第一三共/阿斯利康(AZN.US)重磅抗体偶联药物(ADC)Enhertu在3期临床试验中获得积极结果

智通财经
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智通财经APP获悉,阿斯利康(AZN.US)和第一三共(Daiichi Sankyo)公司日前宣布,双方联合开发的重磅抗体偶联药物(ADC)Enhertu(trastuzumab deruxtecan),在3期临床试验DESTINY-Gastric04中获得积极结果。在HER2阳性不可切除和/或转移性胃癌或胃食管交界腺癌患者中,Enhertu在二线治疗中,与活性对照相比,在总生存期(OS)这一主要终点达到了统计学显著和具有临床意义的改善。在预定的中期分析时,独立数据监查委员会基于Enhertu的积极疗效,建议提前揭盲该试验。

新闻稿表示,Enhertu是首个在随机3期临床试验中,作为二线疗法显著改善HER2阳性胃癌患者总生存期的HER2靶向疗法。

Enhertu是阿斯利康和第一三共联合开发的ADC疗法。它采用第一三共专有的DXd ADC技术平台设计,由靶向HER2的人源化单克隆抗体通过四肽可裂解连接子,与拓扑异构酶1抑制剂有效载荷连接组成。

胃癌是全球第五大常见癌症,也是癌症相关死亡的第五大原因。胃癌的预后较差,特别是晚期阶段,五年生存率为5%到10%。大约五分之一的胃癌被认为是HER2阳性。新闻稿指出,转移性HER2阳性胃癌一线治疗出现疾病进展后,历史上在随机临床试验中,尚未有HER2靶向药物在二线治疗中展示出生存获益。

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