{"id":55900,"date":"2021-12-09T11:21:00","date_gmt":"2021-12-09T04:21:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2021120911210055900"},"modified":"2021-12-09T17:55:07","modified_gmt":"2021-12-09T09:55:07","slug":"her2%e5%8f%8c%e6%8a%97kn026%e4%b8%a4%e9%a1%b9%e4%b8%b4%e5%ba%8a%e6%95%b0%e6%8d%ae%e4%ba%ae%e7%9b%b8%e5%9c%a3%e5%ae%89%e4%b8%9c%e5%b0%bc%e5%a5%a5%e4%b9%b3%e8%85%ba%e7%99%8c%e5%a4%a7%e4%bc%9a","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2021120911210055900","title":{"rendered":"HER2\u53cc\u6297KN026\u4e24\u9879\u4e34\u5e8a\u6570\u636e\u4eae\u76f8\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u817a\u764c\u5927\u4f1a"},"content":{"rendered":"

\u4e2d\u56fd\u82cf\u5dde2021\u5e7412\u67089\u65e5 \/\u7f8e\u901a\u793e\/ — \u5eb7\u5b81\u6770\u745e\u751f\u7269\u5236\u836f(\u80a1\u7968\u4ee3\u7801\uff1a9966.HK) \u4e0e\u77f3\u836f\u96c6\u56e2\uff08\u80a1\u7968\u4ee3\u7801\uff1a1093.HK\uff09\u5171\u540c\u5ba3\u5e03\uff0cHER2\u53cc\u6297KN026\u4e24\u9879\u4e34\u5e8a\u7814\u7a76\u6570\u636e\uff0c\u4ee5\u58c1\u62a5\u5f62\u5f0f\u5728\u7b2c44\u5c4a\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u817a\u764c\u5927\u4f1a\uff08SABCS 2021\uff09\u4e0a\u516c\u5e03\u3002<\/p>\n

\u58c1\u62a5\u4e3b\u9898\uff1a<\/b> KN026\uff08HER2\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff09\u8054\u5408KN046\uff08PD-L1\/CTLA-4\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff09\u6cbb\u7597\u8f6c\u79fb\u6027HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u7684\u521d\u6b65\u5b89\u5168\u6027\u548c\u7597\u6548\u7ed3\u679c\uff1a\u4e00\u9879\u2161\u671f\u8bd5\u9a8c<\/p>\n

\u7f16\u53f7\uff1a<\/b> P5-16-04<\/p>\n

\u7b2c\u4e00\u4f5c\u8005\uff1a<\/b> \u5218\u6d01\u743c\u6559\u6388\uff0c\u5e7f\u4e1c\u7701\u5e7f\u5dde\u5e02\u4e2d\u5c71\u5927\u5b66\u5b59\u9038\u4ed9\u7eaa\u5ff5\u533b\u9662\u4e73\u817a\u80bf\u7624\u4e2d\u5fc3\u5e7f\u4e1c\u7701\u6076\u6027\u80bf\u7624\u8868\u89c2\u9057\u4f20\u5b66\u4e0e\u57fa\u56e0\u8c03\u63a7\u91cd\u70b9\u5b9e\u9a8c\u5ba4
                   \u5b8b\u4f20\u8d35\u6559\u6388\uff0c\u798f\u5efa\u533b\u79d1\u5927\u5b66\u9644\u5c5e\u534f\u548c\u533b\u9662\u4e73\u817a\u5916\u79d1<\/p>\n

KN026-203\u662f\u4e00\u9879\u5f00\u653e\u3001\u591a\u4e2d\u5fc3\u7684\u2161\u671f\u4e34\u5e8a\u7814\u7a76\uff0c\u8bc4\u4f30KN026\u8054\u5408KN046\u6cbb\u7597HER2\u9633\u6027\u5b9e\u4f53\u7624\u7684\u6709\u6548\u6027\u3001\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027,\u4ee5\u7814\u7a76\u8005\u6839\u636e RECIST 1.1\u8bc4\u4f30\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a\u4e3b\u8981\u7ec8\u70b9\u3002\u6b64\u6b21\u516c\u5e03\u7684\u662f\u8fd9\u9879\u6b63\u5728\u8fdb\u884c\u7684\u7814\u7a76\u4e2d\uff0c\u9488\u5bf9\u8f6c\u79fb\u6027HER2\u9633\u6027\u4e73\u817a\u764c\u7684\u521d\u6b65\u6570\u636e\uff0c\u5165\u7ec4\u5148\u524d\u7ecf\u8fc7\u81f3\u5c11\u4e00\u79cd HER2 \u9776\u5411\u8054\u5408\u6cbb\u7597\u7684\u8f6c\u79fb\u6027HER2\u9633\u6027\u4e73\u817a\u764c\u5973\u6027\u60a3\u8005\uff0c\u63a5\u53d7KN026\uff08iv.30mg\/kg Q3W)\u52a0KN046\uff08iv.5mg\/kg Q3W\uff09\u6cbb\u7597\u3002 <\/p>\n

\u622a\u81f3 2021 \u5e74 8 \u6708 10 \u65e5\uff0c\u5171\u5165\u7ec436\u4f8b\u60a3\u8005\uff0c\u4e2d\u4f4d\u5e74\u9f84\u4e3a53.0\u5c81\uff08\u8303\u56f4\uff1a33-67\uff09\u3002\u5176\u4e2d30\u4f8b\u60a3\u8005(83.3%)\u63a5\u53d7\u4e862\u7ebf\u4ee5\u4e0aHER2\u9776\u5411\u8054\u5408\u6cbb\u7597\u300233\u4f8b\u60a3\u8005\u53ef\u8fdb\u884c\u603b\u4f53\u6709\u6548\u7387\u5206\u6790\uff0c\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a48.5% (16\/33\uff0c95%CI\uff1a30.8-66.5)\uff0c1\u4f8b\u60a3\u8005\u8fbe\u5230\u5b8c\u5168\u7f13\u89e3(CR)\uff1b\u75be\u75c5\u63a7\u5236\u7387(DCR)\u4e3a78.8% (26\/33\uff0c95%CI 61.1-91.0)\u3002<\/p>\n

36\u4f8b\u60a3\u8005\u8fdb\u5165\u5b89\u5168\u6027\u5206\u6790\uff0c\u5176\u4e2d32\u4f8b\u60a3\u8005(88.9%)\u53d1\u751f\u81f3\u5c11\u4e00\u6b21\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6(TRAE)\uff0c 5\u4f8b\u60a3\u8005(13.9%)\u53d1\u751f3\u7ea7\u53ca\u4ee5\u4e0aTRAE\u3002\u6700\u5e38\u89c1(\u226510%)\u7684TRAE\u4e3a\u8f93\u6db2\u76f8\u5173\u53cd\u5e94(41.7%)\u3001\u7619\u75d2(22.2%)\u3001\u8179\u6cfb(19.4%)\u3001\u76ae\u75b9(16.7%)\u3001\u4e19\u6c28\u9178\u6c28\u57fa\u8f6c\u79fb\u9176\u5347\u9ad8(16.7%)\u3001\u5929\u95e8\u51ac\u6c28\u9178\u6c28\u57fa\u8f6c\u79fb\u9176\u5347\u9ad8(16.7%)\u3001\u7532\u72b6\u817a\u529f\u80fd\u51cf\u9000(13.9%)\u3001\u4f53\u91cd\u4e0b\u964d(11.1%)\u3001\u809d\u529f\u80fd\u5f02\u5e38(11.1%)\u3002\u672a\u89c2\u5bdf\u5230\u6cbb\u7597\u76f8\u5173\u6b7b\u4ea1\u3002<\/p>\n

\u58c1\u62a5\u4e3b\u9898\uff1a<\/b> HER2\u53cc\u7279\u5f02\u6027\u6297\u4f53KN026\u6cbb\u7597HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u7684I\u671f\u4e34\u5e8a\u7814\u7a76\u7ed3\u679c<\/p>\n

\u7f16\u53f7\uff1a<\/b> P2-13-10<\/p>\n

\u7b2c\u4e00\u4f5c\u8005\uff1a<\/b> \u590d\u65e6\u5927\u5b66\u9644\u5c5e\u80bf\u7624\u533b\u9662\u5f20\u5251\u6559\u6388
                   \u590d\u65e6\u5927\u5b66\u9644\u5c5e\u80bf\u7624\u533b\u9662\u5b63\u51ac\u6885\u535a\u58eb<\/p>\n

\u8fd9\u662fHER2\u53cc\u6297KN026\u9996\u4e2a\u6982\u5ff5\u9a8c\u8bc1I\u671f\u4e34\u5e8a\u7814\u7a76\uff0c\u5165\u7ec4\u81f3\u5c11\u4e00\u7ebf\u6297HER2\u6cbb\u7597\u5931\u8d25\u7684HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u5973\u6027\u60a3\u8005\uff0c\u8bc4\u4f30KN026\u5355\u836f\u6cbb\u7597\u7684\u5b89\u5168\u6027\u3001\u8010\u53d7\u6027\u548c\u836f\u4ee3\u52a8\u529b\u5b66 (PK)\u3001\u521d\u6b65\u7597\u6548\u3002\u60a3\u8005\u4ee53+3\u7684\u65b9\u6cd5\u8fdb\u884c\u5242\u91cf\u9012\u589e\uff0c\u5206\u522b\u63a5\u53d75 mg\/kg QW\u300110 mg\/kg QW\u300120 mg\/kg Q2W\u548c30 mg\/kg Q3W\u7684\u6cbb\u7597\uff0c\u5e76\u5f00\u5c55\u4e86\u5242\u91cf\u6269\u5c55\u7814\u7a76\uff0c\u4ee5KN026\u7684\u5b89\u5168\u6027\u548c\u786e\u8ba4\u4e34\u5e8a\u2161\u671f\u63a8\u8350\u5242\u91cf\uff08RP2D\uff09\u4f5c\u4e3a\u4e3b\u8981\u7ec8\u70b9\u3002<\/p>\n

\u7814\u7a76\u5171\u5165\u7ec463\u540d\u60a3\u8005\uff0c\u5e73\u5747\u65e2\u5f80\u63a5\u53d7\u8fc73\u7ebf\u7cfb\u7edf\u6cbb\u7597\u30012\u7ebf\u6297HER2\u9776\u5411\u6cbb\u7597\uff0c\u7ed3\u679c\u663e\u793aKN026\u8010\u53d7\u6027\u826f\u597d\uff0c\u672a\u89c2\u5bdf\u5230\u5242\u91cf\u9650\u5236\u6027\u6bd2\u6027\uff0c\u5728HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e2d\u5177\u6709\u826f\u597d\u7684\u5b89\u5168\u6027\u548c\u6297\u80bf\u7624\u6d3b\u6027\u3002<\/p>\n

\u6700\u5e38\u89c1\u7684\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6 (TRAE) \u4e3a\u53d1\u70ed (23.8%)\u3001\u8179\u6cfb (22.2%)\u3001\u5929\u51ac\u6c28\u9178\u8f6c\u6c28\u9176\u5347\u9ad8 (22.2%)\u3001\u4e19\u6c28\u9178\u8f6c\u6c28\u9176\u5347\u9ad8 (22.2%)\u30024\u4f8b\u60a3\u8005\u53d1\u751f3 \u7ea7 TRAE\u3002<\/p>\n

\u836f\u7269\u66b4\u9732-\u6548\u5e94\u76f8\u5173\u5206\u6790\u652f\u63012\u671f\u63a8\u8350\u5242\u91cf\uff08RP2D\uff09\u4e3a20 mg\/kg Q2W \u6216 30 mg\/kg Q3W\uff0c\u5176\u76f8\u5e94\u7684\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f (PFS) \u5206\u522b\u4e3a 5.5 \u548c 7.4 \u4e2a\u6708\u3002<\/p>\n

\u5173\u4e8e<\/b>KN026<\/b><\/p>\n

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

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

2021\u5e748\u6708\uff0c\u5eb7\u5b81\u6770\u745e\u4e0e\u77f3\u836f\u96c6\u56e2\u5168\u8d44\u9644\u5c5e\u516c\u53f8\u4e0a\u6d77\u6d25\u66fc\u7279\u751f\u7269\u79d1\u6280\u6709\u9650\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0\u201c\u6d25\u66fc\u7279\u751f\u7269\u201d\uff09\u5c31KN026\u7b7e\u8ba2\u4e86\u5728\u4e2d\u56fd\u5185\u5730\u7684\u5f00\u53d1\u53ca\u5546\u4e1a\u5316\u6388\u6743\u534f\u8bae\u3002\u6839\u636e\u534f\u8bae\u6761\u6b3e\uff0c\u6d25\u66fc\u7279\u751f\u7269\u5c06\u83b7\u5f97KN026\u5728\u4e2d\u56fd\u5185\u5730\uff08\u4e0d\u5305\u62ec\u9999\u6e2f\u3001\u6fb3\u95e8\u53ca\u53f0\u6e7e\u5730\u533a\uff09\u5728\u4e73\u817a\u764c\u3001\u80c3\u764c\u9002\u5e94\u75c7\u4e0a\u7684\u6392\u4ed6\u6027\u5f00\u53d1\u4e0e\u72ec\u5360\u6027\u5546\u4e1a\u5316\u8bb8\u53ef\u6743\u3002<\/p>\n

\u5173\u4e8e<\/b>KN046<\/b><\/p>\n

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

KN046\u5728\u4e2d\u56fd\u3001\u7f8e\u56fd\u548c\u6fb3\u5927\u5229\u4e9a\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\u5173\u952e\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u6b63\u5728\u8fdb\u884c\u4e2d\u3002<\/p>\n

\u5173\u4e8e\u5eb7\u5b81\u6770\u745e<\/b><\/p>\n

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