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\u4e2d\u56fd\u539f\u521bTROP2-ADC\u52c7\u6500\u9ad8\u5cf0\uff0c\u6311\u6218\u7ecf\u6cbbHR+\/HER2-\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u6cbb\u7597\u56f0\u5c40<\/p>\n
\u636e\u56fd\u9645\u764c\u75c7\u7814\u7a76\u673a\u6784(IARC)2020\u6570\u636e\u663e\u793a\uff0c\u4e73\u817a\u764c\u65b0\u53d1\u75c5\u4f8b\u6570\u5df2\u8d85\u8fc7\u80ba\u764c\uff0c\u6210\u4e3a\u5168\u7403\u7b2c\u4e00\u5927\u764c\u79cd\u3002\u5176\u4e2dHR+\/HER2-\u4e73\u817a\u764c\u5360\u6bd4\u7ea6\u4e3a70%\uff0c\u662f\u6700\u5e38\u89c1\u7684\u4e73\u817a\u764c\u4e9a\u578b\u3002\u5185\u5206\u6ccc\u6cbb\u7597\u662fHR+\/HER2-\u4e73\u817a\u764c\u6cbb\u7597\u7684\u57fa\u77f3\uff0c\u800cCDK4\/6\u6291\u5236\u5242\u6781\u5927\u5ef6\u957f\u4e86HR+\/HER2-\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u7684\u751f\u5b58\u65f6\u95f4\u3002\u4f46\u5bf9\u4e8e\u5185\u5206\u6ccc\u548cCDK4\/6\u6291\u5236\u5242\u6cbb\u7597\u5931\u8d25\u7684HR+\/HER2-\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\uff0c\u5f53\u524d\u53ef\u9009\u7684\u6cbb\u7597\u65b9\u6848\u7597\u6548\u6709\u9650\uff0c\u4e9f\u9700\u66f4\u6709\u6548\u7684\u6cbb\u7597\u836f\u7269\uff0c\u6539\u5584\u4e34\u5e8a\u9884\u540e\u3002<\/p>\n
\u8fd1\u5e74\u6765\uff0c\u4ee5TROP2-ADC\u4e3a\u4ee3\u8868\u7684\u65b0\u578bADC\u836f\u7269\uff0c\u4e3aHR+\/HER2-\u4e73\u817a\u764c\u60a3\u8005\u5e26\u6765\u4e86\u65b0\u7684\u9009\u62e9\u3002\u6208\u6c99\u59a5\u73e0\u5355\u6297\uff08SG\uff09\u5df2\u83b7FDA\u6279\u51c6\u7528\u4e8e\u63a5\u53d7\u8fc7\u5185\u5206\u6ccc\u6cbb\u7597\u548c\u22652\u7ebf\u7cfb\u7edf\u6cbb\u7597\uff08\u9488\u5bf9\u8f6c\u79fb\u6027\u75be\u75c5\uff09\u7684HR+\/HER2-\u4e73\u817a\u764c\u9002\u5e94\u75c7\uff1b\u6b64\u5916\uff0c\u540c\u6837\u9776\u5411TROP2\u7684Dato-DXd\u7684\u2162\u671f\u7814\u7a76\u4e5f\u5728\u4eca\u5e74ESMO\u5927\u4f1a\u4e0a\u516c\u5e03\u3002\u4f46\u76ee\u524d\u5c1a\u65e0TROP2-ADC\u5728\u56fd\u5185\u83b7\u6279\u7528\u4e8eHR+\/HER2-\u4e73\u817a\u764c\u60a3\u8005\u3002<\/p>\n
SKB264\u662f\u7531\u79d1\u4f26\u535a\u6cf0\u81ea\u4e3b\u7814\u53d1\u7684\u521b\u65b0TROP2-ADC\uff0c\u6b64\u6b21\u4eae\u76f82023 ESMO\u7684\u7814\u7a76\uff0c\u521d\u6b65\u63a2\u7d22\u4e86SKB264\u5728\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u7ebf\u5316\u7597\u7684HR+\/HER2-\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e2d\u7684\u7597\u6548\u53ca\u5b89\u5168\u6027\uff0c\u5176\u5c55\u793a\u7684\u5353\u6709\u524d\u666f\u7684\u7597\u6548\u6570\u636e\uff0c\u5bf9\u4e34\u5e8a\u6cbb\u7597\u548c\u540e\u7eed\u63a2\u7d22\u7684\u4ef7\u503c\uff0c\u6210\u4e3a\u672c\u6b21\u5165\u9009ESMO\u53e3\u5934\u62a5\u544a\u7684\u4e3b\u8981\u56e0\u7d20\u3002SKB264\u7528\u4e8e\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e8c\u7ebf\u7cfb\u7edf\u5316\u7597\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027HR+\/HER2-\u4e73\u817a\u764c\u60a3\u8005\u5df2\u83b7\u5f97\u4e2d\u56fd\u836f\u76d1\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u6388\u4e88\u7684\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\u3002<\/p>\n
\u5728\u4e73\u817a\u764c\u9886\u57df\uff0c\u9664\u4e86HR+\/HER2-\u4e73\u817a\u764c\uff0cSKB264\u6cbb\u7597\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027TNBC\u4e5f\u83b7\u5f97CDE\u6388\u4e88\u7684\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\u3002SKB264\u6cbb\u7597\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027TNBC\u7684\u2162\u671f\u6ce8\u518c\u7814\u7a76\u5df2\u8fbe\u5230\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\uff0c\u8ba1\u5212\u5e74\u5e95\u7533\u62a5\u4e0a\u5e02\uff0c\u6709\u671b\u5728\u4e2d\u56fd\u6210\u4e3a\u9996\u4e2a\u5b8c\u5168\u83b7\u6279\u7684TROP2-ADC\u3002<\/p>\n
SKB264\u7597\u6548\u6570\u636e\u4eae\u773c\uff0c\u6709\u671b\u6210\u4e3a\u7ecf\u6cbbHR+\/HER2-\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u6cbb\u7597\u65b0\u9009\u62e9<\/p>\n
\u672c\u6b21ESMO\u4eae\u76f8\u7684II\u671f\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30SKB264\u5728\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u7ebf\u5316\u7597\u7684HR+\/HER2-\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e2d\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u3002\u5165\u7ec4\u60a3\u8005\u63a5\u53d75mg\/kg Q2W\u7684SKB264\u6cbb\u7597\uff0c\u76f4\u81f3\u75be\u75c5\u8fdb\u5c55\u6216\u51fa\u73b0\u4e0d\u80fd\u8010\u53d7\u7684\u6bd2\u6027\u3002\u4e2d\u4f4d\u968f\u8bbf\u65f6\u95f4\u4e3a8.2\u4e2a\u6708\uff0c\u5171\u670938\u4f8b\u60a3\u8005\u7597\u6548\u53ef\u8bc4\u4f30\uff0c\u5176\u4e2d47%\u7684\u60a3\u8005\u4e3a\u539f\u53d1\u6027\u5185\u5206\u6ccc\u8010\u836f\uff0c79%\u7684\u60a3\u8005\u63a5\u53d7\u8fc7\u22652\u7ebf\u5316\u7597\uff0c65.8%\u7684\u60a3\u8005\u65e2\u5f80\u63a5\u53d7\u8fc7CDK4\/6\u6291\u5236\u5242\u6cbb\u7597\u3002<\/p>\n
\u5728\u80bf\u7624\u7f13\u89e3\u65b9\u9762\uff0cSKB264\u6cbb\u7597\u540e\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a36.8%\uff0c\u75be\u75c5\u63a7\u5236\u7387\uff08DCR\uff09\u4e3a89.5%\uff0c 6\u4e2a\u6708DoR\u7387\u4e3a80%\uff1b\u751f\u5b58\u6570\u636e\u65b9\u9762\uff0c\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u65f6\u95f4\uff08PFS\uff09\u4e3a11.1\u4e2a\u6708\u3002\u5f53\u524d\u6307\u5357\u9488\u5bf9\u6b64\u7c7b\u4eba\u7fa4\u63a8\u8350\u7684\u4e3b\u8981\u6cbb\u7597\u65b9\u6848\u4ecd\u7136\u662f\u5316\u7597\uff0c\u4f46\u5316\u7597\u7684ORR\u4ec5\u4e3a15%\u5de6\u53f3\uff0cPFS\u53ea\u67094~5\u4e2a\u6708\u3002\u800c\u8fd9\u9879II\u671f\u7814\u7a76\u7ed3\u679c\u63d0\u793aSKB264\u7684\u7597\u6548\u8fdc\u8d85\u5316\u7597\uff0c\u80fd\u4e3a\u60a3\u8005\u5e26\u6765\u66f4\u591a\u83b7\u76ca\uff0c\u671f\u5f85\u968f\u7740\u968f\u8bbf\u65f6\u95f4\u5ef6\u957f\uff0c\u672c\u7814\u7a76\u7684\u751f\u5b58\u6570\u636e\u80fd\u591f\u5e26\u6765\u66f4\u591a\u60ca\u559c\u3002\u5c24\u5176\u503c\u5f97\u4e00\u63d0\u7684\u662f\uff0c\u6240\u6709\u4e9a\u7ec4\u4eba\u7fa4\u5747\u53ef\u4eceSKB264\u6cbb\u7597\u4e2d\u83b7\u76ca\uff0c\u5305\u62ecHER2\u4f4e\u8868\u8fbe\u548c\u96f6\u8868\u8fbe\u3001\u539f\u53d1\u548c\u7ee7\u53d1\u5185\u5206\u6ccc\u8010\u836f\u3001\u65e2\u5f80\u4f7f\u7528\u548c\u672a\u4f7f\u7528\u8fc7CDK4\/6\u6291\u5236\u5242\u7684\u60a3\u8005\u3002<\/p>\n
\u5b89\u5168\u6027\u65b9\u9762\uff0c\u7814\u7a76\u4e2d\u22653\u7ea7\u836f\u7269\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff08TRAE\uff09\u7684\u53d1\u751f\u7387\u8f83\u4f4e\uff0c\u4ec517.1%\u7684\u60a3\u8005\u56e0TRAE\u5bfc\u81f4\u5242\u91cf\u964d\u4f4e\uff0c\u65e0TRAE\u5bfc\u81f4\u505c\u836f\u548c\u6b7b\u4ea1\u3002\u4e3b\u8981\u4e0d\u826f\u4e8b\u4ef6\u4e3a\u4e34\u5e8a\u5e38\u89c1\u7684\u8840\u6db2\u5b66\u6bd2\u6027\uff0c\u65e0\u95f4\u8d28\u6027\u80ba\u75c5(ILD)\u53d1\u751f\u3002<\/p>\n
SKB264\u72ec\u7279\u7ed3\u6784\u8bbe\u8ba1\uff0c\u517c\u987e\u5f3a\u5927\u6297\u80bf\u7624\u6d3b\u6027\u4e0e\u5b89\u5168\u6027<\/p>\n
SKB264\u6240\u5c55\u793a\u51fa\u7684\u826f\u597d\u6297\u80bf\u7624\u4f5c\u7528\u548c\u5b89\u5168\u6027\uff0c\u5f97\u76ca\u4e8e\u5176ADC\u836f\u7269\u7684\u8bbe\u8ba1\u3002SKB264\u7531\u5177\u6709\u826f\u597d\u4eb2\u548c\u529b\u548c\u9776\u5411\u6027\u7684\u4eba\u6e90\u5316\u6297TROP2\u5355\u6297\uff0c\u901a\u8fc7\u7a33\u5b9a\u6027\u7ecf\u8fc7\u4f18\u5316\u7684CL2A\u8fde\u63a5\u5b50\uff08\u8fde\u63a5\u5b50\u7684\u6297\u4f53\u7aef\u91c7\u7528\u7532\u78fa\u9170\u57fa\u5627\u5576\u5b9e\u73b0\u4e0e\u6297\u4f53\u4e0d\u53ef\u9006\u5076\u8054\uff09\uff0c\u4e0e\u81ea\u7814\u6bd2\u7d20\u5c0f\u5206\u5b50T030(\u62d3\u6251\u5f02\u6784\u9176\u2160\u6291\u5236\u5242)\u7ed3\u5408\u800c\u6210\uff0c\u836f\u7269\u6297\u4f53\u6bd4(DAR)\u5e73\u5747\u9ad8\u8fbe7.4\u3002T030\u6d3b\u6027\u4e0eDXD\u76f8\u5f53\uff0c\u542b\u6709\u7532\u57fa\u781c\u7ed3\u6784\uff0c\u53ef\u4e0e\u8fde\u63a5\u5b50\u7684\u6bd2\u7d20\u7aef\u7a33\u5b9a\u7ed3\u5408\uff0c\u51cf\u5c11\u8131\u843d\u3002SKB264\u5728\u8840\u6db2\u5faa\u73af\u4e2d\u7a33\u5b9a\u6027\u8f83\u9ad8\uff0c\u534a\u8870\u671f\u8f83\u957f\uff0c\u4f7f\u66f4\u591a\u836f\u7269\u80fd\u5230\u8fbe\u8868\u8fbeTROP2\u7684\u80bf\u7624\u7ec6\u80de\uff0c\u53d1\u6325\u6297\u80bf\u7624\u4f5c\u7528\u3002<\/p>\n
SKB264\u5177\u6709\u4e09\u91cd\u6297\u80bf\u7624\u4f5c\u7528\uff0c\u9996\u5148\uff0c\u901a\u8fc7\u9776\u5411TROP2\u7684\u6297\u4f53\u5230\u8fbe\u80bf\u7624\u7ec6\u80de\u540e\uff0c\u5bf9pH\u654f\u611f\u7684\u8fde\u63a5\u5b50\u5728\u9178\u6027\u80bf\u7624\u5fae\u73af\u5883\u5373\u53ef\u88c2\u89e3\uff0c\u91ca\u653e\u6bd2\u7d20\u5c0f\u5206\u5b50\u6740\u4f24\u5468\u56f4\u80bf\u7624\u7ec6\u80de\u3002\u5176\u6b21\uff0cSKB264\u88ab\u5185\u541e\u8fdb\u8868\u8fbeTROP2\u6297\u539f\u7684\u80bf\u7624\u7ec6\u80de\u540e\uff0c\u8fde\u63a5\u5b50\u7684\u6bd2\u7d20\u7aef\u53ef\u88ab\u80de\u5185\u6eb6\u9176\u4f53\u5207\u5272\uff0c\u91ca\u653e\u6bd2\u7d20\u5c0f\u5206\u5b50\u6740\u4f24\u80bf\u7624\u7ec6\u80de\u3002\u6700\u540e\uff0c\u6bd2\u7d20\u5c0f\u5206\u5b50\u8fd8\u80fd\u900f\u51fa\u7ec6\u80de\u819c\uff0c\u53d1\u6325”\u65c1\u89c2\u8005\u6548\u5e94”\uff0c\u7ee7\u7eed\u6740\u4f24\u5468\u56f4\u80bf\u7624\u7ec6\u80de\u3002<\/p>\n
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