{"id":19258,"date":"2024-05-24T00:00:00","date_gmt":"2024-05-23T16:00:00","guid":{"rendered":"https:\/\/www.franchise.com.hk\/%e5%89%b5%e5%8b%9d%e9%9b%86%e5%9c%98%e6%96%bcasco-2024%e9%a6%96%e6%ac%a1%e5%85%ac%e4%bd%88osemitamab-tst001%e4%b8%89%e8%81%af%e7%99%82%e6%b3%95%e4%b8%80%e7%b7%9a%e6%b2%bb%e7%99%82%e8%83%83%e6%88%96\/19258"},"modified":"2024-05-24T00:00:00","modified_gmt":"2024-05-23T16:00:00","slug":"%e5%89%b5%e5%8b%9d%e9%9b%86%e5%9c%98%e6%96%bcasco-2024%e9%a6%96%e6%ac%a1%e5%85%ac%e4%bd%88osemitamab-tst001%e4%b8%89%e8%81%af%e7%99%82%e6%b3%95%e4%b8%80%e7%b7%9a%e6%b2%bb%e7%99%82%e8%83%83%e6%88%96","status":"publish","type":"post","link":"https:\/\/www.franchise.com.hk\/en\/%e5%89%b5%e5%8b%9d%e9%9b%86%e5%9c%98%e6%96%bcasco-2024%e9%a6%96%e6%ac%a1%e5%85%ac%e4%bd%88osemitamab-tst001%e4%b8%89%e8%81%af%e7%99%82%e6%b3%95%e4%b8%80%e7%b7%9a%e6%b2%bb%e7%99%82%e8%83%83%e6%88%96\/19258","title":{"rendered":"\u5275\u52dd\u96c6\u5718\u65bcASCO 2024\u9996\u6b21\u516c\u4f48Osemitamab (TST001)\u4e09\u806f\u7642\u6cd5\u4e00\u7dda\u6cbb\u7642\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4ee4\u4eba\u9f13\u821e\u7684II\u671f\u81e8\u5e8a\u6578\u64da"},"content":{"rendered":"

II\u671f\u81e8\u5e8a\u7d50\u679c\u986f\u793a\uff0cCLDN18.2\u9ad8\/\u4e2d\u8868\u9054\uff0c\u5305\u62ecPD-L1 CPS<5\u60a3\u8005\u7684\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f\uff08mPFS\uff09\u70ba12.6\u500b\u6708\u3002<\/p>\n

\u7f8e\u570b\u65b0\u6fa4\u897f\u5dde\u666e\u6797\u65af\u9813\u548c\u4e2d\u570b\u8607\u5dde2024\u5e745\u670824\u65e5 \/\u7f8e\u901a\u793e\/ — \u5275\u52dd\u96c6\u5718\uff0806628.HK\uff09\uff0c\u4e00\u5bb6\u5177\u5099\u751f\u7269\u85e5\u54c1\u767c\u73fe\u3001\u7814\u767c\u3001\u5de5\u85dd\u958b\u767c\u548c\u751f\u7522\u5168\u6d41\u7a0b\u6574\u5408\u80fd\u529b\u7684\u81e8\u5e8a\u968e\u6bb5\u7684\u570b\u969b\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u4eca\u65e5\u516c\u4f48Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684I\/IIa\u671fG\u968a\u5217\u7814\u7a76\u6578\u64da\u3002\u8a72\u9805\u7814\u7a76\u7684\u60a3\u8005\u672a\u7d93\u904eCLDN18.2\u548cPD-L1 CPS\u8868\u9054\u7be9\u9078\u5165\u7d44\uff0c\u7814\u7a76\u7d50\u679c\u986f\u793a\u4e09\u806f\u7642\u6cd5\u53d6\u5f97\u4ee4\u4eba\u9f13\u821e\u7684\u7642\u6548\uff0c\u7279\u5225\u5728CLDN18.2\u9ad8\/\u4e2d\u8868\u9054\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff08\u7121\u8ad6PD-L1 CPS\u8868\u9054\u6c34\u5e73\u5982\u4f55\uff09\u5c24\u70ba\u986f\u8457\u3002<\/p>\n

\u7814\u7a76\u7d50\u679c\u8868\u660e\uff0c\u5728CLDN18.2\u9ad8\/\u4e2d\u8868\u9054\uff08\u7121\u8ad6PD-L1\u8868\u9054\u6c34\u5e73\u5982\u4f55\uff09\uff0c\u4ee5\u53ca\u5360\u6bd480%\u7684PD-L1 CPS<5\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f(mPFS)\u9054\u5230\u4e8612.6\u500b\u6708\u3002\u4ee5CLDN18.2\u6975\u4f4e\/\u7121\u8868\u9054\u7684\u60a3\u8005\u7fa4\u9ad4\u4f5c\u70ba\u66ff\u4ee3\u5c0d\u7167\u7d44\uff0c\u4e09\u806f\u7642\u6cd5\u964d\u4f4e\u4e8656%\u7684\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\uff08HR\u70ba0.443\uff0c95%CI\uff0c0.205-0.958\uff09\uff0cCLDN18.2\u9ad8\/\u4e2d\u8868\u9054\u60a3\u8005\u7684\u78ba\u8a8d\u5ba2\u89c0\u7de9\u89e3\u7387\u70ba68%\u3002<\/p>\n

\u5927\u591a\u6578\uff08\u7d0480%\uff09CLDN18.2\u967d\u6027\u60a3\u8005\u70baPD-L1 \u4f4e\u8868\u9054\uff08CPS<5\uff09\u3002\u5148\u524d\u7814\u7a76\u767c\u73fe\uff0c\u7121\u8ad6PD-L1\u8868\u9054\u6c34\u5e73\u5982\u4f55\uff0cZolbetuximab\u548cCAPOX\u7684\u806f\u7528\u53ef\u4ee5\u5c07CLDN18.2\u967d\u6027\u60a3\u8005\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f\u5f9e6.80\u500b\u6708\u63d0\u9ad8\u81f38.21\u500b\u6708\uff08HR = 0.687\uff0895% CI\uff0c0.544-0.866\uff09\uff08\u4f86\u6e90\uff1aShah, Manish A et al. Nature Medicine 2023 Aug 29 (8): 2133-2141\uff09\u3002\u4f46\u662f\uff0c\u5728PD-L1 CPS<5\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u806f\u5408\u5316\u7642\u5728\u7121\u9032\u5c55\u751f\u5b58\u671f\u65b9\u9762\u7684\u7372\u76ca\u975e\u5e38\u5c0f\uff08mPFS 7.5\u500b\u6708vs 8.2\u500b\u6708\uff0cHR=0.93\uff09\uff08\u4f86\u6e90\uff1aCheckmate-649\u7814\u7a76\uff09\u3002I\/IIa\u671fG\u968a\u5217\u6578\u64da\u986f\u793a\uff0cOsemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u7684\u4e09\u806f\u7642\u6cd5\u8207\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u806f\u5408CAPOX\u6216Zolbetuximab\u806f\u5408CAPOX\u7684\u6b77\u53f2\u6578\u64da\u76f8\u6bd4\uff0c\u5177\u6709\u660e\u986f\u7684\u7642\u6548\u512a\u52e2\uff0c\u5305\u62ecPD-L1 CPS<5\u7684\u60a3\u8005\u3002<\/p>\n

Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684I\/IIa\u671fG\u968a\u5217\u7814\u7a76\u6578\u64da\u5c07\u4ee5\u58c1\u5831\u5f62\u5f0f\uff08\u6458\u8981#4048\uff09\u65bc2024\u5e746\u67081\u65e5\u5728\u7f8e\u570b\u829d\u52a0\u54e5\u8209\u8fa6\u7684ASCO 2024\u5e74\u6703\u516c\u4f48\u3002<\/p>\n

\u300c\u8a72II\u671f\u81e8\u5e8a\u7d50\u679c\u6a19\u8a8c\u8457Osemitamab (TST001)\u5728\u7814\u767c\u9032\u7a0b\u4e2d\u53d6\u5f97\u91cd\u8981\u91cc\u7a0b\u7891\uff0c\u6578\u64da\u986f\u793aOsemitamab (TST001)\u5177\u6709\u986f\u8457\u7684\u6297\u816b\u7624\u6548\u679c\uff0c\u7279\u5225\u5728CLDN18.2\u9ad8\/\u4e2d\u8868\u9054\uff08\u5305\u62ecPD-L1 CPS<5\uff09\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\u7642\u509a\u5c24\u70ba\u660e\u986f\uff0c\u9019\u8207\u81e8\u5e8a\u524d\u6578\u64da\u548c\u5047\u8a2d\u7684\u4f5c\u7528\u6a5f\u5236\u76f8\u543b\u5408\u3002\u300d \u5275\u52dd\u96c6\u5718\u5168\u7403\u85e5\u7269\u958b\u767c\u57f7\u884c\u526f\u7e3d\u88c1\uff0c\u9996\u5e2d\u91ab\u5b78\u5b98Caroline Germa\u535a\u58eb\u8868\u793a\uff0c\u300c\u5728\u4e0a\u8ff0\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u4e09\u806f\u7642\u6cd5\u76f8\u8f03\u65bc\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u6216CLDN18.2\u6297\u9ad4\u8207\u5316\u7642\u806f\u7528\uff0c\u53d6\u5f97\u4e86\u66f4\u70ba\u512a\u7570\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f\u7372\u76ca\u3002\u8a72\u7d50\u679c\u9032\u4e00\u6b65\u9a57\u8b49\u4e86\u5df2\u7372\u5f97FDA\u548cCDE\u6279\u51c6\u7684Osemitamab (TST001)\u5168\u7403III\u671f\u8a66\u9a57\u7b56\u7565\u7684\u53ef\u884c\u6027\uff0c\u6211\u5011\u5c07\u52a0\u901f\u63a8\u52d5Osemitamab (TST001)\u7684\u81e8\u5e8a\u9032\u7a0b\uff0c\u4f7f\u5176\u6210\u70ba\u5168\u7403\u6027\u7642\u6cd5\uff0c\u63d0\u5347HER2\u9670\u6027\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u7684\u73fe\u884c\u6a19\u6e96\u6cbb\u7642\u3002\u300d<\/p>\n

\u300c\u9019\u9805\u7814\u7a76\u7684\u81e8\u5e8a\u7d50\u679c\u4ee4\u4eba\u632f\u596e\uff0c\u8a72\u7642\u6cd5\u6709\u671b\u6539\u5584HER2\u9670\u6027\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u60a3\u8005\u7684\u4e00\u7dda\u6cbb\u7642\u6548\u679c\u4e26\u5ef6\u9577\u7121\u9032\u5c55\u751f\u5b58\u671f\u548c\u7e3d\u751f\u5b58\u671f\uff0c\u300d\u5317\u4eac\u5927\u5b78\u816b\u7624\u91ab\u9662\u6d88\u5316\u816b\u7624\u5167\u79d1\u53caI\u671f\u81e8\u5e8a\u8a66\u9a57\u75c5\u5340\u4e3b\u4efb\uff0c\u672c\u6b21\u7814\u7a76\u7684\u4e3b\u8981\u7814\u7a76\u8005\u6c88\u7433\u6559\u6388\u8868\u793a\uff0c\u300c\u6211\u5011\u671f\u5f85\u5728\u5373\u5c07\u5230\u4f86\u7684ASCO 2024\u5e74\u6703\u4e0a\u8207\u5927\u5bb6\u5206\u4eab\u8a73\u7d30\u6578\u64da\u3002\u300d<\/p>\n

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TranStar102\u7814\u7a76G\u968a\u5217(NCT04495296)\u5305\u542b\u5b89\u5168\u5c0e\u5165\u968e\u6bb5\u548c\u5291\u91cf\u64f4\u5c55\u968e\u6bb5\uff0c\u65e8\u5728\u63a2\u7d22Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u7b26\u5408\u5165\u7d44\u689d\u4ef6\u7684\u5c0d\u8c61\u70baHER2\u9670\u6027\u6216\u672a\u77e5\uff0c\u4e0d\u53ef\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u60a3\u8005\uff0c\u7121\u8ad6\u5176CLDN18.2\u6216PD-L1\u7684\u8868\u9054\u6c34\u5e73\u5982\u4f55\u3002\u5728\u4e2d\u5fc3\u5be6\u9a57\u5ba4\uff0c\u6211\u5011\u63a1\u7528Claudin 18.2 IHC 14G11 LDT\u65b9\u6cd5\u548cPD-L1 IHC 28-8 pharmDx\u56de\u9867\u6027\u5206\u6790\u60a3\u8005\u7684CLDN18.2\u548cPD-L1\u8868\u9054\u6c34\u5e73\u3002\u6839\u64da\u6309Claudin 18.2 IHC 14G11 LDT\u65b9\u6cd5\u5f97\u51fa\u7684CLDN18.2\u86cb\u767d\u5728\u816b\u7624\u7d30\u80de\u819c\u67d3\u8272\u7684\u767e\u5206\u6bd4\uff0cCLDN18.2\u8868\u9054\u6c34\u5e73\u5206\u70ba\u4e09\u500b\u4e9e\u7d44\uff1aH\/M\uff08\u9ad8\/\u4e2d\uff09\uff0cL\uff08\u4f4e\uff09\u548cR\uff08\u5176\u9918\uff1a\u66f4\u4f4e\u6216\u9670\u6027\uff09\u3002<\/p>\n

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\u622a\u81f3\u7d71\u8a08\u65e5\u671f\uff0c82\u540d\u60a3\u8005\u5df2\u63a5\u53d7\u6cbb\u7642\uff0c\u4e2d\u4f4d\u96a8\u8a2a\u6642\u9593\u70ba12.6\u500b\u6708\u3002\u5c0d66\u540d\u5df2\u77e5CLDN18.2\u548cPD-L1\u8868\u9054\u6c34\u5e73\u7684\u60a3\u8005\u9032\u884c\u7642\u6548\u5206\u6790\u3002\u7d50\u679c\u986f\u793a\uff0c\u7642\u6548\u8207CLDN18.2\u8868\u9054\u6c34\u5e73\u4e4b\u9593\u5b58\u5728\u660e\u986f\u95dc\u806f\u8da8\u52e2\uff0c\u9ad8\/\u4e2d\u8868\u9054\uff08H\/M\uff09\u60a3\u8005\u7684\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f\uff08mPFS\uff09\u70ba12.6\u500b\u6708\uff0c\u4f4e\u8868\u9054\uff08L\uff09\u60a3\u8005\u70ba8.5\u500b\u6708\uff0c\u5176\u9918\u60a3\u8005\uff08R\uff09\u70ba6.7\u500b\u6708\u3002\u78ba\u8a8d\u5ba2\u89c0\u7de9\u89e3\u7387\u5206\u5225\u70ba68%\u300161.1%\u53ca50%\u3002\u8207R\u7d44\u5c0d\u6bd4\uff0cHM\u7d44\u8207R\u7d44\u7684PFS\u98a8\u96aa\u6bd4\uff08HR\uff09\u70ba0.443\uff0895% CI 0.205, 0.985\uff09\uff0cHML\u7d44\u8207R\u7d44\u7684PFS\u98a8\u96aa\u6bd4\u70ba0.560\uff0895% CI 0.292, 1.074\uff09\u3002\u5728PD-L1 CPS<5\u60a3\u8005\u7fa4\u9ad4\u4e2d\u4e5f\u89c0\u5bdf\u5230\u4e86\u76f8\u540c\u7684\u8da8\u52e2\uff0cCLDN18.2\u9ad8\/\u4e2d\u8868\u9054\u60a3\u8005\u7684mPFS\u5728\u9019\u500b\u4e9e\u7d44\u4e2d\u540c\u6a23\u70ba12.6\u500b\u6708\u3002<\/p>\n

\u53ef\u63a7\u7684\u5b89\u5168\u6027<\/p>\n

\u4e09\u806f\u7642\u6cd5\u7684\u5b89\u5168\u6027\u7279\u5fb5\u8207\u6b64\u524dOsemitamab (TST001)\u806f\u5408CAPOX\u4e00\u7dda\u6cbb\u7642\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u60a3\u8005\u6240\u5c55\u73fe\u7684\u5b89\u5168\u6027\u6578\u64da\u5927\u9ad4\u4e00\u81f4\uff08\u300a\u81e8\u5e8a\u816b\u7624\u5b78\u96dc\u8a8c\u300b\u7b2c41\u5377\uff0c\u7b2c16\u671f\uff0c 2023\u5e746\u67081\u65e5\uff0c\u6458\u8981#4046\uff09\u3002\u4e3b\u8981\u6bd2\u6027\u662f\u53ef\u63a7\u7684\u300con-target-off-tumor\u300d\u6548\u61c9\uff0c\u5305\u62ec\u5641\u5fc3\u3001\u4f4e\u767d\u86cb\u767d\u8840\u75c7\u548c\u5614\u5410\uff0c\u5927\u591a\u70ba1\u7d1a\u62162\u7d1a\u3002<\/p>\n

\u95dc\u65bcOsemitamab (TST001)<\/p>\n

Osemitamab (TST001) \u662f\u4e00\u7a2e\u9ad8\u89aa\u548c\u529b\u7684\u9776\u5411CLDN 18.2\u7684\u4eba\u6e90\u5316\u55ae\u514b\u9686\u6297\u9ad4\uff0c\u5177\u6709\u589e\u5f37\u7684\u6297\u9ad4\u4f9d\u8cf4\u6027\u7d30\u80de\u6bd2\u6027\uff08ADCC\uff09\uff0c\u5728\u7570\u7a2e\u79fb\u690d\u8a66\u9a57\u4e2d\u986f\u793a\u51fa\u5f37\u5927\u7684\u6297\u816b\u7624\u6d3b\u6027\u3002Osemitamab (TST001) \u662f\u5168\u7403\u7bc4\u570d\u5167\u958b\u767c\u7684\u7b2c\u4e8c\u500b\u6700\u5148\u9032\u7684CLDN18.2\u9776\u5411\u6297\u9ad4\u85e5\u7269\uff0c\u7531\u672c\u516c\u53f8\u901a\u904e\u5176\u514d\u75ab\u8010\u53d7\u7a81\u7834(IMTB)\u6280\u8853\u5e73\u53f0\u958b\u767c\u3002Osemitamab (TST001) \u901a\u904eADCC\u6a5f\u5236\u6bba\u6b7b\u8868\u9054CLDN 18.2\u7684\u816b\u7624\u7d30\u80de\u3002\u5229\u7528\u5148\u9032\u7684\u751f\u7269\u52a0\u5de5\u6280\u8853\uff0cOsemitamab (TST001) \u7684\u5dd6\u85fb\u7cd6\u542b\u91cf\u5728\u751f\u7522\u904e\u7a0b\u4e2d\u5927\u5927\u964d\u4f4e\uff0c\u9032\u4e00\u6b65\u589e\u5f37\u4e86Osemitamab (TST001) \u7684NK\u7d30\u80de\u4ecb\u5c0e\u7684ADCC\u6d3b\u6027\u3002\u4e2d\u570b\u548c\u7f8e\u570b\u5747\u4e00\u76f4\u5728\u9032\u884cOsemitamab (TST001) \u7684\u81e8\u5e8a\u8a66\u9a57(TranStar101\/NCT04396821, TranStar102\/NCT04495296)\u3002\u7f8e\u570b\u98df\u54c1\u548c\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40(FDA)\u5df2\u6388\u4e88Osemitamab (TST001) \u7528\u65bc\u6cbb\u7642\u80c3\u764c\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u548c\u80f0\u817a\u764c\u60a3\u8005\u7684\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u3002<\/p>\n

\u95dc\u65bc\u5275\u52dd\u96c6\u5718<\/p>\n

\u5275\u52dd\u96c6\u5718\u662f\u4e00\u5bb6\u81e8\u5e8a\u968e\u6bb5\u7684\u5728\u751f\u7269\u85e5\u767c\u73fe\u3001\u7814\u767c\u3001\u5de5\u85dd\u958b\u767c\u548c\u751f\u7522\u65b9\u9762\u5177\u6709\u5168\u9762\u7d9c\u5408\u80fd\u529b\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\u3002<\/p>\n

\u5275\u52dd\u96c6\u5718\u7e3d\u90e8\u4f4d\u65bc\u8607\u5dde\uff0c\u5df2\u6210\u529f\u642d\u5efa\u4e86\u5168\u7403\u7684\u696d\u52d9\u4f48\u5c40\uff1a\u5728\u8607\u5dde\u8a2d\u6709\u85e5\u7269\u767c\u73fe\u3001\u81e8\u5e8a\u548c\u8f49\u5316\u7814\u7a76\u4e2d\u5fc3\uff0c\u5275\u52dd\u96c6\u5718\u7e3d\u90e8\u53ca\u4ee5\u9023\u7e8c\u704c\u6d41\u751f\u7522\u5de5\u85dd\u70ba\u6838\u5fc3\u6280\u8853\u7684\u751f\u7522\u57fa\u5730\u4e5f\u6b63\u5728\u5efa\u8a2d\u4e2d\u3002\u5728\u676d\u5dde\u64c1\u6709\u5de5\u85dd\u8207\u7522\u54c1\u958b\u767c\u4e2d\u5fc3\u4ee5\u53ca\u85e5\u7269\u751f\u7522\u57fa\u5730\uff0c\u5728\u7f8e\u570b\u666e\u6797\u65af\u9813\u3001\u5317\u4eac\u3001\u4e0a\u6d77\u3001\u5ee3\u5dde\u5206\u5225\u8a2d\u6709\u81e8\u5e8a\u958b\u767c\u4e2d\u5fc3\uff0c\u4e26\u5728\u7f8e\u570b\u6ce2\u58eb\u9813\u3001\u6d1b\u6749\u78ef\u8a2d\u7acb\u4e86\u696d\u52d9\u62d3\u5c55\u4e2d\u5fc3\u3002\u5275\u52dd\u96c6\u5718\u7684\u958b\u767c\u7ba1\u7dda\u5df2\u6709\u5341\u4e09\u500b\u6cbb\u7642\u7528\u6297\u9ad4\u65b0\u85e5\u5206\u5b50\uff0c\u6db5\u84cb\u816b\u7624\u3001\u9aa8\u79d1\u548c\u814e\u75c5\u7b49\u9818\u57df\u3002<\/p>\n

\u5982\u9700\u77ad\u89e3\u95dc\u65bc\u5275\u52dd\u96c6\u5718\u7684\u66f4\u591a\u4fe1\u606f\uff0c\u8acb\u8a2a\u554f\u516c\u53f8\u7db2\u7ad9\uff1awww.transcenta.com<\/a> \u6216\u9818\u82f1\u8cec\u865f\uff1aTranscenta\u3002<\/p>\n

\u672c\u6587\u4e2d\u7684\u6240\u6709\u5546\u6a19\u548c\u8a3b\u518a\u5546\u6a19\u5747\u70ba\u5404\u81ea\u6240\u6709\u8005\u7684\u8ca1\u7522\u3002<\/p>","protected":false},"excerpt":{"rendered":"

II\u671f\u81e8\u5e8a\u7d50\u679c\u986f\u793a\uff0cCLDN18.2\u9ad8\/\u4e2d\u8868\u9054\uff0c\u5305\u62ecPD-L1 CPS<5\u60a3\u8005\u7684\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f\uff08mPFS\uff09\u70ba12.6\u500b\u6708\u3002 \u7f8e\u570b\u65b0\u6fa4\u897f\u5dde\u666e\u6797\u65af\u9813\u548c\u4e2d\u570b\u8607\u5dde2024\u5e745\u670824\u65e5 \/\u7f8e\u901a\u793e\/ — \u5275\u52dd\u96c6\u5718\uff0806628.HK\uff09\uff0c\u4e00\u5bb6\u5177\u5099\u751f\u7269\u85e5\u54c1\u767c\u73fe\u3001\u7814\u767c\u3001\u5de5\u85dd\u958b\u767c\u548c\u751f\u7522\u5168\u6d41\u7a0b\u6574\u5408\u80fd\u529b\u7684\u81e8\u5e8a\u968e\u6bb5\u7684\u570b\u969b\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u4eca\u65e5\u516c\u4f48Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684I\/IIa\u671fG\u968a\u5217\u7814\u7a76\u6578\u64da\u3002\u8a72\u9805\u7814\u7a76\u7684\u60a3\u8005\u672a\u7d93\u904eCLDN18.2\u548cPD-L1 CPS\u8868\u9054\u7be9\u9078\u5165\u7d44\uff0c\u7814\u7a76\u7d50\u679c\u986f\u793a\u4e09\u806f\u7642\u6cd5\u53d6\u5f97\u4ee4\u4eba\u9f13\u821e\u7684\u7642\u6548\uff0c\u7279\u5225\u5728CLDN18.2\u9ad8\/\u4e2d\u8868\u9054\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff08\u7121\u8ad6PD-L1 CPS\u8868\u9054\u6c34\u5e73\u5982\u4f55\uff09\u5c24\u70ba\u986f\u8457\u3002 \u7814\u7a76\u7d50\u679c\u8868\u660e\uff0c\u5728CLDN18.2\u9ad8\/\u4e2d\u8868\u9054\uff08\u7121\u8ad6PD-L1\u8868\u9054\u6c34\u5e73\u5982\u4f55\uff09\uff0c\u4ee5\u53ca\u5360\u6bd480%\u7684PD-L1 CPS<5\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f(mPFS)\u9054\u5230\u4e8612.6\u500b\u6708\u3002\u4ee5CLDN18.2\u6975\u4f4e\/\u7121\u8868\u9054\u7684\u60a3\u8005\u7fa4\u9ad4\u4f5c\u70ba\u66ff\u4ee3\u5c0d\u7167\u7d44\uff0c\u4e09\u806f\u7642\u6cd5\u964d\u4f4e\u4e8656%\u7684\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\uff08HR\u70ba0.443\uff0c95%CI\uff0c0.205-0.958\uff09\uff0cCLDN18.2\u9ad8\/\u4e2d\u8868\u9054\u60a3\u8005\u7684\u78ba\u8a8d\u5ba2\u89c0\u7de9\u89e3\u7387\u70ba68%\u3002 \u5927\u591a\u6578\uff08\u7d0480%\uff09CLDN18.2\u967d\u6027\u60a3\u8005\u70baPD-L1 \u4f4e\u8868\u9054\uff08CPS<5\uff09\u3002\u5148\u524d\u7814\u7a76\u767c\u73fe\uff0c\u7121\u8ad6PD-L1\u8868\u9054\u6c34\u5e73\u5982\u4f55\uff0cZolbetuximab\u548cCAPOX\u7684\u806f\u7528\u53ef\u4ee5\u5c07CLDN18.2\u967d\u6027\u60a3\u8005\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f\u5f9e6.80\u500b\u6708\u63d0\u9ad8\u81f38.21\u500b\u6708\uff08HR = 0.687\uff0895% CI\uff0c0.544-0.866\uff09\uff08\u4f86\u6e90\uff1aShah, Manish A et al. Nature Medicine 2023 Aug 29 (8): 2133-2141\uff09\u3002\u4f46\u662f\uff0c\u5728PD-L1 CPS<5\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u806f\u5408\u5316\u7642\u5728\u7121\u9032\u5c55\u751f\u5b58\u671f\u65b9\u9762\u7684\u7372\u76ca\u975e\u5e38\u5c0f\uff08mPFS 7.5\u500b\u6708vs 8.2\u500b\u6708\uff0cHR=0.93\uff09\uff08\u4f86\u6e90\uff1aCheckmate-649\u7814\u7a76\uff09\u3002I\/IIa\u671fG\u968a\u5217\u6578\u64da\u986f\u793a\uff0cOsemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u7684\u4e09\u806f\u7642\u6cd5\u8207\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u806f\u5408CAPOX\u6216Zolbetuximab\u806f\u5408CAPOX\u7684\u6b77\u53f2\u6578\u64da\u76f8\u6bd4\uff0c\u5177\u6709\u660e\u986f\u7684\u7642\u6548\u512a\u52e2\uff0c\u5305\u62ecPD-L1 CPS<5\u7684\u60a3\u8005\u3002 Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684I\/IIa\u671fG\u968a\u5217\u7814\u7a76\u6578\u64da\u5c07\u4ee5\u58c1\u5831\u5f62\u5f0f\uff08\u6458\u8981#4048\uff09\u65bc2024\u5e746\u67081\u65e5\u5728\u7f8e\u570b\u829d\u52a0\u54e5\u8209\u8fa6\u7684ASCO 2024\u5e74\u6703\u516c\u4f48\u3002 \u300c\u8a72II\u671f\u81e8\u5e8a\u7d50\u679c\u6a19\u8a8c\u8457Osemitamab (TST001)\u5728\u7814\u767c\u9032\u7a0b\u4e2d\u53d6\u5f97\u91cd\u8981\u91cc\u7a0b\u7891\uff0c\u6578\u64da\u986f\u793aOsemitamab (TST001)\u5177\u6709\u986f\u8457\u7684\u6297\u816b\u7624\u6548\u679c\uff0c\u7279\u5225\u5728CLDN18.2\u9ad8\/\u4e2d\u8868\u9054\uff08\u5305\u62ecPD-L1 CPS<5\uff09\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\u7642\u509a\u5c24\u70ba\u660e\u986f\uff0c\u9019\u8207\u81e8\u5e8a\u524d\u6578\u64da\u548c\u5047\u8a2d\u7684\u4f5c\u7528\u6a5f\u5236\u76f8\u543b\u5408\u3002\u300d \u5275\u52dd\u96c6\u5718\u5168\u7403\u85e5\u7269\u958b\u767c\u57f7\u884c\u526f\u7e3d\u88c1\uff0c\u9996\u5e2d\u91ab\u5b78\u5b98Caroline Germa\u535a\u58eb\u8868\u793a\uff0c\u300c\u5728\u4e0a\u8ff0\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u4e09\u806f\u7642\u6cd5\u76f8\u8f03\u65bc\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u6216CLDN18.2\u6297\u9ad4\u8207\u5316\u7642\u806f\u7528\uff0c\u53d6\u5f97\u4e86\u66f4\u70ba\u512a\u7570\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f\u7372\u76ca\u3002\u8a72\u7d50\u679c\u9032\u4e00\u6b65\u9a57\u8b49\u4e86\u5df2\u7372\u5f97FDA\u548cCDE\u6279\u51c6\u7684Osemitamab (TST001)\u5168\u7403III\u671f\u8a66\u9a57\u7b56\u7565\u7684\u53ef\u884c\u6027\uff0c\u6211\u5011\u5c07\u52a0\u901f\u63a8\u52d5Osemitamab (TST001)\u7684\u81e8\u5e8a\u9032\u7a0b\uff0c\u4f7f\u5176\u6210\u70ba\u5168\u7403\u6027\u7642\u6cd5\uff0c\u63d0\u5347HER2\u9670\u6027\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u7684\u73fe\u884c\u6a19\u6e96\u6cbb\u7642\u3002\u300d 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TranStar102\u7814\u7a76G\u968a\u5217(NCT04495296)\u5305\u542b\u5b89\u5168\u5c0e\u5165\u968e\u6bb5\u548c\u5291\u91cf\u64f4\u5c55\u968e\u6bb5\uff0c\u65e8\u5728\u63a2\u7d22Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u7b26\u5408\u5165\u7d44\u689d\u4ef6\u7684\u5c0d\u8c61\u70baHER2\u9670\u6027\u6216\u672a\u77e5\uff0c\u4e0d\u53ef\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u60a3\u8005\uff0c\u7121\u8ad6\u5176CLDN18.2\u6216PD-L1\u7684\u8868\u9054\u6c34\u5e73\u5982\u4f55\u3002\u5728\u4e2d\u5fc3\u5be6\u9a57\u5ba4\uff0c\u6211\u5011\u63a1\u7528Claudin 18.2 IHC 14G11 LDT\u65b9\u6cd5\u548cPD-L1 IHC 28-8 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CPS<5\u60a3\u8005\u7684\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f\uff08mPFS\uff09\u70ba12.6\u500b\u6708\u3002 \u7f8e\u570b\u65b0\u6fa4\u897f\u5dde\u666e\u6797\u65af\u9813\u548c\u4e2d\u570b\u8607\u5dde2024\u5e745\u670824\u65e5 \/\u7f8e\u901a\u793e\/ — \u5275\u52dd\u96c6\u5718\uff0806628.HK\uff09\uff0c\u4e00\u5bb6\u5177\u5099\u751f\u7269\u85e5\u54c1\u767c\u73fe\u3001\u7814\u767c\u3001\u5de5\u85dd\u958b\u767c\u548c\u751f\u7522\u5168\u6d41\u7a0b\u6574\u5408\u80fd\u529b\u7684\u81e8\u5e8a\u968e\u6bb5\u7684\u570b\u969b\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u4eca\u65e5\u516c\u4f48Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684I\/IIa\u671fG\u968a\u5217\u7814\u7a76\u6578\u64da\u3002\u8a72\u9805\u7814\u7a76\u7684\u60a3\u8005\u672a\u7d93\u904eCLDN18.2\u548cPD-L1 CPS\u8868\u9054\u7be9\u9078\u5165\u7d44\uff0c\u7814\u7a76\u7d50\u679c\u986f\u793a\u4e09\u806f\u7642\u6cd5\u53d6\u5f97\u4ee4\u4eba\u9f13\u821e\u7684\u7642\u6548\uff0c\u7279\u5225\u5728CLDN18.2\u9ad8\/\u4e2d\u8868\u9054\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff08\u7121\u8ad6PD-L1 CPS\u8868\u9054\u6c34\u5e73\u5982\u4f55\uff09\u5c24\u70ba\u986f\u8457\u3002 \u7814\u7a76\u7d50\u679c\u8868\u660e\uff0c\u5728CLDN18.2\u9ad8\/\u4e2d\u8868\u9054\uff08\u7121\u8ad6PD-L1\u8868\u9054\u6c34\u5e73\u5982\u4f55\uff09\uff0c\u4ee5\u53ca\u5360\u6bd480%\u7684PD-L1 CPS<5\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f(mPFS)\u9054\u5230\u4e8612.6\u500b\u6708\u3002\u4ee5CLDN18.2\u6975\u4f4e\/\u7121\u8868\u9054\u7684\u60a3\u8005\u7fa4\u9ad4\u4f5c\u70ba\u66ff\u4ee3\u5c0d\u7167\u7d44\uff0c\u4e09\u806f\u7642\u6cd5\u964d\u4f4e\u4e8656%\u7684\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\uff08HR\u70ba0.443\uff0c95%CI\uff0c0.205-0.958\uff09\uff0cCLDN18.2\u9ad8\/\u4e2d\u8868\u9054\u60a3\u8005\u7684\u78ba\u8a8d\u5ba2\u89c0\u7de9\u89e3\u7387\u70ba68%\u3002 \u5927\u591a\u6578\uff08\u7d0480%\uff09CLDN18.2\u967d\u6027\u60a3\u8005\u70baPD-L1 \u4f4e\u8868\u9054\uff08CPS<5\uff09\u3002\u5148\u524d\u7814\u7a76\u767c\u73fe\uff0c\u7121\u8ad6PD-L1\u8868\u9054\u6c34\u5e73\u5982\u4f55\uff0cZolbetuximab\u548cCAPOX\u7684\u806f\u7528\u53ef\u4ee5\u5c07CLDN18.2\u967d\u6027\u60a3\u8005\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f\u5f9e6.80\u500b\u6708\u63d0\u9ad8\u81f38.21\u500b\u6708\uff08HR = 0.687\uff0895% CI\uff0c0.544-0.866\uff09\uff08\u4f86\u6e90\uff1aShah, Manish A et al. Nature Medicine 2023 Aug 29 (8): 2133-2141\uff09\u3002\u4f46\u662f\uff0c\u5728PD-L1 CPS<5\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u806f\u5408\u5316\u7642\u5728\u7121\u9032\u5c55\u751f\u5b58\u671f\u65b9\u9762\u7684\u7372\u76ca\u975e\u5e38\u5c0f\uff08mPFS 7.5\u500b\u6708vs 8.2\u500b\u6708\uff0cHR=0.93\uff09\uff08\u4f86\u6e90\uff1aCheckmate-649\u7814\u7a76\uff09\u3002I\/IIa\u671fG\u968a\u5217\u6578\u64da\u986f\u793a\uff0cOsemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u7684\u4e09\u806f\u7642\u6cd5\u8207\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u806f\u5408CAPOX\u6216Zolbetuximab\u806f\u5408CAPOX\u7684\u6b77\u53f2\u6578\u64da\u76f8\u6bd4\uff0c\u5177\u6709\u660e\u986f\u7684\u7642\u6548\u512a\u52e2\uff0c\u5305\u62ecPD-L1 CPS<5\u7684\u60a3\u8005\u3002 Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684I\/IIa\u671fG\u968a\u5217\u7814\u7a76\u6578\u64da\u5c07\u4ee5\u58c1\u5831\u5f62\u5f0f\uff08\u6458\u8981#4048\uff09\u65bc2024\u5e746\u67081\u65e5\u5728\u7f8e\u570b\u829d\u52a0\u54e5\u8209\u8fa6\u7684ASCO 2024\u5e74\u6703\u516c\u4f48\u3002 \u300c\u8a72II\u671f\u81e8\u5e8a\u7d50\u679c\u6a19\u8a8c\u8457Osemitamab (TST001)\u5728\u7814\u767c\u9032\u7a0b\u4e2d\u53d6\u5f97\u91cd\u8981\u91cc\u7a0b\u7891\uff0c\u6578\u64da\u986f\u793aOsemitamab (TST001)\u5177\u6709\u986f\u8457\u7684\u6297\u816b\u7624\u6548\u679c\uff0c\u7279\u5225\u5728CLDN18.2\u9ad8\/\u4e2d\u8868\u9054\uff08\u5305\u62ecPD-L1 CPS<5\uff09\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\u7642\u509a\u5c24\u70ba\u660e\u986f\uff0c\u9019\u8207\u81e8\u5e8a\u524d\u6578\u64da\u548c\u5047\u8a2d\u7684\u4f5c\u7528\u6a5f\u5236\u76f8\u543b\u5408\u3002\u300d \u5275\u52dd\u96c6\u5718\u5168\u7403\u85e5\u7269\u958b\u767c\u57f7\u884c\u526f\u7e3d\u88c1\uff0c\u9996\u5e2d\u91ab\u5b78\u5b98Caroline Germa\u535a\u58eb\u8868\u793a\uff0c\u300c\u5728\u4e0a\u8ff0\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u4e09\u806f\u7642\u6cd5\u76f8\u8f03\u65bc\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u6216CLDN18.2\u6297\u9ad4\u8207\u5316\u7642\u806f\u7528\uff0c\u53d6\u5f97\u4e86\u66f4\u70ba\u512a\u7570\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f\u7372\u76ca\u3002\u8a72\u7d50\u679c\u9032\u4e00\u6b65\u9a57\u8b49\u4e86\u5df2\u7372\u5f97FDA\u548cCDE\u6279\u51c6\u7684Osemitamab (TST001)\u5168\u7403III\u671f\u8a66\u9a57\u7b56\u7565\u7684\u53ef\u884c\u6027\uff0c\u6211\u5011\u5c07\u52a0\u901f\u63a8\u52d5Osemitamab (TST001)\u7684\u81e8\u5e8a\u9032\u7a0b\uff0c\u4f7f\u5176\u6210\u70ba\u5168\u7403\u6027\u7642\u6cd5\uff0c\u63d0\u5347HER2\u9670\u6027\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u7684\u73fe\u884c\u6a19\u6e96\u6cbb\u7642\u3002\u300d \u300c\u9019\u9805\u7814\u7a76\u7684\u81e8\u5e8a\u7d50\u679c\u4ee4\u4eba\u632f\u596e\uff0c\u8a72\u7642\u6cd5\u6709\u671b\u6539\u5584HER2\u9670\u6027\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u60a3\u8005\u7684\u4e00\u7dda\u6cbb\u7642\u6548\u679c\u4e26\u5ef6\u9577\u7121\u9032\u5c55\u751f\u5b58\u671f\u548c\u7e3d\u751f\u5b58\u671f\uff0c\u300d\u5317\u4eac\u5927\u5b78\u816b\u7624\u91ab\u9662\u6d88\u5316\u816b\u7624\u5167\u79d1\u53caI\u671f\u81e8\u5e8a\u8a66\u9a57\u75c5\u5340\u4e3b\u4efb\uff0c\u672c\u6b21\u7814\u7a76\u7684\u4e3b\u8981\u7814\u7a76\u8005\u6c88\u7433\u6559\u6388\u8868\u793a\uff0c\u300c\u6211\u5011\u671f\u5f85\u5728\u5373\u5c07\u5230\u4f86\u7684ASCO 2024\u5e74\u6703\u4e0a\u8207\u5927\u5bb6\u5206\u4eab\u8a73\u7d30\u6578\u64da\u3002\u300d \u7814\u7a76\u6982\u8981\u5982\u4e0b\uff1a \u8a66\u9a57\u8a2d\u8a08 TranStar102\u7814\u7a76G\u968a\u5217(NCT04495296)\u5305\u542b\u5b89\u5168\u5c0e\u5165\u968e\u6bb5\u548c\u5291\u91cf\u64f4\u5c55\u968e\u6bb5\uff0c\u65e8\u5728\u63a2\u7d22Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u7b26\u5408\u5165\u7d44\u689d\u4ef6\u7684\u5c0d\u8c61\u70baHER2\u9670\u6027\u6216\u672a\u77e5\uff0c\u4e0d\u53ef\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u60a3\u8005\uff0c\u7121\u8ad6\u5176CLDN18.2\u6216PD-L1\u7684\u8868\u9054\u6c34\u5e73\u5982\u4f55\u3002\u5728\u4e2d\u5fc3\u5be6\u9a57\u5ba4\uff0c\u6211\u5011\u63a1\u7528Claudin 18.2 IHC 14G11 LDT\u65b9\u6cd5\u548cPD-L1 IHC 28-8 pharmDx\u56de\u9867\u6027\u5206\u6790\u60a3\u8005\u7684CLDN18.2\u548cPD-L1\u8868\u9054\u6c34\u5e73\u3002\u6839\u64da\u6309Claudin 18.2 IHC 14G11 LDT\u65b9\u6cd5\u5f97\u51fa\u7684CLDN18.2\u86cb\u767d\u5728\u816b\u7624\u7d30\u80de\u819c\u67d3\u8272\u7684\u767e\u5206\u6bd4\uff0cCLDN18.2\u8868\u9054\u6c34\u5e73\u5206\u70ba\u4e09\u500b\u4e9e\u7d44\uff1aH\/M\uff08\u9ad8\/\u4e2d\uff09\uff0cL\uff08\u4f4e\uff09\u548cR\uff08\u5176\u9918\uff1a\u66f4\u4f4e\u6216\u9670\u6027\uff09\u3002 \u4ee4\u4eba\u9f13\u821e\u7684\u5ba2\u89c0\u7de9\u89e3\u7387\u8207\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f \u622a\u81f3\u7d71\u8a08\u65e5\u671f\uff0c82\u540d\u60a3\u8005\u5df2\u63a5\u53d7\u6cbb\u7642\uff0c\u4e2d\u4f4d\u96a8\u8a2a\u6642\u9593\u70ba12.6\u500b\u6708\u3002\u5c0d66\u540d\u5df2\u77e5CLDN18.2\u548cPD-L1\u8868\u9054\u6c34\u5e73\u7684\u60a3\u8005\u9032\u884c\u7642\u6548\u5206\u6790\u3002\u7d50\u679c\u986f\u793a\uff0c\u7642\u6548\u8207CLDN18.2\u8868\u9054\u6c34\u5e73\u4e4b\u9593\u5b58\u5728\u660e\u986f\u95dc\u806f\u8da8\u52e2\uff0c\u9ad8\/\u4e2d\u8868\u9054\uff08H\/M\uff09\u60a3\u8005\u7684\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f\uff08mPFS\uff09\u70ba12.6\u500b\u6708\uff0c\u4f4e\u8868\u9054\uff08L\uff09\u60a3\u8005\u70ba8.5\u500b\u6708\uff0c\u5176\u9918\u60a3\u8005\uff08R\uff09\u70ba6.7\u500b\u6708\u3002\u78ba\u8a8d\u5ba2\u89c0\u7de9\u89e3\u7387\u5206\u5225\u70ba68%\u300161.1%\u53ca50%\u3002\u8207R\u7d44\u5c0d\u6bd4\uff0cHM\u7d44\u8207R\u7d44\u7684PFS\u98a8\u96aa\u6bd4\uff08HR\uff09\u70ba0.443\uff0895% CI 0.205, 0.985\uff09\uff0cHML\u7d44\u8207R\u7d44\u7684PFS\u98a8\u96aa\u6bd4\u70ba0.560\uff0895% CI 0.292, 1.074\uff09\u3002\u5728PD-L1 CPS<5\u60a3\u8005\u7fa4\u9ad4\u4e2d\u4e5f\u89c0\u5bdf\u5230\u4e86\u76f8\u540c\u7684\u8da8\u52e2\uff0cCLDN18.2\u9ad8\/\u4e2d\u8868\u9054\u60a3\u8005\u7684mPFS\u5728\u9019\u500b\u4e9e\u7d44\u4e2d\u540c\u6a23\u70ba12.6\u500b\u6708\u3002 \u53ef\u63a7\u7684\u5b89\u5168\u6027 \u4e09\u806f\u7642\u6cd5\u7684\u5b89\u5168\u6027\u7279\u5fb5\u8207\u6b64\u524dOsemitamab (TST001)\u806f\u5408CAPOX\u4e00\u7dda\u6cbb\u7642\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u60a3\u8005\u6240\u5c55\u73fe\u7684\u5b89\u5168\u6027\u6578\u64da\u5927\u9ad4\u4e00\u81f4\uff08\u300a\u81e8\u5e8a\u816b\u7624\u5b78\u96dc\u8a8c\u300b\u7b2c41\u5377\uff0c\u7b2c16\u671f\uff0c 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CPS<5\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f(mPFS)\u9054\u5230\u4e8612.6\u500b\u6708\u3002\u4ee5CLDN18.2\u6975\u4f4e\/\u7121\u8868\u9054\u7684\u60a3\u8005\u7fa4\u9ad4\u4f5c\u70ba\u66ff\u4ee3\u5c0d\u7167\u7d44\uff0c\u4e09\u806f\u7642\u6cd5\u964d\u4f4e\u4e8656%\u7684\u75be\u75c5\u9032\u5c55\u6216\u6b7b\u4ea1\u7684\u98a8\u96aa\uff08HR\u70ba0.443\uff0c95%CI\uff0c0.205-0.958\uff09\uff0cCLDN18.2\u9ad8\/\u4e2d\u8868\u9054\u60a3\u8005\u7684\u78ba\u8a8d\u5ba2\u89c0\u7de9\u89e3\u7387\u70ba68%\u3002 \u5927\u591a\u6578\uff08\u7d0480%\uff09CLDN18.2\u967d\u6027\u60a3\u8005\u70baPD-L1 \u4f4e\u8868\u9054\uff08CPS<5\uff09\u3002\u5148\u524d\u7814\u7a76\u767c\u73fe\uff0c\u7121\u8ad6PD-L1\u8868\u9054\u6c34\u5e73\u5982\u4f55\uff0cZolbetuximab\u548cCAPOX\u7684\u806f\u7528\u53ef\u4ee5\u5c07CLDN18.2\u967d\u6027\u60a3\u8005\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f\u5f9e6.80\u500b\u6708\u63d0\u9ad8\u81f38.21\u500b\u6708\uff08HR = 0.687\uff0895% CI\uff0c0.544-0.866\uff09\uff08\u4f86\u6e90\uff1aShah, Manish A et al. Nature Medicine 2023 Aug 29 (8): 2133-2141\uff09\u3002\u4f46\u662f\uff0c\u5728PD-L1 CPS<5\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u806f\u5408\u5316\u7642\u5728\u7121\u9032\u5c55\u751f\u5b58\u671f\u65b9\u9762\u7684\u7372\u76ca\u975e\u5e38\u5c0f\uff08mPFS 7.5\u500b\u6708vs 8.2\u500b\u6708\uff0cHR=0.93\uff09\uff08\u4f86\u6e90\uff1aCheckmate-649\u7814\u7a76\uff09\u3002I\/IIa\u671fG\u968a\u5217\u6578\u64da\u986f\u793a\uff0cOsemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u7684\u4e09\u806f\u7642\u6cd5\u8207\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u806f\u5408CAPOX\u6216Zolbetuximab\u806f\u5408CAPOX\u7684\u6b77\u53f2\u6578\u64da\u76f8\u6bd4\uff0c\u5177\u6709\u660e\u986f\u7684\u7642\u6548\u512a\u52e2\uff0c\u5305\u62ecPD-L1 CPS<5\u7684\u60a3\u8005\u3002 Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684I\/IIa\u671fG\u968a\u5217\u7814\u7a76\u6578\u64da\u5c07\u4ee5\u58c1\u5831\u5f62\u5f0f\uff08\u6458\u8981#4048\uff09\u65bc2024\u5e746\u67081\u65e5\u5728\u7f8e\u570b\u829d\u52a0\u54e5\u8209\u8fa6\u7684ASCO 2024\u5e74\u6703\u516c\u4f48\u3002 \u300c\u8a72II\u671f\u81e8\u5e8a\u7d50\u679c\u6a19\u8a8c\u8457Osemitamab (TST001)\u5728\u7814\u767c\u9032\u7a0b\u4e2d\u53d6\u5f97\u91cd\u8981\u91cc\u7a0b\u7891\uff0c\u6578\u64da\u986f\u793aOsemitamab (TST001)\u5177\u6709\u986f\u8457\u7684\u6297\u816b\u7624\u6548\u679c\uff0c\u7279\u5225\u5728CLDN18.2\u9ad8\/\u4e2d\u8868\u9054\uff08\u5305\u62ecPD-L1 CPS<5\uff09\u7684\u60a3\u8005\u7fa4\u9ad4\u4e2d\u7642\u509a\u5c24\u70ba\u660e\u986f\uff0c\u9019\u8207\u81e8\u5e8a\u524d\u6578\u64da\u548c\u5047\u8a2d\u7684\u4f5c\u7528\u6a5f\u5236\u76f8\u543b\u5408\u3002\u300d \u5275\u52dd\u96c6\u5718\u5168\u7403\u85e5\u7269\u958b\u767c\u57f7\u884c\u526f\u7e3d\u88c1\uff0c\u9996\u5e2d\u91ab\u5b78\u5b98Caroline Germa\u535a\u58eb\u8868\u793a\uff0c\u300c\u5728\u4e0a\u8ff0\u60a3\u8005\u7fa4\u9ad4\u4e2d\uff0c\u4e09\u806f\u7642\u6cd5\u76f8\u8f03\u65bc\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\u6216CLDN18.2\u6297\u9ad4\u8207\u5316\u7642\u806f\u7528\uff0c\u53d6\u5f97\u4e86\u66f4\u70ba\u512a\u7570\u7684\u7121\u9032\u5c55\u751f\u5b58\u671f\u7372\u76ca\u3002\u8a72\u7d50\u679c\u9032\u4e00\u6b65\u9a57\u8b49\u4e86\u5df2\u7372\u5f97FDA\u548cCDE\u6279\u51c6\u7684Osemitamab (TST001)\u5168\u7403III\u671f\u8a66\u9a57\u7b56\u7565\u7684\u53ef\u884c\u6027\uff0c\u6211\u5011\u5c07\u52a0\u901f\u63a8\u52d5Osemitamab (TST001)\u7684\u81e8\u5e8a\u9032\u7a0b\uff0c\u4f7f\u5176\u6210\u70ba\u5168\u7403\u6027\u7642\u6cd5\uff0c\u63d0\u5347HER2\u9670\u6027\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u7684\u73fe\u884c\u6a19\u6e96\u6cbb\u7642\u3002\u300d \u300c\u9019\u9805\u7814\u7a76\u7684\u81e8\u5e8a\u7d50\u679c\u4ee4\u4eba\u632f\u596e\uff0c\u8a72\u7642\u6cd5\u6709\u671b\u6539\u5584HER2\u9670\u6027\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u60a3\u8005\u7684\u4e00\u7dda\u6cbb\u7642\u6548\u679c\u4e26\u5ef6\u9577\u7121\u9032\u5c55\u751f\u5b58\u671f\u548c\u7e3d\u751f\u5b58\u671f\uff0c\u300d\u5317\u4eac\u5927\u5b78\u816b\u7624\u91ab\u9662\u6d88\u5316\u816b\u7624\u5167\u79d1\u53caI\u671f\u81e8\u5e8a\u8a66\u9a57\u75c5\u5340\u4e3b\u4efb\uff0c\u672c\u6b21\u7814\u7a76\u7684\u4e3b\u8981\u7814\u7a76\u8005\u6c88\u7433\u6559\u6388\u8868\u793a\uff0c\u300c\u6211\u5011\u671f\u5f85\u5728\u5373\u5c07\u5230\u4f86\u7684ASCO 2024\u5e74\u6703\u4e0a\u8207\u5927\u5bb6\u5206\u4eab\u8a73\u7d30\u6578\u64da\u3002\u300d \u7814\u7a76\u6982\u8981\u5982\u4e0b\uff1a \u8a66\u9a57\u8a2d\u8a08 TranStar102\u7814\u7a76G\u968a\u5217(NCT04495296)\u5305\u542b\u5b89\u5168\u5c0e\u5165\u968e\u6bb5\u548c\u5291\u91cf\u64f4\u5c55\u968e\u6bb5\uff0c\u65e8\u5728\u63a2\u7d22Osemitamab (TST001)\u806f\u5408\u7d0d\u6b66\u5229\u5c24\u55ae\u6297\u548cCAPOX\u4f5c\u70ba\u665a\u671f\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u4e00\u7dda\u6cbb\u7642\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u7b26\u5408\u5165\u7d44\u689d\u4ef6\u7684\u5c0d\u8c61\u70baHER2\u9670\u6027\u6216\u672a\u77e5\uff0c\u4e0d\u53ef\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u60a3\u8005\uff0c\u7121\u8ad6\u5176CLDN18.2\u6216PD-L1\u7684\u8868\u9054\u6c34\u5e73\u5982\u4f55\u3002\u5728\u4e2d\u5fc3\u5be6\u9a57\u5ba4\uff0c\u6211\u5011\u63a1\u7528Claudin 18.2 IHC 14G11 LDT\u65b9\u6cd5\u548cPD-L1 IHC 28-8 pharmDx\u56de\u9867\u6027\u5206\u6790\u60a3\u8005\u7684CLDN18.2\u548cPD-L1\u8868\u9054\u6c34\u5e73\u3002\u6839\u64da\u6309Claudin 18.2 IHC 14G11 LDT\u65b9\u6cd5\u5f97\u51fa\u7684CLDN18.2\u86cb\u767d\u5728\u816b\u7624\u7d30\u80de\u819c\u67d3\u8272\u7684\u767e\u5206\u6bd4\uff0cCLDN18.2\u8868\u9054\u6c34\u5e73\u5206\u70ba\u4e09\u500b\u4e9e\u7d44\uff1aH\/M\uff08\u9ad8\/\u4e2d\uff09\uff0cL\uff08\u4f4e\uff09\u548cR\uff08\u5176\u9918\uff1a\u66f4\u4f4e\u6216\u9670\u6027\uff09\u3002 \u4ee4\u4eba\u9f13\u821e\u7684\u5ba2\u89c0\u7de9\u89e3\u7387\u8207\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f \u622a\u81f3\u7d71\u8a08\u65e5\u671f\uff0c82\u540d\u60a3\u8005\u5df2\u63a5\u53d7\u6cbb\u7642\uff0c\u4e2d\u4f4d\u96a8\u8a2a\u6642\u9593\u70ba12.6\u500b\u6708\u3002\u5c0d66\u540d\u5df2\u77e5CLDN18.2\u548cPD-L1\u8868\u9054\u6c34\u5e73\u7684\u60a3\u8005\u9032\u884c\u7642\u6548\u5206\u6790\u3002\u7d50\u679c\u986f\u793a\uff0c\u7642\u6548\u8207CLDN18.2\u8868\u9054\u6c34\u5e73\u4e4b\u9593\u5b58\u5728\u660e\u986f\u95dc\u806f\u8da8\u52e2\uff0c\u9ad8\/\u4e2d\u8868\u9054\uff08H\/M\uff09\u60a3\u8005\u7684\u4e2d\u4f4d\u7121\u9032\u5c55\u751f\u5b58\u671f\uff08mPFS\uff09\u70ba12.6\u500b\u6708\uff0c\u4f4e\u8868\u9054\uff08L\uff09\u60a3\u8005\u70ba8.5\u500b\u6708\uff0c\u5176\u9918\u60a3\u8005\uff08R\uff09\u70ba6.7\u500b\u6708\u3002\u78ba\u8a8d\u5ba2\u89c0\u7de9\u89e3\u7387\u5206\u5225\u70ba68%\u300161.1%\u53ca50%\u3002\u8207R\u7d44\u5c0d\u6bd4\uff0cHM\u7d44\u8207R\u7d44\u7684PFS\u98a8\u96aa\u6bd4\uff08HR\uff09\u70ba0.443\uff0895% CI 0.205, 0.985\uff09\uff0cHML\u7d44\u8207R\u7d44\u7684PFS\u98a8\u96aa\u6bd4\u70ba0.560\uff0895% CI 0.292, 1.074\uff09\u3002\u5728PD-L1 CPS<5\u60a3\u8005\u7fa4\u9ad4\u4e2d\u4e5f\u89c0\u5bdf\u5230\u4e86\u76f8\u540c\u7684\u8da8\u52e2\uff0cCLDN18.2\u9ad8\/\u4e2d\u8868\u9054\u60a3\u8005\u7684mPFS\u5728\u9019\u500b\u4e9e\u7d44\u4e2d\u540c\u6a23\u70ba12.6\u500b\u6708\u3002 \u53ef\u63a7\u7684\u5b89\u5168\u6027 \u4e09\u806f\u7642\u6cd5\u7684\u5b89\u5168\u6027\u7279\u5fb5\u8207\u6b64\u524dOsemitamab (TST001)\u806f\u5408CAPOX\u4e00\u7dda\u6cbb\u7642\u80c3\u6216\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u60a3\u8005\u6240\u5c55\u73fe\u7684\u5b89\u5168\u6027\u6578\u64da\u5927\u9ad4\u4e00\u81f4\uff08\u300a\u81e8\u5e8a\u816b\u7624\u5b78\u96dc\u8a8c\u300b\u7b2c41\u5377\uff0c\u7b2c16\u671f\uff0c 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