DIYISANGONGZHIYAO（Daiichi Sankyo）JINRIXUANBU，RIBENHOUSHENGLAODONGSHENG（MHLW）YIPIZHUNHER2BAXIANGKANGTIOULIANYAOWU（ADC）Enhertu（fam-trastuzumab deruxtecan，DS-8201），YONGYUZHILIAOHER2YANGXINGBUKEQIECHUXINGWANQIHUOFUFAXINGWEIAIHUANZHE。ZHIQIAN，EnhertuYIBEIMHLWSHOUYUZHILIAOHER2YANGXINGWEIAIDESAKIGAKE（CHUANGXINYAOWU）ZIGE。GAIYAOYOUDIYISANGONGYUASILIKANGJINXINGQUANQIUKAIFA，DIYISANGONGBAOLIURIBENQUANLI。

　　ZHIDEYITIDESHI，EnhertuSHIDIYIGEBEIPIZHUNZHILIAOHER2YANGXINGWEIAIDEADCYAOWU，JIANGWEIZHEILEIAIZHENGDAILAIYOUYIYIDEZHILIAOJINBU。CICIPIZHUN，YEBIAOZHIZHEEnhertuZAI6GEYUENEIHUODEMHLWPIZHUNDEDIERGESHIYINGZHENG。JINNIAN3YUE，EnhertuZAIRIBENHUOPI，YONGYUZHILIAOHER2YANGXING、BUKEQIECHUXINGHUOZHUANYIXING、ZAIXIANQIANHUALIAOHOUFUFADERUXIANAIHUANZHE（XIANYONGYUDUIBIAOZHUNZHILIAOWUXIAOHUOBUNAISHOUDEHUANZHE）。

　　RIBENSHIQUANSHIJIEWEIAIFABINGLVDISANGAODEGUOJIA，QIZHONGYUEWUFENZHIYIDEBINGLIBEIRENWEISHIHER2YANGXING。HER2YANGXINGZHUANYIXINGWEIAIHUANZHE，YIDANZAIZUICHUSHIYONGKANGHER2FANGANHOUBINGQINGJINZHAN，ZHILIAOXUANZEFEICHANGYOUXIAN。EnhertuSHIDIYIGEYESHIWEIYIYIGEXIANSHIZAIXIANQIANJIESHOUGUOHUALIAOHEKANGHER2LIAOFAZHILIAODEHER2YANGXINGZHUANYIXINGWEIAIHUANZHEZHONGYUHUALIAOXIANGBIXIANZHUYANZHANGZONGSHENGCUNQI（OS）DEHER2BAXIANGLIAOFA。GENJULINCHUANGSHIYANZHONGLINGRENXINFUDEQIANGJINGLIAOXIAO，EnhertuJIANGCHENGWEIZHEILEIHUANZHELINCHUANGZHILIAODEXINHULIBIAOZHUN。

　　XUYAOZHICHUDESHI，EnhertuZAIXIANQIANMEIYOUJIESHOUGUOQUTUOZHUDANKANG（trastuzumab，HER2BAXIANGLIAOFA）FANGANZHILIAODEHER2YANGXINGBUKEQIECHUXINGHUOFUFAXINGWEIAIHUANZHEZHONGDELIAOXIAOHEANQUANXINGSHANGWEIQUEDING。

　　CICIPIZHUN，JIYUKAIFANGBIAOQIAN、SUIJI2QIDESTINY-Gastric01SHIYANDEJIEGUO。GAISHIYANRUZULE187LI（BAOKUORIBEN149LI）HER2YANGXINGWANQIWEIAIHUOWEISHIGUANJIAOJIEXIANAI（DINGYIWEI：IHC3+HUOIHC2+/ISH+）HUANZHE，ZHEIXIEHUANZHEXIANQIANJIESHOUGUO2ZHONGHUODUOZHONGFANGAN（BAOKUO5-FU、HANBOHUALIAO、QUTUOZHUDANKANG）DANBINGQINGJINZHAN。YANJIUZHONG，HUANZHEYI2：1DEBILISUIJIFENPEI，JIESHOUEnhertu（6.4mg/kg）HUOYANJIUDIAOCHAYUANXUANZEDEHUALIAO（ZISHANCHUNHUOYILITIKANGDANYAOZHILIAO），MEISANZHOUYICI。

　　JIEGUOXIANSHI，YANJIUDADAOLEZHUYAOZHONGDIANHEGUANJIANCIYAOZHONGDIAN：YUHUALIAOZUXIANGBI，EnhertuZHILIAOZUZAIKEGUANHUANJIELV（ORR）HEZONGSHENGCUNQI（OS）FANGMIANQUDELETONGJIXUEYIYIHELINCHUANGYIYIDEGAISHAN。

　　JUTISHUJUWEI：ZAI175LIKEPINGGUHUANZHE（BAOKUO140LIRIBENHUANZHE）ZHONG，TONGGUODULIZHONGYANGSHENCHA（ICR）PINGGU：（1）EnhertuZUDEORRWEI51.3%（95%CI：41.9-60.5%）、HUALIAOZUWEI14.3%（95%CI：6.4-26.2%）。ZAIYIXIANGYUXIANZHIDINGDEZHONGQIFENXIZHONG，EnhertuZUYUHUALIAOZUXIANGBISIWANGFENGXIANJIANGDI41%（HR=0.59；95%CI：0.ag娱乐网址登录-0.88；p=0.0097）。EnhertuZUDEZHONGWEIOSWEI12.5GEYUE、HUALIAOZUWEI8.4GEYUE。

　　GAISHIYANZHONG，EnhertuDEANQUANXINGHENAISHOUXINGYUXIANQIANBAODAODEEnhertuSHIYANYIZHI。JIESHOUEnhertuZHILIAODE125LIHUANZHE（BAOKUO99LIRIBENHUANZHE）ZHONG，YOU122LI（97.6%）CHUXIANYAOWUXIANGGUANBULIANGFANYING。ZUICHANGJIANDEBULIANGFANYINGWEIZHONGXINGLIXIBAOJIANSHAO（78LI，62.4%）、EXIN（72LI，57.6%）、SHIYUXIAJIANG（66LI，52.8%）、PINXUE（51LI，40.8%）、XUEXIAOBANJIANSHAO（48LI，38.4%）、BAIXIBAOJIANSHAO（47LI，37.6%）、FALI43LI（34.4%）、FUXIE（31LI，24.8%）、TUOFA（28LI，22.4%）、LINBAXIBAOJISHUXIAJIANG（27LI，21.6%）、OUTU（26LI，20.8%）JIQITA。ZAIRIBENHUANZHEZHONG，99LIZHONGYOU11LIFASHENGLEJIANZHIXINGFEIBING（ILD，11.1%）。

　　Enhertu（trastuzumab deruxtecan，DS-8201）SHIYIZHONGXINYIDAIKANGTIYAOWUOULIANWU（ADC），TONGGUOYIZHONG4TAILIANJIEZIJIANGBAXIANGHER2DERENYUANHUADANKELONGKANGTItrastuzumab（QUTUOZHUDANKANG）YUYIZHONGXINXINGTUOPUYIGOUMEI1YIZHIJIexatecanYANSHENGWU（DX-8951YANSHENGWU，DXd）LIANJIEZAIYIQI，KEBAXIANGDISONGXIBAODUZHIJIZHIAIXIBAONEI，YUTONGCHANGDEHUALIAOXIANGBI，KEJIANSHAOXIBAODUZHIJIDEQUANSHENBAOLU。

　　2019NIAN3YUE，ASILIKANGYUDIYISANGONGDACHENGLEYIXIANGZONGJIAZHIGAODA69YIMEIYUANDEMIANYIZHONGLIUXUEHEZUO，GONGTONGKAIFAEnhertu，YONGYUZHILIAOGEZHONGHER2BIAODASHUIPINGHUOHER2TUBIANDEAIZHENGHUANZHE，BAOKUOWEIAI、JIEZHICHANGAIHEFEIAI，YIJIHER2DIBIAODADERUXIANAI。GENJUXIEYI，SHUANGFANGJIANGZAIQUANQIUFANWEINEIGONGTONGKAIFAHESHANGYEHUAEnhertu，DIYISANGONGBAOLIURIBENSHICHANGDEDUJIAQUANLI，TONGSHIJIANGQUANQUANFUZEZHIZAOHEGONGYING。

　　2019NIAN12YUE，EnhertuZAIMEIGUOHUODEQUANQIUSHOUPI：FDAJIASUPIZHUNEnhertu，YONGYUZAIZHUANYIXINGJIBINGZHONGYIJIESHOUGUO2ZHONGHUO2ZHONGYISHANGKANGHER2YAOWUZHILIAODEHER2YANGXINGZHUANYIXINGRUXIANAICHENGRENHUANZHE。EnhertuYU2019NIAN12YUEZAIMEIGUOHUODEQUANQIUSHOUPI：HUOFDAJIASUPIZHUN，YONGYUZAIZHUANYIXINGJIBINGZHONGYIJIESHOUGUO2ZHONGHUO2ZHONGYISHANGKANGHER2YAOWUZHILIAODEHER2YANGXINGZHUANYIXINGRUXIANAICHENGRENHUANZHE。

　　CIQIAN，FDAYISHOUYUEnhertu 3GETUPOXINGYAOWUZIGE（BTD）：（1）YONGYUZHILIAOJIESHOUHANBOHUALIAOQIJIANHUOZHIHOUBINGQINGJINZHAN、ZHONGLIUZHONGCUNZAIHER2TUBIANDEZHUANYIXINGFEIXIAOXIBAOFEIAI（NSCLC）HUANZHE；（2）YONGYUZHILIAOXIANQIANYIJIESHOUGUOZHISHAO2ZHONGFANGAN（BAOKUOQUTUOZHUDANKANG，trastuzumab）DEHER2YANGXING、BUKEQIECHUXINGHUOZHUANYIXINGWEIHUOWEISHIGUANJIAOJIEXIANAIHUANZHE；（3）YONGYUZHILIAOHER2YANGXINGZHUANYIXINGRUXIANAIHUANZHE，GAIZHILIAOSHIYINGZHENGYU2019NIAN12YUEHUODEPIZHUN。

　　YEJIEDUIEnhertuDESHANGYEQIANJINGFEICHANGKANHAO，YIYAOSHICHANGDIAOYANJIGOUEvaluatePharmaCIQIANYUCE，EnhertuZAI2024NIANDEXIAOSHOUEYUJIJIANGNENGGOUDADAO20YIMEIYUAN。（SHENGWUGUBioon.com）