{"id":19258,"date":"2021-02-01T09:54:00","date_gmt":"2021-02-01T02:54:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2021020109540019258"},"modified":"2021-02-02T09:12:41","modified_gmt":"2021-02-02T01:12:41","slug":"%e5%ba%b7%e5%ae%81%e6%9d%b0%e7%91%9epd-l1-ctla-4%e5%8f%8c%e7%89%b9%e5%bc%82%e6%80%a7%e6%8a%97%e4%bd%93kn046%e4%b8%a4%e9%a1%b9%e4%b8%b4%e5%ba%8a%e7%a0%94%e7%a9%b6%e6%95%b0%e6%8d%ae%e5%9c%a8%e7%ac%ac21","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2021020109540019258","title":{"rendered":"\u5eb7\u5b81\u6770\u745ePD-L1\/CTLA-4\u53cc\u7279\u5f02\u6027\u6297\u4f53KN046\u4e24\u9879\u4e34\u5e8a\u7814\u7a76\u6570\u636e\u5728\u7b2c21\u5c4a\u4e16\u754c\u80ba\u764c\u5927\u4f1a(WCLC 2020)\u4e0a\u516c\u5e03"},"content":{"rendered":"<ul 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<\/i><\/li>\n<li><i>KN046\u5728\u80f8\u817a\u4e0a\u76ae\u80bf\u7624\u60a3\u8005\u4e2d\u5177\u6709\u826f\u597d\u7684\u5b89\u5168\u6027\u548c\u7597\u6548\uff0c\u5df2\u83b7\u7f8e\u56fdFDA\u6388\u4e88\u6cbb\u7597\u80f8\u817a\u4e0a\u76ae\u80bf\u7624\u7684\u5b64\u513f\u836f\u8d44\u683c\u3002\u6fb3\u5927\u5229\u4e9a\u2160\u671f\u4e34\u5e8a\u7814\u7a76\u4e2d\u76844\u4f8b\u80f8\u817a\u4e0a\u76ae\u80bf\u7624\u60a3\u8005\u4e2d\uff0c\u5ba2\u89c2\u7f13\u89e3\u7387(ORR)\u4e3a75%\uff0cDCR\u4e3a100%\u3002<\/i> <\/li>\n<li><i>KN046\u6cbb\u7597\u4e00\u7ebf\u9cde\u72b6NSCLC\u7684\u2162\u671f\u5173\u952e\u6027\u4e34\u5e8a\u8bd5\u9a8c(ENREACH-LUNG-01)\u548c\u6cbb\u7597\u665a\u671f\u80f8\u817a\u764c\u7684\u2161\u671f\u56fd\u9645\u6027\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\uff08KN046-205\uff09\u5df2\u7ecf\u542f\u52a8\u3002<\/i><\/li>\n<\/ul>\n<p><p>\u82cf\u5dde2021\u5e742\u67081\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; 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id=\"spanHghlt4c1b\">\u5168\u7403\u89c4\u6a21\u6700\u5927<\/span>\u7684\u81f4\u529b\u4e8e\u80ba\u764c\u548c\u5176\u4ed6\u80f8\u90e8\u6076\u6027\u80bf\u7624\u7684\u591a\u5b66\u79d1\u80bf\u7624\u5b66\u4f1a\u8bae\u30022020\u5e74\u4e16\u754c\u80ba\u764c\u5927\u4f1a\uff08WCLC 2020 \u865a\u62df\u4f1a\u8bae\uff09\u4e8e2021\u5e741\u670828\u65e5\u81f331\u65e5\u4e3e\u884c\u3002<\/p>\n<p><b>\u58c1\u62a5\u5c55\u793a<br \/><\/b><b>\u6807\u9898\uff1a<\/b>KN046\u7528\u4e8e\u6cbb\u7597\u665a\u671f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c(NSCLC)\u60a3\u8005\u7684\u2161\u671f\u4e34\u5e8a\u7814\u7a76\u6570\u636e<br \/><b>\u5c55\u793a\u5f62\u5f0f\uff1a<\/b>\u58c1\u62a5<br \/><b>\u6458\u8981\u7f16\u53f7\uff1a<\/b>#1665<br \/><b>\u62a5\u544a\u8005\uff1a<\/b>\u540c\u6d4e\u5927\u5b66\u9644\u5c5e\u4e0a\u6d77\u5e02\u80ba\u79d1\u533b\u9662\u80bf\u7624\u79d1\u4e3b\u4efb \u5468\u5f69\u5b58\u6559\u6388<\/p>\n<p>KN046-201\u662f\u4e00\u9879\u2161\u671f\u3001\u5f00\u653e\u3001\u591a\u4e2d\u5fc3\u4e34\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30KN046\u7528\u4e8e\u4e8c\u7ebf\u6cbb\u7597\u665a\u671f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u7684\u6709\u6548\u6027\u3001\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u3002\u7ed3\u679c\u663e\u793aKN046\u8010\u53d7\u6027\u597d\u3001\u7528\u4e8e\u665a\u671fNSCLC\u7684\u4e8c\u7ebf\u6cbb\u7597\u6709\u6548\uff0c\u5c55\u793a\u51fa\u65e0\u8fdb\u5c55\u751f\u5b58\u671f(PFS)\u548c\u603b\u751f\u5b58\u671f(OS)\u83b7\u76ca\u3002<\/p>\n<p>\u672c\u7814\u7a76\u5171\u5165\u7ec464\u4f8b\u65e2\u5f80\u63a5\u53d7\u8fc7\u4e00\u7ebf\u7cfb\u7edf\u6027\u6cbb\u7597\u7684NSCLC\u60a3\u8005\uff0c\u4e2d\u4f4d\u6cbb\u7597\u65f6\u95f4\u4e3a3.8\u4e2a\u6708\uff0c\u4e2d\u4f4d\u968f\u8bbf\u671f\u4e3a13\u4e2a\u6708\u3002<\/p>\n<p>\u4e2d\u4f4dPFS\u4e3a3.68\u4e2a\u6708(95%CI 3.35\uff0c7.29)\uff1a\u5176\u4e2d\u9cde\u72b6NSCLC\u548c\u975e\u9cde\u72b6NSCLC\u5206\u522b\u4e3a7.29\u4e2a\u6708(3.68,9.23)\u548c3.58\u4e2a\u6708(2.46,5.52)\uff1b\u4e2d\u4f4dOS\u672a\u8fbe\u5230\uff0c6\u4e2a\u6708\u751f\u5b58\u738785.6%\uff0c12\u4e2a\u6708\u751f\u5b58\u738769.7%\u3002DCR\u9ad8\u8fbe70%\u3002\u8fd9\u4e0ePD-(L)1\u6297\u4f53\u7684\u5386\u53f2\u6570\u636e\u76f8\u6bd4\uff0c\u4f53\u73b0\u51fa\u4f18\u52bf\u3002\u5728\u672c\u7814\u7a76\u4e2dPD-L1\u22651%\u7684\u60a3\u8005\u5360\u6bd440%\uff0cPD-L1\u9633\u6027\u548c\u9634\u6027\u4eba\u7fa4\u5747\u83b7\u76ca\u3002<\/p>\n<p>\u5b89\u5168\u6027\u65b9\u9762\uff0c64\u4f8b\u60a3\u8005\u4e2d\u670924\u4f8b(37.5\uff05)\u53d1\u751f\u22653\u7ea7\u7684TRAE\uff0c\u4e3b\u8981\u662f\u8f93\u6db2\u53cd\u5e94(10.9%)\uff0c\u8d2b\u8840(4.7%)\uff0c\u836f\u7269\u6027\u809d\u635f\u4f24(3.1%)\uff0c\u809d\u529f\u80fd\u5f02\u5e38(3.1%)\uff0c\u80ba\u90e8\u611f\u67d3(3.1%)\u7b49\u3002\u514d\u75ab\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6(irAE)\u4e3b\u8981\u662f\u55dc\u4e2d\u6027\u7c92\u7ec6\u80de\u8ba1\u6570\u51cf\u5c11(3.1%)\uff0c\u767d\u7ec6\u80de\u8ba1\u6570\u4e0b\u964d\uff083.1%\uff09\u3002\u4e0d\u826f\u4e8b\u4ef6\u53ef\u9006\u3001\u53ef\u76d1\u63a7\u3002<\/p>\n<p><b>\u8ff7\u4f60\u53e3\u5934\u62a5\u544a<br \/><\/b><b>\u6807\u9898\uff1a<\/b>KN046\u5728\u7f55\u89c1\u80f8\u90e8\u80bf\u7624\u60a3\u8005\u4e2d\u7684\u521d\u6b65\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7ed3\u679c<br \/><b>\u5c55\u793a\u5f62\u5f0f\uff1a<\/b>\u8ff7\u4f60\u53e3\u5934\u62a5\u544a<br \/><b>\u6458\u8981\u7f16\u53f7\uff1a<\/b>#1313<br \/><b>\u62a5\u544a\u8005\uff1a<\/b>Gary Richardson\u6559\u6388<\/p>\n<p>KN046-AUS-001\u662f\u5728\u6fb3\u5927\u5229\u4e9a\u5f00\u5c55\u7684\u2160\u671f\u4e34\u5e8a\u7814\u7a76\u3002<\/p>\n<p>\u672c\u7814\u7a76\u5165\u7ec45\u4f8b\u7f55\u89c1\u80f8\u90e8\u80bf\u7624\u60a3\u8005\uff0c\u5305\u62ec4\u4f8b\u80f8\u817a\u4e0a\u76ae\u80bf\u7624(2\u4f8b\u80f8\u817a\u764c(\u2163\u671f)\u30012\u4f8b\u80f8\u817a\u7624(\u2163\u671f) )\u548c1\u4f8b\u80f8\u819c\u95f4\u76ae\u7624(\u8089\u7624\u6837\u53d8\uff0c\u2162B\u671f)\u3002\u6cbb\u7597\u7684\u4e2d\u4f4d\u6301\u7eed\u65f6\u95f4\u4e3a22.7\u5468(\u8303\u56f4\uff1a16-48)\u3002<\/p>\n<p>KN046\u57284\u4f8b\u80f8\u817a\u4e0a\u76ae\u80bf\u7624\u7684\u786e\u8ba4\u75be\u75c5\u7f13\u89e3\u7387\u4e3a50%\uff0c\u786e\u8ba4\u548c\u672a\u786e\u8ba4\u75be\u75c5\u7f13\u89e3\u7387\u4e3a75%(2\u4f8b\u786e\u8ba4PR\u30011\u4f8b\u672a\u786e\u8ba4PR)\uff0c\u75be\u75c5\u63a7\u5236\u7387\u4e3a100%\u3002<\/p>\n<p>5\u4f8b\u60a3\u8005\u4e2d3\u4f8b\u60a3\u8005\u53d1\u751f\u4e8614\u4f8b\u6b21\u514d\u75ab\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff0c\u5927\u591a\u5c5e\u4e8e1-2\u7ea7\uff1b\u4ec51\u4f8b\u53d7\u8bd5\u8005\u53d1\u751f\u4e862\u4f8b\u6b213\u7ea7\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6(\u81ea\u8eab\u514d\u75ab\u6027\u809d\u708e\u548cALT\u5347\u9ad8)\u3002<\/p>\n<p><b>\u5173\u4e8e<\/b><b>KN046<\/b><\/p>\n<p>KN046\u662f\u5eb7\u5b81\u6770\u745e\u81ea\u4e3b\u7814\u53d1\u7684PD-L1\/CTLA-4\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff0c\u5176\u521b\u65b0\u8bbe\u8ba1\u5305\u62ec\uff1a\u91c7\u7528\u673a\u5236\u4e0d\u540c\u7684CTLA-4\u4e0ePD-L1\u5355\u57df\u6297\u4f53\u878d\u5408\u7ec4\u6210\uff1b\u53ef\u9776\u5411\u5bcc\u96c6\u4e8ePD-L1\u9ad8\u8868\u8fbe\u7684\u80bf\u7624\u5fae\u73af\u5883\u53ca\u6e05\u9664\u6291\u5236\u80bf\u7624\u514d\u75ab\u7684Treg\u3002<\/p>\n<p>KN046\u5728\u6fb3\u5927\u5229\u4e9a\u548c\u4e2d\u56fd\u5df2\u5f00\u5c55\u8986\u76d6\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u3001\u4e09\u9634\u4e73\u817a\u764c\u3001\u98df\u7ba1\u9cde\u764c\u3001\u809d\u764c\u3001\u80f0\u817a\u764c\u7b4910\u4f59\u79cd\u80bf\u7624\u7684\u8fd120\u9879\u4e0d\u540c\u9636\u6bb5\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\u60a3\u8005\u83b7\u5f97\u751f\u5b58\u83b7\u76ca\u7684\u4f18\u52bf\u3002\u7f8e\u56fdFDA\u57fa\u4e8e\u5728\u6fb3\u5927\u5229\u4e9a\u548c\u4e2d\u56fd\u53d6\u5f97\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\uff0c\u6279\u51c6KN046\u5728\u7f8e\u56fd\u76f4\u63a5\u8fdb\u5165\u2161\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5e76\u4e8e2020\u5e749\u6708\u6388\u4e88KN046\u7528\u4e8e\u6cbb\u7597\u80f8\u817a\u4e0a\u76ae\u80bf\u7624\u7684\u5b64\u513f\u836f\u8d44\u683c\u3002\u76ee\u524dKN046\u4e24\u4e2a\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u6b63\u5728\u8fdb\u884c\u4e2d\u3002<\/p>\n<p><b>\u5173\u4e8e\u5eb7\u5b81\u6770\u745e<\/b><\/p>\n<p>\u5eb7\u5b81\u6770\u745e\u751f\u7269\u5236\u836f\u662f\u4e00\u5bb6\u4e13\u6ce8\u4e8e\u7814\u53d1\u3001\u751f\u4ea7\u548c\u5546\u4e1a\u5316\u521b\u65b0\u6297\u80bf\u7624\u751f\u7269\u5927\u5206\u5b50\u836f\u7269\u7684\u751f\u7269\u5236\u836f\u516c\u53f8\u30022019\u5e7412\u670812\u65e5\uff0c\u516c\u53f8\u5728\u9999\u6e2f\u8054\u5408\u4ea4\u6613\u6240\u4e3b\u677f\u4e0a\u5e02\uff0c\u80a1\u7968\u4ee3\u7801\uff1a9966\u3002<\/p>\n<p>\u5eb7\u5b81\u6770\u745e\u751f\u7269\u5236\u836f\u5728\u53cc\u7279\u5f02\u6027\u6297\u4f53\u53ca\u86cb\u767d\u8d28\u5de5\u7a0b\u65b9\u9762\u62e5\u6709\u5168\u9762\u6574\u5408\u7684\u53d1\u73b0\u3001\u7814\u53d1\u548c\u5236\u9020\u5e73\u53f0\u3002\u516c\u53f8\u4ea7\u54c1\u7ba1\u7ebf\u5305\u62ec\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u3001\u9ad8\u5ea6\u5dee\u5f02\u5316\u768414\u79cd\u4ee5\u53cc\u6297\u4e3a\u4e3b\u7684\u6297\u80bf\u7624\u5019\u9009\u836f\u7269\uff0c\u548c1\u79cdCovid-19\u7684\u591a\u529f\u80fd\u6297\u4f53\uff0c\u5176\u4e2d4\u4e2a\u4ea7\u54c1\u5728\u4e2d\u56fd\u3001\u7f8e\u56fd\u3001\u65e5\u672c\u3001\u6fb3\u5927\u5229\u4e9a\u5904\u4e8e\u2160-\u2162\u671f\u4e34\u5e8a\u3002\u6069\u6c83\u5229\u5355\u6297\u6ce8\u5c04\u6db2\uff08KN035\uff09\u4e0a\u5e02\u7533\u8bf7\u5df2\u83b7\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6b63\u5f0f\u53d7\u7406\u5e76\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u3002<\/p>\n<p>\u516c\u53f8\u62e5\u6709\u5f02\u4e8c\u805a\u4f53\u53ca\u6df7\u5408\u6297\u4f53\u7b49\u591a\u4e2a\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u6280\u672f\u5e73\u53f0\uff0c\u548c\u7b26\u5408\u4e2d\u56fd\u3001\u7f8e\u56fd\u548c\u6b27\u76dfcGMP\u6807\u51c6\u7684\u5927\u89c4\u6a21\u751f\u4ea7\u80fd\u529b\uff0c\u5e76\u4e14\u901a\u8fc7\u5305\u62ec\u6b27\u76dfQP\u5728\u5185\u591a\u6b21\u5ba1\u8ba1\u7684\u5b8c\u6574\u7684\u8d28\u91cf\u4f53\u7cfb\u3002\u516c\u53f8\u81f4\u529b\u4e8e\u5efa\u8bbe\u56fd\u9645\u9886\u5148\u7684\uff0c\u591a\u7ef4\u5ea6\u7684\u836f\u7269\u5f00\u53d1\u548c\u4ea7\u4e1a\u5316\u5e73\u53f0\uff0c\u805a\u7126\u591a\u529f\u80fd\u751f\u7269\u5927\u5206\u5b50\u65b0\u836f\uff0c\u60e0\u53ca\u4e2d\u56fd\u548c\u5168\u7403\u7684\u60a3\u8005\u3002<\/p>\n<p>\u6b22\u8fce\u8bbf\u95ee\u516c\u53f8\u7f51\u7ad9\uff1a<a 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