{"id":39925,"date":"2026-06-04T11:46:55","date_gmt":"2026-06-04T03:46:55","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=39925"},"modified":"2026-06-04T15:49:06","modified_gmt":"2026-06-04T07:49:06","slug":"%e9%87%8c%e7%a8%8b%e7%a2%91%ef%bc%81fda%e5%85%a8%e6%96%b0adc%e8%8d%af%e7%89%a9%e8%8e%b7%e6%89%b9%e6%b2%bb%e7%96%97%e4%b8%89%e9%98%b4%e6%80%a7%e4%b9%b3%e8%85%ba%e7%99%8c%ef%bc%8c%e7%96%97%e6%95%88","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/%e9%87%8c%e7%a8%8b%e7%a2%91%ef%bc%81fda%e5%85%a8%e6%96%b0adc%e8%8d%af%e7%89%a9%e8%8e%b7%e6%89%b9%e6%b2%bb%e7%96%97%e4%b8%89%e9%98%b4%e6%80%a7%e4%b9%b3%e8%85%ba%e7%99%8c%ef%bc%8c%e7%96%97%e6%95%88\/","title":{"rendered":"\u91cc\u7a0b\u7891\uff01FDA\u5168\u65b0ADC\u836f\u7269\u83b7\u6279\u6cbb\u7597\u4e09\u9634\u6027\u4e73\u817a\u764c\uff0c\u7597\u6548\u8fdc\u8d85\u5316\u7597\uff0c\u751f\u5b58\u671f\u5927\u5e45\u63d0\u5347"},"content":{"rendered":"\n

2026\u5e745\u670822\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6b63\u5f0f\u6279\u51c6datopotamab deruxtecan-dlnk<\/strong>\u7528\u4e8e\u6cbb\u7597\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u4e09\u9634\u6027\u4e73\u817a\u764c\uff08TNBC\uff09\u6210\u4eba\u60a3\u8005<\/strong>\uff0c\u4e14\u60a3\u8005\u4e0d\u9002\u5408\u63a5\u53d7 PD-1\/PD-L1 \u6291\u5236\u5242\u6cbb\u7597\u3002\u8fd9\u662f\u4e09\u9634\u6027\u4e73\u817a\u764c\u6cbb\u7597\u9886\u57df\u7684\u91cd\u5927\u7a81\u7834\uff0c\u4e3a\u957f\u671f\u4f9d\u8d56\u5316\u7597\u7684\u665a\u671f\u60a3\u8005\u5e26\u6765\u65b0\u7684\u7cbe\u51c6\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n\n\n\n

1. <\/strong>\u4e09\u9634\u6027\u4e73\u817a\u764c\uff1a\u9884\u540e\u5dee\u3001\u6cbb\u7597\u96be\u7684\u201c\u786c\u9aa8\u5934\u201d<\/strong><\/strong><\/p>\n\n\n\n

\u4e09\u9634\u6027\u4e73\u817a\u764c\u662f\u6307\u96cc\u6fc0\u7d20\u53d7\u4f53\uff08ER\uff09\u3001\u5b55\u6fc0\u7d20\u53d7\u4f53\uff08PR\uff09\u548c\u4eba\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53 2\uff08HER2\uff09\u5747\u4e3a\u9634\u6027\u7684\u4e73\u817a\u764c\u4e9a\u578b\uff0c\u7ea6\u5360\u6240\u6709\u4e73\u817a\u764c\u7684 15%\u3002\u8be5\u4e9a\u578b\u5177\u6709\u4fb5\u88ad\u6027\u5f3a\u3001\u590d\u53d1\u8f6c\u79fb\u65e9\u3001\u9884\u540e\u6781\u5dee<\/strong>\u7684\u7279\u70b9\uff0c\u9ad8\u53d1\u4e8e40\u5c81\u4ee5\u4e0b\u5973\u6027\uff0c\u4e14\u9ed1\u4eba\u5973\u6027\u53d1\u75c5\u6bd4\u4f8b\u66f4\u9ad8\u3002<\/p>\n\n\n\n

\u6839\u636e\u7f8e\u56fd\u764c\u75c7\u534f\u4f1a\uff08ACS\uff092025\u5e74\u6570\u636e\uff0c\u5c40\u90e8\u665a\u671f\u4e09\u9634\u6027\u4e73\u817a\u764c5\u5e74\u76f8\u5bf9\u751f\u5b58\u7387\u4ec567%\uff0c\u8fdc\u5904\u8f6c\u79fb\u60a3\u8005\u66f4\u662f\u4f4e\u81f315%\u3002<\/strong>\u957f\u671f\u4ee5\u6765\uff0c\u56e0\u7f3a\u4e4f\u6709\u6548\u9776\u70b9\uff0c\u5185\u5206\u6ccc\u6cbb\u7597\u4e0eHER2\u9776\u5411\u6cbb\u7597\u5747\u65e0\u6548\uff0c\u5316\u7597\u662f\u665a\u671f\u60a3\u8005\u552f\u4e00\u7684\u6807\u51c6\u6cbb\u7597\uff0c<\/strong>\u4f46\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4ec520%-30%\uff0c\u4e2d\u4f4d\u603b\u751f\u5b58\u671f\uff08OS\uff09\u4ec512-18\u4e2a\u6708\uff0c\u4e34\u5e8a\u9700\u6c42\u8fdc\u672a\u6ee1\u8db3\u3002<\/p>\n\n\n\n

2. <\/strong>\u5168\u65b0TROP2-ADC\u836f\u7269\uff1a\u7cbe\u51c6\u9776\u5411\uff0c\u673a\u5236\u72ec\u7279<\/strong><\/strong><\/p>\n\n\n\n

datopotamab deruxtecan-dlnk \u662f\u4e00\u6b3e\u9776\u5411 TROP2 \u7684\u6297\u4f53\u836f\u7269\u5076\u8054\u7269\uff08ADC\uff09\uff0c<\/strong>\u4f9d\u6258\u836f\u5382\u7ecf\u5178DXd-ADC\u6280\u672f\u5e73\u53f0\uff0c\u7531\u6297TROP2\u5355\u514b\u9686\u6297\u4f53\u3001\u53ef\u88c2\u89e3\u8fde\u63a5\u5b50\u4e0e\u62d3\u6251\u5f02\u6784\u9176I\u6291\u5236\u5242\uff08DXd\uff09\u7ec4\u6210\u3002<\/p>\n\n\n\n

\u5176\u4f5c\u7528\u673a\u5236\u517c\u5177\u7cbe\u51c6\u9776\u5411\u4e0e\u5f3a\u6548\u6740\u4f24\u4f18\u52bf\uff1a<\/strong><\/strong><\/p>\n\n\n\n

1. \u6297\u4f53\u90e8\u5206\u7279\u5f02\u6027\u7ed3\u5408\u80bf\u7624\u7ec6\u80de\u8868\u9762\u9ad8\u8868\u8fbe\u7684TROP2\u6297\u539f\uff0c\u51cf\u5c11\u5bf9\u6b63\u5e38\u7ec6\u80de\u7684\u635f\u4f24\uff1b<\/p>\n\n\n\n

2. \u5185\u541e\u8fdb\u5165\u80bf\u7624\u7ec6\u80de\u540e\uff0c\u8fde\u63a5\u5b50\u88c2\u89e3\u91ca\u653eDXd\uff0c\u5f3a\u6548\u6740\u4f24\u80bf\u7624\u7ec6\u80de\uff1b<\/p>\n\n\n\n

3. \u517c\u5177\u201c\u65c1\u89c2\u8005\u6548\u5e94\u201d\uff0c\u53ef\u6740\u4f24\u5468\u56f4\u6297\u539f\u9634\u6027\u7684\u80bf\u7624\u7ec6\u80de\uff0c\u6291\u5236\u80bf\u7624\u751f\u957f\u4e0e\u8f6c\u79fb\u3002<\/p>\n\n\n\n

\u6b64\u524d\uff0c\u8be5\u836f\u7269\u5df2\u83b7FDA\u6279\u51c6\u7528\u4e8eHR \u9633\u6027\/HER2\u9634\u6027\u665a\u671f\u4e73\u817a\u764c\uff0c\u672c\u6b21\u4e3a\u5176\u7b2c\u4e8c\u9879\u4e73\u817a\u764c\u9002\u5e94\u75c7\uff0c\u4e5f\u662f\u9996\u4e2a\u83b7\u6279\u7528\u4e8e\u4e0d\u9002\u5408\u514d\u75ab\u6cbb\u7597 TNBC\u4e00\u7ebf\u6cbb\u7597\u7684TROP2-ADC\u836f\u7269\u3002<\/strong><\/strong><\/p>\n\n\n\n

3<\/strong>. \u2162\u671f\u4e34\u5e8a\u6570\u636e\uff1a\u7597\u6548\u5168\u9762\u8d85\u8d8a\u5316\u7597\uff0c\u751f\u5b58\u671f\u663e\u8457\u5ef6\u957f<\/strong><\/strong><\/p>\n\n\n\n

\u672c\u6b21\u83b7\u6279\u57fa\u4e8e\u5168\u7403\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u2162\u671fTROPION-Breast02\u7814\u7a76\uff08NCT05374512\uff09\u7684\u4f18\u5f02\u7ed3\u679c\uff0c\u8be5\u7814\u7a76\u5171\u7eb3\u5165644\u4f8b\u521d\u6cbb\u4e0d\u53ef\u5207\u9664\/\u8f6c\u79fb\u6027TNBC\u60a3\u8005\uff08\u5747\u4e0d\u9002\u5408PD-1\/PD-L1\u6291\u5236\u5242\u6cbb\u7597\uff09\uff0c1:1\u968f\u673a\u5206\u4e3a datopotamab deruxtecan-dlnk\u7ec4\uff086mg\/kg\uff0c\u6bcf3\u5468\u9759\u8109\u8f93\u6ce8\uff09\u4e0e\u7814\u7a76\u8005\u9009\u62e9\u5316\u7597\u7ec4\uff08\u7d2b\u6749\u9187\u3001\u767d\u86cb\u767d\u7d2b\u6749\u9187\u3001\u5361\u57f9\u4ed6\u6ee8\u7b49\uff09\u3002<\/p>\n\n\n\n

\u25b6\u00a0\u6838\u5fc3\u7597\u6548\u6570\u636e\uff08vs\u5316\u7597\uff09<\/strong><\/p>\n\n\n\n

\u25ab \u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\uff1a<\/strong>10.8\u4e2a\u6708 vs 5.6\u4e2a\u6708\uff0c\u75be\u75c5\u8fdb\u5c55\u6216\u6b7b\u4ea1\u98ce\u9669\u964d\u4f4e43%\uff08HR=0.57\uff0cP<0.0001\uff09\uff1b<\/p>\n\n\n\n

\u25ab \u4e2d\u4f4d\u603b\u751f\u5b58\u671f\uff08OS\uff09\uff1a<\/strong>23.7\u4e2a\u6708 vs 18.7\u4e2a\u6708\uff0c\u751f\u5b58\u671f\u5ef6\u957f5\u4e2a\u6708\uff0c\u6b7b\u4ea1\u98ce\u9669\u964d\u4f4e21%\uff08HR=0.79\uff0cP=0.0290\uff09\uff1b<\/p>\n\n\n\n

\u25ab \u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\uff1a<\/strong>64% vs 30%\uff0c\u7f13\u89e3\u7387\u63d0\u53471\u500d\u4ee5\u4e0a\uff0c\u5176\u4e2d\u5b8c\u5168\u7f13\u89e3\uff08CR\uff0929\u4f8b vs 8\u4f8b\uff1b<\/p>\n\n\n\n

\u25ab \u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DoR\uff09\uff1a<\/strong>12.3\u4e2a\u6708 vs 7.1\u4e2a\u6708\uff0c\u7597\u6548\u66f4\u6301\u4e45\u3002<\/p>\n\n\n\n

\u8be5\u7814\u7a76\u7ed3\u679c\u5df2\u4e8e2025\u5e74\u6b27\u6d32\u80bf\u7624\u5185\u79d1\u5b66\u4f1a\uff08ESMO\uff09\u5e74\u4f1a\u516c\u5e03\uff0c\u5e76\u53d1\u8868\u4e8e\u300aClinical Cancer Research\u300b\uff0c\u8bc1\u5b9e datopotamab deruxtecan-dlnk \u5728PFS\u3001OS\u3001ORR\u3001DoR<\/strong>\u56db\u5927\u5173\u952e\u7ec8\u70b9\u4e0a\u5747\u663e\u8457\u4f18\u4e8e\u4f20\u7edf\u5316\u7597\uff0c\u4e14\u5b89\u5168\u6027\u53ef\u63a7\u3002<\/p>\n\n\n\n

4. <\/strong>\u5b89\u5168\u6027\u4e0e\u7528\u836f\u89c4\u8303\uff1a\u98ce\u9669\u53ef\u63a7\uff0c\u9700\u89c4\u8303\u76d1\u6d4b<\/strong><\/strong><\/p>\n\n\n\n

FDA\u5728\u6279\u51c6\u540c\u65f6\u53d1\u5e03\u9ed1\u6846\u8b66\u793a<\/strong>\uff0c\u660e\u786e\u7528\u836f\u6838\u5fc3\u98ce\u9669\u4e0e\u76d1\u6d4b\u8981\u6c42\uff0c\u6574\u4f53\u83b7\u76ca\u5927\u4e8e\u98ce\u9669\uff1a<\/p>\n\n\n\n

\u2022 \u6838\u5fc3\u8b66\u793a\uff1a<\/strong>\u95f4\u8d28\u6027\u80ba\u75c5\/\u80ba\u708e\u3001\u773c\u90e8\u6bd2\u6027\uff08\u89d2\u819c\u708e\u3001\u5e72\u773c\u75c7\uff09\u3001\u53e3\u8154\u708e\/\u9ecf\u819c\u708e\u3001\u80da\u80ce – \u80ce\u513f\u6bd2\u6027\uff1b<\/p>\n\n\n\n

\u2022 \u5e38\u89c1\u4e0d\u826f\u53cd\u5e94\uff08\u226520%\uff09\uff1a<\/strong>\u53e3\u8154\u708e\u3001\u6076\u5fc3\u3001\u75b2\u52b3\u3001\u8131\u53d1\u3001\u4fbf\u79d8\u3001\u5e72\u773c\u75c7\u3001\u5455\u5410\u7b49\uff0c\u591a\u4e3a1-2\u7ea7\uff0c\u53ef\u7ba1\u7406\uff1b<\/p>\n\n\n\n

\u2022 \u7528\u6cd5\u7528\u91cf\uff1a<\/strong>\u63a8\u8350\u5242\u91cf6mg\/kg\uff0c\u226590kg\u60a3\u8005\u4e0a\u9650540mg\uff0c\u9759\u8109\u8f93\u6ce8\uff0c\u6bcf3\u54681\u6b21\uff0c\u6301\u7eed\u81f3\u75be\u75c5\u8fdb\u5c55\u6216\u4e0d\u53ef\u8010\u53d7\u6bd2\u6027\uff1b<\/p>\n\n\n\n

\u2022 \u7279\u6b8a\u4eba\u7fa4\uff1a<\/strong>\u80b2\u9f84\u671f\u5973\u6027\u7528\u836f\u671f\u95f4\u53ca\u505c\u836f\u540e7\u4e2a\u6708\u5185\u9700\u4e25\u683c\u907f\u5b55\uff0c\u907f\u514d\u80ce\u513f\u635f\u4f24\u3002<\/p>\n\n\n\n

5. <\/strong>\u4e34\u5e8a\u610f\u4e49\uff1a\u6539\u5199\u665a\u671fTNBC\u6cbb\u7597\u683c\u5c40<\/strong><\/strong><\/p>\n\n\n\n

\u672c\u6b21 datopotamab deruxtecan-dlnk \u83b7\u6279\uff0c\u662f\u4e09\u9634\u6027\u4e73\u817a\u764c\u6cbb\u7597\u7684\u91cc\u7a0b\u7891\u5f0f\u7a81\u7834<\/strong>\uff0c\u5177\u6709\u4e09\u5927\u6838\u5fc3\u4ef7\u503c\uff1a<\/p>\n\n\n\n

1. \u586b\u8865\u521a\u9700\u7a7a\u767d\uff1a<\/strong>\u9996\u6b21\u4e3a\u4e0d\u9002\u5408\u514d\u75ab\u6cbb\u7597\u7684\u665a\u671f TNBC \u60a3\u8005\u63d0\u4f9b\u4f18\u4e8e\u5316\u7597\u7684\u4e00\u7ebf\u9776\u5411\u65b9\u6848\uff0c<\/strong>\u6253\u7834\u201c\u5316\u7597\u552f\u4e00\u201d\u7684\u56f0\u5883\uff1b<\/p>\n\n\n\n

2.<\/strong> \u5ef6\u957f\u751f\u5b58\u83b7\u76ca\uff1a<\/strong>\u4e2d\u4f4dOS\u8fbe23.7\u4e2a\u6708\uff0c\u662f\u9996\u4e2a\u5728\u665a\u671fTNBC\u4e00\u7ebf\u6cbb\u7597\u4e2d\u5b9e\u73b0\u4e2d\u4f4dOS\u8d852\u5e74\u7684ADC\u836f\u7269\uff0c<\/strong>\u663e\u8457\u6539\u5584\u60a3\u8005\u957f\u671f\u9884\u540e\uff1b<\/p>\n\n\n\n

3. \u5de9\u56faADC\u5730\u4f4d\uff1a<\/strong>\u518d\u6b21\u9a8c\u8bc1TROP2\u9776\u70b9\u5728\u4e73\u817a\u764c\u6cbb\u7597\u4e2d\u7684\u6838\u5fc3\u4ef7\u503c\uff0c\u63a8\u52a8ADC\u836f\u7269\u6210\u4e3aTNBC\u7cbe\u51c6\u6cbb\u7597\u7684\u4e3b\u6d41\u65b9\u5411\u3002<\/p>\n\n\n\n

\u76ee\u524d\uff0c\u8be5\u836f\u7269\u5df2\u901a\u8fc7FDA\u4f18\u5148\u5ba1\u8bc4\u53caProject Orbis\u56fd\u9645\u534f\u540c\u5ba1\u8bc4\uff08\u540c\u6b65\u7f8e\u3001\u6fb3\u3001\u52a0\u7b497\u56fd\uff09\uff0c\u672a\u6765\u6709\u671b\u5feb\u901f\u5728\u5168\u7403\u591a\u5730\u83b7\u6279\uff0c\u60e0\u53ca\u66f4\u591a\u665a\u671fTNBC\u60a3\u8005\u3002<\/p>\n\n\n\n

\u603b\u7ed3<\/strong><\/strong><\/p>\n\n\n\n

datopotamab deruxtecan-dlnk \u7684\u83b7\u6279\uff0c\u6807\u5fd7\u7740\u4e0d\u9002\u5408\u514d\u75ab\u6cbb\u7597\u7684\u665a\u671f\u4e09\u9634\u6027\u4e73\u817a\u764c\u6b63\u5f0f\u8fdb\u5165ADC\u7cbe\u51c6\u6cbb\u7597\u65f6\u4ee3\u3002<\/strong>\u5176\u4ee5\u201cPFS\u7ffb\u500d\u3001OS\u5ef6\u957f5\u4e2a\u6708\u3001ORR\u8d8560%\u201d<\/strong>\u7684\u4f18\u5f02\u6570\u636e\uff0c\u4e3a\u60a3\u8005\u5e26\u6765\u66f4\u957f\u751f\u5b58\u671f\u4e0e\u66f4\u597d\u751f\u6d3b\u8d28\u91cf\uff0c\u4e5f\u4e3a\u4e09\u9634\u6027\u4e73\u817a\u764c\u7684\u6cbb\u7597\u63d0\u4f9b\u5168\u65b0\u6807\u51c6\u65b9\u6848\u3002<\/p>\n\n\n\n

\u671f\u5f85\u672a\u6765\u66f4\u591a\u4e34\u5e8a\u7814\u7a76\u5f00\u5c55\uff0c\u8fdb\u4e00\u6b65\u63a2\u7d22 datopotamab deruxtecan-dlnk \u5728\u65e9\u671fTNBC\u3001\u8054\u5408\u6cbb\u7597\u7b49\u573a\u666f\u4e2d\u7684\u4ef7\u503c\uff0c\u4e3a\u4e73\u817a\u764c\u60a3\u8005\u5e26\u6765\u66f4\u591a\u6cbb\u6108\u5e0c\u671b\u3002<\/p>\n\n\n\n

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