{"id":259356,"date":"2024-09-04T08:00:00","date_gmt":"2024-09-04T00:00:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=259356"},"modified":"2024-09-04T08:00:00","modified_gmt":"2024-09-04T00:00:00","slug":"%e4%bf%a1%e9%81%94%e7%94%9f%e7%89%a9ibi363-pd-1-il-2%ce%b1-bias%e9%9b%99%e7%89%b9%e7%95%b0%e6%80%a7%e6%8a%97%e9%ab%94%e8%9e%8d%e5%90%88%e8%9b%8b%e7%99%bd-%e7%8d%b2%e5%be%97%e7%be%8e%e5%9c%8bfda","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=259356","title":{"rendered":"\u4fe1\u9054\u751f\u7269IBI363 (PD-1\/IL-2\u03b1-bias\u96d9\u7279\u7570\u6027\u6297\u9ad4\u878d\u5408\u86cb\u767d) \u7372\u5f97\u7f8e\u570bFDA\u5feb\u901f\u901a\u9053\u8cc7\u683c\u8a8d\u5b9a\uff0c\u6cbb\u7642\u9ed1\u8272\u7d20\u7624"},"content":{"rendered":"<div>\n<p>\u7f8e\u570b\u820a\u91d1\u5c71\u548c\u4e2d\u570b\u8607\u5dde2024\u5e749\u67084\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; \u4fe1\u9054\u751f\u7269\u88fd\u85e5\u96c6\u5718\uff08\u9999\u6e2f\u806f\u4ea4\u6240\u80a1\u7968\u4ee3\u78bc\uff1a01801\uff09\uff0c\u4e00\u5bb6\u81f4\u529b\u65bc\u7814\u767c\u3001\u751f\u7522\u548c\u92b7\u552e\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u3001\u4ee3\u8b1d\u3001\u773c\u79d1\u7b49\u91cd\u5927\u75be\u75c5\u9818\u57df\u5275\u65b0\u85e5\u7269\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u5ba3\u4f48\u5176PD-1\/IL-2<sup>\u03b1-bias<\/sup>\u96d9\u7279\u7570\u6027\u6297\u9ad4\u878d\u5408\u86cb\u767dIBI363\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u548c\u85e5\u7269\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u5feb\u901f\u901a\u9053\u8cc7\u683c\uff08fast track designation, FTD\uff09\uff0c\u64ec\u5b9a\u9069\u61c9\u75c7\u70ba\u65e2\u5f80\u63a5\u53d7\u904e\u81f3\u5c11\u4e00\u7dda\u542bPD-1\/L1\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u7cfb\u7d71\u6027\u6cbb\u7642\u5f8c\u9032\u5c55\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u9ed1\u8272\u7d20\u7624\uff08\u8108\u7d61\u819c\u9ed1\u8272\u7d20\u7624\u9664\u5916\uff09\u3002\u76ee\u524d\uff0c\u4fe1\u9054\u751f\u7269\u6b63\u5728\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u6fb3\u5927\u5229\u4e9e\u540c\u6642\u958b\u5c551\/2\u671f\u81e8\u5e8a\u7814\u7a76\u63a2\u7d22IBI363\u5728\u5404\u7a2e\u665a\u671f\u60e1\u6027\u816b\u7624\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002<\/p>\n<p>2024\u5e746\u670814\u65e5\u7684ESMO\u5168\u9ad4\u6703\u8b70\u4e0a\uff0cIBI363\u5831\u9053\u4e86\u5728\u65e2\u5f80\u63a5\u53d7\u904e\u514d\u75ab\u6cbb\u7642\u7684\u9ed1\u8272\u7d20\u7624\u53d7\u8a66\u8005\u4e2d\u89c0\u5bdf\u5230\u4ee4\u4eba\u6b23\u559c\u7684\u7642\u6548\u4fe1\u865f\uff1a37\u4f8b\u65e2\u5f80\u63a5\u53d7\u904e\u514d\u75ab\u6cbb\u7642\u7684\u9ed1\u8272\u7d20\u7624\u60a3\u8005\u63a5\u53d7\u4e861mg\/kg IBI363\u6cbb\u7642\u4e26\u81f3\u5c11\u63a5\u53d7\u4e86\u4e00\u6b21\u57fa\u7dda\u5f8c\u816b\u7624\u8a55\u4f30\uff0c11\u4f8b\u60a3\u8005\u7372\u5f97\u4e86\u5ba2\u89c0\u7de9\u89e3\uff0c\u5305\u62ec1\u4f8bCR\u548c10\u4f8bPR\uff0cORR\u548cDCR\u5206\u5225\u70ba29.7%<span id=\"spanHghlt3832\">\u548c73.0%\u3002\uff08<a href=\"https:\/\/cnmobile.prnasia.com\/story\/450727-1.shtml\" target=\"_blank\" rel=\"nofollow noopener\">\u93c8\u63a5<\/a>\uff09<\/span><\/p>\n<p><b>\u4fe1\u9054\u751f\u7269\u88fd\u85e5\u96c6\u5718\u9ad8\u7d1a\u526f\u7e3d\u88c1\u5468\u8f1d\u535a\u58eb<\/b>\u8868\u793a\uff1a\u300c\u9ed1\u8272\u7d20\u7624\u662f\u6b50\u7f8e\u570b\u5bb6\u6700\u5e38\u898b\u7684\u81f4\u6b7b\u6027\u76ae\u819a\u764c\u75c7\u3002\u5728\u4e2d\u570b\uff0c\u9ed1\u8272\u7d20\u7624\u96d6\u5c6c\u65bc\u5c11\u898b\u60e1\u6027\u816b\u7624\uff0c\u4f46\u75c5\u6b7b\u7387\u9ad8\uff0c\u767c\u75c5\u7387\u4e5f\u5728\u9010\u5e74\u589e\u52a0\u3002\u5118\u7ba1\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u5728\u9ed1\u8272\u7d20\u7624\u6cbb\u7642\u4e0a\u5df2\u53d6\u5f97\u4e86\u6210\u529f\uff0c\u4f46\u5168\u7403\u76ee\u524d\u5c1a\u7121\u91dd\u5c0d\u514d\u75ab\u6cbb\u7642\u5931\u6557\u9ed1\u8272\u7d20\u7624\u7684\u85e5\u7269\u7372\u6279\uff0c\u50b3\u7d71\u7684\u5316\u7642\u00b1\u6297\u8840\u7ba1\u6cbb\u7642\u514d\u75ab\u6cbb\u7642\u5931\u6557\u9ed1\u8272\u7d20\u7624\u7684ORR\u50c53.8%~6.8%\uff0c\u4e2d\u4f4dPFS\u4e0d\u8db33\u500b\u6708\uff0c\u7372\u76ca\u975e\u5e38\u6709\u9650<sup>[1]-[2]<\/sup>\u3002\u56e0\u6b64\uff0c\u5c0d\u65bc\u65e2\u5f80\u514d\u75ab\u6cbb\u7642\u5931\u6557\u7684\u60a3\u8005\uff0c\u5b58\u5728\u4e9f\u5f85\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002\u4f5c\u70ba\u5168\u7403\u9996\u5275\uff08First-in-class\uff09PD-1\/IL-2<sup>\u03b1-bias<\/sup>\u96d9\u7279\u7570\u6027\u6297\u9ad4\u878d\u5408\u86cb\u767d\uff0c\u76ee\u524dIBI363\u55ae\u85e5\u5728\u65e2\u5f80\u63a5\u53d7\u904e\u514d\u75ab\u6cbb\u7642\u7684\u9ed1\u8272\u7d20\u7624\u53d7\u8a66\u8005\u4e2d\u986f\u793a\u51fa\u9f13\u821e\u4eba\u5fc3\u7684\u7642\u6548\u548c\u826f\u597d\u7684\u5b89\u5168\u6027\u3002\u6211\u5011\u5c07\u7e7c\u7e8c\u63a2\u7d22IBI363\u5728\u9ed1\u8272\u7d20\u7624\u4e2d\u7684\u7642\u6548\u548c\u5b89\u5168\u6027\u6578\u64da\uff0c\u70ba\u514d\u75ab\u8010\u85e5\u7684\u9ed1\u8272\u7d20\u7624\u60a3\u8005\u63d0\u4f9b\u66f4\u6709\u6548\u7684\u81e8\u5e8a\u6cbb\u7642\u624b\u6bb5\u3002\u300d<\/p>\n<p>\u5feb\u901f\u901a\u9053\u8a8d\u5b9a\uff08Fast Track Designation, FTD\uff09\u662f\u6709FDA\u8a2d\u7acb\u7684\u85e5\u7269\u81e8\u5e8a\u958b\u767c\u5feb\u901f\u5be9\u8a55\u904e\u7a0b\uff0c\u65e8\u5728\u4fc3\u9032\u7528\u65bc\u6cbb\u7642\u56b4\u91cd\u75be\u75c5\u548c\u89e3\u6c7a\u672a\u6eff\u8db3\u81e8\u5e8a\u9700\u6c42\u7684\u65b0\u85e5\u7814\u767c\u3002\u6839\u64da\u898f\u5b9a\uff0c\u7372\u5f97FTD\u8cc7\u683c\u7684\u5019\u9078\u85e5\u7269\uff0c\u5c07\u5728\u5f8c\u7e8c\u7684\u85e5\u7269\u7814\u767c\u8207\u5be9\u8a55\u904e\u7a0b\u4e2d\uff0c\u7372\u5f97\u66f4\u591a\u8207FDA\u6e9d\u901a\u4ea4\u6d41\u7684\u6a5f\u6703\uff0c\u6709\u52a9\u65bc\u52a0\u5feb\u85e5\u7269\u7684\u5f8c\u7e8c\u7814\u767c\u548c\u7372\u6279\u4e0a\u5e02\u3002<\/p>\n<p><b>\u95dc\u65bc<\/b><b>IBI363\uff08PD-1\/IL-2<sup>\u03b1-bias<\/sup>\u96d9\u7279\u7570\u6027\u878d\u5408\u86cb\u767d\uff09<\/b><\/p>\n<p>IBI363\u662f\u7531\u4fe1\u9054\u751f\u7269\u81ea\u4e3b\u7814\u767c\u7684\u5168\u7403\u9996\u5275PD-1\/IL-2\u96d9\u7279\u7570\u6027\u878d\u5408\u86cb\u767d\uff0c\u540c\u6642\u5177\u6709\u963b\u65b7PD-1\/PD-L1\u901a\u8def\u548c\u6fc0\u6d3bIL-2\u901a\u8def\u5169\u9805\u529f\u80fd\u3002IBI363\u7684IL-2\u81c2\u7d93\u904e\u4e86\u8a2d\u8a08\u6539\u9020\uff0c\u4fdd\u7559\u4e86\u5176\u5c0dIL-2 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BRAF V600 \u7a81\u8b8a\uff0c\u5247\u9996\u9078\u5206\u5b50\u9776\u5411\u85e5\u7269BRAF\u6291\u5236\u5291\u806f\u5408MEK\u6291\u5236\u5291\uff0c\u7121BRAF V600\u7a81\u8b8a\u7684\u60a3\u8005\u4e00\u7dda\u6cbb\u7642\u53ef\u8003\u616e\u5316\u7642\u8207\u6297\u8840\u7ba1\u751f\u6210\u85e5\u7269\u806f\u5408\u6cbb\u7642\uff0c\u514d\u75ab\u6cbb\u7642\u5c1a\u672a\u5728\u570b\u5167\u7372\u6279\u665a\u671f\u9ed1\u8272\u7d20\u7624\u4e00\u7dda\u6cbb\u7642\u7684\u9069\u61c9\u75c7\u3002\u4e8c\u7dda\u4e3b\u8981\u8003\u616e\u8207\u5df2\u63a5\u53d7\u4e00\u7dda\u6cbb\u7642\u4e0d\u540c\u7684\u85e5\u7269\u6cbb\u7642\uff0c\u5c0d\u65bc\u4e00\u7dda\u672a\u4f7f\u7528\u904ePD-1\u55ae\u6297\u7684\u53d7\u8a66\u8005\uff0c\u4e8c\u7dda\u6cbb\u7642\u53ef\u9078\u64c7PD-1\u55ae\u6297\u3002\u5c0d\u65bc\u665a\u671f\u7c98\u819c\u9ed1\u8272\u7d20\u7624\uff0c\u4e00\u7dda\u6cbb\u7642\u53ef\u8003\u616e\u5316\u7642\u6216PD-1\u55ae\u6297\u806f\u5408\u6297\u8840\u7ba1\u751f\u6210\u85e5\u7269\uff0c\u5982\u651c\u5e36BRAF 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href=\"https:\/\/www.innoventbio.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.innoventbio.com<\/a> \u6216\u516c\u53f8\u9818\u82f1\u8cec\u865f<a href=\"https:\/\/www.linkedin.com\/company\/innovent-biologics\/\" target=\"_blank\" rel=\"nofollow noopener\">www.linkedin.com\/company\/innovent-biologics\/<\/a>\u3002<\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><i>1.\u4fe1\u9054\u751f\u7269\u4e0d\u63a8\u85a6\u672a\u7372\u6279\u7684\u85e5\u54c1\/\u9069\u61c9\u75c7\u7684\u4f7f\u7528<\/i><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><i>2.\u96f7\u83ab\u897f\u5c24\u55ae\u6297\u6ce8\u5c04\u6db2\uff08\u5e0c\u5189\u64c7\u00ae\uff09\u548c\u585e\u666e\u66ff\u5c3c\u81a0\u56ca\uff08\u777f\u59a5\u00ae\uff09\u7531\u79ae\u4f86\u516c\u53f8\u7814\u767c<\/i><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p><b>\u524d\u77bb\u6027\u8072\u660e<\/b><\/p>\n<p>\u672c\u65b0\u805e\u7a3f\u6240\u767c\u4f48\u7684\u4fe1\u606f\u4e2d\u53ef\u80fd\u6703\u5305\u542b\u67d0\u4e9b\u524d\u77bb\u6027\u8868\u8ff0\u3002\u9019\u4e9b\u8868\u8ff0\u672c\u8cea\u4e0a\u5177\u6709\u76f8\u7576\u98a8\u96aa\u548c\u4e0d\u78ba\u5b9a\u6027\u3002\u5728\u4f7f\u7528\u300c\u9810\u671f\u300d\u3001\u300c\u76f8\u4fe1\u300d\u3001\u300c\u9810\u6e2c\u300d\u3001\u300c\u671f\u671b\u300d\u3001\u300c\u6253\u7b97\u300d\u53ca\u5176\u4ed6\u985e\u4f3c\u8a5e\u8a9e\u9032\u884c\u8868\u8ff0\u6642\uff0c\u51e1\u8207\u672c\u516c\u53f8\u6709\u95dc\u7684\uff0c\u76ee\u7684\u5747\u662f\u8981\u6307\u660e\u5176\u5c6c\u524d\u77bb\u6027\u8868\u8ff0\u3002\u672c\u516c\u53f8\u4e26\u7121\u7fa9\u52d9\u4e0d\u65b7\u5730\u66f4\u65b0\u9019\u4e9b\u9810\u6e2c\u6027\u9673\u8ff0\u3002<\/p>\n<p>\u9019\u4e9b\u524d\u77bb\u6027\u8868\u8ff0\u4e43\u57fa\u65bc\u672c\u516c\u53f8\u7ba1\u7406\u5c64\u5728\u505a\u51fa\u8868\u8ff0\u6642\u5c0d\u672a\u4f86\u4e8b\u52d9\u7684\u73fe\u6709\u770b\u6cd5\u3001\u5047\u8a2d\u3001\u671f\u671b\u3001\u4f30\u8a08\u3001\u9810\u6e2c\u548c\u7406\u89e3\u3002\u9019\u4e9b\u8868\u8ff0\u4e26\u975e\u5c0d\u672a\u4f86\u767c\u5c55\u7684\u4fdd\u8b49\uff0c\u6703\u53d7\u5230\u98a8\u96aa\u3001\u4e0d\u78ba\u6027\u53ca\u5176\u4ed6\u56e0\u7d20\u7684\u5f71\u97ff\uff0c\u6709\u4e9b\u4e43\u8d85\u51fa\u672c\u516c\u53f8\u7684\u63a7\u5236\u7bc4\u570d\uff0c\u96e3\u4ee5\u9810\u8a08\u3002\u56e0\u6b64\uff0c\u53d7\u6211\u5011\u7684\u696d\u52d9\u3001\u7af6\u722d\u74b0\u5883\u3001\u653f\u6cbb\u3001\u7d93\u6fdf\u3001\u6cd5\u5f8b\u548c\u793e\u6703\u60c5\u6cc1\u7684\u672a\u4f86\u8b8a\u5316\u53ca\u767c\u5c55\u7684\u5f71\u97ff\uff0c\u5be6\u969b\u7d50\u679c\u53ef\u80fd\u6703\u8207\u524d\u77bb\u6027\u8868\u8ff0\u6240\u542b\u8cc7\u6599\u6709\u8f03\u5927\u5dee\u5225\u3002<\/p>\n<p>\u672c\u516c\u53f8\u3001\u672c\u516c\u53f8\u8463\u4e8b\u53ca\u50f1\u54e1\u4ee3\u7406\u6982\u4e0d\u627f\u64d4\u00a0(a) \u66f4\u6b63\u6216\u66f4\u65b0\u672c\u7db2\u7ad9\u6240\u8f09\u524d\u77bb\u6027\u8868\u8ff0\u7684\u4efb\u4f55\u7fa9\u52d9;\u53ca (b) \u82e5\u56e0\u4efb\u4f55\u524d\u77bb\u6027\u8868\u8ff0\u4e0d\u80fd\u5be6\u73fe\u6216\u8b8a\u6210\u4e0d\u6b63\u78ba\u800c\u5f15\u81f4\u7684\u4efb\u4f55\u8cac\u4efb\u3002<\/p>\n<p>\u00a0<\/p>\n<p>\u53c3\u8003\u6587\u737b<\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup>[1]<\/sup> Wang X, Xu W, Chi Z, et al. Chemotherapy combined with antiangiogenic drugs as salvage therapy in advanced melanoma patients progressing on PD-1 immunotherapy. Transl Oncol. 2021;14(1):100949.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup>[2]<\/sup> European Journal of Cancer 162 (2022) 22e33\uff1b<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup>[3]<\/sup> National Cancer Institute Melanoma of the Skin-Cancer Stat Facts:<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><a href=\"https:\/\/seer.cancer.gov\/statfacts\/html\/melan.html\" target=\"_blank\" class=\"prnews_a\" rel=\"nofollow noopener\">https:\/\/seer.cancer.gov\/statfacts\/html\/melan.html<\/a>.\u00a0<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup>[4] <\/sup>\u9ed1\u8272\u7d20\u7624\u8a3a\u7642\u898f\u7bc4\uff082022 \u5e74\u7248\uff09 .<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup>[5] <\/sup>\u4e2d\u570b\u81e8\u5e8a\u816b\u7624\u5b78\u6703(CSCO)\u9ed1\u8272\u7d20\u7624\u8a3a\u7642\u6307\u5357\uff082022\u5e74\u7248\uff09 .<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u570b\u820a\u91d1\u5c71\u548c\u4e2d\u570b\u8607\u5dde2024\u5e74&#8230;<\/p>\n","protected":false},"author":16,"featured_media":199219,"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-259356","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-40567"],"acf":[],"yoast_head":"<!-- This site is optimized with the 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\u4fe1\u9054\u751f\u7269\u88fd\u85e5\u96c6\u5718\uff08\u9999\u6e2f\u806f\u4ea4\u6240\u80a1\u7968\u4ee3\u78bc\uff1a01801\uff09\uff0c\u4e00\u5bb6\u81f4\u529b\u65bc\u7814\u767c\u3001\u751f\u7522\u548c\u92b7\u552e\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u3001\u4ee3\u8b1d\u3001\u773c\u79d1\u7b49\u91cd\u5927\u75be\u75c5\u9818\u57df\u5275\u65b0\u85e5\u7269\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u5ba3\u4f48\u5176PD-1\/IL-2\u03b1-bias\u96d9\u7279\u7570\u6027\u6297\u9ad4\u878d\u5408\u86cb\u767dIBI363\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u548c\u85e5\u7269\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u5feb\u901f\u901a\u9053\u8cc7\u683c\uff08fast track designation, FTD\uff09\uff0c\u64ec\u5b9a\u9069\u61c9\u75c7\u70ba\u65e2\u5f80\u63a5\u53d7\u904e\u81f3\u5c11\u4e00\u7dda\u542bPD-1\/L1\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u7cfb\u7d71\u6027\u6cbb\u7642\u5f8c\u9032\u5c55\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u9ed1\u8272\u7d20\u7624\uff08\u8108\u7d61\u819c\u9ed1\u8272\u7d20\u7624\u9664\u5916\uff09\u3002\u76ee\u524d\uff0c\u4fe1\u9054\u751f\u7269\u6b63\u5728\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u6fb3\u5927\u5229\u4e9e\u540c\u6642\u958b\u5c551\/2\u671f\u81e8\u5e8a\u7814\u7a76\u63a2\u7d22IBI363\u5728\u5404\u7a2e\u665a\u671f\u60e1\u6027\u816b\u7624\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002 2024\u5e746\u670814\u65e5\u7684ESMO\u5168\u9ad4\u6703\u8b70\u4e0a\uff0cIBI363\u5831\u9053\u4e86\u5728\u65e2\u5f80\u63a5\u53d7\u904e\u514d\u75ab\u6cbb\u7642\u7684\u9ed1\u8272\u7d20\u7624\u53d7\u8a66\u8005\u4e2d\u89c0\u5bdf\u5230\u4ee4\u4eba\u6b23\u559c\u7684\u7642\u6548\u4fe1\u865f\uff1a37\u4f8b\u65e2\u5f80\u63a5\u53d7\u904e\u514d\u75ab\u6cbb\u7642\u7684\u9ed1\u8272\u7d20\u7624\u60a3\u8005\u63a5\u53d7\u4e861mg\/kg IBI363\u6cbb\u7642\u4e26\u81f3\u5c11\u63a5\u53d7\u4e86\u4e00\u6b21\u57fa\u7dda\u5f8c\u816b\u7624\u8a55\u4f30\uff0c11\u4f8b\u60a3\u8005\u7372\u5f97\u4e86\u5ba2\u89c0\u7de9\u89e3\uff0c\u5305\u62ec1\u4f8bCR\u548c10\u4f8bPR\uff0cORR\u548cDCR\u5206\u5225\u70ba29.7%\u548c73.0%\u3002\uff08\u93c8\u63a5\uff09 \u4fe1\u9054\u751f\u7269\u88fd\u85e5\u96c6\u5718\u9ad8\u7d1a\u526f\u7e3d\u88c1\u5468\u8f1d\u535a\u58eb\u8868\u793a\uff1a\u300c\u9ed1\u8272\u7d20\u7624\u662f\u6b50\u7f8e\u570b\u5bb6\u6700\u5e38\u898b\u7684\u81f4\u6b7b\u6027\u76ae\u819a\u764c\u75c7\u3002\u5728\u4e2d\u570b\uff0c\u9ed1\u8272\u7d20\u7624\u96d6\u5c6c\u65bc\u5c11\u898b\u60e1\u6027\u816b\u7624\uff0c\u4f46\u75c5\u6b7b\u7387\u9ad8\uff0c\u767c\u75c5\u7387\u4e5f\u5728\u9010\u5e74\u589e\u52a0\u3002\u5118\u7ba1\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u5728\u9ed1\u8272\u7d20\u7624\u6cbb\u7642\u4e0a\u5df2\u53d6\u5f97\u4e86\u6210\u529f\uff0c\u4f46\u5168\u7403\u76ee\u524d\u5c1a\u7121\u91dd\u5c0d\u514d\u75ab\u6cbb\u7642\u5931\u6557\u9ed1\u8272\u7d20\u7624\u7684\u85e5\u7269\u7372\u6279\uff0c\u50b3\u7d71\u7684\u5316\u7642\u00b1\u6297\u8840\u7ba1\u6cbb\u7642\u514d\u75ab\u6cbb\u7642\u5931\u6557\u9ed1\u8272\u7d20\u7624\u7684ORR\u50c53.8%~6.8%\uff0c\u4e2d\u4f4dPFS\u4e0d\u8db33\u500b\u6708\uff0c\u7372\u76ca\u975e\u5e38\u6709\u9650-\u3002\u56e0\u6b64\uff0c\u5c0d\u65bc\u65e2\u5f80\u514d\u75ab\u6cbb\u7642\u5931\u6557\u7684\u60a3\u8005\uff0c\u5b58\u5728\u4e9f\u5f85\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002\u4f5c\u70ba\u5168\u7403\u9996\u5275\uff08First-in-class\uff09PD-1\/IL-2\u03b1-bias\u96d9\u7279\u7570\u6027\u6297\u9ad4\u878d\u5408\u86cb\u767d\uff0c\u76ee\u524dIBI363\u55ae\u85e5\u5728\u65e2\u5f80\u63a5\u53d7\u904e\u514d\u75ab\u6cbb\u7642\u7684\u9ed1\u8272\u7d20\u7624\u53d7\u8a66\u8005\u4e2d\u986f\u793a\u51fa\u9f13\u821e\u4eba\u5fc3\u7684\u7642\u6548\u548c\u826f\u597d\u7684\u5b89\u5168\u6027\u3002\u6211\u5011\u5c07\u7e7c\u7e8c\u63a2\u7d22IBI363\u5728\u9ed1\u8272\u7d20\u7624\u4e2d\u7684\u7642\u6548\u548c\u5b89\u5168\u6027\u6578\u64da\uff0c\u70ba\u514d\u75ab\u8010\u85e5\u7684\u9ed1\u8272\u7d20\u7624\u60a3\u8005\u63d0\u4f9b\u66f4\u6709\u6548\u7684\u81e8\u5e8a\u6cbb\u7642\u624b\u6bb5\u3002\u300d \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\uff08Fast Track Designation, FTD\uff09\u662f\u6709FDA\u8a2d\u7acb\u7684\u85e5\u7269\u81e8\u5e8a\u958b\u767c\u5feb\u901f\u5be9\u8a55\u904e\u7a0b\uff0c\u65e8\u5728\u4fc3\u9032\u7528\u65bc\u6cbb\u7642\u56b4\u91cd\u75be\u75c5\u548c\u89e3\u6c7a\u672a\u6eff\u8db3\u81e8\u5e8a\u9700\u6c42\u7684\u65b0\u85e5\u7814\u767c\u3002\u6839\u64da\u898f\u5b9a\uff0c\u7372\u5f97FTD\u8cc7\u683c\u7684\u5019\u9078\u85e5\u7269\uff0c\u5c07\u5728\u5f8c\u7e8c\u7684\u85e5\u7269\u7814\u767c\u8207\u5be9\u8a55\u904e\u7a0b\u4e2d\uff0c\u7372\u5f97\u66f4\u591a\u8207FDA\u6e9d\u901a\u4ea4\u6d41\u7684\u6a5f\u6703\uff0c\u6709\u52a9\u65bc\u52a0\u5feb\u85e5\u7269\u7684\u5f8c\u7e8c\u7814\u767c\u548c\u7372\u6279\u4e0a\u5e02\u3002 \u95dc\u65bcIBI363\uff08PD-1\/IL-2\u03b1-bias\u96d9\u7279\u7570\u6027\u878d\u5408\u86cb\u767d\uff09 IBI363\u662f\u7531\u4fe1\u9054\u751f\u7269\u81ea\u4e3b\u7814\u767c\u7684\u5168\u7403\u9996\u5275PD-1\/IL-2\u96d9\u7279\u7570\u6027\u878d\u5408\u86cb\u767d\uff0c\u540c\u6642\u5177\u6709\u963b\u65b7PD-1\/PD-L1\u901a\u8def\u548c\u6fc0\u6d3bIL-2\u901a\u8def\u5169\u9805\u529f\u80fd\u3002IBI363\u7684IL-2\u81c2\u7d93\u904e\u4e86\u8a2d\u8a08\u6539\u9020\uff0c\u4fdd\u7559\u4e86\u5176\u5c0dIL-2 R\u03b1\u7684\u89aa\u548c\u529b\uff0c\u4f46\u524a\u5f31\u4e86\u5c0dIL-2R\u03b2\u548cIL-2R\u03b3\u7684\u7d50\u5408\u80fd\u529b\uff0c\u4ee5\u6b64\u964d\u4f4e\u6bd2\u6027\uff1b\u800cPD-1\u7d50\u5408\u81c2\u53ef\u4ee5\u540c\u6642\u5be6\u73fe\u5c0dPD-1\u7684\u963b\u65b7\u548cIL-2\u7684\u9078\u64c7\u6027\u905e\u9001\u3002\u7531\u65bc\u65b0\u6fc0\u6d3b\u7684\u816b\u7624\u7279\u7570\u6027T\u7d30\u80de\u540c\u6642\u8868\u9054PD-1\u548cIL-2\u03b1\uff0c\u9019\u4e00\u5dee\u7570\u6027\u7b56\u7565\u53ef\u4ee5\u66f4\u7cbe\u78ba\u548c\u6709\u6548\u5730\u5be6\u73fe\u5c0d\u8a72T\u7d30\u80de\u4e9e\u7fa4\u7684\u9776\u5411\u548c\u6fc0\u6d3b\u3002IBI363\u4e0d\u50c5\u5728\u591a\u7a2e\u8377\u7624\u85e5\u7406\u5b78\u6a21\u578b\u4e2d\u5c55\u73fe\u51fa\u4e86\u826f\u597d\u6297\u816b\u7624\u6d3b\u6027\uff0c\u5728PD-1\u8010\u85e5\u548c\u8f49\u79fb\u6a21\u578b\u4e2d\u4e5f\u8868\u73fe\u51fa\u4e86\u7a81\u51fa\u7684\u6291\u7624\u6548\u529b\u3002\u5f9e\u81e8\u5e8a\u8feb\u5207\u9700\u6c42\u51fa\u767c\uff0c\u4fe1\u9054\u751f\u7269\u6b63\u5728\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u6fb3\u5927\u5229\u4e9e\u958b\u5c55\u81e8\u5e8a\u7814\u7a76\u63a2\u7d22IBI363\u5728\u91dd\u5c0d\u5404\u7a2e\u665a\u671f\u60e1\u6027\u816b\u7624\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002 \u95dc\u65bc\u9ed1\u8272\u7d20\u7624 \u9ed1\u8272\u7d20\u7624\u662f\u4e00\u7a2e\u5f9e\u9ed1\u8272\u7d20\u7d30\u80de\u767c\u5c55\u800c\u4f86\u7684\u60e1\u6027\u816b\u7624\uff0c\u662f\u7f8e\u570b\u7b2c\u4e94\u5927\u6700\u5e38\u898b\u7684\u764c\u75c7\u75c5\u56e0\u3002\u96d6\u7136\u9ed1\u8272\u7d20\u7624\u53ea\u4f54\u6240\u6709\u985e\u578b\u76ae\u819a\u764c\u76843%\uff0c\u4f46\u5b83\u7684\u6b7b\u4ea1\u7387\u662f\u6240\u6709\u985e\u578b\u4e2d\u6700\u9ad8\u7684\uff0c\u800c\u4e14\u6700\u5bb9\u6613\u767c\u751f\u8f49\u79fb\u3002\u5728\u4e2d\u570b\uff0c\u9ed1\u8272\u7d20\u7624\u7684\u767c\u751f\u7387\u548c\u6b7b\u4ea1\u7387\u4e5f\u5728\u9010\u5e74\u589e\u52a0\u3002\u6309\u767c\u75c5\u90e8\u4f4d\u5206\u985e\uff0c\u9ed1\u8272\u7d20\u7624\u4e3b\u8981\u5206\u70ba\u76ae\u819a\u9ed1\u8272\u7d20\u7624\u3001\u80a2\u7aef\u9ed1\u8272\u7d20\u7624\u548c\u7c98\u819c\u9ed1\u8272\u7d20\u7624\u7b49\u3002\u4e2d\u570b\u9ed1\u8272\u7d20\u7624\u8207\u6b50\u7f8e\u767d\u7a2e\u4eba\u5dee\u7570\u8f03\u5927\uff0c\u5169\u8005\u5728\u767c\u75c5\u6a5f\u5236\u3001\u751f\u7269\u5b78\u884c\u70ba\u3001\u7d44\u7e54\u5b78\u5f62\u614b\u3001\u6cbb\u7642\u65b9\u6cd5\u4ee5\u53ca\u9810\u5f8c\u7b49\u65b9\u9762\u5dee\u7570\u8f03\u5927\u3002\u5c0d\u65bc\u665a\u671f\u76ae\u819a\u548c\u80a2\u7aef\u9ed1\u8272\u7d20\u7624\uff0c\u5982\u651c\u5e36 BRAF V600 \u7a81\u8b8a\uff0c\u5247\u9996\u9078\u5206\u5b50\u9776\u5411\u85e5\u7269BRAF\u6291\u5236\u5291\u806f\u5408MEK\u6291\u5236\u5291\uff0c\u7121BRAF V600\u7a81\u8b8a\u7684\u60a3\u8005\u4e00\u7dda\u6cbb\u7642\u53ef\u8003\u616e\u5316\u7642\u8207\u6297\u8840\u7ba1\u751f\u6210\u85e5\u7269\u806f\u5408\u6cbb\u7642\uff0c\u514d\u75ab\u6cbb\u7642\u5c1a\u672a\u5728\u570b\u5167\u7372\u6279\u665a\u671f\u9ed1\u8272\u7d20\u7624\u4e00\u7dda\u6cbb\u7642\u7684\u9069\u61c9\u75c7\u3002\u4e8c\u7dda\u4e3b\u8981\u8003\u616e\u8207\u5df2\u63a5\u53d7\u4e00\u7dda\u6cbb\u7642\u4e0d\u540c\u7684\u85e5\u7269\u6cbb\u7642\uff0c\u5c0d\u65bc\u4e00\u7dda\u672a\u4f7f\u7528\u904ePD-1\u55ae\u6297\u7684\u53d7\u8a66\u8005\uff0c\u4e8c\u7dda\u6cbb\u7642\u53ef\u9078\u64c7PD-1\u55ae\u6297\u3002\u5c0d\u65bc\u665a\u671f\u7c98\u819c\u9ed1\u8272\u7d20\u7624\uff0c\u4e00\u7dda\u6cbb\u7642\u53ef\u8003\u616e\u5316\u7642\u6216PD-1\u55ae\u6297\u806f\u5408\u6297\u8840\u7ba1\u751f\u6210\u85e5\u7269\uff0c\u5982\u651c\u5e36BRAF V600\u7a81\u8b8a\uff0c\u53ef\u9078\u64c7BRAF\u6291\u5236\u5291\u00b1MEK \u6291\u5236\u5291\uff0c\u5f8c\u7dda\u6cbb\u7642\u9078\u64c7\u5341\u5206\u6709\u9650\u3002 \u95dc\u65bc\u4fe1\u9054\u751f\u7269 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\u8a73\u60c5\u8acb\u8a2a\u554f\u516c\u53f8\u7db2\u7ad9\uff1awww.innoventbio.com \u6216\u516c\u53f8\u9818\u82f1\u8cec\u865fwww.linkedin.com\/company\/innovent-biologics\/\u3002          1.\u4fe1\u9054\u751f\u7269\u4e0d\u63a8\u85a6\u672a\u7372\u6279\u7684\u85e5\u54c1\/\u9069\u61c9\u75c7\u7684\u4f7f\u7528         2.\u96f7\u83ab\u897f\u5c24\u55ae\u6297\u6ce8\u5c04\u6db2\uff08\u5e0c\u5189\u64c7\u00ae\uff09\u548c\u585e\u666e\u66ff\u5c3c\u81a0\u56ca\uff08\u777f\u59a5\u00ae\uff09\u7531\u79ae\u4f86\u516c\u53f8\u7814\u767c         \u524d\u77bb\u6027\u8072\u660e 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\u672c\u516c\u53f8\u3001\u672c\u516c\u53f8\u8463\u4e8b\u53ca\u50f1\u54e1\u4ee3\u7406\u6982\u4e0d\u627f\u64d4\u00a0(a) \u66f4\u6b63\u6216\u66f4\u65b0\u672c\u7db2\u7ad9\u6240\u8f09\u524d\u77bb\u6027\u8868\u8ff0\u7684\u4efb\u4f55\u7fa9\u52d9;\u53ca (b) \u82e5\u56e0\u4efb\u4f55\u524d\u77bb\u6027\u8868\u8ff0\u4e0d\u80fd\u5be6\u73fe\u6216\u8b8a\u6210\u4e0d\u6b63\u78ba\u800c\u5f15\u81f4\u7684\u4efb\u4f55\u8cac\u4efb\u3002 \u00a0 \u53c3\u8003\u6587\u737b           Wang X, Xu W, Chi Z, et al. Chemotherapy combined with antiangiogenic drugs as salvage therapy in advanced melanoma patients progressing on PD-1 immunotherapy. Transl Oncol. 2021;14(1):100949.         European Journal of Cancer 162 (2022) 22e33\uff1b         National Cancer Institute Melanoma of the Skin-Cancer Stat Facts:         https:\/\/seer.cancer.gov\/statfacts\/html\/melan.html.\u00a0         \u9ed1\u8272\u7d20\u7624\u8a3a\u7642\u898f\u7bc4\uff082022 \u5e74\u7248\uff09 .         \u4e2d\u570b\u81e8\u5e8a\u816b\u7624\u5b78\u6703(CSCO)\u9ed1\u8272\u7d20\u7624\u8a3a\u7642\u6307\u5357\uff082022\u5e74\u7248\uff09 .         \u00a0 \u00a0\" \/>\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=259356\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u4fe1\u9054\u751f\u7269IBI363 (PD-1\/IL-2\u03b1-bias\u96d9\u7279\u7570\u6027\u6297\u9ad4\u878d\u5408\u86cb\u767d) 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designation, FTD\uff09\uff0c\u64ec\u5b9a\u9069\u61c9\u75c7\u70ba\u65e2\u5f80\u63a5\u53d7\u904e\u81f3\u5c11\u4e00\u7dda\u542bPD-1\/L1\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u7cfb\u7d71\u6027\u6cbb\u7642\u5f8c\u9032\u5c55\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u9ed1\u8272\u7d20\u7624\uff08\u8108\u7d61\u819c\u9ed1\u8272\u7d20\u7624\u9664\u5916\uff09\u3002\u76ee\u524d\uff0c\u4fe1\u9054\u751f\u7269\u6b63\u5728\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u6fb3\u5927\u5229\u4e9e\u540c\u6642\u958b\u5c551\/2\u671f\u81e8\u5e8a\u7814\u7a76\u63a2\u7d22IBI363\u5728\u5404\u7a2e\u665a\u671f\u60e1\u6027\u816b\u7624\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002 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\u4fe1\u9054\u751f\u7269\u88fd\u85e5\u96c6\u5718\u9ad8\u7d1a\u526f\u7e3d\u88c1\u5468\u8f1d\u535a\u58eb\u8868\u793a\uff1a\u300c\u9ed1\u8272\u7d20\u7624\u662f\u6b50\u7f8e\u570b\u5bb6\u6700\u5e38\u898b\u7684\u81f4\u6b7b\u6027\u76ae\u819a\u764c\u75c7\u3002\u5728\u4e2d\u570b\uff0c\u9ed1\u8272\u7d20\u7624\u96d6\u5c6c\u65bc\u5c11\u898b\u60e1\u6027\u816b\u7624\uff0c\u4f46\u75c5\u6b7b\u7387\u9ad8\uff0c\u767c\u75c5\u7387\u4e5f\u5728\u9010\u5e74\u589e\u52a0\u3002\u5118\u7ba1\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u5728\u9ed1\u8272\u7d20\u7624\u6cbb\u7642\u4e0a\u5df2\u53d6\u5f97\u4e86\u6210\u529f\uff0c\u4f46\u5168\u7403\u76ee\u524d\u5c1a\u7121\u91dd\u5c0d\u514d\u75ab\u6cbb\u7642\u5931\u6557\u9ed1\u8272\u7d20\u7624\u7684\u85e5\u7269\u7372\u6279\uff0c\u50b3\u7d71\u7684\u5316\u7642\u00b1\u6297\u8840\u7ba1\u6cbb\u7642\u514d\u75ab\u6cbb\u7642\u5931\u6557\u9ed1\u8272\u7d20\u7624\u7684ORR\u50c53.8%~6.8%\uff0c\u4e2d\u4f4dPFS\u4e0d\u8db33\u500b\u6708\uff0c\u7372\u76ca\u975e\u5e38\u6709\u9650-\u3002\u56e0\u6b64\uff0c\u5c0d\u65bc\u65e2\u5f80\u514d\u75ab\u6cbb\u7642\u5931\u6557\u7684\u60a3\u8005\uff0c\u5b58\u5728\u4e9f\u5f85\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002\u4f5c\u70ba\u5168\u7403\u9996\u5275\uff08First-in-class\uff09PD-1\/IL-2\u03b1-bias\u96d9\u7279\u7570\u6027\u6297\u9ad4\u878d\u5408\u86cb\u767d\uff0c\u76ee\u524dIBI363\u55ae\u85e5\u5728\u65e2\u5f80\u63a5\u53d7\u904e\u514d\u75ab\u6cbb\u7642\u7684\u9ed1\u8272\u7d20\u7624\u53d7\u8a66\u8005\u4e2d\u986f\u793a\u51fa\u9f13\u821e\u4eba\u5fc3\u7684\u7642\u6548\u548c\u826f\u597d\u7684\u5b89\u5168\u6027\u3002\u6211\u5011\u5c07\u7e7c\u7e8c\u63a2\u7d22IBI363\u5728\u9ed1\u8272\u7d20\u7624\u4e2d\u7684\u7642\u6548\u548c\u5b89\u5168\u6027\u6578\u64da\uff0c\u70ba\u514d\u75ab\u8010\u85e5\u7684\u9ed1\u8272\u7d20\u7624\u60a3\u8005\u63d0\u4f9b\u66f4\u6709\u6548\u7684\u81e8\u5e8a\u6cbb\u7642\u624b\u6bb5\u3002\u300d \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\uff08Fast Track Designation, FTD\uff09\u662f\u6709FDA\u8a2d\u7acb\u7684\u85e5\u7269\u81e8\u5e8a\u958b\u767c\u5feb\u901f\u5be9\u8a55\u904e\u7a0b\uff0c\u65e8\u5728\u4fc3\u9032\u7528\u65bc\u6cbb\u7642\u56b4\u91cd\u75be\u75c5\u548c\u89e3\u6c7a\u672a\u6eff\u8db3\u81e8\u5e8a\u9700\u6c42\u7684\u65b0\u85e5\u7814\u767c\u3002\u6839\u64da\u898f\u5b9a\uff0c\u7372\u5f97FTD\u8cc7\u683c\u7684\u5019\u9078\u85e5\u7269\uff0c\u5c07\u5728\u5f8c\u7e8c\u7684\u85e5\u7269\u7814\u767c\u8207\u5be9\u8a55\u904e\u7a0b\u4e2d\uff0c\u7372\u5f97\u66f4\u591a\u8207FDA\u6e9d\u901a\u4ea4\u6d41\u7684\u6a5f\u6703\uff0c\u6709\u52a9\u65bc\u52a0\u5feb\u85e5\u7269\u7684\u5f8c\u7e8c\u7814\u767c\u548c\u7372\u6279\u4e0a\u5e02\u3002 \u95dc\u65bcIBI363\uff08PD-1\/IL-2\u03b1-bias\u96d9\u7279\u7570\u6027\u878d\u5408\u86cb\u767d\uff09 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\u672c\u516c\u53f8\u3001\u672c\u516c\u53f8\u8463\u4e8b\u53ca\u50f1\u54e1\u4ee3\u7406\u6982\u4e0d\u627f\u64d4\u00a0(a) \u66f4\u6b63\u6216\u66f4\u65b0\u672c\u7db2\u7ad9\u6240\u8f09\u524d\u77bb\u6027\u8868\u8ff0\u7684\u4efb\u4f55\u7fa9\u52d9;\u53ca (b) \u82e5\u56e0\u4efb\u4f55\u524d\u77bb\u6027\u8868\u8ff0\u4e0d\u80fd\u5be6\u73fe\u6216\u8b8a\u6210\u4e0d\u6b63\u78ba\u800c\u5f15\u81f4\u7684\u4efb\u4f55\u8cac\u4efb\u3002 \u00a0 \u53c3\u8003\u6587\u737b           Wang X, Xu W, Chi Z, et al. Chemotherapy combined with antiangiogenic drugs as salvage therapy in advanced melanoma patients progressing on PD-1 immunotherapy. Transl Oncol. 2021;14(1):100949.         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Chemotherapy combined with antiangiogenic drugs as salvage therapy in advanced melanoma patients progressing on PD-1 immunotherapy. Transl Oncol. 2021;14(1):100949. 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2024\u5e746\u670814\u65e5\u7684ESMO\u5168\u9ad4\u6703\u8b70\u4e0a\uff0cIBI363\u5831\u9053\u4e86\u5728\u65e2\u5f80\u63a5\u53d7\u904e\u514d\u75ab\u6cbb\u7642\u7684\u9ed1\u8272\u7d20\u7624\u53d7\u8a66\u8005\u4e2d\u89c0\u5bdf\u5230\u4ee4\u4eba\u6b23\u559c\u7684\u7642\u6548\u4fe1\u865f\uff1a37\u4f8b\u65e2\u5f80\u63a5\u53d7\u904e\u514d\u75ab\u6cbb\u7642\u7684\u9ed1\u8272\u7d20\u7624\u60a3\u8005\u63a5\u53d7\u4e861mg\/kg IBI363\u6cbb\u7642\u4e26\u81f3\u5c11\u63a5\u53d7\u4e86\u4e00\u6b21\u57fa\u7dda\u5f8c\u816b\u7624\u8a55\u4f30\uff0c11\u4f8b\u60a3\u8005\u7372\u5f97\u4e86\u5ba2\u89c0\u7de9\u89e3\uff0c\u5305\u62ec1\u4f8bCR\u548c10\u4f8bPR\uff0cORR\u548cDCR\u5206\u5225\u70ba29.7%\u548c73.0%\u3002\uff08\u93c8\u63a5\uff09 \u4fe1\u9054\u751f\u7269\u88fd\u85e5\u96c6\u5718\u9ad8\u7d1a\u526f\u7e3d\u88c1\u5468\u8f1d\u535a\u58eb\u8868\u793a\uff1a\u300c\u9ed1\u8272\u7d20\u7624\u662f\u6b50\u7f8e\u570b\u5bb6\u6700\u5e38\u898b\u7684\u81f4\u6b7b\u6027\u76ae\u819a\u764c\u75c7\u3002\u5728\u4e2d\u570b\uff0c\u9ed1\u8272\u7d20\u7624\u96d6\u5c6c\u65bc\u5c11\u898b\u60e1\u6027\u816b\u7624\uff0c\u4f46\u75c5\u6b7b\u7387\u9ad8\uff0c\u767c\u75c5\u7387\u4e5f\u5728\u9010\u5e74\u589e\u52a0\u3002\u5118\u7ba1\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u5728\u9ed1\u8272\u7d20\u7624\u6cbb\u7642\u4e0a\u5df2\u53d6\u5f97\u4e86\u6210\u529f\uff0c\u4f46\u5168\u7403\u76ee\u524d\u5c1a\u7121\u91dd\u5c0d\u514d\u75ab\u6cbb\u7642\u5931\u6557\u9ed1\u8272\u7d20\u7624\u7684\u85e5\u7269\u7372\u6279\uff0c\u50b3\u7d71\u7684\u5316\u7642\u00b1\u6297\u8840\u7ba1\u6cbb\u7642\u514d\u75ab\u6cbb\u7642\u5931\u6557\u9ed1\u8272\u7d20\u7624\u7684ORR\u50c53.8%~6.8%\uff0c\u4e2d\u4f4dPFS\u4e0d\u8db33\u500b\u6708\uff0c\u7372\u76ca\u975e\u5e38\u6709\u9650-\u3002\u56e0\u6b64\uff0c\u5c0d\u65bc\u65e2\u5f80\u514d\u75ab\u6cbb\u7642\u5931\u6557\u7684\u60a3\u8005\uff0c\u5b58\u5728\u4e9f\u5f85\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002\u4f5c\u70ba\u5168\u7403\u9996\u5275\uff08First-in-class\uff09PD-1\/IL-2\u03b1-bias\u96d9\u7279\u7570\u6027\u6297\u9ad4\u878d\u5408\u86cb\u767d\uff0c\u76ee\u524dIBI363\u55ae\u85e5\u5728\u65e2\u5f80\u63a5\u53d7\u904e\u514d\u75ab\u6cbb\u7642\u7684\u9ed1\u8272\u7d20\u7624\u53d7\u8a66\u8005\u4e2d\u986f\u793a\u51fa\u9f13\u821e\u4eba\u5fc3\u7684\u7642\u6548\u548c\u826f\u597d\u7684\u5b89\u5168\u6027\u3002\u6211\u5011\u5c07\u7e7c\u7e8c\u63a2\u7d22IBI363\u5728\u9ed1\u8272\u7d20\u7624\u4e2d\u7684\u7642\u6548\u548c\u5b89\u5168\u6027\u6578\u64da\uff0c\u70ba\u514d\u75ab\u8010\u85e5\u7684\u9ed1\u8272\u7d20\u7624\u60a3\u8005\u63d0\u4f9b\u66f4\u6709\u6548\u7684\u81e8\u5e8a\u6cbb\u7642\u624b\u6bb5\u3002\u300d \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\uff08Fast Track Designation, FTD\uff09\u662f\u6709FDA\u8a2d\u7acb\u7684\u85e5\u7269\u81e8\u5e8a\u958b\u767c\u5feb\u901f\u5be9\u8a55\u904e\u7a0b\uff0c\u65e8\u5728\u4fc3\u9032\u7528\u65bc\u6cbb\u7642\u56b4\u91cd\u75be\u75c5\u548c\u89e3\u6c7a\u672a\u6eff\u8db3\u81e8\u5e8a\u9700\u6c42\u7684\u65b0\u85e5\u7814\u767c\u3002\u6839\u64da\u898f\u5b9a\uff0c\u7372\u5f97FTD\u8cc7\u683c\u7684\u5019\u9078\u85e5\u7269\uff0c\u5c07\u5728\u5f8c\u7e8c\u7684\u85e5\u7269\u7814\u767c\u8207\u5be9\u8a55\u904e\u7a0b\u4e2d\uff0c\u7372\u5f97\u66f4\u591a\u8207FDA\u6e9d\u901a\u4ea4\u6d41\u7684\u6a5f\u6703\uff0c\u6709\u52a9\u65bc\u52a0\u5feb\u85e5\u7269\u7684\u5f8c\u7e8c\u7814\u767c\u548c\u7372\u6279\u4e0a\u5e02\u3002 \u95dc\u65bcIBI363\uff08PD-1\/IL-2\u03b1-bias\u96d9\u7279\u7570\u6027\u878d\u5408\u86cb\u767d\uff09 IBI363\u662f\u7531\u4fe1\u9054\u751f\u7269\u81ea\u4e3b\u7814\u767c\u7684\u5168\u7403\u9996\u5275PD-1\/IL-2\u96d9\u7279\u7570\u6027\u878d\u5408\u86cb\u767d\uff0c\u540c\u6642\u5177\u6709\u963b\u65b7PD-1\/PD-L1\u901a\u8def\u548c\u6fc0\u6d3bIL-2\u901a\u8def\u5169\u9805\u529f\u80fd\u3002IBI363\u7684IL-2\u81c2\u7d93\u904e\u4e86\u8a2d\u8a08\u6539\u9020\uff0c\u4fdd\u7559\u4e86\u5176\u5c0dIL-2 R\u03b1\u7684\u89aa\u548c\u529b\uff0c\u4f46\u524a\u5f31\u4e86\u5c0dIL-2R\u03b2\u548cIL-2R\u03b3\u7684\u7d50\u5408\u80fd\u529b\uff0c\u4ee5\u6b64\u964d\u4f4e\u6bd2\u6027\uff1b\u800cPD-1\u7d50\u5408\u81c2\u53ef\u4ee5\u540c\u6642\u5be6\u73fe\u5c0dPD-1\u7684\u963b\u65b7\u548cIL-2\u7684\u9078\u64c7\u6027\u905e\u9001\u3002\u7531\u65bc\u65b0\u6fc0\u6d3b\u7684\u816b\u7624\u7279\u7570\u6027T\u7d30\u80de\u540c\u6642\u8868\u9054PD-1\u548cIL-2\u03b1\uff0c\u9019\u4e00\u5dee\u7570\u6027\u7b56\u7565\u53ef\u4ee5\u66f4\u7cbe\u78ba\u548c\u6709\u6548\u5730\u5be6\u73fe\u5c0d\u8a72T\u7d30\u80de\u4e9e\u7fa4\u7684\u9776\u5411\u548c\u6fc0\u6d3b\u3002IBI363\u4e0d\u50c5\u5728\u591a\u7a2e\u8377\u7624\u85e5\u7406\u5b78\u6a21\u578b\u4e2d\u5c55\u73fe\u51fa\u4e86\u826f\u597d\u6297\u816b\u7624\u6d3b\u6027\uff0c\u5728PD-1\u8010\u85e5\u548c\u8f49\u79fb\u6a21\u578b\u4e2d\u4e5f\u8868\u73fe\u51fa\u4e86\u7a81\u51fa\u7684\u6291\u7624\u6548\u529b\u3002\u5f9e\u81e8\u5e8a\u8feb\u5207\u9700\u6c42\u51fa\u767c\uff0c\u4fe1\u9054\u751f\u7269\u6b63\u5728\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u6fb3\u5927\u5229\u4e9e\u958b\u5c55\u81e8\u5e8a\u7814\u7a76\u63a2\u7d22IBI363\u5728\u91dd\u5c0d\u5404\u7a2e\u665a\u671f\u60e1\u6027\u816b\u7624\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002 \u95dc\u65bc\u9ed1\u8272\u7d20\u7624 \u9ed1\u8272\u7d20\u7624\u662f\u4e00\u7a2e\u5f9e\u9ed1\u8272\u7d20\u7d30\u80de\u767c\u5c55\u800c\u4f86\u7684\u60e1\u6027\u816b\u7624\uff0c\u662f\u7f8e\u570b\u7b2c\u4e94\u5927\u6700\u5e38\u898b\u7684\u764c\u75c7\u75c5\u56e0\u3002\u96d6\u7136\u9ed1\u8272\u7d20\u7624\u53ea\u4f54\u6240\u6709\u985e\u578b\u76ae\u819a\u764c\u76843%\uff0c\u4f46\u5b83\u7684\u6b7b\u4ea1\u7387\u662f\u6240\u6709\u985e\u578b\u4e2d\u6700\u9ad8\u7684\uff0c\u800c\u4e14\u6700\u5bb9\u6613\u767c\u751f\u8f49\u79fb\u3002\u5728\u4e2d\u570b\uff0c\u9ed1\u8272\u7d20\u7624\u7684\u767c\u751f\u7387\u548c\u6b7b\u4ea1\u7387\u4e5f\u5728\u9010\u5e74\u589e\u52a0\u3002\u6309\u767c\u75c5\u90e8\u4f4d\u5206\u985e\uff0c\u9ed1\u8272\u7d20\u7624\u4e3b\u8981\u5206\u70ba\u76ae\u819a\u9ed1\u8272\u7d20\u7624\u3001\u80a2\u7aef\u9ed1\u8272\u7d20\u7624\u548c\u7c98\u819c\u9ed1\u8272\u7d20\u7624\u7b49\u3002\u4e2d\u570b\u9ed1\u8272\u7d20\u7624\u8207\u6b50\u7f8e\u767d\u7a2e\u4eba\u5dee\u7570\u8f03\u5927\uff0c\u5169\u8005\u5728\u767c\u75c5\u6a5f\u5236\u3001\u751f\u7269\u5b78\u884c\u70ba\u3001\u7d44\u7e54\u5b78\u5f62\u614b\u3001\u6cbb\u7642\u65b9\u6cd5\u4ee5\u53ca\u9810\u5f8c\u7b49\u65b9\u9762\u5dee\u7570\u8f03\u5927\u3002\u5c0d\u65bc\u665a\u671f\u76ae\u819a\u548c\u80a2\u7aef\u9ed1\u8272\u7d20\u7624\uff0c\u5982\u651c\u5e36 BRAF V600 \u7a81\u8b8a\uff0c\u5247\u9996\u9078\u5206\u5b50\u9776\u5411\u85e5\u7269BRAF\u6291\u5236\u5291\u806f\u5408MEK\u6291\u5236\u5291\uff0c\u7121BRAF V600\u7a81\u8b8a\u7684\u60a3\u8005\u4e00\u7dda\u6cbb\u7642\u53ef\u8003\u616e\u5316\u7642\u8207\u6297\u8840\u7ba1\u751f\u6210\u85e5\u7269\u806f\u5408\u6cbb\u7642\uff0c\u514d\u75ab\u6cbb\u7642\u5c1a\u672a\u5728\u570b\u5167\u7372\u6279\u665a\u671f\u9ed1\u8272\u7d20\u7624\u4e00\u7dda\u6cbb\u7642\u7684\u9069\u61c9\u75c7\u3002\u4e8c\u7dda\u4e3b\u8981\u8003\u616e\u8207\u5df2\u63a5\u53d7\u4e00\u7dda\u6cbb\u7642\u4e0d\u540c\u7684\u85e5\u7269\u6cbb\u7642\uff0c\u5c0d\u65bc\u4e00\u7dda\u672a\u4f7f\u7528\u904ePD-1\u55ae\u6297\u7684\u53d7\u8a66\u8005\uff0c\u4e8c\u7dda\u6cbb\u7642\u53ef\u9078\u64c7PD-1\u55ae\u6297\u3002\u5c0d\u65bc\u665a\u671f\u7c98\u819c\u9ed1\u8272\u7d20\u7624\uff0c\u4e00\u7dda\u6cbb\u7642\u53ef\u8003\u616e\u5316\u7642\u6216PD-1\u55ae\u6297\u806f\u5408\u6297\u8840\u7ba1\u751f\u6210\u85e5\u7269\uff0c\u5982\u651c\u5e36BRAF V600\u7a81\u8b8a\uff0c\u53ef\u9078\u64c7BRAF\u6291\u5236\u5291\u00b1MEK \u6291\u5236\u5291\uff0c\u5f8c\u7dda\u6cbb\u7642\u9078\u64c7\u5341\u5206\u6709\u9650\u3002 \u95dc\u65bc\u4fe1\u9054\u751f\u7269 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\u672c\u516c\u53f8\u3001\u672c\u516c\u53f8\u8463\u4e8b\u53ca\u50f1\u54e1\u4ee3\u7406\u6982\u4e0d\u627f\u64d4\u00a0(a) \u66f4\u6b63\u6216\u66f4\u65b0\u672c\u7db2\u7ad9\u6240\u8f09\u524d\u77bb\u6027\u8868\u8ff0\u7684\u4efb\u4f55\u7fa9\u52d9;\u53ca (b) \u82e5\u56e0\u4efb\u4f55\u524d\u77bb\u6027\u8868\u8ff0\u4e0d\u80fd\u5be6\u73fe\u6216\u8b8a\u6210\u4e0d\u6b63\u78ba\u800c\u5f15\u81f4\u7684\u4efb\u4f55\u8cac\u4efb\u3002 \u00a0 \u53c3\u8003\u6587\u737b           Wang X, Xu W, Chi Z, et al. Chemotherapy combined with antiangiogenic drugs as salvage therapy in advanced melanoma patients progressing on PD-1 immunotherapy. Transl Oncol. 2021;14(1):100949.         European Journal of Cancer 162 (2022) 22e33\uff1b         National Cancer Institute Melanoma of the Skin-Cancer Stat Facts:         https:\/\/seer.cancer.gov\/statfacts\/html\/melan.html.\u00a0         \u9ed1\u8272\u7d20\u7624\u8a3a\u7642\u898f\u7bc4\uff082022 \u5e74\u7248\uff09 .         \u4e2d\u570b\u81e8\u5e8a\u816b\u7624\u5b78\u6703(CSCO)\u9ed1\u8272\u7d20\u7624\u8a3a\u7642\u6307\u5357\uff082022\u5e74\u7248\uff09 .         \u00a0 \u00a0","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=259356","og_locale":"zh_TW","og_type":"article","og_title":"\u4fe1\u9054\u751f\u7269IBI363 (PD-1\/IL-2\u03b1-bias\u96d9\u7279\u7570\u6027\u6297\u9ad4\u878d\u5408\u86cb\u767d) \u7372\u5f97\u7f8e\u570bFDA\u5feb\u901f\u901a\u9053\u8cc7\u683c\u8a8d\u5b9a\uff0c\u6cbb\u7642\u9ed1\u8272\u7d20\u7624 - 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\u672c\u516c\u53f8\u3001\u672c\u516c\u53f8\u8463\u4e8b\u53ca\u50f1\u54e1\u4ee3\u7406\u6982\u4e0d\u627f\u64d4\u00a0(a) \u66f4\u6b63\u6216\u66f4\u65b0\u672c\u7db2\u7ad9\u6240\u8f09\u524d\u77bb\u6027\u8868\u8ff0\u7684\u4efb\u4f55\u7fa9\u52d9;\u53ca (b) \u82e5\u56e0\u4efb\u4f55\u524d\u77bb\u6027\u8868\u8ff0\u4e0d\u80fd\u5be6\u73fe\u6216\u8b8a\u6210\u4e0d\u6b63\u78ba\u800c\u5f15\u81f4\u7684\u4efb\u4f55\u8cac\u4efb\u3002 \u00a0 \u53c3\u8003\u6587\u737b           Wang X, Xu W, Chi Z, et al. Chemotherapy combined with antiangiogenic drugs as salvage therapy in advanced melanoma patients progressing on PD-1 immunotherapy. Transl Oncol. 2021;14(1):100949.         European Journal of Cancer 162 (2022) 22e33\uff1b         National Cancer Institute Melanoma of the Skin-Cancer Stat Facts:         https:\/\/seer.cancer.gov\/statfacts\/html\/melan.html.\u00a0         \u9ed1\u8272\u7d20\u7624\u8a3a\u7642\u898f\u7bc4\uff082022 \u5e74\u7248\uff09 .         \u4e2d\u570b\u81e8\u5e8a\u816b\u7624\u5b78\u6703(CSCO)\u9ed1\u8272\u7d20\u7624\u8a3a\u7642\u6307\u5357\uff082022\u5e74\u7248\uff09 .         \u00a0 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