\u9999\u6e2f\u7efc\u5408\u80bf\u7624\u4e2d\u5fc3\u81f4\u529b\u63a8\u52a8\u764c\u75c7\u9632\u62a4, \u6cbb\u7597\u548c\u5eb7\u590d\u6559\u80b2\u3002\u6211\u4eec\u4ea6\u4f1a\u5b9a\u671f\u4e3a\u5927\u5bb6\u6309\u4e0d\u540c\u764c\u75c7\u7c7b\u522b\uff0c\u6574\u7406\u6700\u65b0\u836f\u7269\u4e34\u5e8a\u7814\u7a76\u7ed3\u679c\uff0c\u53ca\u7f8e\u56fdFDA\u65b0\u836f\u6279\u51c6\u8fdb\u5ea6\u7684\u6587\u7ae0\u3002\u672c\u671f\u6587\u7ae0\u5e26\u5927\u5bb6\u770b\u5b97\u683c\u66ff\u5c3c\uff08Zongertinib\uff09\uff0c\u76ee\u524d\u6b63\u5728\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40(FDA)\u4e0b\u4ee5\u5feb\u901f\u901a\u9053\u548c\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\u8fdb\u884c\u5ba1\u67e5\uff0c\u7528\u4e8e\u8bc4\u4f30\u672c\u7814\u7a76\u4e2d\u7684\u9002\u5e94\u75c7\u3002<\/p>\n\n\n\n
\u5b97\u683c\u66ff\u5c3c\uff08Zongertinib\uff09\u2014\u2014\u4e00\u79cd\u6b63\u5728\u7814\u7a76\u7684\u53e3\u670d\u3001HER2\u9009\u62e9\u6027\u3001EGFR\u4fdd\u7559\u578b\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\uff0c\u5728\u665a\u671f\u3001\u7ecf\u6cbbHER2\u7a81\u53d8\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u60a3\u8005\u4e2d\u5f15\u53d1\u4e86\u6301\u4e45\u53cd\u5e94\u5e76\u663e\u793a\u51fa\u9f13\u821e\u7684\u4e34\u5e8a\u7597\u6548\u3002<\/p>\n\n\n\n
Ia\/Ib\u671fBeamion LUNG-1\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\uff0c\u786e\u8ba4\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\u4e3a71%\uff0c\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u4e3a12.4\u4e2a\u6708\u3002\u7814\u7a76\u4eba\u5458\u5f3a\u8c03\u4e86\u8be5\u836f\u7269\u53ef\u63a7\u7684\u5b89\u5168\u6027\uff0c\u91ce\u751f\u578bEGFR\u76f8\u5173\u6bd2\u6027\u53d1\u751f\u7387\u4f4e\uff0c\u4e14\u672a\u62a5\u544a\u4e0e\u836f\u7269\u76f8\u5173\u7684\u95f4\u8d28\u6027\u80ba\u75c5\uff0c\u89e3\u51b3\u4e86\u65e2\u5f80HER2\u9776\u5411\u836f\u7269\u7684\u5173\u952e\u5c40\u9650\u6027\u3002 <\/p>\n\n\n\n
\u5b97\u683c\u66ff\u5c3c\uff08Zongertinib\uff09\u8fd9\u4e00\u53ef\u80fd\u6539\u53d8\u4e34\u5e8a\u5b9e\u8df5\u7684\u6279\u51c6\uff0c\u5c06\u63d0\u4f9b\u4e00\u79cd\u9ad8\u6548\u4e14\u5b89\u5168\u6027\u53ef\u63a7\u7684\u6cbb\u7597\u9009\u62e9\uff0c\u5e76\u4e14\u5c06\u6210\u4e3a\u9996\u4e2a\u83b7\u6279\u7528\u4e8eHER2\u7a81\u53d8NSCLC\u60a3\u8005\u7684\u53e3\u670d\u7597\u6cd5\u548c\u552f\u4e00\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\u3002<\/p>\n\n\n\n
\u7814\u7a76\u4eae\u70b9<\/strong><\/p>\n\n\n\n \u5728 Beamion LUNG-1 \u8bd5\u9a8c\u4e2d\uff0c\u53e3\u670d\u3001HER2 \u9009\u62e9\u6027\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\u5b97\u745e\u66ff\u5c3c\u5728\u65e2\u5f80\u63a5\u53d7\u8fc7\u6cbb\u7597\u7684 HER2 \u6fc0\u9176\u7ed3\u6784\u57df\u7a81\u53d8\u7684\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u4e2d\uff0c\u786e\u8ba4\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\u4e3a 71%\uff0c\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u4e3a 12.4 \u4e2a\u6708\u3002<\/p>\n\n\n\n \u5b97\u745e\u66ff\u5c3c\u663e\u793a\u51fa\u53ef\u63a7\u7684\u5b89\u5168\u6027\uff0c\u91ce\u751f\u578b EGFR \u4ecb\u5bfc\u7684\u6bd2\u6027\u53d1\u751f\u7387\u8f83\u4f4e\uff0c\u4e14\u65e0\u836f\u7269\u76f8\u5173\u95f4\u8d28\u6027\u80ba\u75c5\u7684\u62a5\u9053\uff0c\u89e3\u51b3\u4e86\u65e2\u5f80 HER2 \u9776\u5411\u836f\u7269\u7684\u5173\u952e\u5c40\u9650\u6027\u3002<\/p>\n\n\n\n \u80cc\u666f<\/strong><\/strong><\/p>\n\n\n\n HER2 \u7a81\u53d8\u7684\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u60a3\u8005\uff0c\u4e00\u76f4\u8feb\u5207\u9700\u8981\u6709\u6548\u3001\u8010\u53d7\u6027\u4f73\u4e14\u4f7f\u7528\u4fbf\u6377\u7684\u9776\u5411\u6cbb\u7597\u65b9\u6848\u3002\u5728 NSCLC \u60a3\u8005\u4e2d\uff0cHER2 \u6fc0\u6d3b\u7a81\u53d8\u7ea6\u5360 2% – 4%\uff0c\u8fd9\u7c7b\u60a3\u8005\u603b\u4f53\u9884\u540e\u5f80\u5f80\u66f4\u5dee\uff0c\u8111\u8f6c\u79fb\u53d1\u751f\u7387\u4e5f\u66f4\u9ad8\u3002<\/p>\n\n\n\n \u7531\u4e8e\u7a81\u53d8\u6fc0\u9176\u7ed3\u6784\u57df\u7684\u7ed3\u6784\u590d\u6742\uff0c\u4e14\u8131\u9776\u6291\u5236\u91ce\u751f\u578b EGFR\uff08\u4e00\u79cd\u7ed3\u6784\u76f8\u5173\u6fc0\u9176\uff09\u53ef\u80fd\u5f15\u53d1\u663e\u8457\u6bd2\u6027\uff0c\u5f00\u53d1\u9488\u5bf9 HER2 \u7a81\u53d8\u7684\u6709\u6548\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\u56f0\u96be\u91cd\u91cd\u3002\u5c3d\u7ba1\u50cffam-trastuzumab deruxtecan-nxki\uff08T-DXd\uff09\u8fd9\u6837\u7684\u6297\u4f53 – \u836f\u7269\u5076\u8054\u7269\u5df2\u5c55\u73b0\u51fa\u7597\u6548\u5e76\u83b7\u5f97\u52a0\u901f\u6279\u51c6\uff0c\u4f46\u5176\u4f34\u968f\u7684\u9aa8\u9ad3\u6291\u5236\u3001\u95f4\u8d28\u6027\u80ba\u75c5\u7b49\u6bd2\u6027\uff0c\u5728 NSCLC \u60a3\u8005\u7fa4\u4f53\u4e2d\u4e0d\u5bb9\u5ffd\u89c6\u3002<\/p>\n\n\n\n \u7814\u7a76\u65b9\u6cd5<\/strong><\/strong><\/p>\n\n\n\n Beamion LUNG-1\u7814\u7a76\u662f\u4e00\u9879\u591a\u4e2d\u5fc3Ia\/Ib\u671f\u8bd5\u9a8c\uff0c\u8bc4\u4f30\u5b97\u683c\u66ff\u5c3c\u5728\u7ecf\u6cbb\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027HER2\u7a81\u53d8NSCLC\u60a3\u8005\u4e2d\u7684\u7597\u6548\u3002\u57fa\u4e8eIa\/Ib\u671f\u5242\u91cf\u9012\u589e\u7814\u7a76\uff0c\u9009\u5b9a\u6bcf\u65e5120 mg\u7684\u5242\u91cf\u7528\u4e8e\u6240\u5448\u73b0\u7684\u6269\u5c55\u60a3\u8005\u7ec4\u3002<\/p>\n\n\n\n \u7ed3\u679c\u805a\u7126\u4e8e\u4e09\u4e2a\u5173\u952e\u7684\u7ecf\u6cbb\u60a3\u8005\u7ec4\uff1a<\/p>\n\n\n\n 1 \u53f7\u60a3\u8005\u7ec4\uff08n = 75\uff09\u7eb3\u5165\u4e86\u65e2\u5f80\u672a\u63a5\u53d7\u8fc7 HER2 \u6297\u4f53 – \u836f\u7269\u5076\u8054\u7269\u6cbb\u7597\u3001\u5b58\u5728\u916a\u6c28\u9178\u6fc0\u9176\u7ed3\u6784\u57df\uff08TKD\uff09\u7a81\u53d8\u7684\u60a3\u8005\uff1b5 \u53f7\u60a3\u8005\u7ec4\uff08n = 31\uff09\u7eb3\u5165\u4e86\u65e2\u5f80\u63a5\u53d7\u8fc7 HER2 \u6297\u4f53 – \u836f\u7269\u5076\u8054\u7269\u6cbb\u7597\u3001\u5b58\u5728 TKD \u7a81\u53d8\u7684\u60a3\u8005\uff1b3 \u53f7\u60a3\u8005\u7ec4\uff08n = 20\uff09\u7eb3\u5165\u4e86\u5b58\u5728\u975e TKD \u7a81\u53d8\u7684\u60a3\u8005\u3002\u4e3b\u8981\u7ec8\u70b9\u4e3a\u5ba2\u89c2\u7f13\u89e3\u7387\uff0c1 \u53f7\u548c 5 \u53f7\u60a3\u8005\u7ec4\u901a\u8fc7\u76f2\u6001\u72ec\u7acb\u4e2d\u5fc3\u5ba1\u67e5\u8fdb\u884c\u8bc4\u4f30\uff0c3 \u53f7\u60a3\u8005\u7ec4\u901a\u8fc7\u7814\u7a76\u8005\u8bc4\u4f30\u3002\u6b21\u8981\u7ec8\u70b9\u5305\u62ec\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u3001\u75be\u75c5\u63a7\u5236\u7387\u548c\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u3002<\/p>\n\n\n\n \u5173\u952e\u7ed3\u679c<\/strong><\/strong><\/p>\n\n\n\n \u57281 \u53f7\u60a3\u8005\u7ec4\u4e2d\uff0c\u5b97\u683c\u66ff\u5c3c\u663e\u793a\u51fa\u7597\u6548\uff0c\u786e\u8ba4\u7684\u603b\u4f53\u7f13\u89e3\u7387\u4e3a71%<\/strong>\uff0c\u75be\u75c5\u63a7\u5236\u7387\u4e3a96%<\/strong>\u3002\u7f13\u89e3\u51fa\u73b0\u8fc5\u901f\uff0c\u4e2d\u4f4d\u7f13\u89e3\u65f6\u95f4\u4e3a1.4\u4e2a\u6708<\/strong>\uff0c\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u4e3a14.1\u4e2a\u6708<\/strong>\u3002\u8be5\u60a3\u8005\u7ec4\u7684\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u4e3a12.4\u4e2a\u6708<\/strong>\u3002 <\/p>\n\n\n\n \u5b97\u683c\u66ff\u5c3c\u8fd8\u663e\u793a\u51fa\u9885\u5185\u6d3b\u6027\u8bc1\u636e\u3002\u57281 \u53f7\u60a3\u8005\u7ec4\u4e2d\u53ef\u8bc4\u4f30\u8111\u8f6c\u79fb\u768427\u4f8b\u60a3\u8005\u4e2d\uff0c\u9885\u5185\u603b\u4f53\u7f13\u89e3\u7387\u4e3a41%\uff0c\u75be\u75c5\u63a7\u5236\u7387\u4e3a81%<\/strong>\u3002 <\/p>\n\n\n\n \u57285\u53f7\u60a3\u8005\u7ec4\u4e2d\uff0c\u5b97\u683c\u66ff\u5c3c\u5728\u9884\u5904\u7406\u66f4\u5145\u5206\u7684\u4eba\u7fa4\u4e2d\u663e\u793a\u51fa\u6d3b\u6027\uff0c\u603b\u4f53\u7f13\u89e3\u7387\u4e3a48%<\/strong>\u3002\u572822\u4f8b\u5148\u524d\u63a5\u53d7\u8fc7T-DXd\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\uff0c\u603b\u4f53\u7f13\u89e3\u7387\u4e3a41%<\/strong>\u3002 <\/p>\n\n\n\n \u8fd9\u4e00\u53d1\u73b0\u8868\u660e\uff0c\u5b97\u683c\u66ff\u5c3c\u53ef\u80fd\u5bf9\u5df2\u5bf9HER2\u5bfc\u5411\u7684\u6297\u4f53-\u836f\u7269\u5076\u8054\u7269\u4ea7\u751f\u8010\u836f\u7684\u60a3\u8005\u6709\u6548\uff0c\u8fd9\u53ef\u80fd\u662f\u7531\u4e8e\u8010\u836f\u673a\u5236\u4e0d\u91cd\u53e0\u3002\u8be5\u7ec4\u522b\u7684\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u4e3a5.3\u4e2a\u6708<\/strong>\uff0c\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u4e3a6.8\u4e2a\u6708<\/strong>\u3002 <\/p>\n\n\n\n \u57283\u53f7\u60a3\u8005\u7ec4\u4e2d\uff0c\u5b97\u683c\u66ff\u5c3c\u663e\u793a\u51fa\u6d3b\u6027\uff0c\u603b\u4f53\u7f13\u89e3\u7387\u4e3a30%<\/strong>\uff0c\u75be\u75c5\u63a7\u5236\u7387\u4e3a65%<\/strong>\u3002\u572817\u4f8b\u5df2\u77e5\u6fc0\u6d3b\u578b\u975eTKD\u7a81\u53d8\u60a3\u8005\u4e2d\uff0c\u603b\u4f53\u7f13\u89e3\u7387\u4e3a35%<\/strong>\u3002\u8fd9\u662f\u62a5\u9053\u7684\u975eTKD HER2\u7a81\u53d8NSCLC\u4eba\u7fa4\u4e2d\u6700\u5927\u7684\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\u6570\u636e\u96c6\u3002\u5728\u5206\u6790\u65f6\uff0c\u8be5\u60a3\u8005\u7ec4\u7684\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u548c\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u5c1a\u672a\u6210\u719f<\/strong>\u3002 <\/p>\n\n\n\n \u5b89\u5168\u6027<\/strong><\/strong><\/p>\n\n\n\n \u6bcf\u65e5120 mg\u5242\u91cf\u7684\u5b97\u683c\u66ff\u5c3c\u7684\u5b89\u5168\u6027\u4e5f\u88ab\u62a5\u544a\u4e3a\u53ef\u63a7\u4e14\u5728\u6240\u6709\u60a3\u8005\u7ec4\u4e2d\u4e00\u81f4\u3002\u5927\u591a\u6570\u836f\u7269\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u4e3a1\u7ea7\u62162\u7ea7\u30023\u7ea7\u6216\u66f4\u9ad8\u4e0d\u826f\u4e8b\u4ef6\u7684\u53d1\u751f\u7387\u57281\u53f7\u60a3\u8005\u7ec4\u4e2d\u4e3a17%\uff0c\u57283\u53f7\u60a3\u8005\u7ec4\u4e2d\u4e3a25%\uff0c\u57285\u53f7\u60a3\u8005\u7ec4\u4e2d\u4e3a3%\u3002\u91ce\u751f\u578bEGFR\u4ecb\u5bfc\u7684\u6bd2\u6027\u636e\u62a5\u544a\u6781\u5c11\uff0c\u4e25\u91cd\u76ae\u75b9\u6216\u8179\u6cfb\u7684\u53d1\u751f\u7387\u4f4e\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u6240\u6709\u7ec4\u522b\u4e2d\u5747\u672a\u62a5\u544a\u4e0e\u836f\u7269\u76f8\u5173\u7684\u95f4\u8d28\u6027\u80ba\u75c5\u75c5\u4f8b\u3002 <\/p>\n\n\n\n \u25b6 \u7279\u6b8a\u6bd2\u6027<\/strong><\/strong><\/p>\n\n\n\n \u91ce\u751f\u578bEGFR\u4ecb\u5bfc\u7684\u6bd2\u6027\u6700\u5c0f\uff0c\u4e25\u91cd\u76ae\u75b9\u6216\u8179\u6cfb\u53d1\u751f\u7387\u4f4e\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u5728\u4efb\u4f55\u961f\u5217\u4e2d\u5747\u672a\u62a5\u544a\u836f\u7269\u76f8\u5173\u95f4\u8d28\u6027\u80ba\u75c5\u3002<\/p>\n\n\n\n \u25b6 \u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6<\/strong><\/strong><\/p>\n\n\n\n 3\u7ea7\u6216\u4ee5\u4e0a\u4e0d\u826f\u4e8b\u4ef6\u53d1\u751f\u7387\uff1a<\/p>\n\n\n\n \u961f\u52171\uff1a17%<\/p>\n\n\n\n \u961f\u52173\uff1a25%<\/p>\n\n\n\n \u961f\u52175\uff1a3%<\/p>\n\n\n\n \u25b6 \u603b\u4f53\u5b89\u5168\u6027<\/strong><\/strong><\/p>\n\n\n\n \u5b97\u5c14\u66ff\u5c3c\u5728120mg\u6bcf\u65e5\u4e00\u6b21\u7684\u5242\u91cf\u4e0b\uff0c\u5b89\u5168\u6027\u53ef\u7ba1\u7406\u4e14\u5728\u6240\u6709\u961f\u5217\u4e2d\u4e00\u81f4\u3002\u5927\u591a\u6570\u836f\u7269\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u4e3a1\u7ea7\u62162\u7ea7\u3002<\/p>\n\n\n\n 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