{"id":67313,"date":"2022-04-11T08:35:00","date_gmt":"2022-04-11T01:35:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2022041108350067313"},"modified":"2022-04-11T18:26:38","modified_gmt":"2022-04-11T10:26:38","slug":"kn026%e8%81%94%e5%90%88kn046%e6%b2%bb%e7%96%97her2%e9%98%b3%e6%80%a7%e5%ae%9e%e4%bd%93%e7%98%a4%e7%9a%84%e6%9c%80%e6%96%b0%e6%95%b0%e6%8d%ae%e4%ba%ae%e7%9b%b8aacr-2022","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2022041108350067313","title":{"rendered":"KN026\u8054\u5408KN046\u6cbb\u7597HER2\u9633\u6027\u5b9e\u4f53\u7624\u7684\u6700\u65b0\u6570\u636e\u4eae\u76f8AACR 2022"},"content":{"rendered":"<ul type=\"disc\">\n<li><b>\u622a\u81f3<\/b><b>2021\u5e748\u670810\u65e5\uff0c\u5171\u5165\u7ec424\u4f8b\u63a5\u53d7\u8fc7\u22651L\u7cfb\u7edf\u6cbb\u7597\u3001HER2\u9633\u6027\u975e\u4e73\u817a\u764c\u548c\u80c3\u764c\u3001\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u5b9e\u4f53\u7624\u60a3\u8005\uff0c20\u4f8b\u60a3\u8005\u63a5\u53d7\u81f3\u5c11\u4e00\u6b21\u80bf\u7624\u8bc4\u4f30\uff1a\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a55.0%\uff0c\u75be\u75c5\u63a7\u5236\u7387 (DCR) \u4e3a85.0%\uff0c6\u4e2a\u6708\u7684PFS\u7387\u4e3a84.1%\uff1b\u5176\u4e2d11\u540d\u53ef\u8bc4\u4f30\u7684\u7ed3\u76f4\u80a0\u764c\u60a3\u8005ORR\u548cDCR\u5206\u522b\u4e3a45.5%\u548c90.9%\u3002<\/b><\/li>\n<\/ul>\n<p><p><span>\u82cf\u5dde<\/span><span>2022\u5e744\u670811\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212;&nbsp;\u5eb7\u5b81\u6770\u745e\u751f\u7269\u5236\u836f(\u80a1\u7968\u4ee3\u7801\uff1a9966.HK)\u5ba3\u5e03\uff0cKN026\u8054\u5408KN046\u7684\u65e0\u5316\u7597\u65b9\u6848\u2161\u671f\u4e34\u5e8a\u6570\u636e (\u7814\u7a76\u7f16\u53f7\uff1aKN026-203), \u4ee5\u58c1\u62a5\u5f62\u5f0f\u57282022\u5e74\u7f8e\u56fd\u764c\u75c7\u7814\u7a76\u5b66\u4f1a\uff08AACR 2022\uff09\u5e74\u4f1a\u4e0a\u516c\u5e03\u3002<\/p>\n<p>KN026-203\u662f\u4e00\u9879\u5f00\u653e\u3001\u2161\u671f\u3001\u591a\u4e2d\u5fc3\u4e34\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30KN026\u8054\u5408KN046\u6cbb\u7597HER2\u9633\u6027\u5b9e\u4f53\u7624\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\uff0c\u5df2\u5b8c\u6210\u5168\u90e8102\u4f8b\u60a3\u8005\u5165\u7ec4\uff0c\u5305\u62ecHER2\u9633\u6027\u7684\u80c3\u764c\/\u80c3\u98df\u7ba1\u7ed3\u5408\u90e8\u764c\u3001\u4e73\u817a\u764c\u53ca\u5176\u4ed6HER2\u9633\u6027\u5b9e\u4f53\u7624\u3002\u6b64\u524d\uff0c\u8be5\u9879\u7814\u7a76\u5728HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e2d\u7684\u521d\u6b65\u7597\u6548\u6570\u636e\u826f\u597d\uff0c\u5df2\u57282021\u5e74\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u817a\u764c\u5927\u4f1a\u4e0a\u516c\u5e03\u3002\u6b64\u6b21\u516c\u5e03\u7684\u662fKN026\u8054\u5408KN046\u6cbb\u7597\u7ecf\u8fc7\u22651L\u7cfb\u7edf\u6cbb\u7597\u3001HER2\u9633\u6027\u3001\u975e\u4e73\u817a\u764c\u548c\u80c3\u764c\u3001\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u5b9e\u4f53\u7624\u7684\u4e34\u5e8a\u6570\u636e\u3002&nbsp;&nbsp;<\/p>\n<p>\u622a\u81f32021\u5e748\u670810\u65e5\uff0c\u7814\u7a76\u5171\u5165\u7ec4\u4e8624\u4f8b\u65e2\u5f80\u63a5\u53d7\u8fc7\u22651L\u7cfb\u7edf\u6cbb\u7597\u540e\u8fdb\u5c55\u7684\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027HER2 \u9633\u6027\u5176\u4ed6\u5b9e\u4f53\u7624\u60a3\u8005\uff0c\u5305\u62ec14\u4f8b\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u30014\u4f8b\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u30014\u4f8b\u80c6\u56ca\u764c\u60a3\u8005\u30011\u4f8b\u80be\u76c2\u764c\u60a3\u8005\u548c1\u4f8b\u80f0\u817a\u764c\u60a3\u8005\u3002\u60a3\u8005\u63a5\u53d7KN046(iv.5mg\/kg Q3W)\u52a0KN026(iv.30mg\/kg Q3W,C1D1,D8\u8d1f\u8377)\u6cbb\u7597\uff0c\u76f4\u81f3\u75be\u75c5\u8fdb\u5c55\u3001\u51fa\u73b0\u4e0d\u53ef\u63a5\u53d7\u7684\u6bd2\u6027\u6216\u60a3\u8005\u9000\u51fa\uff0c\u4ee5\u7814\u7a76\u8005\u6839\u636e RECIST 1.1 \u6bcf6\u5468\u4e00\u6b21\u8bc4\u4f30\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a\u4e3b\u8981\u7ec8\u70b9\u3002<\/p>\n<p>\u5176\u4e2d20\u4f8b\u60a3\u8005\u7eb3\u5165\u6709\u6548\u6027\u8bc4\u4f30\uff0c24\u4f8b\u60a3\u8005\u7eb3\u5165\u5b89\u5168\u6027\u8bc4\u4f30\u3002\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a55.0%\uff0811\/20, 95% CI: 31.5-76.9\uff09\uff0c\u75be\u75c5\u63a7\u5236\u7387\uff08DCR\uff09\u4e3a85.0%\uff0817\/20, 95% CI: 62.1-96.8\uff09\uff0c6\u4e2a\u6708\u65e0\u8fdb\u5c55\u751f\u5b58\u7387\uff08PFS\uff09\u4e3a84.1%\u3002\u5176\u4e2d11\u4f8b\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u53ef\u8bc4\u4f30\u7597\u6548\uff0c \u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u548c\u75be\u75c5\u63a7\u5236\u7387\uff08DCR\uff09\u5206\u522b\u4e3a45.5%\uff085\/11, 95% CI: 16.7-76.6\uff09\u548c90.9%\uff0810\/11, 95% CI: 58.7-98.8\uff09\u3002<\/p>\n<p>\u5b89\u5168\u6027\u65b9\u9762\uff0c24\u4f8b\u60a3\u8005\u4e2d\u670920\u4f8b\uff0883.3%\uff09\u53d1\u751f\u81f3\u5c11\u4e00\u6b21\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff08TRAEs\uff09\uff0c4\u4f8b\u60a3\u8005\uff0816.7%\uff09\u53d1\u751f3\u7ea7\u53ca\u4ee5\u4e0aTRAEs\u3002\u6700\u5e38\u89c1(\u226510%)\u7684TRAEs\u4e3a\u8f93\u6db2\u76f8\u5173\u53cd\u5e94(29.2%)\u3001\u8179\u6cfb(19.4%)\u3001\u4e19\u6c28\u9178\u6c28\u57fa\u8f6c\u79fb\u9176\u5347\u9ad8 (16.7%)\u3001\u5929\u51ac\u6c28\u9178\u6c28\u57fa\u8f6c\u79fb\u9176\u5347\u9ad8(16.7%)\u3001\u5455\u5410(12.5%)\u548c\u98df\u6b32\u4e0b\u964d(12.5 %\uff09\u3002\u65e0\u6cbb\u7597\u76f8\u5173\u7684\u6b7b\u4ea1\u4e8b\u4ef6\u53d1\u751f\u3002<\/p>\n<p><b>\u8be5\u9879\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e3b\u8981\u7814\u7a76\u8005\u3001\u5317\u4eac\u5927\u5b66\u80bf\u7624\u533b\u9662\u6c88\u7433\u6559\u6388\u8868\u793a\uff1a<\/b>&quot;\u9664\u4e73\u817a\u764c\u548c\u80c3\u764c\u5916\uff0cHER2\u57fa\u56e0\u6269\u589e\u6216\u8fc7\u8868\u8fbe\u4e5f\u5728\u5176\u4ed6\u5b9e\u4f53\u7624\u4e2d\u53d1\u751f\uff0c\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u7ed3\u76f4\u80a0\u764c\u3001\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u3001\u80c6\u56ca\u764c\u3001\u80be\u76c2\u764c\u548c\u80f0\u817a\u764c\u3002\u76ee\u524d\uff0c\u514d\u75ab\u6cbb\u7597\u8054\u5408 HER2 \u9776\u5411\u6cbb\u7597\u5728HER2\u9633\u6027\u5176\u4ed6\u5b9e\u4f53\u7624\u7684\u7814\u7a76\u62a5\u9053\u975e\u5e38\u6709\u9650\u3002\u6211\u4eec\u5f88\u9ad8\u5174\u770b\u5230KN026\u8054\u5408KN046\u8fd9\u4e00\u53bb\u5316\u7597\u8054\u5408\u7597\u6cd5\u5728HER2\u9633\u6027\u5176\u4ed6\u5b9e\u4f53\u7624\u4e2d\u663e\u793a\u51fa\u4e86\u826f\u597d\u7684\u6cbb\u7597\u6548\u679c\uff0cORR\u9ad8\u8fbe55%\u3002\u5c24\u5176\u5728\u4e2d\u56fd\u9ad8\u53d1\u7684\u7ed3\u76f4\u80a0\u764c\u4e2d\uff0cORR\u4ea6\u9ad8\u8fbe45.5%\u3002\u6211\u4eec\u671f\u5f85\u5728\u540e\u7eed\u4e34\u5e8a\u7814\u7a76\u4e2d\u8fdb\u4e00\u6b65\u63a2\u7d22\u8fd9\u4e00\u53bb\u5316\u7597\u65b9\u6848\u7684\u5de8\u5927\u4ef7\u503c\uff0c\u4e3a\u5e7f\u5927HER2\u9633\u6027\u80bf\u7624\u60a3\u8005\u7684\u6cbb\u7597\u5e26\u6765\u798f\u97f3\u3002&quot;<\/p>\n<p><b>\u5173\u4e8e<\/b><b>KN026<\/b><\/p>\n<p>KN026\u662f\u5eb7\u5b81\u6770\u745e\u91c7\u7528\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743Fc\u5f02\u4e8c\u805a\u4f53\u5e73\u53f0\u6280\u672f(CRIB)\u5f00\u53d1\u7684HER2\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff0c\u53ef\u540c\u65f6\u7ed3\u5408HER2\u7684\u4e24\u4e2a\u975e\u91cd\u53e0\u8868\u4f4d\uff0c\u5bfc\u81f4HER2\u4fe1\u53f7\u963b\u65ad\uff0c\u4f18\u4e8e\u66f2\u59a5\u73e0\u5355\u6297\u6216\u8005\u5e15\u59a5\u73e0\u5355\u6297\u5355\u7528\uff0c\u8fbe\u5230\u66f2\u59a5\u73e0\u5355\u6297\u548c\u5e15\u59a5\u73e0\u5355\u6297\u8054\u7528\u7684\u6548\u679c\uff0c\u5982\u5c55\u793a\u51fa\u66f4\u9ad8\u7684\u4eb2\u548c\u529b\uff0c\u5728HER2\u9633\u6027\u80bf\u7624\u7ec6\u80de\u682a\u4e2d\u5177\u5907\u4f18\u6548\u7684\u80bf\u7624\u6291\u5236\u4f5c\u7528\u3002\u540c\u65f6\uff0cKN026\u5bf9 HER2\u4e2d\u4f4e\u8868\u8fbe\u80bf\u7624\u548c\u66f2\u59a5\u73e0\u5355\u6297\u6297\u6027\u7ec6\u80de\u682a\u4e5f\u6709\u6291\u5236\u4f5c\u7528\u3002<\/p>\n<p>KN026\u5df2\u4e8e2018\u5e74\u5206\u522b\u83b7\u5f97\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40(NMPA)\u548c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40(FDA)\u7684\u6279\u51c6\uff0c\u76ee\u524d\u6b63\u5728\u4e2d\u56fd\u5f00\u5c55\u591a\u9879\u2160\/\u2161\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u540c\u65f6\u5728\u7f8e\u56fd\u63a8\u8fdb\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u8868\u660e\uff0cKN026\u5177\u6709\u826f\u597d\u7684\u8010\u53d7\u6027\u548c\u5b89\u5168\u6027\uff0c\u5728\u591a\u7ebf\u6297HER2\u6cbb\u7597\u540e\u8fdb\u5c55\u7684HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e2d\u4ecd\u7136\u8868\u73b0\u51fa\u663e\u8457\u7684\u6297\u80bf\u7624\u6d3b\u6027\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\u3001\u7f8e\u56fd\u548c\u4e2d\u56fd\u5df2\u5f00\u5c55\u8986\u76d6\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u3001\u80f8\u817a\u764c\u3001\u80f0\u817a\u764c\u3001\u809d\u764c\u3001\u98df\u7ba1\u9cde\u764c\u3001\u4e09\u9634\u4e73\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\u56db\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\u4e13\u6ce8\u4e8e\u7814\u53d1\u3001\u751f\u4ea7\u548c\u5546\u4e1a\u5316\u521b\u65b0\u6297\u80bf\u7624\u836f\u7269\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\u4ea7\u4e1a\u94fe\u7684\u53d1\u73b0\u3001\u7814\u53d1\u548c\u5236\u9020\u5e73\u53f0\u3002\u516c\u53f8\u9ad8\u5ea6\u5dee\u5f02\u5316\u7684\u4ea7\u54c1\u7ba1\u7ebf\u7531\u5355\u514b\u9686\u6297\u4f53\u3001\u53cc\u7279\u5f02\u6027\u6297\u4f53\u53ca\u6297\u4f53\u5076\u8054\u7269\u7b49\u6297\u80bf\u7624\u65b0\u836f\u7ec4\u6210\u3002\u5176\u4e2d\u4e94\u4e2a\u4ea7\u54c1\u5728\u4e2d\u56fd\u3001\u7f8e\u56fd\u3001\u65e5\u672c\u3001\u6fb3\u5927\u5229\u4e9a\u5904\u4e8e\u2160-\u2162\u671f\u4e34\u5e8a\u30022021\u5e7411\u6708\uff0c\u6069\u7ef4\u8fbe&reg;\uff08\u6069\u6c83\u5229\u5355\u6297\u6ce8\u5c04\u6db2\uff09\u6b63\u5f0f\u5728\u4e2d\u56fd\u83b7\u6279\u4e0a\u5e02\uff0c\u9002\u7528\u4e8e\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u5fae\u536b\u661f\u9ad8\u5ea6\u4e0d\u7a33\u5b9a(MSI-H)\u6216\u9519\u914d\u4fee\u590d\u57fa\u56e0\u7f3a\u9677\u578b(dMMR)\u7684\u6210\u4eba\u665a\u671f\u5b9e\u4f53\u7624\u60a3\u8005\u7684\u6cbb\u7597\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\u3001\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 target=\"_blank\" href=\"http:\/\/www.alphamabonc.com\/\" rel=\"nofollow noopener\">www.alphamabonc.com<\/a>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u622a\u81f32021\u5e748\u670810\u65e5\uff0c\u5171\u5165\u7ec424\u4f8b\u63a5\u53d7\u8fc7\u22651L\u7cfb\u7edf\u6cbb\u7597\u3001HER2\u9633\u6027\u975e\u4e73\u817a\u764c\u548c\u80c3\u764c\u3001\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u5b9e\u4f53\u7624\u60a3\u8005\uff0c20\u4f8b\u60a3\u8005\u63a5\u53d7\u81f3\u5c11\u4e00\u6b21\u80bf\u7624\u8bc4\u4f30\uff1a\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a55.0%\uff0c\u75be\u75c5\u63a7\u5236\u7387 (DCR) \u4e3a85.0%\uff0c6\u4e2a\u6708\u7684PFS\u7387\u4e3a84.1%\uff1b\u5176\u4e2d11\u540d\u53ef\u8bc4\u4f30\u7684\u7ed3\u76f4\u80a0\u764c\u60a3\u8005ORR\u548cDCR\u5206\u522b\u4e3a45.5%\u548c90.9%\u3002 \u82cf\u5dde2022\u5e744\u670811\u65e5 \/\u7f8e\u901a\u793e\/ &#8212;&nbsp;\u5eb7\u5b81\u6770\u745e\u751f\u7269\u5236\u836f(\u80a1\u7968\u4ee3\u7801\uff1a9966.HK)\u5ba3\u5e03\uff0cKN026\u8054\u5408KN046\u7684\u65e0\u5316\u7597\u65b9\u6848\u2161\u671f\u4e34\u5e8a\u6570\u636e (\u7814\u7a76\u7f16\u53f7\uff1aKN026-203), \u4ee5\u58c1\u62a5\u5f62\u5f0f\u57282022\u5e74\u7f8e\u56fd\u764c\u75c7\u7814\u7a76\u5b66\u4f1a\uff08AACR 2022\uff09\u5e74\u4f1a\u4e0a\u516c\u5e03\u3002 KN026-203\u662f\u4e00\u9879\u5f00\u653e\u3001\u2161\u671f\u3001\u591a\u4e2d\u5fc3\u4e34\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30KN026\u8054\u5408KN046\u6cbb\u7597HER2\u9633\u6027\u5b9e\u4f53\u7624\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\uff0c\u5df2\u5b8c\u6210\u5168\u90e8102\u4f8b\u60a3\u8005\u5165\u7ec4\uff0c\u5305\u62ecHER2\u9633\u6027\u7684\u80c3\u764c\/\u80c3\u98df\u7ba1\u7ed3\u5408\u90e8\u764c\u3001\u4e73\u817a\u764c\u53ca\u5176\u4ed6HER2\u9633\u6027\u5b9e\u4f53\u7624\u3002\u6b64\u524d\uff0c\u8be5\u9879\u7814\u7a76\u5728HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e2d\u7684\u521d\u6b65\u7597\u6548\u6570\u636e\u826f\u597d\uff0c\u5df2\u57282021\u5e74\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u817a\u764c\u5927\u4f1a\u4e0a\u516c\u5e03\u3002\u6b64\u6b21\u516c\u5e03\u7684\u662fKN026\u8054\u5408KN046\u6cbb\u7597\u7ecf\u8fc7\u22651L\u7cfb\u7edf\u6cbb\u7597\u3001HER2\u9633\u6027\u3001\u975e\u4e73\u817a\u764c\u548c\u80c3\u764c\u3001\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u5b9e\u4f53\u7624\u7684\u4e34\u5e8a\u6570\u636e\u3002&nbsp;&nbsp; \u622a\u81f32021\u5e748\u670810\u65e5\uff0c\u7814\u7a76\u5171\u5165\u7ec4\u4e8624\u4f8b\u65e2\u5f80\u63a5\u53d7\u8fc7\u22651L\u7cfb\u7edf\u6cbb\u7597\u540e\u8fdb\u5c55\u7684\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027HER2 \u9633\u6027\u5176\u4ed6\u5b9e\u4f53\u7624\u60a3\u8005\uff0c\u5305\u62ec14\u4f8b\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u30014\u4f8b\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u30014\u4f8b\u80c6\u56ca\u764c\u60a3\u8005\u30011\u4f8b\u80be\u76c2\u764c\u60a3\u8005\u548c1\u4f8b\u80f0\u817a\u764c\u60a3\u8005\u3002\u60a3\u8005\u63a5\u53d7KN046(iv.5mg\/kg Q3W)\u52a0KN026(iv.30mg\/kg Q3W,C1D1,D8\u8d1f\u8377)\u6cbb\u7597\uff0c\u76f4\u81f3\u75be\u75c5\u8fdb\u5c55\u3001\u51fa\u73b0\u4e0d\u53ef\u63a5\u53d7\u7684\u6bd2\u6027\u6216\u60a3\u8005\u9000\u51fa\uff0c\u4ee5\u7814\u7a76\u8005\u6839\u636e RECIST 1.1 \u6bcf6\u5468\u4e00\u6b21\u8bc4\u4f30\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a\u4e3b\u8981\u7ec8\u70b9\u3002 \u5176\u4e2d20\u4f8b\u60a3\u8005\u7eb3\u5165\u6709\u6548\u6027\u8bc4\u4f30\uff0c24\u4f8b\u60a3\u8005\u7eb3\u5165\u5b89\u5168\u6027\u8bc4\u4f30\u3002\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a55.0%\uff0811\/20, 95% CI: 31.5-76.9\uff09\uff0c\u75be\u75c5\u63a7\u5236\u7387\uff08DCR\uff09\u4e3a85.0%\uff0817\/20, 95% CI: 62.1-96.8\uff09\uff0c6\u4e2a\u6708\u65e0\u8fdb\u5c55\u751f\u5b58\u7387\uff08PFS\uff09\u4e3a84.1%\u3002\u5176\u4e2d11\u4f8b\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u53ef\u8bc4\u4f30\u7597\u6548\uff0c \u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u548c\u75be\u75c5\u63a7\u5236\u7387\uff08DCR\uff09\u5206\u522b\u4e3a45.5%\uff085\/11, 95% CI: 16.7-76.6\uff09\u548c90.9%\uff0810\/11, 95% CI: 58.7-98.8\uff09\u3002 \u5b89\u5168\u6027\u65b9\u9762\uff0c24\u4f8b\u60a3\u8005\u4e2d\u670920\u4f8b\uff0883.3%\uff09\u53d1\u751f\u81f3\u5c11\u4e00\u6b21\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff08TRAEs\uff09\uff0c4\u4f8b\u60a3\u8005\uff0816.7%\uff09\u53d1\u751f3\u7ea7\u53ca\u4ee5\u4e0aTRAEs\u3002\u6700\u5e38\u89c1(\u226510%)\u7684TRAEs\u4e3a\u8f93\u6db2\u76f8\u5173\u53cd\u5e94(29.2%)\u3001\u8179\u6cfb(19.4%)\u3001\u4e19\u6c28\u9178\u6c28\u57fa\u8f6c\u79fb\u9176\u5347\u9ad8 (16.7%)\u3001\u5929\u51ac\u6c28\u9178\u6c28\u57fa\u8f6c\u79fb\u9176\u5347\u9ad8(16.7%)\u3001\u5455\u5410(12.5%)\u548c\u98df\u6b32\u4e0b\u964d(12.5 %\uff09\u3002\u65e0\u6cbb\u7597\u76f8\u5173\u7684\u6b7b\u4ea1\u4e8b\u4ef6\u53d1\u751f\u3002 \u8be5\u9879\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e3b\u8981\u7814\u7a76\u8005\u3001\u5317\u4eac\u5927\u5b66\u80bf\u7624\u533b\u9662\u6c88\u7433\u6559\u6388\u8868\u793a\uff1a&quot;\u9664\u4e73\u817a\u764c\u548c\u80c3\u764c\u5916\uff0cHER2\u57fa\u56e0\u6269\u589e\u6216\u8fc7\u8868\u8fbe\u4e5f\u5728\u5176\u4ed6\u5b9e\u4f53\u7624\u4e2d\u53d1\u751f\uff0c\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u7ed3\u76f4\u80a0\u764c\u3001\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u3001\u80c6\u56ca\u764c\u3001\u80be\u76c2\u764c\u548c\u80f0\u817a\u764c\u3002\u76ee\u524d\uff0c\u514d\u75ab\u6cbb\u7597\u8054\u5408 HER2 \u9776\u5411\u6cbb\u7597\u5728HER2\u9633\u6027\u5176\u4ed6\u5b9e\u4f53\u7624\u7684\u7814\u7a76\u62a5\u9053\u975e\u5e38\u6709\u9650\u3002\u6211\u4eec\u5f88\u9ad8\u5174\u770b\u5230KN026\u8054\u5408KN046\u8fd9\u4e00\u53bb\u5316\u7597\u8054\u5408\u7597\u6cd5\u5728HER2\u9633\u6027\u5176\u4ed6\u5b9e\u4f53\u7624\u4e2d\u663e\u793a\u51fa\u4e86\u826f\u597d\u7684\u6cbb\u7597\u6548\u679c\uff0cORR\u9ad8\u8fbe55%\u3002\u5c24\u5176\u5728\u4e2d\u56fd\u9ad8\u53d1\u7684\u7ed3\u76f4\u80a0\u764c\u4e2d\uff0cORR\u4ea6\u9ad8\u8fbe45.5%\u3002\u6211\u4eec\u671f\u5f85\u5728\u540e\u7eed\u4e34\u5e8a\u7814\u7a76\u4e2d\u8fdb\u4e00\u6b65\u63a2\u7d22\u8fd9\u4e00\u53bb\u5316\u7597\u65b9\u6848\u7684\u5de8\u5927\u4ef7\u503c\uff0c\u4e3a\u5e7f\u5927HER2\u9633\u6027\u80bf\u7624\u60a3\u8005\u7684\u6cbb\u7597\u5e26\u6765\u798f\u97f3\u3002&quot; \u5173\u4e8eKN026 KN026\u662f\u5eb7\u5b81\u6770\u745e\u91c7\u7528\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743Fc\u5f02\u4e8c\u805a\u4f53\u5e73\u53f0\u6280\u672f(CRIB)\u5f00\u53d1\u7684HER2\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff0c\u53ef\u540c\u65f6\u7ed3\u5408HER2\u7684\u4e24\u4e2a\u975e\u91cd\u53e0\u8868\u4f4d\uff0c\u5bfc\u81f4HER2\u4fe1\u53f7\u963b\u65ad\uff0c\u4f18\u4e8e\u66f2\u59a5\u73e0\u5355\u6297\u6216\u8005\u5e15\u59a5\u73e0\u5355\u6297\u5355\u7528\uff0c\u8fbe\u5230\u66f2\u59a5\u73e0\u5355\u6297\u548c\u5e15\u59a5\u73e0\u5355\u6297\u8054\u7528\u7684\u6548\u679c\uff0c\u5982\u5c55\u793a\u51fa\u66f4\u9ad8\u7684\u4eb2\u548c\u529b\uff0c\u5728HER2\u9633\u6027\u80bf\u7624\u7ec6\u80de\u682a\u4e2d\u5177\u5907\u4f18\u6548\u7684\u80bf\u7624\u6291\u5236\u4f5c\u7528\u3002\u540c\u65f6\uff0cKN026\u5bf9 HER2\u4e2d\u4f4e\u8868\u8fbe\u80bf\u7624\u548c\u66f2\u59a5\u73e0\u5355\u6297\u6297\u6027\u7ec6\u80de\u682a\u4e5f\u6709\u6291\u5236\u4f5c\u7528\u3002 KN026\u5df2\u4e8e2018\u5e74\u5206\u522b\u83b7\u5f97\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40(NMPA)\u548c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40(FDA)\u7684\u6279\u51c6\uff0c\u76ee\u524d\u6b63\u5728\u4e2d\u56fd\u5f00\u5c55\u591a\u9879\u2160\/\u2161\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u540c\u65f6\u5728\u7f8e\u56fd\u63a8\u8fdb\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u8868\u660e\uff0cKN026\u5177\u6709\u826f\u597d\u7684\u8010\u53d7\u6027\u548c\u5b89\u5168\u6027\uff0c\u5728\u591a\u7ebf\u6297HER2\u6cbb\u7597\u540e\u8fdb\u5c55\u7684HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e2d\u4ecd\u7136\u8868\u73b0\u51fa\u663e\u8457\u7684\u6297\u80bf\u7624\u6d3b\u6027\u3002 \u5173\u4e8eKN046 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 KN046\u5728\u6fb3\u5927\u5229\u4e9a\u3001\u7f8e\u56fd\u548c\u4e2d\u56fd\u5df2\u5f00\u5c55\u8986\u76d6\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u3001\u80f8\u817a\u764c\u3001\u80f0\u817a\u764c\u3001\u809d\u764c\u3001\u98df\u7ba1\u9cde\u764c\u3001\u4e09\u9634\u4e73\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\u56db\u4e2a\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u6b63\u5728\u8fdb\u884c\u4e2d\u3002 \u5173\u4e8e\u5eb7\u5b81\u6770\u745e \u5eb7\u5b81\u6770\u745e\u751f\u7269\u5236\u836f\u4e13\u6ce8\u4e8e\u7814\u53d1\u3001\u751f\u4ea7\u548c\u5546\u4e1a\u5316\u521b\u65b0\u6297\u80bf\u7624\u836f\u7269\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 \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\u4ea7\u4e1a\u94fe\u7684\u53d1\u73b0\u3001\u7814\u53d1\u548c\u5236\u9020\u5e73\u53f0\u3002\u516c\u53f8\u9ad8\u5ea6\u5dee\u5f02\u5316\u7684\u4ea7\u54c1\u7ba1\u7ebf\u7531\u5355\u514b\u9686\u6297\u4f53\u3001\u53cc\u7279\u5f02\u6027\u6297\u4f53\u53ca\u6297\u4f53\u5076\u8054\u7269\u7b49\u6297\u80bf\u7624\u65b0\u836f\u7ec4\u6210\u3002\u5176\u4e2d\u4e94\u4e2a\u4ea7\u54c1\u5728\u4e2d\u56fd\u3001\u7f8e\u56fd\u3001\u65e5\u672c\u3001\u6fb3\u5927\u5229\u4e9a\u5904\u4e8e\u2160-\u2162\u671f\u4e34\u5e8a\u30022021\u5e7411\u6708\uff0c\u6069\u7ef4\u8fbe&reg;\uff08\u6069\u6c83\u5229\u5355\u6297\u6ce8\u5c04\u6db2\uff09\u6b63\u5f0f\u5728\u4e2d\u56fd\u83b7\u6279\u4e0a\u5e02\uff0c\u9002\u7528\u4e8e\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u5fae\u536b\u661f\u9ad8\u5ea6\u4e0d\u7a33\u5b9a(MSI-H)\u6216\u9519\u914d\u4fee\u590d\u57fa\u56e0\u7f3a\u9677\u578b(dMMR)\u7684\u6210\u4eba\u665a\u671f\u5b9e\u4f53\u7624\u60a3\u8005\u7684\u6cbb\u7597\u3002 \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\u3001\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 \u6b22\u8fce\u8bbf\u95ee\u516c\u53f8\u7f51\u7ad9\uff1awww.alphamabonc.com&nbsp; &nbsp;&hellip; <a class=\"read-more\" href=\"https:\/\/www.xinwengao.com\/cn\/pr\/2022041108350067313\">Read More<\/a><\/p>\n","protected":false},"author":556,"featured_media":8278,"comment_status":"close","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1965],"tags":[],"class_list":["post-67313","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-partnerships"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/67313","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/users\/556"}],"replies":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/comments?post=67313"}],"version-history":[{"count":1,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/67313\/revisions"}],"predecessor-version":[{"id":67314,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/67313\/revisions\/67314"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/media\/8278"}],"wp:attachment":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/media?parent=67313"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/categories?post=67313"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/tags?post=67313"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}