{"id":39460,"date":"2026-04-13T15:19:00","date_gmt":"2026-04-13T07:19:00","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=39460"},"modified":"2026-04-14T09:56:07","modified_gmt":"2026-04-14T01:56:07","slug":"nejm%e9%a6%96%e5%8f%91-setidegrasib%e4%b8%bakras-g12d%e7%aa%81%e5%8f%98%e8%82%ba%e7%99%8c-%e8%83%b0%e8%85%ba%e7%99%8c%e6%8f%90%e4%be%9b%e6%96%b0%e6%b2%bb%e7%96%97%e6%96%b9%e5%90%91","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/nejm%e9%a6%96%e5%8f%91-setidegrasib%e4%b8%bakras-g12d%e7%aa%81%e5%8f%98%e8%82%ba%e7%99%8c-%e8%83%b0%e8%85%ba%e7%99%8c%e6%8f%90%e4%be%9b%e6%96%b0%e6%b2%bb%e7%96%97%e6%96%b9%e5%90%91\/","title":{"rendered":"NEJM\u9996\u53d1 | Setidegrasib\u4e3aKRAS G12D\u7a81\u53d8\u80ba\u764c\/\u80f0\u817a\u764c\u63d0\u4f9b\u65b0\u6cbb\u7597\u65b9\u5411"},"content":{"rendered":"\n

2026\u5e743\u670825\u65e5\uff0c\u300a\u65b0\u82f1\u683c\u5170\u533b\u5b66\u6742\u5fd7\uff08NEJM\uff09\u300b\u53d1\u8868\u4e86\u9996\u6b3e\u9776\u5411 KRAS G12D \u7684\u86cb\u767d\u964d\u89e3\u5242 Setidegrasib\uff08ASP3082\uff09\u7684\u2160\u671f\u4e34\u5e8a\u7814\u7a76\u7ed3\u679c\u3002\u8be5\u7814\u7a76\u7531\u5168\u7403\u591a\u4e2d\u5fc3\u56e2\u961f\u5f00\u5c55\uff0c\u5b89\u65af\u6cf0\u6765\u5236\u836f\u8d44\u52a9\uff0c\u65e8\u5728\u8bc4\u4f30\u836f\u7269\u5728\u65e2\u5f80\u7ecf\u6cbb\u7684\u665a\u671f KRAS G12D \u7a81\u53d8\u5b9e\u4f53\u7624\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u53ca\u6297\u80bf\u7624\u6d3b\u6027\uff0c\u4e3a\u8fd9\u4e00\u5c1a\u65e0\u83b7\u6279\u9776\u5411\u6cbb\u7597\u7684\u7a81\u53d8\u4e9a\u578b\u63d0\u4f9b\u4e86\u91cd\u8981\u7684\u4e34\u5e8a\u6570\u636e\u652f\u6491\u3002<\/p>\n\n\n\n

KRAS G12D \u662f KRAS \u7a81\u53d8\u4e2d\u5e38\u89c1\u7684\u4e9a\u578b\uff0c\u57285%\u7684\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u300140%\u7684\u80f0\u817a\u5bfc\u7ba1\u817a\u764c\uff08PDAC\uff09\u60a3\u8005\u4e2d\u5b58\u5728\u3002Setidegrasib \u4f5c\u4e3a\u540c\u7c7b\u9996\u521b\u7684\u86cb\u767d\u964d\u89e3\u5242\uff0c\u901a\u8fc7\u8bc6\u522b KRAS G12D \u7a81\u53d8\u86cb\u767d\u4e0e E3 \u6cdb\u7d20\u590d\u5408\u4f53\u7684 VHL \u86cb\u767d\uff0c\u4f7f\u7a81\u53d8\u86cb\u767d\u6cdb\u7d20\u5316\u5e76\u88ab\u86cb\u767d\u9176\u4f53\u964d\u89e3\uff0c\u5176\u72ec\u7279\u7684\u4f5c\u7528\u673a\u5236\u4e3a\u8be5\u9776\u70b9\u7684\u6cbb\u7597\u5f00\u8f9f\u4e86\u65b0\u8def\u5f84\u3002<\/p>\n\n\n\n

\u672c\u6b21\u2160\u671f\u4e34\u5e8a\u7814\u7a76\uff08\u4e34\u5e8a\u8bd5\u9a8c\u6ce8\u518c\u53f7\uff1aNCT05382559\uff09\u4e3a\u5f00\u653e\u6807\u7b7e\u8bbe\u8ba1\uff0c\u5171\u5165\u7ec4203\u4f8b\u65e2\u5f80\u63a5\u53d7\u8fc7\u6807\u51c6\u6cbb\u7597\u7684\u665a\u671f KRAS G12D \u7a81\u53d8\u5b9e\u4f53\u7624\u60a3\u8005\uff0c\u7814\u7a76\u7684\u4e3b\u8981\u7ec8\u70b9\u4e3a\u8bc4\u4f30\u5242\u91cf\u9650\u5236\u6027\u6bd2\u6027\u53ca\u4e0d\u826f\u4e8b\u4ef6\uff0c\u786e\u5b9a \u2161 \u671f\u63a8\u8350\u5242\u91cf\uff08RP2D\uff09\uff0c\u6b21\u8981\u7ec8\u70b9\u5305\u62ec\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u3001\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u3001\u603b\u751f\u5b58\u671f\uff08OS\uff09\u7b49\u6297\u80bf\u7624\u7597\u6548\u6307\u6807\u3002\u7814\u7a76\u6700\u7ec8\u786e\u5b9a600mg\u6bcf\u54681\u6b21\u9759\u8109\u6ce8\u5c04\u4e3a Setidegrasib \u7684\u2161\u671f\u63a8\u8350\u5242\u91cf\uff0c\u8be5\u5242\u91cf\u4e0b\u7684\u5b89\u5168\u6027\u4e0e\u7597\u6548\u6570\u636e\u4e3a\u6838\u5fc3\u7814\u7a76\u7ed3\u679c\uff0c\u5177\u4f53\u5982\u4e0b\uff1a<\/p>\n\n\n\n

1. <\/strong>\u5b89\u5168\u6027\u7279\u5f81\uff1a\u4e0d\u826f\u53cd\u5e94\u53ef\u63a7\uff0c\u6cbb\u7597\u8010\u53d7\u6027\u826f\u597d<\/strong><\/strong><\/p>\n\n\n\n

\u5728\u63a5\u53d7600mg\u5242\u91cf\u768476\u4f8b\u60a3\u8005\u4e2d\uff0c\u5b89\u5168\u6027\u6570\u636e\u663e\u793a\u836f\u7269\u6574\u4f53\u8010\u53d7\u6027\u826f\u597d\uff1a\u6240\u6709\u60a3\u8005\u5747\u51fa\u73b0\u6cbb\u7597\u4e2d\u4e0d\u826f\u4e8b\u4ef6\uff0c\u5176\u4e2d3\u7ea7\u53ca\u4ee5\u4e0a\u4e0d\u826f\u4e8b\u4ef6\u53d1\u751f\u7387\u4e3a42%\uff1b93%\u7684\u60a3\u8005\u51fa\u73b0\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff08TRAEs\uff09\uff0c\u65e0\u81f4\u547d\u6027\u6cbb\u7597\u76f8\u5173\u6bd2\u6027\u3002<\/p>\n\n\n\n

\u6700\u5e38\u89c1\u7684\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u4e3a\u4e00\u77ed\u6682\u8f93\u6ce8\u76f8\u5173\u53cd\u5e94\uff0880%\uff09\u548c\u6076\u5fc3\uff0830%\uff09\uff0c\u8f93\u6ce8\u76f8\u5173\u53cd\u5e94\u4e3b\u8981\u8868\u73b0\u4e3a\u9996\u6b21\u7ed9\u836f\u540e\u7684\u76ae\u75b9\u3001\u7619\u75d2\u6216\u8368\u9ebb\u75b9\uff0c\u4e14\u540e\u7eed\u53d1\u751f\u7387\u9010\u6e10\u964d\u4f4e\uff0c\u4e34\u5e8a\u53ef\u901a\u8fc7\u6297\u7ec4\u80fa\u836f\u7269\u5bf9\u75c7\u7f13\u89e3\u3002\u7814\u7a76\u4e2d\u4ec52\u4f8b\u60a3\u8005\u56e0\u4e0d\u826f\u4e8b\u4ef6\u505c\u836f\uff0c\u6cbb\u7597\u76f8\u5173\u505c\u836f\u7387\u4f4e\uff0c\u63d0\u793a\u836f\u7269\u9002\u5408\u957f\u671f\u7ed9\u836f\u3002<\/p>\n\n\n\n

2. <\/strong>\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u4e9a\u7ec4\uff1a36%\u5ba2\u89c2\u7f13\u89e3\u7387\uff0c\u4e2d\u4f4dPFS\u8fbe8.3\u4e2a\u6708<\/strong><\/strong><\/p>\n\n\n\n

45\u4f8b\u63a5\u53d7600mg\u5242\u91cf\u7684\u665a\u671f KRAS G12D \u7a81\u53d8 NSCLC \u60a3\u8005\uff0c\u5747\u4e3a\u8f6c\u79fb\u6027\u764c\u75c7\u4e14\u65e2\u5f80\u81f3\u5c11\u63a5\u53d7\u8fc71\u7ebf\u6807\u51c6\u6cbb\u7597\uff0c\u4e2d\u4f4d\u65e2\u5f80\u7cfb\u7edf\u6027\u6cbb\u7597\u7ebf\u6570\u4e3a2\u7ebf\uff08\u8303\u56f41-5\u7ebf\uff09\u3002\u8be5\u4e9a\u7ec4\u7597\u6548\u6570\u636e\u663e\u793a\uff1a<\/p>\n\n\n\n

\u00b7 \u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a36%\uff0895% CI\uff1a22-51\uff09\uff0c\u537336%\u7684\u60a3\u8005\u80bf\u7624\u5b9e\u73b0\u90e8\u5206\u7f13\u89e3\uff1b <\/p>\n\n\n\n

\u00b7 \u75be\u75c5\u63a7\u5236\u7387\uff08DCR\uff09\u4e3a84.4%\uff0c\u63d0\u793a\u591a\u6570\u60a3\u8005\u75c5\u60c5\u53ef\u5f97\u5230\u6709\u6548\u63a7\u5236\uff1b <\/p>\n\n\n\n

\u00b7 \u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08mPFS\uff09\u4e3a8.3\u4e2a\u6708\uff0895% CI\uff1a4.1 – \u672a\u4f30\u7b97\uff09\uff1b <\/p>\n\n\n\n

\u00b7 \u9884\u4f3012\u4e2a\u6708\u603b\u751f\u5b58\u7387\uff08OS\uff09\u4e3a59%\uff0895% CI\uff1a40-74\uff09\u3002 <\/p>\n\n\n\n

\u8be5\u4e9a\u7ec4\u7684\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DoR\uff09\u5c1a\u672a\u8fbe\u5230\uff0c\u63d0\u793a\u836f\u7269\u7684\u6297\u80bf\u7624\u6d3b\u6027\u5177\u6709\u6301\u4e45\u6027\uff0c\u4e3a\u7ecf\u6cbb\u665a\u671f KRAS G12D \u7a81\u53d8 NSCLC \u60a3\u8005\u63d0\u4f9b\u4e86\u65b0\u7684\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n\n\n\n

3. <\/strong>\u80f0\u817a\u5bfc\u7ba1\u817a\u764c\u4e9a\u7ec4\uff1a\u540e\u7ebf\u6cbb\u7597\u663e\u6d3b\u6027\uff0c\u4e2d\u4f4dOS\u8fbe10.3\u4e2a\u6708<\/strong><\/strong><\/p>\n\n\n\n

21\u4f8b\u63a5\u53d7600mg\u5242\u91cf\u7684\u8f6c\u79fb\u6027\u80f0\u817a\u5bfc\u7ba1\u817a\u764c\u60a3\u8005\uff0c\u5747\u4e3a\u4e8c\u7ebf\u6216\u4e09\u7ebf\u6cbb\u7597\u4eba\u7fa4\uff0c\u5176\u4e2d67%\u4e3a\u4e09\u7ebf\u6cbb\u7597\uff0c\u5373\u5927\u90e8\u5206\u60a3\u8005\u7ecf\u591a\u6b21\u6807\u51c6\u6cbb\u7597\u5931\u8d25\uff0c\u5c5e\u4e8e\u4e34\u5e8a\u96be\u6cbb\u6027\u4eba\u7fa4\u3002\u8be5\u4e9a\u7ec4\u7597\u6548\u6570\u636e\u663e\u793a\uff1a<\/p>\n\n\n\n

\u00b7 \u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a24%\uff0895% CI\uff1a8-47\uff09\uff1b <\/p>\n\n\n\n

\u00b7 \u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08mPFS\uff09\u4e3a3.0\u4e2a\u6708\uff0895% CI\uff1a1.4-6.9\uff09\uff1b <\/p>\n\n\n\n

\u00b7 \u4e2d\u4f4d\u603b\u751f\u5b58\u671f\uff08mOS\uff09\u4e3a10.3\u4e2a\u6708\uff0895% CI\uff1a4.2-13.0\uff09\u3002 <\/p>\n\n\n\n

\u80f0\u817a\u5bfc\u7ba1\u817a\u764c\u56e0\u6076\u6027\u7a0b\u5ea6\u9ad8\u3001\u6cbb\u7597\u624b\u6bb5\u6709\u9650\uff0c\u4e09\u7ebf\u6cbb\u7597\u540e\u7684\u4f20\u7edf\u5316\u7597\u7597\u6548\u8f83\u5dee\uff0cSetidegrasib\u5728\u8be5\u4eba\u7fa4\u4e2d\u5c55\u73b0\u7684\u6297\u80bf\u7624\u6d3b\u6027\uff0c\u4e3a\u665a\u671f KRAS G12D \u7a81\u53d8\u80f0\u817a\u5bfc\u7ba1\u817a\u764c\u60a3\u8005\u586b\u8865\u4e86\u6cbb\u7597\u7a7a\u767d\u3002<\/p>\n\n\n\n

4. <\/strong>\u7814\u7a76\u7ed3\u8bba\u4e0e\u540e\u7eed\u7814\u7a76\u65b9\u5411<\/strong><\/strong><\/p>\n\n\n\n

\u672c\u6b21\u2160\u671f\u4e34\u5e8a\u7814\u7a76\u5f97\u51fa\u660e\u786e\u7ed3\u8bba\uff1aSetidegrasib\u5728\u65e2\u5f80\u7ecf\u6cbb\u7684\u665a\u671f KRAS G12D \u7a81\u53d8\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u548c\u80f0\u817a\u5bfc\u7ba1\u817a\u764c\u60a3\u8005\u4e2d\uff0c\u5c55\u73b0\u51fa\u660e\u786e\u7684\u6297\u80bf\u7624\u6d3b\u6027\uff0c\u4e14\u56e0\u4e0d\u826f\u4e8b\u4ef6\u5bfc\u81f4\u7684\u6cbb\u7597\u505c\u836f\u7387\u6781\u4f4e\uff0c\u836f\u7269\u6574\u4f53\u5b89\u5168\u6027\u53ef\u63a7\u3002<\/p>\n\n\n\n

\u57fa\u4e8e\u672c\u6b21\u2160\u671f\u7814\u7a76\u7684\u79ef\u6781\u7ed3\u679c\uff0cSetidegrasib\u7684\u5168\u7403\u2162\u671f\u4e34\u5e8a\u7814\u7a76\u5df2\u542f\u52a8\u5e76\u8fdb\u5165\u60a3\u8005\u62db\u52df\u9636\u6bb5\uff0c\u540e\u7eed\u5c06\u8fdb\u4e00\u6b65\u9a8c\u8bc1\u836f\u7269\u5728\u5355\u836f\u53ca\u8054\u5408\u6cbb\u7597\u4e2d\u7684\u7597\u6548\uff0c\u540c\u65f6\u63a2\u7d22\u836f\u7269\u5728\u7ed3\u76f4\u80a0\u764c\u7b49\u5176\u4ed6 KRAS G12D \u7a81\u53d8\u5b9e\u4f53\u7624\u4e2d\u7684\u5e94\u7528\u4ef7\u503c\u3002\u6b64\u5916\uff0c\u7814\u7a76\u56e2\u961f\u8fd8\u5c06\u5f00\u5c55\u751f\u7269\u6807\u5fd7\u7269\u5206\u6790\uff0c\u660e\u786e\u836f\u7269\u7597\u6548\u7684\u9884\u6d4b\u56e0\u5b50\uff0c\u4e3a\u5b9e\u73b0\u7cbe\u51c6\u4e2a\u4f53\u5316\u6cbb\u7597\u63d0\u4f9b\u4f9d\u636e\u3002<\/p>\n\n\n\n

5. <\/strong>\u4e34\u5e8a\u610f\u4e49<\/strong><\/strong><\/p>\n\n\n\n

\u672c\u6b21\u53d1\u8868\u4e8eNEJM\u7684\u7814\u7a76\u7ed3\u679c\uff0c\u662f KRAS G12D \u7a81\u53d8\u9776\u5411\u6cbb\u7597\u9886\u57df\u7684\u91cd\u8981\u7a81\u7834\uff1a\u4e00\u65b9\u9762\u9a8c\u8bc1\u4e86\u86cb\u767d\u964d\u89e3\u5242\u9776\u5411 KRAS G12D \u7684\u53ef\u884c\u6027\uff0c\u6253\u7834\u4e86\u8be5\u9776\u70b9\u957f\u671f\u4ee5\u6765\u7684\u6cbb\u7597\u56f0\u5883\uff0c\u4e3a\u540e\u7eed KRAS \u9776\u5411\u836f\u7269\u7814\u53d1\u63d0\u4f9b\u4e86\u65b0\u7684\u6280\u672f\u8def\u5f84\uff1b\u53e6\u4e00\u65b9\u9762\uff0cSetidegrasib\u5728\u7ecf\u6cbb\u665a\u671f\u80ba\u764c\u548c\u80f0\u817a\u764c\u60a3\u8005\u4e2d\u5c55\u73b0\u7684\u7597\u6548\u4e0e\u5b89\u5168\u6027\uff0c\u4e3a\u4e34\u5e8a\u6cbb\u7597\u63d0\u4f9b\u4e86\u65b0\u7684\u9009\u62e9\uff0c\u5c24\u5176\u4e3a\u7f3a\u4e4f\u6709\u6548\u6cbb\u7597\u624b\u6bb5\u7684 KRAS G12D \u7a81\u53d8\u60a3\u8005\u5e26\u6765\u4e86\u65b0\u7684\u5e0c\u671b\u3002<\/p>\n\n\n\n

\u76ee\u524d\uff0c\u9488\u5bf9 KRAS \u7a81\u53d8\u7684\u9776\u5411\u6cbb\u7597\u4ecd\u5728\u5feb\u901f\u53d1\u5c55\uff0c\u4ece\u6700\u521d\u7684 \u201c\u4e0d\u53ef\u6210\u836f\u201d \u5230\u5982\u4eca G12C \u6291\u5236\u5242\u7684\u83b7\u6279\u3001G12D\u964d\u89e3\u5242\u7684\u4e34\u5e8a\u7a81\u7834\uff0c\u4e3a\u80bf\u7624\u7cbe\u51c6\u6cbb\u7597\u5e26\u6765\u4e86\u66f4\u591a\u53ef\u80fd\u3002\u540e\u7eed\u968f\u7740\u5927\u6837\u672c \u2162 \u671f\u4e34\u5e8a\u7814\u7a76\u7684\u5f00\u5c55\uff0c\u6709\u671b\u4e3a Setidegrasib \u7684\u4e34\u5e8a\u5e94\u7528\u63d0\u4f9b\u66f4\u5145\u5206\u7684\u8bc1\u636e\uff0c\u8fdb\u4e00\u6b65\u63a8\u52a8 KRAS G12D \u7a81\u53d8\u5b9e\u4f53\u7624\u7684\u6cbb\u7597\u8fdb\u5c55\u3002<\/p>\n\n\n\n

\u8d44\u6599\u6765\u6e90\uff1a<\/p>\n\n\n\n

https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2600752<\/a><\/p>\n\n\n\n

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