\u8a3a\u65b7\u516c\u53f8 Menarini Group\uff08\u300cMenarini\u300d\uff09\u4ee5\u53ca Menarini Group \u7684\u5168\u8cc7\u5b50\u516c\u53f8 Stemline Therapeutics Inc.\uff08\u300cStemline\u300d\uff09\u4eca\u5929\u5ba3\u5e03\uff0c\u6b50\u6d32\u59d4\u54e1\u6703\u5df2\u6838\u51c6 ORSERDU\u00ae (elacestrant) \u4f5c\u70ba\u55ae\u85e5\u6cbb\u7642\u6cd5\uff0c\u7528\u65bc\u6cbb\u7642\u651c\u5e36\u6d3b\u5316 ESR1 \u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\uff0cHER2 \u9670\u6027\uff0c\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\uff0c\u4e26\u4e14\u5728\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6 \u6291\u5236\u5291\uff09\u5f8c\u75be\u75c5\u52a0\u5287\u7684\u60a3\u8005\u3002<\/p>\n<p>\u6b50\u6d32\u59d4\u54e1\u6703\u7684\u6b64\u6b21\u6838\u51c6\u662f\u57fa\u65bc\u6b50\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40 (EMA) \u65bc <a href=\"https:\/\/www.menarini.com\/en-us\/news\/news-detail\/menarini-group-receives-positive-chmp-opinion-recommending-ec-approval-of-orserdu174-elacestrant-for-the-treatment-of-patients-with-er-her2-locally-advanced-or-metastatic-breast-cancer\" target=\"_blank\" rel=\"nofollow noopener\">2023\u00a0\u5e74 7\u00a0\u6708<\/a>\u516c\u4f48\u7684\u4eba\u7528\u85e5\u54c1 (CHMP)\u00a0\u7684\u80af\u5b9a\u610f\u898b\u3002\u6b64\u6b21\u6838\u51c6\u610f\u5473\u8457 ORSERDU\u00a0\u662f\u7b2c\u4e00\u7a2e\uff0c\u4e5f\u662f\u552f\u4e00\u4e00\u7a2e\u660e\u78ba\u6307\u793a\u7528\u65bc\u6cbb\u7642\u651c\u5e36 <i>ESR1<\/i>\u00a0\u7a81\u8b8a\u7684 ER+\uff0cHER2-\u00a0\u816b\u7624\u7684\u6cbb\u7642\u65b9\u6cd5\u3002<i>ESR1<\/i>\u00a0\u7a81\u8b8a\u662f\u7531\u65bc\u63a5\u53d7\u5167\u5206\u6ccc\u6cbb\u7642\u800c\u7522\u751f\u7684\u5f8c\u5929\u7a81\u8b8a\uff0c\u4e26\u4e14\u5728 ER+\uff0cHER2- mBC\u00a0\u4e73\u764c\u60a3\u8005\u4e2d\u767c\u751f\u7387\u9ad8\u9054 40%\u3002<i>ESR1<\/i>\u00a0\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<\/p>\n<p>Menarini\u00a0Group\u00a0\u7684\u884c\u653f\u7e3d\u88c1\u00a0Elcin\u00a0Barker\u00a0Ergun\u00a0\u8868\u793a\uff1a\u300c\u6211\u5011\u65e9\u5df2\u77e5\u9053\uff0c\u60a3\u6709\u8f49\u79fb\u6027\u4e73\u764c\u7684\u60a3\u8005\u9700\u8981\u6709\u6548\u4e14\u6613\u65bc\u8010\u53d7\u7684\u6cbb\u7642\u9078\u9805\uff0c\u4ee5\u5728\u6cbb\u7642\u75be\u75c5\u7684\u540c\u6642\u8b93\u4ed6\u5011\u5c08\u6ce8\u65bc\u5c0d\u4ed6\u5011\u800c\u8a00\u91cd\u8981\u7684\u4e8b\u60c5\u3002\u300d\u300c\u80fd\u5920\u63d0\u4f9b\u6bcf\u65e5\u53ea\u9700\u53e3\u670d\u4e00\u6b21\u7684\u65b0\u578b\u4e73\u764c\u6cbb\u7642\u65b9\u6848\u4f7f\u6211\u5011\u500d\u611f\u81ea\u8c6a\uff0c\u9019\u4e5f\u662f\u8fd1\u4e8c\u5341\u5e74\u4f86\u5167\u5206\u6ccc\u6cbb\u7642\u9818\u57df\u7684\u9996\u6b21\u5275\u65b0\uff1b\u540c\u6642\uff0c\u6211\u5011\u975e\u5e38\u611f\u8b1d\u816b\u7624\u5b78\u7814\u7a76\u4eba\u54e1\u4ee5\u53ca\u53c3\u8207\u81e8\u5e8a\u7814\u7a76\u7684\u6240\u6709\u60a3\u8005\uff0c\u6b63\u662f\u56e0\u70ba\u4ed6\u5011\u7684\u652f\u6301\u548c\u53c3\u8207\uff0c\u624d\u80fd\u6536\u7a6b\u4eca\u5929\u7684\u6210\u679c\u3002\u300d<\/p>\n<p>\u7531\u65bc\u76f8\u7576\u591a\u7684 ER+ HER2- \u60a3\u8005\u662f\u5728\u8f49\u79fb\u6027\u764c\u75c7\u904e\u7a0b\u4e2d\u7684\u67d0\u500b\u6642\u523b\u6700\u7d42\u767c\u5c55\u51fa <i>ESR1<\/i>\u00a0\u7a81\u8b8a\uff0c\u56e0\u6b64\u5728\u6bcf\u6b21 mBC\u00a0\u60a3\u8005\u51fa\u73fe\u75be\u75c5\u52a0\u5287\u6642\u9032\u884c <i>ESR1<\/i>\u00a0\u6e2c\u8a66\u975e\u5e38\u91cd\u8981\uff0c\u4ee5\u77ad\u89e3\u5176\u4e73\u764c\u7684\u60e1\u5316\u56e0\u7d20\u3002\u300c\u4eca\u5929\u7684\u6838\u51c6\u70ba\u6211\u5011\u63d0\u4f9b\u4e86\u9996\u500b\u6cbb\u7642\u65b9\u6848\uff0c\u4f7f\u6211\u5011\u80fd\u5920\u76f4\u63a5\u5c0d\u6297\u9019\u7a2e\u5c0e\u81f4\u4e73\u764c\u66f4\u96e3\u6cbb\u7642\u7684\u7a81\u8b8a\uff0c\u70ba\u60a3\u8005\u548c\u5176\u5bb6\u4eba\u5e36\u4f86\u4e86\u5e0c\u671b\u3002\u300d\u610f\u5927\u5229\u6b50\u6d32\u816b\u7624\u7814\u7a76\u6240 (IRCCS)\u00a0\u65e9\u671f\u85e5\u7269\u958b\u767c\u90e8\u9580\u4e3b\u4efb\u3001\u7c73\u862d\u5927\u5b78\u91ab\u5b78\u816b\u7624\u5b78\u79d1\u6559\u6388 Giuseppe Curigliano\u00a0\u91ab\u5b78\u535a\u58eb\u8aaa\u9053\u3002<\/p>\n<p>\u7b2c\u4e09\u671f EMERALD\u00a0\u8a66\u9a57\u7684\u8cc7\u6599\u70ba ORSERDU\u00a0\u7684\u6838\u51c6\u63d0\u4f9b\u4e86\u652f\u6301\uff0c\u8a72\u8a66\u9a57\u8868\u660e\uff0c\u8207\u6a19\u6e96\u6cbb\u7642 (SOC)\u00a0\u76f8\u6bd4\uff0c\u4f7f\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u00a0\u5177\u6709\u7d71\u8a08\u5b78\u610f\u7fa9\uff0c\u6a19\u6e96\u6cbb\u7642\u7684\u5b9a\u7fa9\u70ba\u7814\u7a76\u4eba\u54e1\u9078\u64c7\u7684\u5df2\u7372\u51c6\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\u3002\u672c\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5168\u9ad4\u60a3\u8005\u7fa4\u9ad4\u548c\u5e36\u6709 <i>ESR1<\/i>\u00a0\u7a81\u8b8a\u60a3\u8005\u4e2d\u7684 PFS\u00a0\u5c0d\u6bd4\u3002\u5728\u816b\u7624\u5177\u6709 <i>ESR1<\/i>\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u51fa\u73fe\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS HR=0.55, 95% CI: 0.39, 0.77)\u3002<\/p>\n<p>\u5728 2022\u00a0\u5e74\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u764c\u7814\u8ba8\u4f1a (SABCS)\u00a0\u4e0a\u958b\u5c55\u4e86\u95dc\u65bc EMERALD\u00a0PFS\u00a0\u7d50\u679c\u7684\u4e8b\u5f8c\u4e9e\u7d44\u5206\u6790\uff0c\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6i\u00a0\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 elacestrant\u00a0\u5f8c\u7684 PFS\u00a0\u5ef6\u9577\u5448\u6b63\u76f8\u95dc\uff0c\u4f46\u5728 SOC\u00a0\u4e0a\u4e26\u7121\u5448\u73fe\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD\u00a0\u96a8\u6a5f\u7be9\u67e5\u4e4b\u524d\u63a5\u53d7 CDK4\/6i\u00a0\u6cbb\u7642 12\u00a0\u500b\u6708\u4ee5\u4e0a\uff0c\u4e14\u767c\u751f <i>ESR1<\/i>\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\uff0c<\/p>\n<p>elacestrant\u00a0\u7684 PFS\u00a0\u4e2d\u4f4d\u6578\u70ba 8.6\u00a0\u500b\u6708\uff0c\u800c SOC\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u98a8\u96aa\u964d\u4f4e\u4e86 59\uff05\u00a0(HR=0.41 95% CI: 0.26-0.63)\u3002\u00b3<\/p>\n<p>\u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002ORSERDU\u00a0\u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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\u3002ORSERDU\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002<\/p>\n<p>Stemline\u00a0\u53ca\u5176\u9644\u5c6c\u516c\u53f8\u5c07\u5728\u6b50\u6d32\u63a8\u51fa\u8a72\u7522\u54c1\u3002<\/p>\n<p><b>EMERALD<\/b><b>\u00a0\u7b2c <\/b><b>3<\/b><b>\u00a0\u671f\u7814\u7a76 <\/b><b>(NCT03778931)<\/b><b>\u00a0\u7c21\u4ecb<\/b><br \/>EMERALD\u00a0\u7b2c 3\u00a0\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\u00a0\u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2-\u00a0\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u8a72\u7814\u7a76\u62db\u52df\u4e86 478\u00a0\u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5\uff08\u5305\u62ec CDK4\/6\u00a0\u6291\u5236\u5291\uff09\u7684\u60a3\u8005\u3002\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7 elacestrant\u00a0\u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5728\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u4ee5\u53ca\u5177\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 1\u00a0\u57fa\u56e0 (<i>ESR1<\/i>)\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u4e2d\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u3002\u5728\u816b\u7624\u5177\u6709 <i>ESR1<\/i>\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\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 HR=0.55, 95% CI: 0.39, 0.77)\u3002<\/p>\n<p><b>\u95dc\u65bc <\/b><b>ORSERDU\u00ae (elacestrant)<\/b><\/p>\n<p><b>\u9069\u61c9\u75c7\uff1a<\/b>ORSERDU (elacestrant) \u55ae\u85e5\u6cbb\u7642\u7528\u65bc\u651c\u5e36\u6d3b\u5316 <i>ESR1<\/i>\u00a0\u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER)\u00a0\u967d\u6027\u3001HER2\u00a0\u9670\u6027\u3001\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u4e14\u5728\u63a5\u53d7\u904e\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6\u00a0\u6291\u5236\u5291\uff09\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\u3002<\/p>\n<p><b>ORSERDU<\/b>\u00a0<b>SmPC<\/b><b>\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a <\/b><\/p>\n<p><b>\u809d\u529f\u80fd\u53d7\u640d\uff1a<\/b>\u00a0\u809d\u529f\u80fd\u4e2d\u5ea6\u53d7\u640d\u7684\u60a3\u8005 (Child-Pugh B) \u61c9\u8b39\u614e\u4f7f\u7528 ORSERDU\uff0c\u6bcf\u65e5\u5291\u91cf\u70ba 258\u00a0\u6beb\u514b\u3002\u5728\u7f3a\u4e4f\u81e8\u5e8a\u8cc7\u6599\u7684\u60c5\u6cc1\u4e0b\uff0c\u4e0d\u5efa\u8b70\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C)\u00a0\u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002<\/p>\n<p><b>\u8207 <\/b><b>CYP3A4<\/b><b>\u00a0\u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a <\/b>\u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\u3002 \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u8a98\u5c0e\u5291\u540c\u6642\u4f7f\u7528\u3002<\/p>\n<p><b>\u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff1a<\/b>\u665a\u671f\u4e73\u764c\u60a3\u8005\u5e38\u898b\u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff0c\u4e14\u5728 ORSERDU\u00a0\u7684\u81e8\u5e8a\u7814\u7a76\u4e2d\u4e5f\u89c0\u5bdf\u5230\u6b64\u73fe\u8c61\u3002\u7576\u70ba\u9ad8\u98a8\u96aa\u60a3\u8005\u958b\u7acb ORSERDU\u00a0\u6642\uff0c\u61c9\u8457\u91cd\u8003\u616e\u6b64\u4e8b\u9805\u3002<\/p>\n<p><b>\u4e0d\u826f\u53cd\u61c9\uff1a <\/b><\/p>\n<p>\u22651%\u00a0\u7684\u60a3\u8005\u5831\u544a\u7684\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3\u3001\u547c\u5438\u56f0\u96e3\u548c\u8840\u6813\u6813\u585e\uff08\u975c\u8108\uff09\u3002<\/p>\n<p>ORSERDU \u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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<\/p>\n<p>Elacestrant\u00a0\u6700\u5e38\u898b\u7684\u4e09\u7d1a\u53ca\u4ee5\u4e0a (\u22652%)\u00a0\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3 (2.7%)\uff0cAST\u00a0\u5347\u9ad8 (2.7%)\uff0cALT\u00a0\u5347\u9ad8 (2.3%)\uff0c\u8ca7\u8840 (2%)\uff0c\u80cc\u75db (2%)\u00a0\u548c\u9aa8\u75db (2%)\u3002<\/p>\n<p><b>\u5641\u5fc3\uff1a<\/b>35%\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u5641\u5fc3\u30022.5% \u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe 3-4\u00a0\u7d1a\u5641\u5fc3\u4e8b\u4ef6\u3002\u5728\u7b2c\u4e00\u500b\u9031\u671f\u4e2d\uff0c\u5641\u5fc3\u7684\u767c\u751f\u983b\u7387\u66f4\u9ad8\uff0c\u800c\u5f9e\u7b2c\u4e8c\u500b\u9031\u671f\u958b\u59cb\uff0c\u5641\u5fc3\u7684\u767c\u751f\u7387\u901a\u5e38\u5728\u5f8c\u7e8c\u9031\u671f\u4e2d\u6709\u6240\u4e0b\u964d\uff08\u5373\u96a8\u8457\u6642\u9593\u7684\u63a8\u79fb\u800c\u964d\u4f4e\uff09\u3002<\/p>\n<p><b>\u5e74\u9577\u8005\uff1a<\/b>75\u00a0\u6b72\u53ca\u4ee5\u4e0a\u60a3\u8005\u66f4\u5e38\u5831\u544a\u8178\u80c3\u9053\u554f\u984c\u3002<\/p>\n<p><b>\u751f\u80b2\u3001\u61f7\u5b55\u548c\u54fa\u4e73\uff1a <\/b><\/p>\n<p>\u8655\u65bc\u61f7\u5b55\u671f\u6216\u672a\u4f7f\u7528\u907f\u5b55\u63aa\u65bd\u7684\u80b2\u9f61\u5a66\u5973\u4e0d\u61c9\u4f7f\u7528 ORSERDU\u3002\u6839\u64da elacestrant\u00a0\u7684\u4f5c\u7528\u6a5f\u5236\u548c\u52d5\u7269\u7684\u751f\u6b96\u6bd2\u6027\u7814\u7a76\u7d50\u679c\uff0c\u5b55\u5a66\u670d\u7528 ORSERDU\u00a0\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u61c9\u544a\u77e5\u80b2\u9f61\u5973\u6027\uff0c\u5728\u63a5\u53d7 ORSERDU\u00a0\u6cbb\u7642\u671f\u9593\u548c\u6700\u5f8c\u4e00\u6b21\u7528\u85e5\u5f8c\u4e00\u9031\u5167\u5fc5\u9808\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u63aa\u65bd\u3002<\/p>\n<p>\u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU\u00a0\u6cbb\u7642\u671f\u9593\u548c\u6700\u5f8c\u4e00\u6b21\u670d\u7528 ORSERDU\u00a0\u5f8c\u4e00\u9031\u5167\u4e0d\u61c9\u54fa\u4e73\u3002<\/p>\n<p>\u57fa\u65bc\u52d5\u7269\u7814\u7a76\u7684\u767c\u73fe\u548c\u5176\u4f5c\u7528\u6a5f\u5236\uff0cORSERDU\u00a0\u53ef\u80fd\u6703\u5f71\u97ff\u6709\u751f\u6b96\u80fd\u529b\u7684\u7537\u6027\u548c\u5973\u6027\u7684\u751f\u80b2\u80fd\u529b\u3002<\/p>\n<p><b>\u5c0d\u99d5\u8eca\u548c\u64cd\u4f5c\u6a5f\u5668\u7684\u5f71\u97ff\uff1a<\/b>\u4e00\u4e9b\u670d\u7528 ORSERDU\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u75b2\u52de\u3001\u865b\u5f31\u548c\u5931\u7720\u75c7\u72c0\u3002\u60a3\u8005\u5728\u958b\u8eca\u6216\u64cd\u4f5c\u6a5f\u5668\u6642\uff0c\u61c9\u7576\u8b39\u614e\u6ce8\u610f\u662f\u5426\u6709\u4e0d\u826f\u53cd\u61c9\u3002<\/p>\n<p>\u5c0d\u65bc\u65b0\u751f\u5152\u81f3 18\u00a0\u6b72\u4ee5\u4e0b\u5152\u7ae5\uff0cORSERDU\u00a0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u7acb\u3002<\/p>\n<p><b>\u5831\u544a\u7591\u4f3c\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61\uff1a<\/b><u><a href=\"mailto:EUPV@menarinistemline.com\" target=\"_blank\" rel=\"nofollow noopener\">EUPV@menarinistemline.com<\/a><\/u><\/p>\n<p>\u5831\u544a\u7522\u54c1\u6295\u8a34\uff0c\u8acb\u806f\u7d61\uff1a<u><a href=\"mailto:EUcustomerservice@menarinistemline.com\" target=\"_blank\" rel=\"nofollow noopener\">EUcustomerservice@menarinistemline.com<\/a><\/u><\/p>\n<p>\u7d22\u53d6\u91ab\u7642\u8cc7\u8a0a\uff0c\u8acb\u806f\u7d61\uff1a<u><a href=\"mailto:EUmedinfo@menarinistemline.com\" target=\"_blank\" rel=\"nofollow noopener\">EUmedinfo@menarinistemline.com<\/a><\/u><\/p>\n<p>Elacestrant\u00a0\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\u00a0(<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05563220\" target=\"_blank\" rel=\"nofollow noopener\">NCT05563220<\/a>)\uff1bELECTRA (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05386108\" target=\"_blank\" rel=\"nofollow noopener\">NCT05386108<\/a>)\uff1b\u4ee5\u53ca ELCIN (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05596409\" target=\"_blank\" rel=\"nofollow noopener\">NCT05596409<\/a>)\u3002Elacestrant\u00a0\u4e5f\u8a08\u5283\u5728\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002<\/p>\n<p><b>2020<\/b><b>\u00a0\u5e74 <\/b><b>7<\/b><b>\u00a0\u6708\uff0c<\/b><b>Menarini<\/b>\u00a0<b>Group<\/b><b>\u00a0\u5f9e <\/b><b>Radius<\/b>\u00a0<b>Health<\/b><b>, <\/b><b>Inc<\/b><b>. \u7372\u5f97\u4e86 <\/b><b>elacestrant<\/b><b>\u00a0\u7684\u5168\u7403\u6388\u6b0a\u3002<\/b><b>Menarini<\/b>\u00a0<b>Group<\/b><b>\u00a0\u73fe\u5728\u5168\u6b0a\u8ca0\u8cac <\/b><b>elacestrant<\/b><b>\u00a0\u7684\u5168\u7403\u8a3b\u518a\u3001\u5546\u696d\u5316\u548c\u9032\u4e00\u6b65\u7814\u767c\u6d3b\u52d5\u3002<\/b><\/p>\n<p><b>Menarini<\/b>\u00a0<b>Group<\/b><b>\u00a0\u7c21\u4ecb<\/b><\/p>\n<p>Menarini Group\u00a0\u662f\u4e00\u5bb6\u9818\u5148\u7684\u570b\u969b\u91ab\u85e5\u548c\u8a3a\u65b7\u516c\u53f8\uff0c\u5e74\u71df\u696d\u984d\u8d85\u904e 44\u00a0\u5104\u7f8e\u5143\uff0c\u64c1\u6709\u8d85\u904e 17,000\u00a0\u540d\u54e1\u5de5\u3002Menarini\u00a0\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\u00a0\u64c1\u6709 18\u00a0\u500b\u751f\u7522\u57fa\u5730\u548c 9\u00a0\u500b\u7814\u767c\u4e2d\u5fc3\uff0c\u7522\u54c1\u92b7\u5f80\u5168\u7403 140\u00a0\u500b\u570b\u5bb6\/\u5730\u5340\u3002 \u6b32\u4e86\u89e3\u66f4\u591a\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd <a href=\"http:\/\/www.menarini.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.menarini.com<\/a>\u3002<\/p>\n<p><b>\u95dc\u65bc <\/b><b>Stemline<\/b>\u00a0<b>Therapeutics<\/b>\u00a0<b>Inc<\/b><b>. <\/b><\/p>\n<p><b>Stemline<\/b>\u00a0<b>Therapeutics<\/b><b>, <\/b><b>Inc<\/b><b>.\uff08\u300c<\/b><b>Stemline<\/b><b>\u300d\uff09\u662f <\/b><b>Menarini<\/b>\u00a0<b>Group<\/b><b>\u00a0\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\u3002<\/b><b>Stemline<\/b><b>\u00a0\u5c07\u5728\u7f8e\u570b\u5546\u696d\u5316 <\/b><b>ORSERDU\u00ae (elacestrant)<\/b><b>\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 <\/b><b>(ER)<\/b><b>\u00a0\u967d\u6027\u3001\u4eba\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 <\/b><b>2<\/b>\u00a0<b>(HER2)<\/b><b>\u00a0\u9670\u6027\u3001<\/b><b>ESR1<\/b><b>\u00a0\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\u3002<\/b><b>Stemline<\/b><b>\u00a0\u9084\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u63a8\u51fa\u4e86 <\/b><b>ELZONRIS\u00ae (tagraxofusp-erzs)<\/b><b>\uff0c<\/b><b>\u9019\u662f\u4e00\u7a2e\u91dd\u5c0d <\/b><b>CD123<\/b><b>\u00a0\u7684\u5275\u65b0\u6a19\u9776\u6cbb\u7642\uff0c\u7528\u65bc\u6cbb\u7642\u7206\u767c\u6027\u6d46\u7d30\u80de\u6a39\u7a81\u7d30\u80de\u816b\u7624 <\/b><b>(BPDCN)<\/b><b>\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 <\/b><b>BPDCN<\/b><b>\u00a0\u6cbb\u7642\u65b9\u6848\u3002<\/b><b>Stemline<\/b><b>\u00a0\u4ea6\u5c07\u5728\u6b50\u6d32\u5546\u696d\u5316 <\/b><b>NEXPOVIO\u00ae<\/b><b>\uff0c\u4e00\u7a2e\u7528\u65bc\u6cbb\u7642\u591a\u767c\u6027\u9aa8\u9ad3\u7624\u7684 <\/b><b>XPO1<\/b><b>\u00a0\u6291\u5236\u5291\u3002\u6b64\u5916\uff0c<\/b><b>Stemline<\/b><b>\u00a0\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 <\/b><\/p>\n<p>\u00b9\u00a0\u6c7a\u7b56\u8cc7\u6e90\u5718\u968a \/ Clarivate\u00a0\u4e73\u764c\u524d\u77bb \/ \u6d41\u884c\u75c5\u5b78 \u20132023\u00a0\u5e74 6\u00a0\u6708 14\u00a0\u65e5<\/p>\n<p>\u00b2\u00a0\u570b\u969b\u764c\u75c7\u7814\u7a76\u6a5f\u69cb\uff0c\u4e16\u754c\u885b\u751f\u7d44\u7e54 \u2013 Globocan\u00a0\u2013 2020\u00a0<\/p>\n<p>\u00b3\u00a0Bardia\u00a0\u7b49\u4eba EMERALD\u00a0\u7684 elacestrant\u00a03\u00a0\u671f\u8a66\u9a57\u5c0d\u6bd4\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\/HER2 &#8211; \u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u6548\u679c\uff1a \u5728\u8f49\u79fb\u60c5\u6cc1\u4e0b\uff0c\u65e2\u5f80 CDK4\/6i\u00a0\u6301\u7e8c\u6642\u9577\u7684\u7d50\u679c\u66f4\u65b0\u3002SABCS\u00a02022. GS3-01<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder2\">  <\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u6bcf\u5e74\u5728\u6b50\u6d32\u6709\u8d85\u904e 550,00&#8230;<\/p>\n","protected":false},"author":16,"featured_media":179236,"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-179235","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>\u6b50\u6d32\u59d4\u54e1\u6703\u6838\u51c6 Menarini Group \u7684 ORSERDU\u00ae (Elacestrant) \u7528\u65bc\u6cbb\u7642\u651c\u5e36\u6d3b\u5316 ESR1 \u7a81\u8b8a\u7684ER +\uff0cHER2- \u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u7684\u60a3\u8005 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831<\/title>\n<meta name=\"description\" content=\"\u6bcf\u5e74\u5728\u6b50\u6d32\u6709\u8d85\u904e 550,000 \u540d\u60a3\u8005\u88ab\u8a3a\u65b7\u51fa\u60a3\u6709\u4e73\u764c\uff0c\u5176\u4e2d 70% \u7684\u60a3\u8005\u70ba\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u00b9\uff1b\u6bcf\u5e74\u6b50\u6d32\u6709\u8d85\u904e 147,000 \u540d\u4e73\u764c\u60a3\u8005\u6b7b\u65bc\u8a72\u75be\u75c5\u00b2\u3002  ORSERDU \u662f\u9996\u6b3e\u5c08\u9580\u91dd\u5c0d ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u816b\u7624\u4e14\u651c\u5e36 ESR1 \u7a81\u8b8a\u7684\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u9019\u662f\u8fd1 20 \u5e74\u4f86\u5167\u5206\u6ccc\u6cbb\u7642\u9818\u57df\u7684\u9996\u6b21\u5275\u65b0  ESR1 \u7a81\u8b8a\u5728 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u4e2d\u51fa\u73fe\u7684\u6bd4\u4f8b\u9ad8\u9054 40\uff05\uff0c\u4e14\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u7684\u5df2\u77e5\u8010\u85e5\u9a45\u52d5\u56e0\u7d20\uff0c\u4f7f\u5f97\u9019\u985e\u578b\u816b\u7624\u66f4\u52a0\u96e3\u4ee5\u6cbb\u7642 \u610f\u5927\u5229\u4f5b\u7f85\u502b\u85a9\u53ca\u7d10\u7d04\u00a02023\u5e749\u670822\u65e5 \/\u7f8e\u901a\u793e\/ -- \u9818\u5148\u7684\u570b\u969b\u5236\u85e5\u548c\u8a3a\u65b7\u516c\u53f8 Menarini Group\uff08\u300cMenarini\u300d\uff09\u4ee5\u53ca Menarini Group \u7684\u5168\u8cc7\u5b50\u516c\u53f8 Stemline Therapeutics Inc.\uff08\u300cStemline\u300d\uff09\u4eca\u5929\u5ba3\u5e03\uff0c\u6b50\u6d32\u59d4\u54e1\u6703\u5df2\u6838\u51c6 ORSERDU\u00ae (elacestrant) \u4f5c\u70ba\u55ae\u85e5\u6cbb\u7642\u6cd5\uff0c\u7528\u65bc\u6cbb\u7642\u651c\u5e36\u6d3b\u5316 ESR1 \u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\uff0cHER2 \u9670\u6027\uff0c\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\uff0c\u4e26\u4e14\u5728\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6 \u6291\u5236\u5291\uff09\u5f8c\u75be\u75c5\u52a0\u5287\u7684\u60a3\u8005\u3002 \u6b50\u6d32\u59d4\u54e1\u6703\u7684\u6b64\u6b21\u6838\u51c6\u662f\u57fa\u65bc\u6b50\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40 (EMA) \u65bc 2023\u00a0\u5e74 7\u00a0\u6708\u516c\u4f48\u7684\u4eba\u7528\u85e5\u54c1 (CHMP)\u00a0\u7684\u80af\u5b9a\u610f\u898b\u3002\u6b64\u6b21\u6838\u51c6\u610f\u5473\u8457 ORSERDU\u00a0\u662f\u7b2c\u4e00\u7a2e\uff0c\u4e5f\u662f\u552f\u4e00\u4e00\u7a2e\u660e\u78ba\u6307\u793a\u7528\u65bc\u6cbb\u7642\u651c\u5e36 ESR1\u00a0\u7a81\u8b8a\u7684 ER+\uff0cHER2-\u00a0\u816b\u7624\u7684\u6cbb\u7642\u65b9\u6cd5\u3002ESR1\u00a0\u7a81\u8b8a\u662f\u7531\u65bc\u63a5\u53d7\u5167\u5206\u6ccc\u6cbb\u7642\u800c\u7522\u751f\u7684\u5f8c\u5929\u7a81\u8b8a\uff0c\u4e26\u4e14\u5728 ER+\uff0cHER2- mBC\u00a0\u4e73\u764c\u60a3\u8005\u4e2d\u767c\u751f\u7387\u9ad8\u9054 40%\u3002ESR1\u00a0\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 Menarini\u00a0Group\u00a0\u7684\u884c\u653f\u7e3d\u88c1\u00a0Elcin\u00a0Barker\u00a0Ergun\u00a0\u8868\u793a\uff1a\u300c\u6211\u5011\u65e9\u5df2\u77e5\u9053\uff0c\u60a3\u6709\u8f49\u79fb\u6027\u4e73\u764c\u7684\u60a3\u8005\u9700\u8981\u6709\u6548\u4e14\u6613\u65bc\u8010\u53d7\u7684\u6cbb\u7642\u9078\u9805\uff0c\u4ee5\u5728\u6cbb\u7642\u75be\u75c5\u7684\u540c\u6642\u8b93\u4ed6\u5011\u5c08\u6ce8\u65bc\u5c0d\u4ed6\u5011\u800c\u8a00\u91cd\u8981\u7684\u4e8b\u60c5\u3002\u300d\u300c\u80fd\u5920\u63d0\u4f9b\u6bcf\u65e5\u53ea\u9700\u53e3\u670d\u4e00\u6b21\u7684\u65b0\u578b\u4e73\u764c\u6cbb\u7642\u65b9\u6848\u4f7f\u6211\u5011\u500d\u611f\u81ea\u8c6a\uff0c\u9019\u4e5f\u662f\u8fd1\u4e8c\u5341\u5e74\u4f86\u5167\u5206\u6ccc\u6cbb\u7642\u9818\u57df\u7684\u9996\u6b21\u5275\u65b0\uff1b\u540c\u6642\uff0c\u6211\u5011\u975e\u5e38\u611f\u8b1d\u816b\u7624\u5b78\u7814\u7a76\u4eba\u54e1\u4ee5\u53ca\u53c3\u8207\u81e8\u5e8a\u7814\u7a76\u7684\u6240\u6709\u60a3\u8005\uff0c\u6b63\u662f\u56e0\u70ba\u4ed6\u5011\u7684\u652f\u6301\u548c\u53c3\u8207\uff0c\u624d\u80fd\u6536\u7a6b\u4eca\u5929\u7684\u6210\u679c\u3002\u300d \u7531\u65bc\u76f8\u7576\u591a\u7684 ER+ HER2- \u60a3\u8005\u662f\u5728\u8f49\u79fb\u6027\u764c\u75c7\u904e\u7a0b\u4e2d\u7684\u67d0\u500b\u6642\u523b\u6700\u7d42\u767c\u5c55\u51fa ESR1\u00a0\u7a81\u8b8a\uff0c\u56e0\u6b64\u5728\u6bcf\u6b21 mBC\u00a0\u60a3\u8005\u51fa\u73fe\u75be\u75c5\u52a0\u5287\u6642\u9032\u884c ESR1\u00a0\u6e2c\u8a66\u975e\u5e38\u91cd\u8981\uff0c\u4ee5\u77ad\u89e3\u5176\u4e73\u764c\u7684\u60e1\u5316\u56e0\u7d20\u3002\u300c\u4eca\u5929\u7684\u6838\u51c6\u70ba\u6211\u5011\u63d0\u4f9b\u4e86\u9996\u500b\u6cbb\u7642\u65b9\u6848\uff0c\u4f7f\u6211\u5011\u80fd\u5920\u76f4\u63a5\u5c0d\u6297\u9019\u7a2e\u5c0e\u81f4\u4e73\u764c\u66f4\u96e3\u6cbb\u7642\u7684\u7a81\u8b8a\uff0c\u70ba\u60a3\u8005\u548c\u5176\u5bb6\u4eba\u5e36\u4f86\u4e86\u5e0c\u671b\u3002\u300d\u610f\u5927\u5229\u6b50\u6d32\u816b\u7624\u7814\u7a76\u6240 (IRCCS)\u00a0\u65e9\u671f\u85e5\u7269\u958b\u767c\u90e8\u9580\u4e3b\u4efb\u3001\u7c73\u862d\u5927\u5b78\u91ab\u5b78\u816b\u7624\u5b78\u79d1\u6559\u6388 Giuseppe Curigliano\u00a0\u91ab\u5b78\u535a\u58eb\u8aaa\u9053\u3002 \u7b2c\u4e09\u671f EMERALD\u00a0\u8a66\u9a57\u7684\u8cc7\u6599\u70ba ORSERDU\u00a0\u7684\u6838\u51c6\u63d0\u4f9b\u4e86\u652f\u6301\uff0c\u8a72\u8a66\u9a57\u8868\u660e\uff0c\u8207\u6a19\u6e96\u6cbb\u7642 (SOC)\u00a0\u76f8\u6bd4\uff0c\u4f7f\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u00a0\u5177\u6709\u7d71\u8a08\u5b78\u610f\u7fa9\uff0c\u6a19\u6e96\u6cbb\u7642\u7684\u5b9a\u7fa9\u70ba\u7814\u7a76\u4eba\u54e1\u9078\u64c7\u7684\u5df2\u7372\u51c6\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\u3002\u672c\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5168\u9ad4\u60a3\u8005\u7fa4\u9ad4\u548c\u5e36\u6709 ESR1\u00a0\u7a81\u8b8a\u60a3\u8005\u4e2d\u7684 PFS\u00a0\u5c0d\u6bd4\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u51fa\u73fe\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u5728 2022\u00a0\u5e74\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u764c\u7814\u8ba8\u4f1a (SABCS)\u00a0\u4e0a\u958b\u5c55\u4e86\u95dc\u65bc EMERALD\u00a0PFS\u00a0\u7d50\u679c\u7684\u4e8b\u5f8c\u4e9e\u7d44\u5206\u6790\uff0c\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6i\u00a0\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 elacestrant\u00a0\u5f8c\u7684 PFS\u00a0\u5ef6\u9577\u5448\u6b63\u76f8\u95dc\uff0c\u4f46\u5728 SOC\u00a0\u4e0a\u4e26\u7121\u5448\u73fe\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD\u00a0\u96a8\u6a5f\u7be9\u67e5\u4e4b\u524d\u63a5\u53d7 CDK4\/6i\u00a0\u6cbb\u7642 12\u00a0\u500b\u6708\u4ee5\u4e0a\uff0c\u4e14\u767c\u751f ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\uff0c elacestrant\u00a0\u7684 PFS\u00a0\u4e2d\u4f4d\u6578\u70ba 8.6\u00a0\u500b\u6708\uff0c\u800c SOC\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u98a8\u96aa\u964d\u4f4e\u4e86 59\uff05\u00a0(HR=0.41 95% CI: 0.26-0.63)\u3002\u00b3 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002ORSERDU\u00a0\u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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\u3002ORSERDU\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002 Stemline\u00a0\u53ca\u5176\u9644\u5c6c\u516c\u53f8\u5c07\u5728\u6b50\u6d32\u63a8\u51fa\u8a72\u7522\u54c1\u3002 EMERALD\u00a0\u7b2c 3\u00a0\u671f\u7814\u7a76 (NCT03778931)\u00a0\u7c21\u4ecbEMERALD\u00a0\u7b2c 3\u00a0\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\u00a0\u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2-\u00a0\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u8a72\u7814\u7a76\u62db\u52df\u4e86 478\u00a0\u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5\uff08\u5305\u62ec CDK4\/6\u00a0\u6291\u5236\u5291\uff09\u7684\u60a3\u8005\u3002\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7 elacestrant\u00a0\u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5728\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u4ee5\u53ca\u5177\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 1\u00a0\u57fa\u56e0 (ESR1)\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u4e2d\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\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 HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u95dc\u65bc ORSERDU\u00ae (elacestrant) \u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \u55ae\u85e5\u6cbb\u7642\u7528\u65bc\u651c\u5e36\u6d3b\u5316 ESR1\u00a0\u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER)\u00a0\u967d\u6027\u3001HER2\u00a0\u9670\u6027\u3001\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u4e14\u5728\u63a5\u53d7\u904e\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6\u00a0\u6291\u5236\u5291\uff09\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\u3002 ORSERDU\u00a0SmPC\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a  \u809d\u529f\u80fd\u53d7\u640d\uff1a\u00a0\u809d\u529f\u80fd\u4e2d\u5ea6\u53d7\u640d\u7684\u60a3\u8005 (Child-Pugh B) \u61c9\u8b39\u614e\u4f7f\u7528 ORSERDU\uff0c\u6bcf\u65e5\u5291\u91cf\u70ba 258\u00a0\u6beb\u514b\u3002\u5728\u7f3a\u4e4f\u81e8\u5e8a\u8cc7\u6599\u7684\u60c5\u6cc1\u4e0b\uff0c\u4e0d\u5efa\u8b70\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C)\u00a0\u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002 \u8207 CYP3A4\u00a0\u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\u3002 \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u8a98\u5c0e\u5291\u540c\u6642\u4f7f\u7528\u3002 \u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff1a\u665a\u671f\u4e73\u764c\u60a3\u8005\u5e38\u898b\u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff0c\u4e14\u5728 ORSERDU\u00a0\u7684\u81e8\u5e8a\u7814\u7a76\u4e2d\u4e5f\u89c0\u5bdf\u5230\u6b64\u73fe\u8c61\u3002\u7576\u70ba\u9ad8\u98a8\u96aa\u60a3\u8005\u958b\u7acb ORSERDU\u00a0\u6642\uff0c\u61c9\u8457\u91cd\u8003\u616e\u6b64\u4e8b\u9805\u3002 \u4e0d\u826f\u53cd\u61c9\uff1a  \u22651%\u00a0\u7684\u60a3\u8005\u5831\u544a\u7684\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3\u3001\u547c\u5438\u56f0\u96e3\u548c\u8840\u6813\u6813\u585e\uff08\u975c\u8108\uff09\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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 Elacestrant\u00a0\u6700\u5e38\u898b\u7684\u4e09\u7d1a\u53ca\u4ee5\u4e0a (\u22652%)\u00a0\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3 (2.7%)\uff0cAST\u00a0\u5347\u9ad8 (2.7%)\uff0cALT\u00a0\u5347\u9ad8 (2.3%)\uff0c\u8ca7\u8840 (2%)\uff0c\u80cc\u75db (2%)\u00a0\u548c\u9aa8\u75db (2%)\u3002 \u5641\u5fc3\uff1a35%\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u5641\u5fc3\u30022.5% \u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe 3-4\u00a0\u7d1a\u5641\u5fc3\u4e8b\u4ef6\u3002\u5728\u7b2c\u4e00\u500b\u9031\u671f\u4e2d\uff0c\u5641\u5fc3\u7684\u767c\u751f\u983b\u7387\u66f4\u9ad8\uff0c\u800c\u5f9e\u7b2c\u4e8c\u500b\u9031\u671f\u958b\u59cb\uff0c\u5641\u5fc3\u7684\u767c\u751f\u7387\u901a\u5e38\u5728\u5f8c\u7e8c\u9031\u671f\u4e2d\u6709\u6240\u4e0b\u964d\uff08\u5373\u96a8\u8457\u6642\u9593\u7684\u63a8\u79fb\u800c\u964d\u4f4e\uff09\u3002 \u5e74\u9577\u8005\uff1a75\u00a0\u6b72\u53ca\u4ee5\u4e0a\u60a3\u8005\u66f4\u5e38\u5831\u544a\u8178\u80c3\u9053\u554f\u984c\u3002 \u751f\u80b2\u3001\u61f7\u5b55\u548c\u54fa\u4e73\uff1a  \u8655\u65bc\u61f7\u5b55\u671f\u6216\u672a\u4f7f\u7528\u907f\u5b55\u63aa\u65bd\u7684\u80b2\u9f61\u5a66\u5973\u4e0d\u61c9\u4f7f\u7528 ORSERDU\u3002\u6839\u64da elacestrant\u00a0\u7684\u4f5c\u7528\u6a5f\u5236\u548c\u52d5\u7269\u7684\u751f\u6b96\u6bd2\u6027\u7814\u7a76\u7d50\u679c\uff0c\u5b55\u5a66\u670d\u7528 ORSERDU\u00a0\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u61c9\u544a\u77e5\u80b2\u9f61\u5973\u6027\uff0c\u5728\u63a5\u53d7 ORSERDU\u00a0\u6cbb\u7642\u671f\u9593\u548c\u6700\u5f8c\u4e00\u6b21\u7528\u85e5\u5f8c\u4e00\u9031\u5167\u5fc5\u9808\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u63aa\u65bd\u3002 \u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU\u00a0\u6cbb\u7642\u671f\u9593\u548c\u6700\u5f8c\u4e00\u6b21\u670d\u7528 ORSERDU\u00a0\u5f8c\u4e00\u9031\u5167\u4e0d\u61c9\u54fa\u4e73\u3002 \u57fa\u65bc\u52d5\u7269\u7814\u7a76\u7684\u767c\u73fe\u548c\u5176\u4f5c\u7528\u6a5f\u5236\uff0cORSERDU\u00a0\u53ef\u80fd\u6703\u5f71\u97ff\u6709\u751f\u6b96\u80fd\u529b\u7684\u7537\u6027\u548c\u5973\u6027\u7684\u751f\u80b2\u80fd\u529b\u3002 \u5c0d\u99d5\u8eca\u548c\u64cd\u4f5c\u6a5f\u5668\u7684\u5f71\u97ff\uff1a\u4e00\u4e9b\u670d\u7528 ORSERDU\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u75b2\u52de\u3001\u865b\u5f31\u548c\u5931\u7720\u75c7\u72c0\u3002\u60a3\u8005\u5728\u958b\u8eca\u6216\u64cd\u4f5c\u6a5f\u5668\u6642\uff0c\u61c9\u7576\u8b39\u614e\u6ce8\u610f\u662f\u5426\u6709\u4e0d\u826f\u53cd\u61c9\u3002 \u5c0d\u65bc\u65b0\u751f\u5152\u81f3 18\u00a0\u6b72\u4ee5\u4e0b\u5152\u7ae5\uff0cORSERDU\u00a0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u7acb\u3002 \u5831\u544a\u7591\u4f3c\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61\uff1aEUPV@menarinistemline.com \u5831\u544a\u7522\u54c1\u6295\u8a34\uff0c\u8acb\u806f\u7d61\uff1aEUcustomerservice@menarinistemline.com \u7d22\u53d6\u91ab\u7642\u8cc7\u8a0a\uff0c\u8acb\u806f\u7d61\uff1aEUmedinfo@menarinistemline.com Elacestrant\u00a0\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\u00a0(NCT05563220)\uff1bELECTRA (NCT05386108)\uff1b\u4ee5\u53ca ELCIN (NCT05596409)\u3002Elacestrant\u00a0\u4e5f\u8a08\u5283\u5728\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002 2020\u00a0\u5e74 7\u00a0\u6708\uff0cMenarini\u00a0Group\u00a0\u5f9e Radius\u00a0Health, Inc. \u7372\u5f97\u4e86 elacestrant\u00a0\u7684\u5168\u7403\u6388\u6b0a\u3002Menarini\u00a0Group\u00a0\u73fe\u5728\u5168\u6b0a\u8ca0\u8cac elacestrant\u00a0\u7684\u5168\u7403\u8a3b\u518a\u3001\u5546\u696d\u5316\u548c\u9032\u4e00\u6b65\u7814\u767c\u6d3b\u52d5\u3002 Menarini\u00a0Group\u00a0\u7c21\u4ecb Menarini Group\u00a0\u662f\u4e00\u5bb6\u9818\u5148\u7684\u570b\u969b\u91ab\u85e5\u548c\u8a3a\u65b7\u516c\u53f8\uff0c\u5e74\u71df\u696d\u984d\u8d85\u904e 44\u00a0\u5104\u7f8e\u5143\uff0c\u64c1\u6709\u8d85\u904e 17,000\u00a0\u540d\u54e1\u5de5\u3002Menarini\u00a0\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\u00a0\u64c1\u6709 18\u00a0\u500b\u751f\u7522\u57fa\u5730\u548c 9\u00a0\u500b\u7814\u767c\u4e2d\u5fc3\uff0c\u7522\u54c1\u92b7\u5f80\u5168\u7403 140\u00a0\u500b\u570b\u5bb6\/\u5730\u5340\u3002 \u6b32\u4e86\u89e3\u66f4\u591a\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd www.menarini.com\u3002 \u95dc\u65bc Stemline\u00a0Therapeutics\u00a0Inc.  Stemline\u00a0Therapeutics, Inc.\uff08\u300cStemline\u300d\uff09\u662f Menarini\u00a0Group\u00a0\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\u00a0\u5c07\u5728\u7f8e\u570b\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)\u00a0\u967d\u6027\u3001\u4eba\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2\u00a0(HER2)\u00a0\u9670\u6027\u3001ESR1\u00a0\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\u00a0\u9084\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u63a8\u51fa\u4e86 ELZONRIS\u00ae (tagraxofusp-erzs)\uff0c\u9019\u662f\u4e00\u7a2e\u91dd\u5c0d CD123\u00a0\u7684\u5275\u65b0\u6a19\u9776\u6cbb\u7642\uff0c\u7528\u65bc\u6cbb\u7642\u7206\u767c\u6027\u6d46\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\u00a0\u6cbb\u7642\u65b9\u6848\u3002Stemline\u00a0\u4ea6\u5c07\u5728\u6b50\u6d32\u5546\u696d\u5316 NEXPOVIO\u00ae\uff0c\u4e00\u7a2e\u7528\u65bc\u6cbb\u7642\u591a\u767c\u6027\u9aa8\u9ad3\u7624\u7684 XPO1\u00a0\u6291\u5236\u5291\u3002\u6b64\u5916\uff0cStemline\u00a0\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  \u00b9\u00a0\u6c7a\u7b56\u8cc7\u6e90\u5718\u968a \/ Clarivate\u00a0\u4e73\u764c\u524d\u77bb \/ \u6d41\u884c\u75c5\u5b78 \u20132023\u00a0\u5e74 6\u00a0\u6708 14\u00a0\u65e5 \u00b2\u00a0\u570b\u969b\u764c\u75c7\u7814\u7a76\u6a5f\u69cb\uff0c\u4e16\u754c\u885b\u751f\u7d44\u7e54 \u2013 Globocan\u00a0\u2013 2020\u00a0 \u00b3\u00a0Bardia\u00a0\u7b49\u4eba EMERALD\u00a0\u7684 elacestrant\u00a03\u00a0\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 \u5728\u8f49\u79fb\u60c5\u6cc1\u4e0b\uff0c\u65e2\u5f80 CDK4\/6i\u00a0\u6301\u7e8c\u6642\u9577\u7684\u7d50\u679c\u66f4\u65b0\u3002SABCS\u00a02022. GS3-01\" \/>\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=179235\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u6b50\u6d32\u59d4\u54e1\u6703\u6838\u51c6 Menarini Group \u7684 ORSERDU\u00ae (Elacestrant) \u7528\u65bc\u6cbb\u7642\u651c\u5e36\u6d3b\u5316 ESR1 \u7a81\u8b8a\u7684ER +\uff0cHER2- \u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u7684\u60a3\u8005 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" content=\"\u6bcf\u5e74\u5728\u6b50\u6d32\u6709\u8d85\u904e 550,000 \u540d\u60a3\u8005\u88ab\u8a3a\u65b7\u51fa\u60a3\u6709\u4e73\u764c\uff0c\u5176\u4e2d 70% \u7684\u60a3\u8005\u70ba\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u00b9\uff1b\u6bcf\u5e74\u6b50\u6d32\u6709\u8d85\u904e 147,000 \u540d\u4e73\u764c\u60a3\u8005\u6b7b\u65bc\u8a72\u75be\u75c5\u00b2\u3002  ORSERDU \u662f\u9996\u6b3e\u5c08\u9580\u91dd\u5c0d ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u816b\u7624\u4e14\u651c\u5e36 ESR1 \u7a81\u8b8a\u7684\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u9019\u662f\u8fd1 20 \u5e74\u4f86\u5167\u5206\u6ccc\u6cbb\u7642\u9818\u57df\u7684\u9996\u6b21\u5275\u65b0  ESR1 \u7a81\u8b8a\u5728 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u4e2d\u51fa\u73fe\u7684\u6bd4\u4f8b\u9ad8\u9054 40\uff05\uff0c\u4e14\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u7684\u5df2\u77e5\u8010\u85e5\u9a45\u52d5\u56e0\u7d20\uff0c\u4f7f\u5f97\u9019\u985e\u578b\u816b\u7624\u66f4\u52a0\u96e3\u4ee5\u6cbb\u7642 \u610f\u5927\u5229\u4f5b\u7f85\u502b\u85a9\u53ca\u7d10\u7d04\u00a02023\u5e749\u670822\u65e5 \/\u7f8e\u901a\u793e\/ -- \u9818\u5148\u7684\u570b\u969b\u5236\u85e5\u548c\u8a3a\u65b7\u516c\u53f8 Menarini Group\uff08\u300cMenarini\u300d\uff09\u4ee5\u53ca Menarini Group \u7684\u5168\u8cc7\u5b50\u516c\u53f8 Stemline Therapeutics Inc.\uff08\u300cStemline\u300d\uff09\u4eca\u5929\u5ba3\u5e03\uff0c\u6b50\u6d32\u59d4\u54e1\u6703\u5df2\u6838\u51c6 ORSERDU\u00ae (elacestrant) \u4f5c\u70ba\u55ae\u85e5\u6cbb\u7642\u6cd5\uff0c\u7528\u65bc\u6cbb\u7642\u651c\u5e36\u6d3b\u5316 ESR1 \u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\uff0cHER2 \u9670\u6027\uff0c\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\uff0c\u4e26\u4e14\u5728\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6 \u6291\u5236\u5291\uff09\u5f8c\u75be\u75c5\u52a0\u5287\u7684\u60a3\u8005\u3002 \u6b50\u6d32\u59d4\u54e1\u6703\u7684\u6b64\u6b21\u6838\u51c6\u662f\u57fa\u65bc\u6b50\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40 (EMA) \u65bc 2023\u00a0\u5e74 7\u00a0\u6708\u516c\u4f48\u7684\u4eba\u7528\u85e5\u54c1 (CHMP)\u00a0\u7684\u80af\u5b9a\u610f\u898b\u3002\u6b64\u6b21\u6838\u51c6\u610f\u5473\u8457 ORSERDU\u00a0\u662f\u7b2c\u4e00\u7a2e\uff0c\u4e5f\u662f\u552f\u4e00\u4e00\u7a2e\u660e\u78ba\u6307\u793a\u7528\u65bc\u6cbb\u7642\u651c\u5e36 ESR1\u00a0\u7a81\u8b8a\u7684 ER+\uff0cHER2-\u00a0\u816b\u7624\u7684\u6cbb\u7642\u65b9\u6cd5\u3002ESR1\u00a0\u7a81\u8b8a\u662f\u7531\u65bc\u63a5\u53d7\u5167\u5206\u6ccc\u6cbb\u7642\u800c\u7522\u751f\u7684\u5f8c\u5929\u7a81\u8b8a\uff0c\u4e26\u4e14\u5728 ER+\uff0cHER2- mBC\u00a0\u4e73\u764c\u60a3\u8005\u4e2d\u767c\u751f\u7387\u9ad8\u9054 40%\u3002ESR1\u00a0\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 Menarini\u00a0Group\u00a0\u7684\u884c\u653f\u7e3d\u88c1\u00a0Elcin\u00a0Barker\u00a0Ergun\u00a0\u8868\u793a\uff1a\u300c\u6211\u5011\u65e9\u5df2\u77e5\u9053\uff0c\u60a3\u6709\u8f49\u79fb\u6027\u4e73\u764c\u7684\u60a3\u8005\u9700\u8981\u6709\u6548\u4e14\u6613\u65bc\u8010\u53d7\u7684\u6cbb\u7642\u9078\u9805\uff0c\u4ee5\u5728\u6cbb\u7642\u75be\u75c5\u7684\u540c\u6642\u8b93\u4ed6\u5011\u5c08\u6ce8\u65bc\u5c0d\u4ed6\u5011\u800c\u8a00\u91cd\u8981\u7684\u4e8b\u60c5\u3002\u300d\u300c\u80fd\u5920\u63d0\u4f9b\u6bcf\u65e5\u53ea\u9700\u53e3\u670d\u4e00\u6b21\u7684\u65b0\u578b\u4e73\u764c\u6cbb\u7642\u65b9\u6848\u4f7f\u6211\u5011\u500d\u611f\u81ea\u8c6a\uff0c\u9019\u4e5f\u662f\u8fd1\u4e8c\u5341\u5e74\u4f86\u5167\u5206\u6ccc\u6cbb\u7642\u9818\u57df\u7684\u9996\u6b21\u5275\u65b0\uff1b\u540c\u6642\uff0c\u6211\u5011\u975e\u5e38\u611f\u8b1d\u816b\u7624\u5b78\u7814\u7a76\u4eba\u54e1\u4ee5\u53ca\u53c3\u8207\u81e8\u5e8a\u7814\u7a76\u7684\u6240\u6709\u60a3\u8005\uff0c\u6b63\u662f\u56e0\u70ba\u4ed6\u5011\u7684\u652f\u6301\u548c\u53c3\u8207\uff0c\u624d\u80fd\u6536\u7a6b\u4eca\u5929\u7684\u6210\u679c\u3002\u300d \u7531\u65bc\u76f8\u7576\u591a\u7684 ER+ HER2- \u60a3\u8005\u662f\u5728\u8f49\u79fb\u6027\u764c\u75c7\u904e\u7a0b\u4e2d\u7684\u67d0\u500b\u6642\u523b\u6700\u7d42\u767c\u5c55\u51fa ESR1\u00a0\u7a81\u8b8a\uff0c\u56e0\u6b64\u5728\u6bcf\u6b21 mBC\u00a0\u60a3\u8005\u51fa\u73fe\u75be\u75c5\u52a0\u5287\u6642\u9032\u884c ESR1\u00a0\u6e2c\u8a66\u975e\u5e38\u91cd\u8981\uff0c\u4ee5\u77ad\u89e3\u5176\u4e73\u764c\u7684\u60e1\u5316\u56e0\u7d20\u3002\u300c\u4eca\u5929\u7684\u6838\u51c6\u70ba\u6211\u5011\u63d0\u4f9b\u4e86\u9996\u500b\u6cbb\u7642\u65b9\u6848\uff0c\u4f7f\u6211\u5011\u80fd\u5920\u76f4\u63a5\u5c0d\u6297\u9019\u7a2e\u5c0e\u81f4\u4e73\u764c\u66f4\u96e3\u6cbb\u7642\u7684\u7a81\u8b8a\uff0c\u70ba\u60a3\u8005\u548c\u5176\u5bb6\u4eba\u5e36\u4f86\u4e86\u5e0c\u671b\u3002\u300d\u610f\u5927\u5229\u6b50\u6d32\u816b\u7624\u7814\u7a76\u6240 (IRCCS)\u00a0\u65e9\u671f\u85e5\u7269\u958b\u767c\u90e8\u9580\u4e3b\u4efb\u3001\u7c73\u862d\u5927\u5b78\u91ab\u5b78\u816b\u7624\u5b78\u79d1\u6559\u6388 Giuseppe Curigliano\u00a0\u91ab\u5b78\u535a\u58eb\u8aaa\u9053\u3002 \u7b2c\u4e09\u671f EMERALD\u00a0\u8a66\u9a57\u7684\u8cc7\u6599\u70ba ORSERDU\u00a0\u7684\u6838\u51c6\u63d0\u4f9b\u4e86\u652f\u6301\uff0c\u8a72\u8a66\u9a57\u8868\u660e\uff0c\u8207\u6a19\u6e96\u6cbb\u7642 (SOC)\u00a0\u76f8\u6bd4\uff0c\u4f7f\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u00a0\u5177\u6709\u7d71\u8a08\u5b78\u610f\u7fa9\uff0c\u6a19\u6e96\u6cbb\u7642\u7684\u5b9a\u7fa9\u70ba\u7814\u7a76\u4eba\u54e1\u9078\u64c7\u7684\u5df2\u7372\u51c6\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\u3002\u672c\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5168\u9ad4\u60a3\u8005\u7fa4\u9ad4\u548c\u5e36\u6709 ESR1\u00a0\u7a81\u8b8a\u60a3\u8005\u4e2d\u7684 PFS\u00a0\u5c0d\u6bd4\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u51fa\u73fe\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u5728 2022\u00a0\u5e74\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u764c\u7814\u8ba8\u4f1a (SABCS)\u00a0\u4e0a\u958b\u5c55\u4e86\u95dc\u65bc EMERALD\u00a0PFS\u00a0\u7d50\u679c\u7684\u4e8b\u5f8c\u4e9e\u7d44\u5206\u6790\uff0c\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6i\u00a0\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 elacestrant\u00a0\u5f8c\u7684 PFS\u00a0\u5ef6\u9577\u5448\u6b63\u76f8\u95dc\uff0c\u4f46\u5728 SOC\u00a0\u4e0a\u4e26\u7121\u5448\u73fe\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD\u00a0\u96a8\u6a5f\u7be9\u67e5\u4e4b\u524d\u63a5\u53d7 CDK4\/6i\u00a0\u6cbb\u7642 12\u00a0\u500b\u6708\u4ee5\u4e0a\uff0c\u4e14\u767c\u751f ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\uff0c elacestrant\u00a0\u7684 PFS\u00a0\u4e2d\u4f4d\u6578\u70ba 8.6\u00a0\u500b\u6708\uff0c\u800c SOC\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u98a8\u96aa\u964d\u4f4e\u4e86 59\uff05\u00a0(HR=0.41 95% CI: 0.26-0.63)\u3002\u00b3 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002ORSERDU\u00a0\u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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\u3002ORSERDU\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002 Stemline\u00a0\u53ca\u5176\u9644\u5c6c\u516c\u53f8\u5c07\u5728\u6b50\u6d32\u63a8\u51fa\u8a72\u7522\u54c1\u3002 EMERALD\u00a0\u7b2c 3\u00a0\u671f\u7814\u7a76 (NCT03778931)\u00a0\u7c21\u4ecbEMERALD\u00a0\u7b2c 3\u00a0\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\u00a0\u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2-\u00a0\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u8a72\u7814\u7a76\u62db\u52df\u4e86 478\u00a0\u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5\uff08\u5305\u62ec CDK4\/6\u00a0\u6291\u5236\u5291\uff09\u7684\u60a3\u8005\u3002\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7 elacestrant\u00a0\u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5728\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u4ee5\u53ca\u5177\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 1\u00a0\u57fa\u56e0 (ESR1)\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u4e2d\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\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 HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u95dc\u65bc ORSERDU\u00ae (elacestrant) \u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \u55ae\u85e5\u6cbb\u7642\u7528\u65bc\u651c\u5e36\u6d3b\u5316 ESR1\u00a0\u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER)\u00a0\u967d\u6027\u3001HER2\u00a0\u9670\u6027\u3001\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u4e14\u5728\u63a5\u53d7\u904e\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6\u00a0\u6291\u5236\u5291\uff09\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\u3002 ORSERDU\u00a0SmPC\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a  \u809d\u529f\u80fd\u53d7\u640d\uff1a\u00a0\u809d\u529f\u80fd\u4e2d\u5ea6\u53d7\u640d\u7684\u60a3\u8005 (Child-Pugh B) \u61c9\u8b39\u614e\u4f7f\u7528 ORSERDU\uff0c\u6bcf\u65e5\u5291\u91cf\u70ba 258\u00a0\u6beb\u514b\u3002\u5728\u7f3a\u4e4f\u81e8\u5e8a\u8cc7\u6599\u7684\u60c5\u6cc1\u4e0b\uff0c\u4e0d\u5efa\u8b70\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C)\u00a0\u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002 \u8207 CYP3A4\u00a0\u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\u3002 \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u8a98\u5c0e\u5291\u540c\u6642\u4f7f\u7528\u3002 \u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff1a\u665a\u671f\u4e73\u764c\u60a3\u8005\u5e38\u898b\u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff0c\u4e14\u5728 ORSERDU\u00a0\u7684\u81e8\u5e8a\u7814\u7a76\u4e2d\u4e5f\u89c0\u5bdf\u5230\u6b64\u73fe\u8c61\u3002\u7576\u70ba\u9ad8\u98a8\u96aa\u60a3\u8005\u958b\u7acb ORSERDU\u00a0\u6642\uff0c\u61c9\u8457\u91cd\u8003\u616e\u6b64\u4e8b\u9805\u3002 \u4e0d\u826f\u53cd\u61c9\uff1a  \u22651%\u00a0\u7684\u60a3\u8005\u5831\u544a\u7684\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3\u3001\u547c\u5438\u56f0\u96e3\u548c\u8840\u6813\u6813\u585e\uff08\u975c\u8108\uff09\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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 Elacestrant\u00a0\u6700\u5e38\u898b\u7684\u4e09\u7d1a\u53ca\u4ee5\u4e0a (\u22652%)\u00a0\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3 (2.7%)\uff0cAST\u00a0\u5347\u9ad8 (2.7%)\uff0cALT\u00a0\u5347\u9ad8 (2.3%)\uff0c\u8ca7\u8840 (2%)\uff0c\u80cc\u75db (2%)\u00a0\u548c\u9aa8\u75db (2%)\u3002 \u5641\u5fc3\uff1a35%\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u5641\u5fc3\u30022.5% \u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe 3-4\u00a0\u7d1a\u5641\u5fc3\u4e8b\u4ef6\u3002\u5728\u7b2c\u4e00\u500b\u9031\u671f\u4e2d\uff0c\u5641\u5fc3\u7684\u767c\u751f\u983b\u7387\u66f4\u9ad8\uff0c\u800c\u5f9e\u7b2c\u4e8c\u500b\u9031\u671f\u958b\u59cb\uff0c\u5641\u5fc3\u7684\u767c\u751f\u7387\u901a\u5e38\u5728\u5f8c\u7e8c\u9031\u671f\u4e2d\u6709\u6240\u4e0b\u964d\uff08\u5373\u96a8\u8457\u6642\u9593\u7684\u63a8\u79fb\u800c\u964d\u4f4e\uff09\u3002 \u5e74\u9577\u8005\uff1a75\u00a0\u6b72\u53ca\u4ee5\u4e0a\u60a3\u8005\u66f4\u5e38\u5831\u544a\u8178\u80c3\u9053\u554f\u984c\u3002 \u751f\u80b2\u3001\u61f7\u5b55\u548c\u54fa\u4e73\uff1a  \u8655\u65bc\u61f7\u5b55\u671f\u6216\u672a\u4f7f\u7528\u907f\u5b55\u63aa\u65bd\u7684\u80b2\u9f61\u5a66\u5973\u4e0d\u61c9\u4f7f\u7528 ORSERDU\u3002\u6839\u64da elacestrant\u00a0\u7684\u4f5c\u7528\u6a5f\u5236\u548c\u52d5\u7269\u7684\u751f\u6b96\u6bd2\u6027\u7814\u7a76\u7d50\u679c\uff0c\u5b55\u5a66\u670d\u7528 ORSERDU\u00a0\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u61c9\u544a\u77e5\u80b2\u9f61\u5973\u6027\uff0c\u5728\u63a5\u53d7 ORSERDU\u00a0\u6cbb\u7642\u671f\u9593\u548c\u6700\u5f8c\u4e00\u6b21\u7528\u85e5\u5f8c\u4e00\u9031\u5167\u5fc5\u9808\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u63aa\u65bd\u3002 \u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU\u00a0\u6cbb\u7642\u671f\u9593\u548c\u6700\u5f8c\u4e00\u6b21\u670d\u7528 ORSERDU\u00a0\u5f8c\u4e00\u9031\u5167\u4e0d\u61c9\u54fa\u4e73\u3002 \u57fa\u65bc\u52d5\u7269\u7814\u7a76\u7684\u767c\u73fe\u548c\u5176\u4f5c\u7528\u6a5f\u5236\uff0cORSERDU\u00a0\u53ef\u80fd\u6703\u5f71\u97ff\u6709\u751f\u6b96\u80fd\u529b\u7684\u7537\u6027\u548c\u5973\u6027\u7684\u751f\u80b2\u80fd\u529b\u3002 \u5c0d\u99d5\u8eca\u548c\u64cd\u4f5c\u6a5f\u5668\u7684\u5f71\u97ff\uff1a\u4e00\u4e9b\u670d\u7528 ORSERDU\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u75b2\u52de\u3001\u865b\u5f31\u548c\u5931\u7720\u75c7\u72c0\u3002\u60a3\u8005\u5728\u958b\u8eca\u6216\u64cd\u4f5c\u6a5f\u5668\u6642\uff0c\u61c9\u7576\u8b39\u614e\u6ce8\u610f\u662f\u5426\u6709\u4e0d\u826f\u53cd\u61c9\u3002 \u5c0d\u65bc\u65b0\u751f\u5152\u81f3 18\u00a0\u6b72\u4ee5\u4e0b\u5152\u7ae5\uff0cORSERDU\u00a0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u7acb\u3002 \u5831\u544a\u7591\u4f3c\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61\uff1aEUPV@menarinistemline.com \u5831\u544a\u7522\u54c1\u6295\u8a34\uff0c\u8acb\u806f\u7d61\uff1aEUcustomerservice@menarinistemline.com \u7d22\u53d6\u91ab\u7642\u8cc7\u8a0a\uff0c\u8acb\u806f\u7d61\uff1aEUmedinfo@menarinistemline.com Elacestrant\u00a0\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\u00a0(NCT05563220)\uff1bELECTRA (NCT05386108)\uff1b\u4ee5\u53ca ELCIN (NCT05596409)\u3002Elacestrant\u00a0\u4e5f\u8a08\u5283\u5728\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002 2020\u00a0\u5e74 7\u00a0\u6708\uff0cMenarini\u00a0Group\u00a0\u5f9e Radius\u00a0Health, Inc. \u7372\u5f97\u4e86 elacestrant\u00a0\u7684\u5168\u7403\u6388\u6b0a\u3002Menarini\u00a0Group\u00a0\u73fe\u5728\u5168\u6b0a\u8ca0\u8cac elacestrant\u00a0\u7684\u5168\u7403\u8a3b\u518a\u3001\u5546\u696d\u5316\u548c\u9032\u4e00\u6b65\u7814\u767c\u6d3b\u52d5\u3002 Menarini\u00a0Group\u00a0\u7c21\u4ecb Menarini Group\u00a0\u662f\u4e00\u5bb6\u9818\u5148\u7684\u570b\u969b\u91ab\u85e5\u548c\u8a3a\u65b7\u516c\u53f8\uff0c\u5e74\u71df\u696d\u984d\u8d85\u904e 44\u00a0\u5104\u7f8e\u5143\uff0c\u64c1\u6709\u8d85\u904e 17,000\u00a0\u540d\u54e1\u5de5\u3002Menarini\u00a0\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\u00a0\u64c1\u6709 18\u00a0\u500b\u751f\u7522\u57fa\u5730\u548c 9\u00a0\u500b\u7814\u767c\u4e2d\u5fc3\uff0c\u7522\u54c1\u92b7\u5f80\u5168\u7403 140\u00a0\u500b\u570b\u5bb6\/\u5730\u5340\u3002 \u6b32\u4e86\u89e3\u66f4\u591a\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd www.menarini.com\u3002 \u95dc\u65bc Stemline\u00a0Therapeutics\u00a0Inc.  Stemline\u00a0Therapeutics, Inc.\uff08\u300cStemline\u300d\uff09\u662f Menarini\u00a0Group\u00a0\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\u00a0\u5c07\u5728\u7f8e\u570b\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)\u00a0\u967d\u6027\u3001\u4eba\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2\u00a0(HER2)\u00a0\u9670\u6027\u3001ESR1\u00a0\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\u00a0\u9084\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u63a8\u51fa\u4e86 ELZONRIS\u00ae (tagraxofusp-erzs)\uff0c\u9019\u662f\u4e00\u7a2e\u91dd\u5c0d CD123\u00a0\u7684\u5275\u65b0\u6a19\u9776\u6cbb\u7642\uff0c\u7528\u65bc\u6cbb\u7642\u7206\u767c\u6027\u6d46\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\u00a0\u6cbb\u7642\u65b9\u6848\u3002Stemline\u00a0\u4ea6\u5c07\u5728\u6b50\u6d32\u5546\u696d\u5316 NEXPOVIO\u00ae\uff0c\u4e00\u7a2e\u7528\u65bc\u6cbb\u7642\u591a\u767c\u6027\u9aa8\u9ad3\u7624\u7684 XPO1\u00a0\u6291\u5236\u5291\u3002\u6b64\u5916\uff0cStemline\u00a0\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  \u00b9\u00a0\u6c7a\u7b56\u8cc7\u6e90\u5718\u968a \/ Clarivate\u00a0\u4e73\u764c\u524d\u77bb \/ \u6d41\u884c\u75c5\u5b78 \u20132023\u00a0\u5e74 6\u00a0\u6708 14\u00a0\u65e5 \u00b2\u00a0\u570b\u969b\u764c\u75c7\u7814\u7a76\u6a5f\u69cb\uff0c\u4e16\u754c\u885b\u751f\u7d44\u7e54 \u2013 Globocan\u00a0\u2013 2020\u00a0 \u00b3\u00a0Bardia\u00a0\u7b49\u4eba EMERALD\u00a0\u7684 elacestrant\u00a03\u00a0\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 \u5728\u8f49\u79fb\u60c5\u6cc1\u4e0b\uff0c\u65e2\u5f80 CDK4\/6i\u00a0\u6301\u7e8c\u6642\u9577\u7684\u7d50\u679c\u66f4\u65b0\u3002SABCS\u00a02022. 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Menarini\u00a0Group\u00a0\u7684\u884c\u653f\u7e3d\u88c1\u00a0Elcin\u00a0Barker\u00a0Ergun\u00a0\u8868\u793a\uff1a\u300c\u6211\u5011\u65e9\u5df2\u77e5\u9053\uff0c\u60a3\u6709\u8f49\u79fb\u6027\u4e73\u764c\u7684\u60a3\u8005\u9700\u8981\u6709\u6548\u4e14\u6613\u65bc\u8010\u53d7\u7684\u6cbb\u7642\u9078\u9805\uff0c\u4ee5\u5728\u6cbb\u7642\u75be\u75c5\u7684\u540c\u6642\u8b93\u4ed6\u5011\u5c08\u6ce8\u65bc\u5c0d\u4ed6\u5011\u800c\u8a00\u91cd\u8981\u7684\u4e8b\u60c5\u3002\u300d\u300c\u80fd\u5920\u63d0\u4f9b\u6bcf\u65e5\u53ea\u9700\u53e3\u670d\u4e00\u6b21\u7684\u65b0\u578b\u4e73\u764c\u6cbb\u7642\u65b9\u6848\u4f7f\u6211\u5011\u500d\u611f\u81ea\u8c6a\uff0c\u9019\u4e5f\u662f\u8fd1\u4e8c\u5341\u5e74\u4f86\u5167\u5206\u6ccc\u6cbb\u7642\u9818\u57df\u7684\u9996\u6b21\u5275\u65b0\uff1b\u540c\u6642\uff0c\u6211\u5011\u975e\u5e38\u611f\u8b1d\u816b\u7624\u5b78\u7814\u7a76\u4eba\u54e1\u4ee5\u53ca\u53c3\u8207\u81e8\u5e8a\u7814\u7a76\u7684\u6240\u6709\u60a3\u8005\uff0c\u6b63\u662f\u56e0\u70ba\u4ed6\u5011\u7684\u652f\u6301\u548c\u53c3\u8207\uff0c\u624d\u80fd\u6536\u7a6b\u4eca\u5929\u7684\u6210\u679c\u3002\u300d \u7531\u65bc\u76f8\u7576\u591a\u7684 ER+ HER2- \u60a3\u8005\u662f\u5728\u8f49\u79fb\u6027\u764c\u75c7\u904e\u7a0b\u4e2d\u7684\u67d0\u500b\u6642\u523b\u6700\u7d42\u767c\u5c55\u51fa ESR1\u00a0\u7a81\u8b8a\uff0c\u56e0\u6b64\u5728\u6bcf\u6b21 mBC\u00a0\u60a3\u8005\u51fa\u73fe\u75be\u75c5\u52a0\u5287\u6642\u9032\u884c ESR1\u00a0\u6e2c\u8a66\u975e\u5e38\u91cd\u8981\uff0c\u4ee5\u77ad\u89e3\u5176\u4e73\u764c\u7684\u60e1\u5316\u56e0\u7d20\u3002\u300c\u4eca\u5929\u7684\u6838\u51c6\u70ba\u6211\u5011\u63d0\u4f9b\u4e86\u9996\u500b\u6cbb\u7642\u65b9\u6848\uff0c\u4f7f\u6211\u5011\u80fd\u5920\u76f4\u63a5\u5c0d\u6297\u9019\u7a2e\u5c0e\u81f4\u4e73\u764c\u66f4\u96e3\u6cbb\u7642\u7684\u7a81\u8b8a\uff0c\u70ba\u60a3\u8005\u548c\u5176\u5bb6\u4eba\u5e36\u4f86\u4e86\u5e0c\u671b\u3002\u300d\u610f\u5927\u5229\u6b50\u6d32\u816b\u7624\u7814\u7a76\u6240 (IRCCS)\u00a0\u65e9\u671f\u85e5\u7269\u958b\u767c\u90e8\u9580\u4e3b\u4efb\u3001\u7c73\u862d\u5927\u5b78\u91ab\u5b78\u816b\u7624\u5b78\u79d1\u6559\u6388 Giuseppe Curigliano\u00a0\u91ab\u5b78\u535a\u58eb\u8aaa\u9053\u3002 \u7b2c\u4e09\u671f EMERALD\u00a0\u8a66\u9a57\u7684\u8cc7\u6599\u70ba ORSERDU\u00a0\u7684\u6838\u51c6\u63d0\u4f9b\u4e86\u652f\u6301\uff0c\u8a72\u8a66\u9a57\u8868\u660e\uff0c\u8207\u6a19\u6e96\u6cbb\u7642 (SOC)\u00a0\u76f8\u6bd4\uff0c\u4f7f\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u00a0\u5177\u6709\u7d71\u8a08\u5b78\u610f\u7fa9\uff0c\u6a19\u6e96\u6cbb\u7642\u7684\u5b9a\u7fa9\u70ba\u7814\u7a76\u4eba\u54e1\u9078\u64c7\u7684\u5df2\u7372\u51c6\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\u3002\u672c\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5168\u9ad4\u60a3\u8005\u7fa4\u9ad4\u548c\u5e36\u6709 ESR1\u00a0\u7a81\u8b8a\u60a3\u8005\u4e2d\u7684 PFS\u00a0\u5c0d\u6bd4\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u51fa\u73fe\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u5728 2022\u00a0\u5e74\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u764c\u7814\u8ba8\u4f1a (SABCS)\u00a0\u4e0a\u958b\u5c55\u4e86\u95dc\u65bc EMERALD\u00a0PFS\u00a0\u7d50\u679c\u7684\u4e8b\u5f8c\u4e9e\u7d44\u5206\u6790\uff0c\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\\\/6i\u00a0\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 elacestrant\u00a0\u5f8c\u7684 PFS\u00a0\u5ef6\u9577\u5448\u6b63\u76f8\u95dc\uff0c\u4f46\u5728 SOC\u00a0\u4e0a\u4e26\u7121\u5448\u73fe\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD\u00a0\u96a8\u6a5f\u7be9\u67e5\u4e4b\u524d\u63a5\u53d7 CDK4\\\/6i\u00a0\u6cbb\u7642 12\u00a0\u500b\u6708\u4ee5\u4e0a\uff0c\u4e14\u767c\u751f ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\uff0c elacestrant\u00a0\u7684 PFS\u00a0\u4e2d\u4f4d\u6578\u70ba 8.6\u00a0\u500b\u6708\uff0c\u800c SOC\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u98a8\u96aa\u964d\u4f4e\u4e86 59\uff05\u00a0(HR=0.41 95% CI: 0.26-0.63)\u3002\u00b3 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002ORSERDU\u00a0\u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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\u3002ORSERDU\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002 Stemline\u00a0\u53ca\u5176\u9644\u5c6c\u516c\u53f8\u5c07\u5728\u6b50\u6d32\u63a8\u51fa\u8a72\u7522\u54c1\u3002 EMERALD\u00a0\u7b2c 3\u00a0\u671f\u7814\u7a76 (NCT03778931)\u00a0\u7c21\u4ecbEMERALD\u00a0\u7b2c 3\u00a0\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\u00a0\u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2-\u00a0\u665a\u671f\\\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u8a72\u7814\u7a76\u62db\u52df\u4e86 478\u00a0\u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5\uff08\u5305\u62ec CDK4\\\/6\u00a0\u6291\u5236\u5291\uff09\u7684\u60a3\u8005\u3002\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7 elacestrant\u00a0\u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5728\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u4ee5\u53ca\u5177\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 1\u00a0\u57fa\u56e0 (ESR1)\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u4e2d\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\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 HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u95dc\u65bc ORSERDU\u00ae (elacestrant) \u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \u55ae\u85e5\u6cbb\u7642\u7528\u65bc\u651c\u5e36\u6d3b\u5316 ESR1\u00a0\u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER)\u00a0\u967d\u6027\u3001HER2\u00a0\u9670\u6027\u3001\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u4e14\u5728\u63a5\u53d7\u904e\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\\\/6\u00a0\u6291\u5236\u5291\uff09\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\u3002 ORSERDU\u00a0SmPC\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a \u809d\u529f\u80fd\u53d7\u640d\uff1a\u00a0\u809d\u529f\u80fd\u4e2d\u5ea6\u53d7\u640d\u7684\u60a3\u8005 (Child-Pugh B) \u61c9\u8b39\u614e\u4f7f\u7528 ORSERDU\uff0c\u6bcf\u65e5\u5291\u91cf\u70ba 258\u00a0\u6beb\u514b\u3002\u5728\u7f3a\u4e4f\u81e8\u5e8a\u8cc7\u6599\u7684\u60c5\u6cc1\u4e0b\uff0c\u4e0d\u5efa\u8b70\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C)\u00a0\u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002 \u8207 CYP3A4\u00a0\u8a98\u5c0e\u5291\u53ca\\\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\u3002 \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u8a98\u5c0e\u5291\u540c\u6642\u4f7f\u7528\u3002 \u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff1a\u665a\u671f\u4e73\u764c\u60a3\u8005\u5e38\u898b\u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff0c\u4e14\u5728 ORSERDU\u00a0\u7684\u81e8\u5e8a\u7814\u7a76\u4e2d\u4e5f\u89c0\u5bdf\u5230\u6b64\u73fe\u8c61\u3002\u7576\u70ba\u9ad8\u98a8\u96aa\u60a3\u8005\u958b\u7acb ORSERDU\u00a0\u6642\uff0c\u61c9\u8457\u91cd\u8003\u616e\u6b64\u4e8b\u9805\u3002 \u4e0d\u826f\u53cd\u61c9\uff1a \u22651%\u00a0\u7684\u60a3\u8005\u5831\u544a\u7684\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3\u3001\u547c\u5438\u56f0\u96e3\u548c\u8840\u6813\u6813\u585e\uff08\u975c\u8108\uff09\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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 Elacestrant\u00a0\u6700\u5e38\u898b\u7684\u4e09\u7d1a\u53ca\u4ee5\u4e0a (\u22652%)\u00a0\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3 (2.7%)\uff0cAST\u00a0\u5347\u9ad8 (2.7%)\uff0cALT\u00a0\u5347\u9ad8 (2.3%)\uff0c\u8ca7\u8840 (2%)\uff0c\u80cc\u75db (2%)\u00a0\u548c\u9aa8\u75db (2%)\u3002 \u5641\u5fc3\uff1a35%\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u5641\u5fc3\u30022.5% \u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe 3-4\u00a0\u7d1a\u5641\u5fc3\u4e8b\u4ef6\u3002\u5728\u7b2c\u4e00\u500b\u9031\u671f\u4e2d\uff0c\u5641\u5fc3\u7684\u767c\u751f\u983b\u7387\u66f4\u9ad8\uff0c\u800c\u5f9e\u7b2c\u4e8c\u500b\u9031\u671f\u958b\u59cb\uff0c\u5641\u5fc3\u7684\u767c\u751f\u7387\u901a\u5e38\u5728\u5f8c\u7e8c\u9031\u671f\u4e2d\u6709\u6240\u4e0b\u964d\uff08\u5373\u96a8\u8457\u6642\u9593\u7684\u63a8\u79fb\u800c\u964d\u4f4e\uff09\u3002 \u5e74\u9577\u8005\uff1a75\u00a0\u6b72\u53ca\u4ee5\u4e0a\u60a3\u8005\u66f4\u5e38\u5831\u544a\u8178\u80c3\u9053\u554f\u984c\u3002 \u751f\u80b2\u3001\u61f7\u5b55\u548c\u54fa\u4e73\uff1a \u8655\u65bc\u61f7\u5b55\u671f\u6216\u672a\u4f7f\u7528\u907f\u5b55\u63aa\u65bd\u7684\u80b2\u9f61\u5a66\u5973\u4e0d\u61c9\u4f7f\u7528 ORSERDU\u3002\u6839\u64da elacestrant\u00a0\u7684\u4f5c\u7528\u6a5f\u5236\u548c\u52d5\u7269\u7684\u751f\u6b96\u6bd2\u6027\u7814\u7a76\u7d50\u679c\uff0c\u5b55\u5a66\u670d\u7528 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SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u51fa\u73fe\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u5728 2022\u00a0\u5e74\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u764c\u7814\u8ba8\u4f1a (SABCS)\u00a0\u4e0a\u958b\u5c55\u4e86\u95dc\u65bc EMERALD\u00a0PFS\u00a0\u7d50\u679c\u7684\u4e8b\u5f8c\u4e9e\u7d44\u5206\u6790\uff0c\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6i\u00a0\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 elacestrant\u00a0\u5f8c\u7684 PFS\u00a0\u5ef6\u9577\u5448\u6b63\u76f8\u95dc\uff0c\u4f46\u5728 SOC\u00a0\u4e0a\u4e26\u7121\u5448\u73fe\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD\u00a0\u96a8\u6a5f\u7be9\u67e5\u4e4b\u524d\u63a5\u53d7 CDK4\/6i\u00a0\u6cbb\u7642 12\u00a0\u500b\u6708\u4ee5\u4e0a\uff0c\u4e14\u767c\u751f ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\uff0c elacestrant\u00a0\u7684 PFS\u00a0\u4e2d\u4f4d\u6578\u70ba 8.6\u00a0\u500b\u6708\uff0c\u800c SOC\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u98a8\u96aa\u964d\u4f4e\u4e86 59\uff05\u00a0(HR=0.41 95% CI: 0.26-0.63)\u3002\u00b3 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002ORSERDU\u00a0\u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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\u3002ORSERDU\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002 Stemline\u00a0\u53ca\u5176\u9644\u5c6c\u516c\u53f8\u5c07\u5728\u6b50\u6d32\u63a8\u51fa\u8a72\u7522\u54c1\u3002 EMERALD\u00a0\u7b2c 3\u00a0\u671f\u7814\u7a76 (NCT03778931)\u00a0\u7c21\u4ecbEMERALD\u00a0\u7b2c 3\u00a0\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\u00a0\u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2-\u00a0\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u8a72\u7814\u7a76\u62db\u52df\u4e86 478\u00a0\u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5\uff08\u5305\u62ec CDK4\/6\u00a0\u6291\u5236\u5291\uff09\u7684\u60a3\u8005\u3002\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7 elacestrant\u00a0\u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5728\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u4ee5\u53ca\u5177\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 1\u00a0\u57fa\u56e0 (ESR1)\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u4e2d\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\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 HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u95dc\u65bc ORSERDU\u00ae (elacestrant) \u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \u55ae\u85e5\u6cbb\u7642\u7528\u65bc\u651c\u5e36\u6d3b\u5316 ESR1\u00a0\u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER)\u00a0\u967d\u6027\u3001HER2\u00a0\u9670\u6027\u3001\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u4e14\u5728\u63a5\u53d7\u904e\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6\u00a0\u6291\u5236\u5291\uff09\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\u3002 ORSERDU\u00a0SmPC\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a  \u809d\u529f\u80fd\u53d7\u640d\uff1a\u00a0\u809d\u529f\u80fd\u4e2d\u5ea6\u53d7\u640d\u7684\u60a3\u8005 (Child-Pugh B) \u61c9\u8b39\u614e\u4f7f\u7528 ORSERDU\uff0c\u6bcf\u65e5\u5291\u91cf\u70ba 258\u00a0\u6beb\u514b\u3002\u5728\u7f3a\u4e4f\u81e8\u5e8a\u8cc7\u6599\u7684\u60c5\u6cc1\u4e0b\uff0c\u4e0d\u5efa\u8b70\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C)\u00a0\u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002 \u8207 CYP3A4\u00a0\u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\u3002 \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u8a98\u5c0e\u5291\u540c\u6642\u4f7f\u7528\u3002 \u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff1a\u665a\u671f\u4e73\u764c\u60a3\u8005\u5e38\u898b\u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff0c\u4e14\u5728 ORSERDU\u00a0\u7684\u81e8\u5e8a\u7814\u7a76\u4e2d\u4e5f\u89c0\u5bdf\u5230\u6b64\u73fe\u8c61\u3002\u7576\u70ba\u9ad8\u98a8\u96aa\u60a3\u8005\u958b\u7acb ORSERDU\u00a0\u6642\uff0c\u61c9\u8457\u91cd\u8003\u616e\u6b64\u4e8b\u9805\u3002 \u4e0d\u826f\u53cd\u61c9\uff1a  \u22651%\u00a0\u7684\u60a3\u8005\u5831\u544a\u7684\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3\u3001\u547c\u5438\u56f0\u96e3\u548c\u8840\u6813\u6813\u585e\uff08\u975c\u8108\uff09\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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 Elacestrant\u00a0\u6700\u5e38\u898b\u7684\u4e09\u7d1a\u53ca\u4ee5\u4e0a (\u22652%)\u00a0\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3 (2.7%)\uff0cAST\u00a0\u5347\u9ad8 (2.7%)\uff0cALT\u00a0\u5347\u9ad8 (2.3%)\uff0c\u8ca7\u8840 (2%)\uff0c\u80cc\u75db (2%)\u00a0\u548c\u9aa8\u75db (2%)\u3002 \u5641\u5fc3\uff1a35%\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u5641\u5fc3\u30022.5% \u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe 3-4\u00a0\u7d1a\u5641\u5fc3\u4e8b\u4ef6\u3002\u5728\u7b2c\u4e00\u500b\u9031\u671f\u4e2d\uff0c\u5641\u5fc3\u7684\u767c\u751f\u983b\u7387\u66f4\u9ad8\uff0c\u800c\u5f9e\u7b2c\u4e8c\u500b\u9031\u671f\u958b\u59cb\uff0c\u5641\u5fc3\u7684\u767c\u751f\u7387\u901a\u5e38\u5728\u5f8c\u7e8c\u9031\u671f\u4e2d\u6709\u6240\u4e0b\u964d\uff08\u5373\u96a8\u8457\u6642\u9593\u7684\u63a8\u79fb\u800c\u964d\u4f4e\uff09\u3002 \u5e74\u9577\u8005\uff1a75\u00a0\u6b72\u53ca\u4ee5\u4e0a\u60a3\u8005\u66f4\u5e38\u5831\u544a\u8178\u80c3\u9053\u554f\u984c\u3002 \u751f\u80b2\u3001\u61f7\u5b55\u548c\u54fa\u4e73\uff1a  \u8655\u65bc\u61f7\u5b55\u671f\u6216\u672a\u4f7f\u7528\u907f\u5b55\u63aa\u65bd\u7684\u80b2\u9f61\u5a66\u5973\u4e0d\u61c9\u4f7f\u7528 ORSERDU\u3002\u6839\u64da elacestrant\u00a0\u7684\u4f5c\u7528\u6a5f\u5236\u548c\u52d5\u7269\u7684\u751f\u6b96\u6bd2\u6027\u7814\u7a76\u7d50\u679c\uff0c\u5b55\u5a66\u670d\u7528 ORSERDU\u00a0\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u61c9\u544a\u77e5\u80b2\u9f61\u5973\u6027\uff0c\u5728\u63a5\u53d7 ORSERDU\u00a0\u6cbb\u7642\u671f\u9593\u548c\u6700\u5f8c\u4e00\u6b21\u7528\u85e5\u5f8c\u4e00\u9031\u5167\u5fc5\u9808\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u63aa\u65bd\u3002 \u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU\u00a0\u6cbb\u7642\u671f\u9593\u548c\u6700\u5f8c\u4e00\u6b21\u670d\u7528 ORSERDU\u00a0\u5f8c\u4e00\u9031\u5167\u4e0d\u61c9\u54fa\u4e73\u3002 \u57fa\u65bc\u52d5\u7269\u7814\u7a76\u7684\u767c\u73fe\u548c\u5176\u4f5c\u7528\u6a5f\u5236\uff0cORSERDU\u00a0\u53ef\u80fd\u6703\u5f71\u97ff\u6709\u751f\u6b96\u80fd\u529b\u7684\u7537\u6027\u548c\u5973\u6027\u7684\u751f\u80b2\u80fd\u529b\u3002 \u5c0d\u99d5\u8eca\u548c\u64cd\u4f5c\u6a5f\u5668\u7684\u5f71\u97ff\uff1a\u4e00\u4e9b\u670d\u7528 ORSERDU\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u75b2\u52de\u3001\u865b\u5f31\u548c\u5931\u7720\u75c7\u72c0\u3002\u60a3\u8005\u5728\u958b\u8eca\u6216\u64cd\u4f5c\u6a5f\u5668\u6642\uff0c\u61c9\u7576\u8b39\u614e\u6ce8\u610f\u662f\u5426\u6709\u4e0d\u826f\u53cd\u61c9\u3002 \u5c0d\u65bc\u65b0\u751f\u5152\u81f3 18\u00a0\u6b72\u4ee5\u4e0b\u5152\u7ae5\uff0cORSERDU\u00a0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u7acb\u3002 \u5831\u544a\u7591\u4f3c\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61\uff1aEUPV@menarinistemline.com \u5831\u544a\u7522\u54c1\u6295\u8a34\uff0c\u8acb\u806f\u7d61\uff1aEUcustomerservice@menarinistemline.com \u7d22\u53d6\u91ab\u7642\u8cc7\u8a0a\uff0c\u8acb\u806f\u7d61\uff1aEUmedinfo@menarinistemline.com Elacestrant\u00a0\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\u00a0(NCT05563220)\uff1bELECTRA (NCT05386108)\uff1b\u4ee5\u53ca ELCIN (NCT05596409)\u3002Elacestrant\u00a0\u4e5f\u8a08\u5283\u5728\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002 2020\u00a0\u5e74 7\u00a0\u6708\uff0cMenarini\u00a0Group\u00a0\u5f9e Radius\u00a0Health, Inc. \u7372\u5f97\u4e86 elacestrant\u00a0\u7684\u5168\u7403\u6388\u6b0a\u3002Menarini\u00a0Group\u00a0\u73fe\u5728\u5168\u6b0a\u8ca0\u8cac elacestrant\u00a0\u7684\u5168\u7403\u8a3b\u518a\u3001\u5546\u696d\u5316\u548c\u9032\u4e00\u6b65\u7814\u767c\u6d3b\u52d5\u3002 Menarini\u00a0Group\u00a0\u7c21\u4ecb Menarini Group\u00a0\u662f\u4e00\u5bb6\u9818\u5148\u7684\u570b\u969b\u91ab\u85e5\u548c\u8a3a\u65b7\u516c\u53f8\uff0c\u5e74\u71df\u696d\u984d\u8d85\u904e 44\u00a0\u5104\u7f8e\u5143\uff0c\u64c1\u6709\u8d85\u904e 17,000\u00a0\u540d\u54e1\u5de5\u3002Menarini\u00a0\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\u00a0\u64c1\u6709 18\u00a0\u500b\u751f\u7522\u57fa\u5730\u548c 9\u00a0\u500b\u7814\u767c\u4e2d\u5fc3\uff0c\u7522\u54c1\u92b7\u5f80\u5168\u7403 140\u00a0\u500b\u570b\u5bb6\/\u5730\u5340\u3002 \u6b32\u4e86\u89e3\u66f4\u591a\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd www.menarini.com\u3002 \u95dc\u65bc Stemline\u00a0Therapeutics\u00a0Inc.  Stemline\u00a0Therapeutics, Inc.\uff08\u300cStemline\u300d\uff09\u662f Menarini\u00a0Group\u00a0\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\u00a0\u5c07\u5728\u7f8e\u570b\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)\u00a0\u967d\u6027\u3001\u4eba\u8868\u76ae\u751f\u9577\u56e0\u5b50\u53d7\u9ad4 2\u00a0(HER2)\u00a0\u9670\u6027\u3001ESR1\u00a0\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\u00a0\u9084\u5728\u7f8e\u570b\u548c\u6b50\u6d32\u63a8\u51fa\u4e86 ELZONRIS\u00ae (tagraxofusp-erzs)\uff0c\u9019\u662f\u4e00\u7a2e\u91dd\u5c0d CD123\u00a0\u7684\u5275\u65b0\u6a19\u9776\u6cbb\u7642\uff0c\u7528\u65bc\u6cbb\u7642\u7206\u767c\u6027\u6d46\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\u00a0\u6cbb\u7642\u65b9\u6848\u3002Stemline\u00a0\u4ea6\u5c07\u5728\u6b50\u6d32\u5546\u696d\u5316 NEXPOVIO\u00ae\uff0c\u4e00\u7a2e\u7528\u65bc\u6cbb\u7642\u591a\u767c\u6027\u9aa8\u9ad3\u7624\u7684 XPO1\u00a0\u6291\u5236\u5291\u3002\u6b64\u5916\uff0cStemline\u00a0\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  \u00b9\u00a0\u6c7a\u7b56\u8cc7\u6e90\u5718\u968a \/ Clarivate\u00a0\u4e73\u764c\u524d\u77bb \/ \u6d41\u884c\u75c5\u5b78 \u20132023\u00a0\u5e74 6\u00a0\u6708 14\u00a0\u65e5 \u00b2\u00a0\u570b\u969b\u764c\u75c7\u7814\u7a76\u6a5f\u69cb\uff0c\u4e16\u754c\u885b\u751f\u7d44\u7e54 \u2013 Globocan\u00a0\u2013 2020\u00a0 \u00b3\u00a0Bardia\u00a0\u7b49\u4eba EMERALD\u00a0\u7684 elacestrant\u00a03\u00a0\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 \u5728\u8f49\u79fb\u60c5\u6cc1\u4e0b\uff0c\u65e2\u5f80 CDK4\/6i\u00a0\u6301\u7e8c\u6642\u9577\u7684\u7d50\u679c\u66f4\u65b0\u3002SABCS\u00a02022. GS3-01","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=179235","og_locale":"zh_TW","og_type":"article","og_title":"\u6b50\u6d32\u59d4\u54e1\u6703\u6838\u51c6 Menarini Group \u7684 ORSERDU\u00ae (Elacestrant) \u7528\u65bc\u6cbb\u7642\u651c\u5e36\u6d3b\u5316 ESR1 \u7a81\u8b8a\u7684ER +\uff0cHER2- \u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u7684\u60a3\u8005 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","og_description":"\u6bcf\u5e74\u5728\u6b50\u6d32\u6709\u8d85\u904e 550,000 \u540d\u60a3\u8005\u88ab\u8a3a\u65b7\u51fa\u60a3\u6709\u4e73\u764c\uff0c\u5176\u4e2d 70% \u7684\u60a3\u8005\u70ba\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\u00b9\uff1b\u6bcf\u5e74\u6b50\u6d32\u6709\u8d85\u904e 147,000 \u540d\u4e73\u764c\u60a3\u8005\u6b7b\u65bc\u8a72\u75be\u75c5\u00b2\u3002  ORSERDU \u662f\u9996\u6b3e\u5c08\u9580\u91dd\u5c0d ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u816b\u7624\u4e14\u651c\u5e36 ESR1 \u7a81\u8b8a\u7684\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6cd5\uff0c\u9019\u662f\u8fd1 20 \u5e74\u4f86\u5167\u5206\u6ccc\u6cbb\u7642\u9818\u57df\u7684\u9996\u6b21\u5275\u65b0  ESR1 \u7a81\u8b8a\u5728 ER+\u3001HER2- \u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c\u4e2d\u51fa\u73fe\u7684\u6bd4\u4f8b\u9ad8\u9054 40\uff05\uff0c\u4e14\u662f\u6a19\u6e96\u5167\u5206\u6ccc\u6cbb\u7642\u7684\u5df2\u77e5\u8010\u85e5\u9a45\u52d5\u56e0\u7d20\uff0c\u4f7f\u5f97\u9019\u985e\u578b\u816b\u7624\u66f4\u52a0\u96e3\u4ee5\u6cbb\u7642 \u610f\u5927\u5229\u4f5b\u7f85\u502b\u85a9\u53ca\u7d10\u7d04\u00a02023\u5e749\u670822\u65e5 \/\u7f8e\u901a\u793e\/ -- \u9818\u5148\u7684\u570b\u969b\u5236\u85e5\u548c\u8a3a\u65b7\u516c\u53f8 Menarini Group\uff08\u300cMenarini\u300d\uff09\u4ee5\u53ca Menarini Group \u7684\u5168\u8cc7\u5b50\u516c\u53f8 Stemline Therapeutics Inc.\uff08\u300cStemline\u300d\uff09\u4eca\u5929\u5ba3\u5e03\uff0c\u6b50\u6d32\u59d4\u54e1\u6703\u5df2\u6838\u51c6 ORSERDU\u00ae (elacestrant) \u4f5c\u70ba\u55ae\u85e5\u6cbb\u7642\u6cd5\uff0c\u7528\u65bc\u6cbb\u7642\u651c\u5e36\u6d3b\u5316 ESR1 \u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\uff0cHER2 \u9670\u6027\uff0c\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\uff0c\u4e26\u4e14\u5728\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6 \u6291\u5236\u5291\uff09\u5f8c\u75be\u75c5\u52a0\u5287\u7684\u60a3\u8005\u3002 \u6b50\u6d32\u59d4\u54e1\u6703\u7684\u6b64\u6b21\u6838\u51c6\u662f\u57fa\u65bc\u6b50\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40 (EMA) \u65bc 2023\u00a0\u5e74 7\u00a0\u6708\u516c\u4f48\u7684\u4eba\u7528\u85e5\u54c1 (CHMP)\u00a0\u7684\u80af\u5b9a\u610f\u898b\u3002\u6b64\u6b21\u6838\u51c6\u610f\u5473\u8457 ORSERDU\u00a0\u662f\u7b2c\u4e00\u7a2e\uff0c\u4e5f\u662f\u552f\u4e00\u4e00\u7a2e\u660e\u78ba\u6307\u793a\u7528\u65bc\u6cbb\u7642\u651c\u5e36 ESR1\u00a0\u7a81\u8b8a\u7684 ER+\uff0cHER2-\u00a0\u816b\u7624\u7684\u6cbb\u7642\u65b9\u6cd5\u3002ESR1\u00a0\u7a81\u8b8a\u662f\u7531\u65bc\u63a5\u53d7\u5167\u5206\u6ccc\u6cbb\u7642\u800c\u7522\u751f\u7684\u5f8c\u5929\u7a81\u8b8a\uff0c\u4e26\u4e14\u5728 ER+\uff0cHER2- mBC\u00a0\u4e73\u764c\u60a3\u8005\u4e2d\u767c\u751f\u7387\u9ad8\u9054 40%\u3002ESR1\u00a0\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 Menarini\u00a0Group\u00a0\u7684\u884c\u653f\u7e3d\u88c1\u00a0Elcin\u00a0Barker\u00a0Ergun\u00a0\u8868\u793a\uff1a\u300c\u6211\u5011\u65e9\u5df2\u77e5\u9053\uff0c\u60a3\u6709\u8f49\u79fb\u6027\u4e73\u764c\u7684\u60a3\u8005\u9700\u8981\u6709\u6548\u4e14\u6613\u65bc\u8010\u53d7\u7684\u6cbb\u7642\u9078\u9805\uff0c\u4ee5\u5728\u6cbb\u7642\u75be\u75c5\u7684\u540c\u6642\u8b93\u4ed6\u5011\u5c08\u6ce8\u65bc\u5c0d\u4ed6\u5011\u800c\u8a00\u91cd\u8981\u7684\u4e8b\u60c5\u3002\u300d\u300c\u80fd\u5920\u63d0\u4f9b\u6bcf\u65e5\u53ea\u9700\u53e3\u670d\u4e00\u6b21\u7684\u65b0\u578b\u4e73\u764c\u6cbb\u7642\u65b9\u6848\u4f7f\u6211\u5011\u500d\u611f\u81ea\u8c6a\uff0c\u9019\u4e5f\u662f\u8fd1\u4e8c\u5341\u5e74\u4f86\u5167\u5206\u6ccc\u6cbb\u7642\u9818\u57df\u7684\u9996\u6b21\u5275\u65b0\uff1b\u540c\u6642\uff0c\u6211\u5011\u975e\u5e38\u611f\u8b1d\u816b\u7624\u5b78\u7814\u7a76\u4eba\u54e1\u4ee5\u53ca\u53c3\u8207\u81e8\u5e8a\u7814\u7a76\u7684\u6240\u6709\u60a3\u8005\uff0c\u6b63\u662f\u56e0\u70ba\u4ed6\u5011\u7684\u652f\u6301\u548c\u53c3\u8207\uff0c\u624d\u80fd\u6536\u7a6b\u4eca\u5929\u7684\u6210\u679c\u3002\u300d \u7531\u65bc\u76f8\u7576\u591a\u7684 ER+ HER2- \u60a3\u8005\u662f\u5728\u8f49\u79fb\u6027\u764c\u75c7\u904e\u7a0b\u4e2d\u7684\u67d0\u500b\u6642\u523b\u6700\u7d42\u767c\u5c55\u51fa ESR1\u00a0\u7a81\u8b8a\uff0c\u56e0\u6b64\u5728\u6bcf\u6b21 mBC\u00a0\u60a3\u8005\u51fa\u73fe\u75be\u75c5\u52a0\u5287\u6642\u9032\u884c ESR1\u00a0\u6e2c\u8a66\u975e\u5e38\u91cd\u8981\uff0c\u4ee5\u77ad\u89e3\u5176\u4e73\u764c\u7684\u60e1\u5316\u56e0\u7d20\u3002\u300c\u4eca\u5929\u7684\u6838\u51c6\u70ba\u6211\u5011\u63d0\u4f9b\u4e86\u9996\u500b\u6cbb\u7642\u65b9\u6848\uff0c\u4f7f\u6211\u5011\u80fd\u5920\u76f4\u63a5\u5c0d\u6297\u9019\u7a2e\u5c0e\u81f4\u4e73\u764c\u66f4\u96e3\u6cbb\u7642\u7684\u7a81\u8b8a\uff0c\u70ba\u60a3\u8005\u548c\u5176\u5bb6\u4eba\u5e36\u4f86\u4e86\u5e0c\u671b\u3002\u300d\u610f\u5927\u5229\u6b50\u6d32\u816b\u7624\u7814\u7a76\u6240 (IRCCS)\u00a0\u65e9\u671f\u85e5\u7269\u958b\u767c\u90e8\u9580\u4e3b\u4efb\u3001\u7c73\u862d\u5927\u5b78\u91ab\u5b78\u816b\u7624\u5b78\u79d1\u6559\u6388 Giuseppe Curigliano\u00a0\u91ab\u5b78\u535a\u58eb\u8aaa\u9053\u3002 \u7b2c\u4e09\u671f EMERALD\u00a0\u8a66\u9a57\u7684\u8cc7\u6599\u70ba ORSERDU\u00a0\u7684\u6838\u51c6\u63d0\u4f9b\u4e86\u652f\u6301\uff0c\u8a72\u8a66\u9a57\u8868\u660e\uff0c\u8207\u6a19\u6e96\u6cbb\u7642 (SOC)\u00a0\u76f8\u6bd4\uff0c\u4f7f\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u00a0\u5177\u6709\u7d71\u8a08\u5b78\u610f\u7fa9\uff0c\u6a19\u6e96\u6cbb\u7642\u7684\u5b9a\u7fa9\u70ba\u7814\u7a76\u4eba\u54e1\u9078\u64c7\u7684\u5df2\u7372\u51c6\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\u3002\u672c\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5168\u9ad4\u60a3\u8005\u7fa4\u9ad4\u548c\u5e36\u6709 ESR1\u00a0\u7a81\u8b8a\u60a3\u8005\u4e2d\u7684 PFS\u00a0\u5c0d\u6bd4\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u51fa\u73fe\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u5728 2022\u00a0\u5e74\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u764c\u7814\u8ba8\u4f1a (SABCS)\u00a0\u4e0a\u958b\u5c55\u4e86\u95dc\u65bc EMERALD\u00a0PFS\u00a0\u7d50\u679c\u7684\u4e8b\u5f8c\u4e9e\u7d44\u5206\u6790\uff0c\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6i\u00a0\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 elacestrant\u00a0\u5f8c\u7684 PFS\u00a0\u5ef6\u9577\u5448\u6b63\u76f8\u95dc\uff0c\u4f46\u5728 SOC\u00a0\u4e0a\u4e26\u7121\u5448\u73fe\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD\u00a0\u96a8\u6a5f\u7be9\u67e5\u4e4b\u524d\u63a5\u53d7 CDK4\/6i\u00a0\u6cbb\u7642 12\u00a0\u500b\u6708\u4ee5\u4e0a\uff0c\u4e14\u767c\u751f ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\uff0c elacestrant\u00a0\u7684 PFS\u00a0\u4e2d\u4f4d\u6578\u70ba 8.6\u00a0\u500b\u6708\uff0c\u800c SOC\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u98a8\u96aa\u964d\u4f4e\u4e86 59\uff05\u00a0(HR=0.41 95% CI: 0.26-0.63)\u3002\u00b3 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002ORSERDU\u00a0\u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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\u3002ORSERDU\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002 Stemline\u00a0\u53ca\u5176\u9644\u5c6c\u516c\u53f8\u5c07\u5728\u6b50\u6d32\u63a8\u51fa\u8a72\u7522\u54c1\u3002 EMERALD\u00a0\u7b2c 3\u00a0\u671f\u7814\u7a76 (NCT03778931)\u00a0\u7c21\u4ecbEMERALD\u00a0\u7b2c 3\u00a0\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\u00a0\u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2-\u00a0\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u8a72\u7814\u7a76\u62db\u52df\u4e86 478\u00a0\u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5\uff08\u5305\u62ec CDK4\/6\u00a0\u6291\u5236\u5291\uff09\u7684\u60a3\u8005\u3002\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7 elacestrant\u00a0\u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5728\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u4ee5\u53ca\u5177\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 1\u00a0\u57fa\u56e0 (ESR1)\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u4e2d\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\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 HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u95dc\u65bc ORSERDU\u00ae (elacestrant) \u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \u55ae\u85e5\u6cbb\u7642\u7528\u65bc\u651c\u5e36\u6d3b\u5316 ESR1\u00a0\u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER)\u00a0\u967d\u6027\u3001HER2\u00a0\u9670\u6027\u3001\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u4e14\u5728\u63a5\u53d7\u904e\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6\u00a0\u6291\u5236\u5291\uff09\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\u3002 ORSERDU\u00a0SmPC\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a  \u809d\u529f\u80fd\u53d7\u640d\uff1a\u00a0\u809d\u529f\u80fd\u4e2d\u5ea6\u53d7\u640d\u7684\u60a3\u8005 (Child-Pugh B) \u61c9\u8b39\u614e\u4f7f\u7528 ORSERDU\uff0c\u6bcf\u65e5\u5291\u91cf\u70ba 258\u00a0\u6beb\u514b\u3002\u5728\u7f3a\u4e4f\u81e8\u5e8a\u8cc7\u6599\u7684\u60c5\u6cc1\u4e0b\uff0c\u4e0d\u5efa\u8b70\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C)\u00a0\u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002 \u8207 CYP3A4\u00a0\u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\u3002 \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u8a98\u5c0e\u5291\u540c\u6642\u4f7f\u7528\u3002 \u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff1a\u665a\u671f\u4e73\u764c\u60a3\u8005\u5e38\u898b\u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff0c\u4e14\u5728 ORSERDU\u00a0\u7684\u81e8\u5e8a\u7814\u7a76\u4e2d\u4e5f\u89c0\u5bdf\u5230\u6b64\u73fe\u8c61\u3002\u7576\u70ba\u9ad8\u98a8\u96aa\u60a3\u8005\u958b\u7acb ORSERDU\u00a0\u6642\uff0c\u61c9\u8457\u91cd\u8003\u616e\u6b64\u4e8b\u9805\u3002 \u4e0d\u826f\u53cd\u61c9\uff1a  \u22651%\u00a0\u7684\u60a3\u8005\u5831\u544a\u7684\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3\u3001\u547c\u5438\u56f0\u96e3\u548c\u8840\u6813\u6813\u585e\uff08\u975c\u8108\uff09\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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 Elacestrant\u00a0\u6700\u5e38\u898b\u7684\u4e09\u7d1a\u53ca\u4ee5\u4e0a (\u22652%)\u00a0\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3 (2.7%)\uff0cAST\u00a0\u5347\u9ad8 (2.7%)\uff0cALT\u00a0\u5347\u9ad8 (2.3%)\uff0c\u8ca7\u8840 (2%)\uff0c\u80cc\u75db (2%)\u00a0\u548c\u9aa8\u75db (2%)\u3002 \u5641\u5fc3\uff1a35%\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u5641\u5fc3\u30022.5% \u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe 3-4\u00a0\u7d1a\u5641\u5fc3\u4e8b\u4ef6\u3002\u5728\u7b2c\u4e00\u500b\u9031\u671f\u4e2d\uff0c\u5641\u5fc3\u7684\u767c\u751f\u983b\u7387\u66f4\u9ad8\uff0c\u800c\u5f9e\u7b2c\u4e8c\u500b\u9031\u671f\u958b\u59cb\uff0c\u5641\u5fc3\u7684\u767c\u751f\u7387\u901a\u5e38\u5728\u5f8c\u7e8c\u9031\u671f\u4e2d\u6709\u6240\u4e0b\u964d\uff08\u5373\u96a8\u8457\u6642\u9593\u7684\u63a8\u79fb\u800c\u964d\u4f4e\uff09\u3002 \u5e74\u9577\u8005\uff1a75\u00a0\u6b72\u53ca\u4ee5\u4e0a\u60a3\u8005\u66f4\u5e38\u5831\u544a\u8178\u80c3\u9053\u554f\u984c\u3002 \u751f\u80b2\u3001\u61f7\u5b55\u548c\u54fa\u4e73\uff1a  \u8655\u65bc\u61f7\u5b55\u671f\u6216\u672a\u4f7f\u7528\u907f\u5b55\u63aa\u65bd\u7684\u80b2\u9f61\u5a66\u5973\u4e0d\u61c9\u4f7f\u7528 ORSERDU\u3002\u6839\u64da elacestrant\u00a0\u7684\u4f5c\u7528\u6a5f\u5236\u548c\u52d5\u7269\u7684\u751f\u6b96\u6bd2\u6027\u7814\u7a76\u7d50\u679c\uff0c\u5b55\u5a66\u670d\u7528 ORSERDU\u00a0\u53ef\u80fd\u6703\u5c0d\u80ce\u5152\u9020\u6210\u50b7\u5bb3\u3002\u61c9\u544a\u77e5\u80b2\u9f61\u5973\u6027\uff0c\u5728\u63a5\u53d7 ORSERDU\u00a0\u6cbb\u7642\u671f\u9593\u548c\u6700\u5f8c\u4e00\u6b21\u7528\u85e5\u5f8c\u4e00\u9031\u5167\u5fc5\u9808\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u63aa\u65bd\u3002 \u5efa\u8b70\u54fa\u4e73\u671f\u5a66\u5973\u5728\u63a5\u53d7 ORSERDU\u00a0\u6cbb\u7642\u671f\u9593\u548c\u6700\u5f8c\u4e00\u6b21\u670d\u7528 ORSERDU\u00a0\u5f8c\u4e00\u9031\u5167\u4e0d\u61c9\u54fa\u4e73\u3002 \u57fa\u65bc\u52d5\u7269\u7814\u7a76\u7684\u767c\u73fe\u548c\u5176\u4f5c\u7528\u6a5f\u5236\uff0cORSERDU\u00a0\u53ef\u80fd\u6703\u5f71\u97ff\u6709\u751f\u6b96\u80fd\u529b\u7684\u7537\u6027\u548c\u5973\u6027\u7684\u751f\u80b2\u80fd\u529b\u3002 \u5c0d\u99d5\u8eca\u548c\u64cd\u4f5c\u6a5f\u5668\u7684\u5f71\u97ff\uff1a\u4e00\u4e9b\u670d\u7528 ORSERDU\u00a0\u7684\u60a3\u8005\u5831\u544a\u51fa\u73fe\u75b2\u52de\u3001\u865b\u5f31\u548c\u5931\u7720\u75c7\u72c0\u3002\u60a3\u8005\u5728\u958b\u8eca\u6216\u64cd\u4f5c\u6a5f\u5668\u6642\uff0c\u61c9\u7576\u8b39\u614e\u6ce8\u610f\u662f\u5426\u6709\u4e0d\u826f\u53cd\u61c9\u3002 \u5c0d\u65bc\u65b0\u751f\u5152\u81f3 18\u00a0\u6b72\u4ee5\u4e0b\u5152\u7ae5\uff0cORSERDU\u00a0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5c1a\u672a\u78ba\u7acb\u3002 \u5831\u544a\u7591\u4f3c\u4e0d\u826f\u53cd\u61c9\uff0c\u8acb\u806f\u7d61\uff1aEUPV@menarinistemline.com \u5831\u544a\u7522\u54c1\u6295\u8a34\uff0c\u8acb\u806f\u7d61\uff1aEUcustomerservice@menarinistemline.com \u7d22\u53d6\u91ab\u7642\u8cc7\u8a0a\uff0c\u8acb\u806f\u7d61\uff1aEUmedinfo@menarinistemline.com 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Inc.\uff08\u300cStemline\u300d\uff09\u4eca\u5929\u5ba3\u5e03\uff0c\u6b50\u6d32\u59d4\u54e1\u6703\u5df2\u6838\u51c6 ORSERDU\u00ae (elacestrant) \u4f5c\u70ba\u55ae\u85e5\u6cbb\u7642\u6cd5\uff0c\u7528\u65bc\u6cbb\u7642\u651c\u5e36\u6d3b\u5316 ESR1 \u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER) \u967d\u6027\uff0cHER2 \u9670\u6027\uff0c\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC) \u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\uff0c\u4e26\u4e14\u5728\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6 \u6291\u5236\u5291\uff09\u5f8c\u75be\u75c5\u52a0\u5287\u7684\u60a3\u8005\u3002 \u6b50\u6d32\u59d4\u54e1\u6703\u7684\u6b64\u6b21\u6838\u51c6\u662f\u57fa\u65bc\u6b50\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40 (EMA) \u65bc 2023\u00a0\u5e74 7\u00a0\u6708\u516c\u4f48\u7684\u4eba\u7528\u85e5\u54c1 (CHMP)\u00a0\u7684\u80af\u5b9a\u610f\u898b\u3002\u6b64\u6b21\u6838\u51c6\u610f\u5473\u8457 ORSERDU\u00a0\u662f\u7b2c\u4e00\u7a2e\uff0c\u4e5f\u662f\u552f\u4e00\u4e00\u7a2e\u660e\u78ba\u6307\u793a\u7528\u65bc\u6cbb\u7642\u651c\u5e36 ESR1\u00a0\u7a81\u8b8a\u7684 ER+\uff0cHER2-\u00a0\u816b\u7624\u7684\u6cbb\u7642\u65b9\u6cd5\u3002ESR1\u00a0\u7a81\u8b8a\u662f\u7531\u65bc\u63a5\u53d7\u5167\u5206\u6ccc\u6cbb\u7642\u800c\u7522\u751f\u7684\u5f8c\u5929\u7a81\u8b8a\uff0c\u4e26\u4e14\u5728 ER+\uff0cHER2- mBC\u00a0\u4e73\u764c\u60a3\u8005\u4e2d\u767c\u751f\u7387\u9ad8\u9054 40%\u3002ESR1\u00a0\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 Menarini\u00a0Group\u00a0\u7684\u884c\u653f\u7e3d\u88c1\u00a0Elcin\u00a0Barker\u00a0Ergun\u00a0\u8868\u793a\uff1a\u300c\u6211\u5011\u65e9\u5df2\u77e5\u9053\uff0c\u60a3\u6709\u8f49\u79fb\u6027\u4e73\u764c\u7684\u60a3\u8005\u9700\u8981\u6709\u6548\u4e14\u6613\u65bc\u8010\u53d7\u7684\u6cbb\u7642\u9078\u9805\uff0c\u4ee5\u5728\u6cbb\u7642\u75be\u75c5\u7684\u540c\u6642\u8b93\u4ed6\u5011\u5c08\u6ce8\u65bc\u5c0d\u4ed6\u5011\u800c\u8a00\u91cd\u8981\u7684\u4e8b\u60c5\u3002\u300d\u300c\u80fd\u5920\u63d0\u4f9b\u6bcf\u65e5\u53ea\u9700\u53e3\u670d\u4e00\u6b21\u7684\u65b0\u578b\u4e73\u764c\u6cbb\u7642\u65b9\u6848\u4f7f\u6211\u5011\u500d\u611f\u81ea\u8c6a\uff0c\u9019\u4e5f\u662f\u8fd1\u4e8c\u5341\u5e74\u4f86\u5167\u5206\u6ccc\u6cbb\u7642\u9818\u57df\u7684\u9996\u6b21\u5275\u65b0\uff1b\u540c\u6642\uff0c\u6211\u5011\u975e\u5e38\u611f\u8b1d\u816b\u7624\u5b78\u7814\u7a76\u4eba\u54e1\u4ee5\u53ca\u53c3\u8207\u81e8\u5e8a\u7814\u7a76\u7684\u6240\u6709\u60a3\u8005\uff0c\u6b63\u662f\u56e0\u70ba\u4ed6\u5011\u7684\u652f\u6301\u548c\u53c3\u8207\uff0c\u624d\u80fd\u6536\u7a6b\u4eca\u5929\u7684\u6210\u679c\u3002\u300d \u7531\u65bc\u76f8\u7576\u591a\u7684 ER+ HER2- \u60a3\u8005\u662f\u5728\u8f49\u79fb\u6027\u764c\u75c7\u904e\u7a0b\u4e2d\u7684\u67d0\u500b\u6642\u523b\u6700\u7d42\u767c\u5c55\u51fa ESR1\u00a0\u7a81\u8b8a\uff0c\u56e0\u6b64\u5728\u6bcf\u6b21 mBC\u00a0\u60a3\u8005\u51fa\u73fe\u75be\u75c5\u52a0\u5287\u6642\u9032\u884c ESR1\u00a0\u6e2c\u8a66\u975e\u5e38\u91cd\u8981\uff0c\u4ee5\u77ad\u89e3\u5176\u4e73\u764c\u7684\u60e1\u5316\u56e0\u7d20\u3002\u300c\u4eca\u5929\u7684\u6838\u51c6\u70ba\u6211\u5011\u63d0\u4f9b\u4e86\u9996\u500b\u6cbb\u7642\u65b9\u6848\uff0c\u4f7f\u6211\u5011\u80fd\u5920\u76f4\u63a5\u5c0d\u6297\u9019\u7a2e\u5c0e\u81f4\u4e73\u764c\u66f4\u96e3\u6cbb\u7642\u7684\u7a81\u8b8a\uff0c\u70ba\u60a3\u8005\u548c\u5176\u5bb6\u4eba\u5e36\u4f86\u4e86\u5e0c\u671b\u3002\u300d\u610f\u5927\u5229\u6b50\u6d32\u816b\u7624\u7814\u7a76\u6240 (IRCCS)\u00a0\u65e9\u671f\u85e5\u7269\u958b\u767c\u90e8\u9580\u4e3b\u4efb\u3001\u7c73\u862d\u5927\u5b78\u91ab\u5b78\u816b\u7624\u5b78\u79d1\u6559\u6388 Giuseppe Curigliano\u00a0\u91ab\u5b78\u535a\u58eb\u8aaa\u9053\u3002 \u7b2c\u4e09\u671f EMERALD\u00a0\u8a66\u9a57\u7684\u8cc7\u6599\u70ba ORSERDU\u00a0\u7684\u6838\u51c6\u63d0\u4f9b\u4e86\u652f\u6301\uff0c\u8a72\u8a66\u9a57\u8868\u660e\uff0c\u8207\u6a19\u6e96\u6cbb\u7642 (SOC)\u00a0\u76f8\u6bd4\uff0c\u4f7f\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u00a0\u5177\u6709\u7d71\u8a08\u5b78\u610f\u7fa9\uff0c\u6a19\u6e96\u6cbb\u7642\u7684\u5b9a\u7fa9\u70ba\u7814\u7a76\u4eba\u54e1\u9078\u64c7\u7684\u5df2\u7372\u51c6\u5167\u5206\u6ccc\u55ae\u85e5\u7642\u6cd5\u3002\u672c\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5168\u9ad4\u60a3\u8005\u7fa4\u9ad4\u548c\u5e36\u6709 ESR1\u00a0\u7a81\u8b8a\u60a3\u8005\u4e2d\u7684 PFS\u00a0\u5c0d\u6bd4\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u4e26\u4e14\u76f8\u6bd4\u65bc SOC\uff0c\u51fa\u73fe\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\u964d\u4f4e\u4e86 45% (PFS HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u5728 2022\u00a0\u5e74\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u764c\u7814\u8ba8\u4f1a (SABCS)\u00a0\u4e0a\u958b\u5c55\u4e86\u95dc\u65bc EMERALD\u00a0PFS\u00a0\u7d50\u679c\u7684\u4e8b\u5f8c\u4e9e\u7d44\u5206\u6790\uff0c\u5206\u6790\u8868\u660e\uff0c\u5148\u524d CDK4\/6i\u00a0\u6cbb\u7642\u7684\u6301\u7e8c\u6642\u9593\u8207\u4f7f\u7528 elacestrant\u00a0\u5f8c\u7684 PFS\u00a0\u5ef6\u9577\u5448\u6b63\u76f8\u95dc\uff0c\u4f46\u5728 SOC\u00a0\u4e0a\u4e26\u7121\u5448\u73fe\u76f8\u95dc\u6027\u3002\u5c0d\u65bc\u5728 EMERALD\u00a0\u96a8\u6a5f\u7be9\u67e5\u4e4b\u524d\u63a5\u53d7 CDK4\/6i\u00a0\u6cbb\u7642 12\u00a0\u500b\u6708\u4ee5\u4e0a\uff0c\u4e14\u767c\u751f ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\uff0c elacestrant\u00a0\u7684 PFS\u00a0\u4e2d\u4f4d\u6578\u70ba 8.6\u00a0\u500b\u6708\uff0c\u800c SOC\u00a0\u70ba 1.9\u00a0\u500b\u6708\uff0c\u75c5\u60c5\u60e1\u5316\u6216\u6b7b\u4ea1\u98a8\u96aa\u964d\u4f4e\u4e86 59\uff05\u00a0(HR=0.41 95% CI: 0.26-0.63)\u3002\u00b3 \u5b89\u5168\u6027\u8cc7\u6599\u8207\u5148\u524d\u5831\u544a\u7684\u7d50\u679c\u4e00\u81f4\u3002ORSERDU\u00a0\u6cbb\u7642\u6700\u5e38\u898b (\u226510%)\u00a0\u7684\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\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\u3002ORSERDU\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a\u5982\u4e0b\u3002 Stemline\u00a0\u53ca\u5176\u9644\u5c6c\u516c\u53f8\u5c07\u5728\u6b50\u6d32\u63a8\u51fa\u8a72\u7522\u54c1\u3002 EMERALD\u00a0\u7b2c 3\u00a0\u671f\u7814\u7a76 (NCT03778931)\u00a0\u7c21\u4ecbEMERALD\u00a0\u7b2c 3\u00a0\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\u00a0\u4f5c\u70ba\u7b2c\u4e8c\u6216\u7b2c\u4e09\u7dda\u55ae\u85e5\u6cbb\u7642\u65b9\u6848\u5c0d\u65bc ER+\u3001HER2-\u00a0\u665a\u671f\/\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\u7684\u7642\u6548\u3002\u8a72\u7814\u7a76\u62db\u52df\u4e86 478\u00a0\u540d\u5148\u524d\u63a5\u53d7\u904e\u4e00\u7dda\u6216\u4e8c\u7dda\u5167\u5206\u6ccc\u7642\u6cd5\uff08\u5305\u62ec CDK4\/6\u00a0\u6291\u5236\u5291\uff09\u7684\u60a3\u8005\u3002\u53d7\u8a66\u60a3\u8005\u88ab\u96a8\u6a5f\u5206\u914d\u63a5\u53d7 elacestrant\u00a0\u6216\u7814\u7a76\u8005\u9078\u64c7\u7684\u5df2\u6279\u51c6\u8377\u723e\u8499\u85e5\u7269\u3002\u7814\u7a76\u7684\u4e3b\u8981\u7d42\u9ede\u662f\u5728\u6574\u500b\u60a3\u8005\u7fa4\u9ad4\u4ee5\u53ca\u5177\u6709\u96cc\u6fc0\u7d20\u53d7\u9ad4 1\u00a0\u57fa\u56e0 (ESR1)\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u4e2d\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f (PFS)\u3002\u5728\u816b\u7624\u5177\u6709 ESR1\u00a0\u7a81\u8b8a\u7684\u60a3\u8005\u7d44\u4e2d\uff0c\u63a1\u7528 elacestrant\u00a0\u6cbb\u7642\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 3.8\u00a0\u500b\u6708\uff0c\u800c\u63a1\u7528 SOC\u00a0\u7684\u4e2d\u4f4d PFS\u00a0\u70ba 1.9\u00a0\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 HR=0.55, 95% CI: 0.39, 0.77)\u3002 \u95dc\u65bc ORSERDU\u00ae (elacestrant) \u9069\u61c9\u75c7\uff1aORSERDU (elacestrant) \u55ae\u85e5\u6cbb\u7642\u7528\u65bc\u651c\u5e36\u6d3b\u5316 ESR1\u00a0\u7a81\u8b8a\u7684\u96cc\u6fc0\u7d20\u53d7\u9ad4 (ER)\u00a0\u967d\u6027\u3001HER2\u00a0\u9670\u6027\u3001\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u4e73\u764c (mBC)\uff0c\u4e14\u5728\u63a5\u53d7\u904e\u81f3\u5c11\u4e00\u7dda\u5167\u5206\u6ccc\u6cbb\u7642\uff08\u5305\u62ec CDK 4\/6\u00a0\u6291\u5236\u5291\uff09\u5f8c\u75c5\u60c5\u60e1\u5316\u7684\u7d55\u7d93\u5f8c\u5a66\u5973\u53ca\u7537\u6027\u60a3\u8005\u3002 ORSERDU\u00a0SmPC\u00a0\u7684\u91cd\u8981\u5b89\u5168\u6027\u8cc7\u8a0a \u809d\u529f\u80fd\u53d7\u640d\uff1a\u00a0\u809d\u529f\u80fd\u4e2d\u5ea6\u53d7\u640d\u7684\u60a3\u8005 (Child-Pugh B) \u61c9\u8b39\u614e\u4f7f\u7528 ORSERDU\uff0c\u6bcf\u65e5\u5291\u91cf\u70ba 258\u00a0\u6beb\u514b\u3002\u5728\u7f3a\u4e4f\u81e8\u5e8a\u8cc7\u6599\u7684\u60c5\u6cc1\u4e0b\uff0c\u4e0d\u5efa\u8b70\u56b4\u91cd\u809d\u529f\u80fd\u53d7\u640d (Child-Pugh C)\u00a0\u7684\u60a3\u8005\u4f7f\u7528 ORSERDU\u3002 \u8207 CYP3A4\u00a0\u8a98\u5c0e\u5291\u53ca\/\u6216\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\uff1a \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u6291\u5236\u5291\u540c\u6642\u4f7f\u7528\u3002 \u907f\u514d ORSERDU\u00a0\u8207\u5f37\u6548\u6216\u4e2d\u5ea6 CYP3A4\u00a0\u8a98\u5c0e\u5291\u540c\u6642\u4f7f\u7528\u3002 \u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff1a\u665a\u671f\u4e73\u764c\u60a3\u8005\u5e38\u898b\u8840\u6813\u6813\u585e\u4e8b\u4ef6\uff0c\u4e14\u5728 ORSERDU\u00a0\u7684\u81e8\u5e8a\u7814\u7a76\u4e2d\u4e5f\u89c0\u5bdf\u5230\u6b64\u73fe\u8c61\u3002\u7576\u70ba\u9ad8\u98a8\u96aa\u60a3\u8005\u958b\u7acb ORSERDU\u00a0\u6642\uff0c\u61c9\u8457\u91cd\u8003\u616e\u6b64\u4e8b\u9805\u3002 \u4e0d\u826f\u53cd\u61c9\uff1a \u22651%\u00a0\u7684\u60a3\u8005\u5831\u544a\u7684\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u5641\u5fc3\u3001\u547c\u5438\u56f0\u96e3\u548c\u8840\u6813\u6813\u585e\uff08\u975c\u8108\uff09\u3002 ORSERDU \u6cbb\u7642\u6700\u5e38\u898b 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Elacestrant\u00a0\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\u00a0(NCT05563220)\uff1bELECTRA (NCT05386108)\uff1b\u4ee5\u53ca ELCIN (NCT05596409)\u3002Elacestrant\u00a0\u4e5f\u8a08\u5283\u5728\u65e9\u671f\u4e73\u764c\u75be\u75c5\u4e2d\u9032\u884c\u8a55\u4f30\u3002 2020\u00a0\u5e74 7\u00a0\u6708\uff0cMenarini\u00a0Group\u00a0\u5f9e Radius\u00a0Health, Inc. \u7372\u5f97\u4e86 elacestrant\u00a0\u7684\u5168\u7403\u6388\u6b0a\u3002Menarini\u00a0Group\u00a0\u73fe\u5728\u5168\u6b0a\u8ca0\u8cac elacestrant\u00a0\u7684\u5168\u7403\u8a3b\u518a\u3001\u5546\u696d\u5316\u548c\u9032\u4e00\u6b65\u7814\u767c\u6d3b\u52d5\u3002 Menarini\u00a0Group\u00a0\u7c21\u4ecb Menarini Group\u00a0\u662f\u4e00\u5bb6\u9818\u5148\u7684\u570b\u969b\u91ab\u85e5\u548c\u8a3a\u65b7\u516c\u53f8\uff0c\u5e74\u71df\u696d\u984d\u8d85\u904e 44\u00a0\u5104\u7f8e\u5143\uff0c\u64c1\u6709\u8d85\u904e 17,000\u00a0\u540d\u54e1\u5de5\u3002Menarini\u00a0\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\u00a0\u64c1\u6709 18\u00a0\u500b\u751f\u7522\u57fa\u5730\u548c 9\u00a0\u500b\u7814\u767c\u4e2d\u5fc3\uff0c\u7522\u54c1\u92b7\u5f80\u5168\u7403 140\u00a0\u500b\u570b\u5bb6\/\u5730\u5340\u3002 \u6b32\u4e86\u89e3\u66f4\u591a\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd www.menarini.com\u3002 \u95dc\u65bc Stemline\u00a0Therapeutics\u00a0Inc. 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