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重新定义胃癌治疗!HER2阳性胃癌首个ADC药物!显著延长患者生存

2020-09-27 09:43:55生物谷
核心提示:第一三共制药(Daiichi Sankyo)近日宣布,日本厚生劳动省(MHLW)已批准HER2靶向抗体偶联药物(ADC)Enhertu(fam-trastuzumab deruxtecan,DS-8201),用于治疗HER2阳性不可切除性晚期或复发性胃癌患者。之前,Enhertu已被MHLW授予治疗HER2阳性胃癌的SAKIGAKE(创新药物)资格。该药由第一三共与阿斯利康进行全球开发,第一三共保留日本权利。

  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)

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