{"id":90221,"date":"2023-08-01T11:26:00","date_gmt":"2023-08-01T04:26:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2023080111260090221"},"modified":"2023-08-01T15:38:01","modified_gmt":"2023-08-01T07:38:01","slug":"%e5%ae%89%e6%96%af%e6%b3%b0%e6%9d%a5zolbetuximab%e7%94%9f%e7%89%a9%e5%88%b6%e5%93%81%e4%b8%ad%e5%9b%bd%e4%b8%8a%e5%b8%82%e8%ae%b8%e5%8f%af%e7%94%b3%e8%af%b7%e8%8e%b7%e5%8f%97%e7%90%86","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2023080111260090221","title":{"rendered":"\u5b89\u65af\u6cf0\u6765Zolbetuximab\u751f\u7269\u5236\u54c1\u4e2d\u56fd\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u83b7\u53d7\u7406"},"content":{"rendered":"

\u4e1c\u4eac<\/span>2023\u5e748\u67081\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — \u5b89\u65af\u6cf0\u6765\u5236\u836f\u96c6\u56e2\uff08TSE\uff1a4503\uff0c\u603b\u88c1\u517c\u9996\u5e2d\u6267\u884c\u5b98\uff1a\u5188\u6751\u76f4\u6811\uff0c"\u5b89\u65af\u6cf0\u6765"\uff09\u4eca\u5929\u5ba3\u5e03\uff0c\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u836f\u54c1\u8bc4\u5ba1\u4e2d\u5fc3\uff08CDE\uff09\u5df2\u53d7\u7406zolbetuximab\u7684\u751f\u7269\u5236\u54c1\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff08BLA\uff09\u3002Zolbetuximab\u662f\u4e00\u79cd\u9488\u5bf9Claudin 18.2(CLDN18.2)\u7684\u5728\u7814\u9996\u521b\u5355\u514b\u9686\u6297\u4f53\uff0c\u7528\u4e8e\u4e00\u7ebf\u6cbb\u7597CLDN18.2\u9633\u6027\u3001HER2\u9634\u6027\u7684\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u4ea4\u754c\u5904\uff08GEJ\uff09\u817a\u764c\u60a3\u8005\u3002\u4e00\u7ecf\u6279\u51c6\uff0c\u5bf9\u4e8e\u4e2d\u56fd\u80c3\u764c\u60a3\u8005\u7fa4\u4f53\u800c\u8a00\uff0czolbetuximab\u5c06\u662f\u9996\u6b3e\u9488\u5bf9CLDN18.2\u7684\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n

\u5b89\u65af\u6cf0\u6765\u9ad8\u7ea7\u526f\u603b\u88c1\u517c\u514d\u75ab\u80bf\u7624\u5b66\u9886\u57df\u5f00\u53d1\u8d1f\u8d23\u4eba\u3001\u533b\u5b66\u535a\u58eb\u3001\u5de5\u5546\u7ba1\u7406\u7855\u58eb<\/b>Moitreyee Chatterjee-Kishore<\/span><\/b> <\/p>\n

"\u5728\u5168\u4e16\u754c\u80c3\u764c\u65b0\u53d1\u75c5\u4f8b\u4e2d\uff0c\u4e2d\u56fd\u60a3\u8005\u51e0\u4e4e\u5360\u636e\u4e00\u534a\u30022020\u5e74\u6570\u636e\u663e\u793a\uff0c\u4e2d\u56fd\u6709\u8d85478,000\u4f8b\u65b0\u786e\u8bca\u80c3\u764c\u60a3\u8005\uff0c\u6b7b\u4ea1\u75c5\u4f8b\u8d85373,000\u4f8b\u3002Zolbetuximab\u751f\u7269\u5236\u54c1\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u83b7CDE\u53d7\u7406\uff0c\u4f7f\u6211\u4eec\u4e3a\u4e2d\u56fd\u665a\u671f\u80c3\u764c\u60a3\u8005\u63d0\u4f9b\u4ed6\u4eec\u6240\u4e9f\u9700\u7684\u3001\u521b\u65b0\u7684\u6cbb\u7597\u65b9\u6848\u8fc8\u8fdb\u4e86\u4e00\u5927\u6b65\u3002"<\/p>\n

\u6b64\u9879\u751f\u7269\u5236\u54c1\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u662f\u57fa\u4e8eGLOW<\/a> \u548cSPOTLIGHT<\/a> \u4e24\u9879III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u3002GLOW\u8bd5\u9a8c\u8bc4\u4f30\u4e86zolbetuximab\u8054\u5408CAPOX\uff08\u4e00\u79cd\u5305\u62ec\u5361\u57f9\u4ed6\u6ee8\u548c\u5965\u6c99\u5229\u94c2\u7684\u8054\u5408\u5316\u7597\u65b9\u6848\uff09\u5bf9\u6bd4\u5b89\u6170\u5242\u8054\u5408CAPOX\u7684\u7597\u6548\u3002\u8be5\u7814\u7a76\u4e2d\uff0c\u4e2d\u56fd\u5927\u9646\u5165\u7ec4\u4e86145\u540d\u60a3\u8005\u3002SPOTLIGHT\u8bd5\u9a8c\u8bc4\u4f30\u4e86zolbetuximab\u8054\u5408mFOLFOX6\uff08\u4e00\u79cd\u5305\u62ec\u5965\u6c99\u5229\u94c2\u3001\u4e9a\u53f6\u9178\u548c\u6539\u826f\u76845-\u6c1f\u5c3f\u5627\u5576\u7684\u8054\u5408\u5316\u7597\u65b9\u6848\uff09\u5bf9\u6bd4\u5b89\u6170\u5242\u8054\u5408mFOLFOX6\u7684\u7597\u6548\uff0c\u4e2d\u56fd\u5927\u9646\u5171\u670936\u540d\u60a3\u8005\u5165\u7ec4\u8be5\u8bd5\u9a8c\u3002<\/p>\n

\u5728GLOW<\/a> \u53ca SPOTLIGHT<\/a>\u4e24\u9879\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u6839\u636e\u7ecf\u9a8c\u8bc1\u7684\u514d\u75ab\u7ec4\u5316\u68c0\u6d4b\u5206\u6790\u5224\u5b9a\uff0c\u53c2\u52a0\u8bd5\u9a8c\u7684\u80bf\u7624\u60a3\u8005\u4e2d\uff0c\u7ea638%\u7684\u60a3\u8005\u7b26\u5408CLDN18.2\u8868\u8fbe\u7684\u9633\u6027\u6807\u51c6\uff08\u5b9a\u4e49\u4e3a\u226575%\u7684\u80bf\u7624\u7ec6\u80de\u4e2d\u663e\u793a\u4e2d\u5ea6\u81f3\u5f3a\u7684CLDN18\u819c\u67d3\u8272\uff09\u3002[1],[2]<\/sup><\/p>\n

\u5b89\u65af\u6cf0\u6765\u5df2\u7ecf\u5728\u672c\u8d22\u5e74\uff08\u622a\u81f32024\u5e743\u670831\u65e5\uff09\u8d22\u52a1\u9884\u6d4b\u4e2d\u4f53\u73b0\u51fa\u672c\u9879\u7533\u8bf7\u53d7\u7406\u7684\u5f71\u54cd\u3002<\/p>\n

\u5173\u4e8e\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u80c3\u764c\u6216\u80c3\u98df\u7ba1\u4ea4\u754c\u5904\u764c<\/b><\/p>\n

\u80c3\u764c\uff0c\u901a\u5e38\u4e5f\u88ab\u79f0\u4e3a\u80c3\u90e8\u80bf\u7624\uff0c\u662f\u5168\u7403\u7b2c\u4e94\u9ad8\u53d1\u80bf\u7624\u3002[3]<\/sup>\u5728\u4e2d\u56fd\uff0c\u80c3\u764c\u5728\u6240\u6709\u764c\u75c7\u53d1\u75c5\u7387\u4e2d\u4f4d\u5217\u7b2c\u4e09\uff0c2020\u5e74\u4e2d\u56fd\u65b0\u786e\u8bca\u80c3\u764c\u75c5\u4f8b\u8d85478,000\u4f8b\uff0c\u6b7b\u4ea1\u75c5\u4f8b\u8d85373,000\u4f8b\u3002[4]<\/sup>\u75c7\u72b6\u548c\u4f53\u5f81\u53ef\u5305\u62ec\u6d88\u5316\u4e0d\u826f\u6216\u70e7\u5fc3\uff1b\u8179\u90e8\u75bc\u75db\u6216\u4e0d\u9002\uff1b\u6076\u5fc3\u548c\u5455\u5410\uff1b\u8179\u6cfb\u6216\u4fbf\u79d8\uff1b\u996d\u540e\u80c3\u80c0\uff1b\u4ee5\u53ca\u98df\u6b32\u4e0d\u632f\u548c\u8fdb\u9910\u65f6\u7684\u98df\u7269\u54fd\u54bd\u611f\u89c9\u3002[5]<\/sup>\u665a\u671f\u80c3\u764c\u7684\u75c7\u72b6\u53ef\u80fd\u5305\u62ec\u4e0d\u660e\u539f\u56e0\u7684\u4f53\u91cd\u51cf\u8f7b\uff1b\u865a\u5f31\u548c\u75b2\u52b3\uff1b\u4ee5\u53ca\u5455\u8840\u6216\u4fbf\u8840\u3002[6]<\/sup>\u4e0e\u80c3\u764c\u76f8\u5173\u7684\u98ce\u9669\u56e0\u7d20\u5305\u62ec\u5e74\u9f84\u589e\u957f\u3001\u7537\u6027\u3001\u5bb6\u65cf\u53f2\u3001\u5e7d\u95e8\u87ba\u6746\u83cc\u611f\u67d3\u3001\u5438\u70df\u548c\u80c3\u98df\u7ba1\u53cd\u6d41\u75c5\uff08GERD\uff09\u3002[5],[7]<\/sup>\u7531\u4e8e\u65e9\u671f\u80c3\u764c\u7684\u75c7\u72b6\u5f80\u5f80\u4e0e\u66f4\u5e38\u89c1\u7684\u80c3\u826f\u6027\u75be\u75c5\u91cd\u53e0\uff0c\u80c3\u764c\u5f80\u5f80\u5728\u665a\u671f\u6216\u8f6c\u79fb\u9636\u6bb5\uff0c\u6216\u764c\u7ec6\u80de\u4ece\u80bf\u7624\u539f\u53d1\u90e8\u4f4d\u6269\u6563\u5230\u8eab\u4f53\u5176\u4ed6\u7ec4\u7ec7\u6216\u5668\u5b98\u540e\uff0c\u624d\u88ab\u8bca\u65ad\u51fa\u6765\u3002[5]<\/sup>\u8f6c\u79fb\u6027\u80c3\u764c\u60a3\u8005\u7684\u4e94\u5e74\u76f8\u5bf9\u751f\u5b58\u7387\u4ec5\u4e3a6.6%\u3002[8] <\/sup>\u80c3\u98df\u7ba1\u4ea4\u754c\u5904\uff08GEJ\uff09\u7f10\u764c\u662f\u4e00\u79cd\u59cb\u4e8e\u98df\u7ba1\u4e0e\u80c3\u8fde\u63a5\u5904\u7684\u764c\u75c7\u3002[9]<\/sup><\/p>\n

\u5173\u4e8e<\/b>Zolbetuximab<\/b><\/p>\n

Zolbetuximab\u662f\u4e00\u79cd\u5728\u7814\u7684\u9776\u5411Claudin 18.2 (CLDN18.2)\u7684\u9996\u521b\u5d4c\u5408IgG1\u5355\u514b\u9686\u6297\u4f53\uff08mAb\uff09\uff0c\u53ef\u4e0eCLDN18.2\u7ed3\u5408\uff0cCLDN18.2\u662f\u4e00\u79cd\u8de8\u819c\u86cb\u767d\u3002Zolbetuximab\u901a\u8fc7\u4e0e\u80c3\u764c\u7ec6\u80de\u8868\u9762\u7684CLDN18.2\u7ed3\u5408\u53d1\u6325\u4f5c\u7528\u3002\u4e34\u5e8a\u524d\u7814\u7a76\u8868\u660e\uff0c\u8fd9\u79cd\u7ed3\u5408\u4f5c\u7528\u968f\u540e\u901a\u8fc7\u6fc0\u6d3b\u4e24\u79cd\u4e0d\u540c\u7684\u514d\u75ab\u7cfb\u7edf\u9014\u5f84–\u6297\u4f53\u4f9d\u8d56\u6027\u7ec6\u80de\u6bd2\u6027\uff08ADCC\uff09\u548c\u8865\u4f53\u4f9d\u8d56\u6027\u7ec6\u80de\u6bd2\u6027\uff08CDC\uff09\u8bf1\u5bfc\u764c\u7ec6\u80de\u6b7b\u4ea1\u3002[10]<\/sup>Zolbetuximab\u6682\u672a\u88ab\u4efb\u4f55\u76d1\u7ba1\u90e8\u95e8\u6279\u51c6\u7528\u4e8e\u6cbb\u7597\u80c3\u764c\u53ca\u80c3\u98df\u7ba1\u4ea4\u754c\u5904\uff08GEJ\uff09\u817a\u764c\u60a3\u8005\uff0c\u4e0d\u80fd\u4fdd\u8bc1\u8be5\u836f\u7269\u6b63\u5728\u7814\u7a76\u7684\u9002\u5e94\u75c7\u53ef\u83b7\u5f97\u76d1\u7ba1\u90e8\u95e8\u7684\u6ce8\u518c\u6279\u51c6\u53ca\u5546\u4e1a\u4e0a\u5e02\u3002<\/p>\n

\u7814\u7a76\u6027\u8bd5\u9a8c<\/b><\/p>\n

\u5173\u4e8e<\/b>GLOW III<\/b>\u671f\u4e34\u5e8a\u8bd5\u9a8c<\/b><\/p>\n

GLOW\u662f\u4e00\u9879\u5168\u7403\u3001\u591a\u4e2d\u5fc3\u3001\u53cc\u76f2\u3001\u968f\u673a\u7684III\u671f\u8bd5\u9a8c\uff0c\u8bc4\u4f30zolbetuximab\uff08IMAB362\uff09+CAPOX\uff08\u4e00\u79cd\u5305\u62ec\u5361\u57f9\u4ed6\u6ee8\u548c\u5965\u6c99\u5229\u94c2\u7684\u8054\u5408\u5316\u7597\u65b9\u6848\uff09\u4e0e\u5b89\u6170\u5242+CAPOX\u4e00\u7ebf\u6cbb\u7597CLDN18.2\u9633\u6027\u3001HER2\u9634\u6027\u7684\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u80c3\u764c\u6216\u80c3\u98df\u7ba1\u4ea4\u754c\u5904\u817a\u764c\u60a3\u8005\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u3002\u8be5\u7814\u7a76\u5728\u7f8e\u56fd\u3001\u52a0\u62ff\u5927\u3001\u82f1\u56fd\u3001\u6b27\u6d32\u3001\u5357\u7f8e\u548c\u4e9a\u6d32\uff08\u5305\u62ec\u4e2d\u56fd\u5728\u5185\u7684\uff09\u7684166\u4e2a\u7814\u7a76\u4e2d\u5fc3\u62db\u52df\u4e86507\u540d\u60a3\u8005\u3002\u4e3b\u8981\u7ec8\u70b9\u662f\u5bf9\u6bd4\u63a5\u53d7zolbetuximab\u8054\u5408CAPOX\u6cbb\u7597\u7684\u53c2\u4e0e\u8005\u4e0e\u63a5\u53d7\u5b89\u6170\u5242\u8054\u5408CAPOX\u6cbb\u7597\u7684\u53c2\u4e0e\u8005\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u3002\u6b21\u8981\u7ec8\u70b9\u5305\u62ec\u603b\u751f\u5b58\u671f\u3001\u5ba2\u89c2\u7f13\u89e3\u7387\u3001\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u3001\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u4ee5\u53ca\u751f\u6d3b\u8d28\u91cf\u53c2\u6570\u3002<\/p>\n

GLOW\u7814\u7a76\u6570\u636e\u6700\u521d\u57282023\u5e743\u6708\u7f8e\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff08ASCO\uff09\u5168\u4f53\u4f1a\u8bae\u4e0a\u516c\u5e03\uff0c\u5e76\u5e94\u9080\u57286\u67083\u65e5\u76842023 ASCO\u5e74\u5ea6\u4f1a\u8bae\u505a\u53e3\u5934\u62a5\u544a\u3002[1]<\/span><\/sup><\/p>\n

\u6b32\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95eeclinicaltrials.gov\u7f51\u7ad9\uff0c\u8bc6\u522b\u7801\u4e3aNCT03653507<\/a>\u3002<\/p>\n

\u5173\u4e8e<\/b>SPOTLIGHT<\/b> III<\/b>\u671f\u4e34\u5e8a\u8bd5\u9a8c<\/b><\/p>\n

SPOTLIGHT\u662f\u4e00\u9879\u5168\u7403\u3001\u591a\u4e2d\u5fc3\u3001\u53cc\u76f2\u3001\u968f\u673a\u7684III\u671f\u8bd5\u9a8c\uff0c\u8bc4\u4f30zolbetuximab\uff08IMAB362\uff09+mFOLFOX6\uff08\u4e00\u79cd\u5305\u62ec\u5965\u6c99\u5229\u94c2\u3001\u4e9a\u53f6\u9178\u548c\u6539\u826f\u76845-\u6c1f\u5c3f\u5627\u5576\u7684\u8054\u5408\u5316\u7597\u65b9\u6848\uff09\u4e0e\u5b89\u6170\u5242+mFOLFOX6\u4e00\u7ebf\u6cbb\u7597CLDN18.2\u9633\u6027\u3001HER2\u9634\u6027\u7684\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u80c3\u764c\u6216\u80c3\u98df\u7ba1\u4ea4\u754c\u5904\u817a\u764c\u60a3\u8005\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u3002\u8be5\u7814\u7a76\u5728\u7f8e\u56fd\u3001\u52a0\u62ff\u5927\u3001\u82f1\u56fd\u3001\u6fb3\u5927\u5229\u4e9a\u3001\u6b27\u6d32\u3001\u5357\u7f8e\u548c\u4e9a\u6d32\uff08\u5305\u62ec\u4e2d\u56fd\u5728\u5185\u7684\uff09\u7684215\u4e2a\u7814\u7a76\u4e2d\u5fc3\u62db\u52df\u4e86565\u540d\u60a3\u8005\u3002\u4e3b\u8981\u7ec8\u70b9\u662f\u5bf9\u6bd4\u63a5\u53d7zolbetuximab\u8054\u5408mFOLFOX6\u6cbb\u7597\u7684\u53c2\u4e0e\u8005\u4e0e\u63a5\u53d7\u5b89\u6170\u5242\u8054\u5408mFOLFOX6\u6cbb\u7597\u7684\u53c2\u4e0e\u8005\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u3002\u6b21\u8981\u7ec8\u70b9\u5305\u62ec\u603b\u751f\u5b58\u671f\uff08OS\uff09\u3001\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u3001\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\u3001\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u4ee5\u53ca\u751f\u6d3b\u8d28\u91cf\u53c2\u6570\u3002<\/p>\n

SPOTLIGHT\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u5df2\u4e8e1\u670819\u65e5\u57282023\u5e74\u7f8e\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff08ASCO\uff09\u80c3\u80a0\u9053\u80bf\u7624\u7814\u8ba8\u4f1a\u4e0a\u4ee5\u53e3\u5934\u62a5\u544a\u65b9\u5f0f\u516c\u5e03\uff0c\u968f\u540e\u4e8e4\u670814\u65e5\u5728\u300a\u67f3\u53f6\u5200\u300b<\/a>\u6742\u5fd7\u4e0a\u53d1\u8868\u3002[2]<\/span><\/sup><\/p>\n

\u6b32\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95eeclinicaltrials.gov\u7f51\u7ad9\uff0c\u8bc6\u522b\u7801\u4e3aNCT03504397<\/a>\u3002<\/p>\n

Claudin 18.2<\/b>\u7814\u7a76\u6027\u4ea7\u54c1\u7ba1\u7ebf<\/b><\/p>\n

\u9488\u5bf9\u8f6c\u79fb\u6027\u80f0\u817a\u764c\u7684II\u671f\u6269\u5927\u8bd5\u9a8c\u6b63\u5728\u8fdb\u884c\u4e2d\u3002\u8be5\u8bd5\u9a8c\u662f\u4e00\u9879\u968f\u673a\u3001\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30\u7814\u7a76\u6027zolbetuximab\u8054\u5408\u5409\u897f\u4ed6\u6ee8\u52a0\u767d\u86cb\u767d\u7ed3\u5408\u578b\u7d2b\u6749\u9187\u4e00\u7ebf\u6cbb\u7597CLDN18.2\u9633\u6027\u8f6c\u79fb\u6027\u80f0\u817a\u764c\u60a3\u8005\uff08\u5373\u6839\u636e\u7ecf\u9a8c\u8bc1\u7684\u514d\u75ab\u7ec4\u5316\u68c0\u6d4b\u5206\u6790\u5224\u5b9a\uff0c\u226575%\u7684\u80bf\u7624\u7ec6\u80de\u4e2d\u663e\u793a\u4e2d\u5ea6\u81f3\u5f3a\u7684CLDN18\u819c\u67d3\u8272\uff09\u7684\u5b89\u5168\u6027\u548c\u7597\u6548\u3002\u6b32\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95eeclinicaltrials.gov\u7f51\u7ad9\uff0c\u8bc6\u522b\u7801\u4e3aNCT03816163<\/a>\u3002<\/p>\n

\u9664zolbetuximab\u4e4b\u5916\uff0c\u6211\u4eec\u7684\u9996\u8981\u7126\u70b9\u514d\u75ab\u80bf\u7624\u5b66\u5f00\u53d1\u56e2\u961f<\/a>\u6b63\u5728\u5f00\u53d1ASP2138\u3002ASP2138\u662f\u4e00\u79cd\u53cc\u7279\u5f02\u6027\u5355\u514b\u9686\u6297\u4f53\uff0c\u53ef\u4ee5\u4e0eCD3 \u548cCLDN18.2\u7ed3\u5408\uff0c\u76ee\u524d\u6b63\u5904\u4e8e\u80c3\u764c\u3001\u80c3\u98df\u7ba1\u4ea4\u754c\u5904\u817a\u764c\u6216\u80f0\u817a\u764c\u60a3\u8005\u7684I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u5728\u7814\u836f\u5242\u7684\u5b89\u5168\u6027\u548c\u7597\u6548\u5c1a\u672a\u5728\u8ba8\u8bba\u4e2d\u7684\u5e94\u7528\u9886\u57df\u5f97\u5230\u8bc1\u5b9e\u3002\u6b32\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95eeclinicaltrials.gov\u7f51\u7ad9\uff0c\u8bc6\u522b\u7801\u4e3aNCT05365581<\/a>\u3002<\/p>\n

\u4e0d\u4fdd\u8bc1\u8fd9\u4e9b\u7814\u7a76\u6027\u836f\u7269\u80fd\u83b7\u5f97\u76d1\u7ba1\u90e8\u95e8\u7684\u6279\u51c6\u5728\u5546\u4e1a\u4e0a\u7528\u4e8e\u6b63\u5728\u7814\u7a76\u7684\u5e94\u7528\u9886\u57df\u3002<\/p>\n

\u5173\u4e8e\u5b89\u65af\u6cf0\u6765<\/b><\/p>\n

\u5b89\u65af\u6cf0\u6765\u5236\u836f\u96c6\u56e2\u662f\u4e00\u5bb6\u5236\u836f\u4f01\u4e1a\uff0c\u4e1a\u52a1\u904d\u53ca\u5168\u740370\u591a\u4e2a\u56fd\u5bb6\u548c\u5730\u533a\u3002\u76ee\u524d\uff0c\u6211\u4eec\u6b63\u5728\u63a8\u8fdb"\u7126\u70b9\u9886\u57df\u7684\u7814\u7a76\u7b56\u7565\uff08Focus Area Approach\uff09"\uff0c\u65e8\u5728\u901a\u8fc7\u805a\u7126\u751f\u7406\u673a\u5236\u548c\u6cbb\u7597\u624b\u6bb5\uff0c\u786e\u5b9a\u6301\u7eed\u7814\u53d1\u65b0\u836f\u7684\u673a\u4f1a\uff0c\u89e3\u51b3\u5c1a\u672a\u88ab\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\u3002\u4e0e\u6b64\u540c\u65f6\uff0c\u6211\u4eec\u6b63\u5728\u5c06\u76ee\u5149\u6295\u5411\u5904\u65b9\u836f\u4ee5\u5916\u7684\u4e1a\u52a1\u9886\u57df\uff0c\u5c06\u6211\u4eec\u7684\u4e13\u4e1a\u6280\u80fd\u548c\u77e5\u8bc6\u4e0e\u4e0d\u540c\u9886\u57df\u5916\u90e8\u5408\u4f5c\u4f19\u4f34\u7684\u5c16\u7aef\u6280\u672f\u76f8\u7ed3\u5408\uff0c\u6253\u9020Rx+®\u533b\u7597\u89e3\u51b3\u65b9\u6848\u3002\u901a\u8fc7\u8fd9\u4e9b\u52aa\u529b\uff0c\u5b89\u65af\u6cf0\u6765\u7acb\u5fd7\u5904\u4e8e\u4e0d\u65ad\u53d8\u5316\u7684\u533b\u7597\u884c\u4e1a\u7684\u6700\u524d\u6cbf\uff0c\u5c06\u79d1\u5b66\u7684\u8fdb\u6b65\u8f6c\u53d8\u4e3a\u60a3\u8005\u7684\u4ef7\u503c\u3002\u6b32\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee\u6211\u4eec\u7684\u7f51\u7ad9https:\/\/www.astellas.com\/en<\/a>\u3002<\/p>\n

\u8b66\u793a\u8bf4\u660e<\/b><\/p>\n

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\u672c\u65b0\u95fb\u7a3f\u4e2d\u6d89\u53ca\u7684\u836f\u7269\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u6b63\u5728\u7814\u7a76\u4e2d\uff0c\u5c1a\u672a\u786e\u5b9a\u3002\u4e0d\u80fd\u4fdd\u8bc1\u8fd9\u4e9b\u7814\u7a76\u4e2d\u7684\u836f\u54c1\u5c06\u83b7\u5f97\u76d1\u7ba1\u5f53\u5c40\u7684\u6279\u51c6\uff0c\u53ef\u7528\u4e8e\u5546\u4e1a\u7528\u9014\u3002 \u672c\u65b0\u95fb\u7a3f\u4e2d\u5305\u542b\u7684\u6709\u5173\u836f\u54c1\uff08\u5305\u62ec\u5f53\u524d\u6b63\u5728\u5f00\u53d1\u7684\u4ea7\u54c1\uff09\u7684\u4fe1\u606f\u4e0d\u6784\u6210\u5e7f\u544a\u6216\u533b\u7597\u5efa\u8bae\u3002<\/p>\n

1.\u672c\u6587\u7ffb\u8bd1\u81ea\u5b89\u65af\u6cf0\u6765\u5168\u7403\u65b0\u95fb\u7a3f\uff0c\u539f\u6587\u94fe\u63a5\u4e3a\uff1ahttps:\/\/www.astellas.com.cn\/zh-hans\/news\/14181<\/a><\/p>\n

2."\u672c\u6587\u6240\u6d89\u53ca\u7684\u836f\u54c1\u4e3a\u7814\u7a76\u4e2d\u7684\u836f\u54c1\uff0c\u5c1a\u672a\u5728\u4e2d\u56fd\u83b7\u6279\u9002\u5e94\u75c7, \u5b89\u65af\u6cf0\u6765\u4e2d\u56fd\u4e0d\u63a8\u8350\u4efb\u4f55\u672a\u83b7\u6279\u7684\u836f\u54c1\u4f7f\u7528\uff08\u9664\u4e2d\u56fd\u5927\u9646\u5df2\u83b7\u6279\u7684\u7279\u6b8a\u5730\u57df\u5916\uff09\u3002<\/p>\n

3.\u672c\u6587\u65e8\u5728\u4f20\u9012\u533b\u836f\u524d\u6cbf\u4fe1\u606f\uff0c\u4e0d\u6784\u6210\u5bf9\u4efb\u4f55\u836f\u7269\u6216\u8bca\u7597\u65b9\u6848\u7684\u63a8\u8350\u6216\u63a8\u5e7f\u3002<\/p>\n

4.\u5982\u60a8\u60f3\u4e86\u89e3\u66f4\u591a\u75be\u75c5\u77e5\u8bc6\u6216\u836f\u54c1\u3001\u8bca\u7597\u76f8\u5173\u4fe1\u606f\uff0c\u8bf7\u54a8\u8be2\u533b\u7597\u536b\u751f\u4e13\u4e1a\u4eba\u58eb\u3002<\/p>\n

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\u53c2\u8003\u6ce8\u91ca<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[1] Xu RH, Shitara K, Ajani JA, et al. Updates on Abstract 405736: Zolbetuximab + CAPOX in 1L claudin-18.2+ (CLDN18.2+)\/HER2\u2212 locally advanced (LA) or metastatic gastric or gastroesophageal junction (mG\/GEJ) adenocarcinoma: Primary phase 3 results from GLOW. Presented at: 2023 ASCO Annual Meeting. Abstract 405736.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[2] Shitara K, et al. Zolbetuximab plus mFOLFOX6 in patients with claudin-18 isoform 2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastrooesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. The Lancet. Published online April 14, 2023; S0140-6736(23)00620-7.<\/span><\/p>\n<\/td>\n<\/tr>\n

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[3] Sung H, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-49.<\/span><\/p>\n<\/td>\n<\/tr>\n

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[4] World Health Organization. Cancer Today. Available at: https:\/\/gco.iarc.fr\/today\/. Last accessed June 2, 2023.<\/span><\/p>\n<\/td>\n<\/tr>\n

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[5] American Cancer Society. Signs and symptoms of stomach cancer (01-22-2021). Available at https:\/\/www.cancer.org\/cancer\/stomach-cancer\/detection-diagnosis-staging\/signs-symptoms.html. Last accessed June 2, 2023.<\/span><\/p>\n<\/td>\n<\/tr>\n

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[6] National Cancer Institute. Gastric cancer treatment (PDQ®): patient version (08-24-2021). Available at https:\/\/www.cancer.gov\/types\/stomach\/patient\/stomach-treatment-pdq. Last accessed June 2, 2023.<\/span><\/p>\n<\/td>\n<\/tr>\n

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[7] American Cancer Society. Esophageal cancer risk factors (06-09-2020). Available at https:\/\/www.cancer.org\/cancer\/esophagus-cancer\/causes-risks-prevention\/risk-factors.html. Last accessed June 2, 2023.<\/span><\/p>\n<\/td>\n<\/tr>\n

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[8] National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: stomach cancer. Available at https:\/\/seer.cancer.gov\/statfacts\/html\/stomach.html. Last accessed June 2, 2023.<\/span><\/p>\n<\/td>\n<\/tr>\n

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[9] American Cancer Society. About esophagus cancer (03-20-2020). Available at https:\/\/www.cancer.org\/content\/dam\/CRC\/PDF\/Public\/8614.00.pdf. Last accessed June 2, 2023.<\/span><\/p>\n<\/td>\n<\/tr>\n

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[10] Sahin U, et al. FAST: a randomised phase II study of zolbetuximab (IMAB362) plus EOX versus EOX alone for first-line treatment of advanced CLDN18.2-positive gastric and gastro-oesophageal adenocarcinoma. Ann Oncol. 2021;32(5):609-19.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

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