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美国食品和药物管理局批准摘要:Pembrolizumab用于治疗HER2-阳性胃癌

Sandra J Casak¹, Yiming Zhang², Chi Song³

¹United States Food and Drug Administration Silver Spring, Maryland United States.

Clinical cancer research : an official journal of the American Association for Cancer Research

|March 6, 2026

概括

布罗利祖马布与特拉斯图祖马布和化疗相结合,可以改善HER2阳性胃癌患者的生存率. 治疗效益在PD-L1表达 (CPS ≥1) 的患者中最为显著.

科学领域:

在瘤学瘤学.
胃肠病学胃肠病学
免疫治疗是一种免疫疗法.

背景情况:

胃和胃食道结 (GEJ) 癌症是全球健康面临的重大挑战.
人体表皮生长因子受体-2 (HER2) 阳性亚型代表了一个独特的分子子集.
现有的治疗先进的HER2-阳性胃/GEJ癌症有局限性.

研究的目的:

评估pembrolizumab加上trastuzumab和化疗在不可切割或转移的HER2-阳性胃/GEJ癌症中的疗效和安全性.
评估整体反应率 (ORR) 和整体存活率 (OS) 作为主要终点.
探索不同PD-L1表达水平的治疗益处.

主要方法:

KEYNOTE-811试验:一个随机的,多区域的临床试验.
进行比较:布利祖马布 + 特拉斯图祖马布 + 化疗与安慰剂 + 特拉斯图祖马布 + 化疗.
采用了一次性试验方法,用于加速和定期的审批途径.

主要成果:

基于ORR的加速批准:Pembrolizumab手臂显示了74.4%的ORR,而安慰剂手臂的ORR为51.9% (p=0.00006).
基于OS的定期批准:中位数OS为20.0个月 (pembrolizumab) 与16.8个月 (安慰剂) (HR0.80,p=0.004).
探索性分析:主要在PD-L1 CPS ≥1亚组 (OS HR 0.79) 中观察到益处;在CPS <1亚组中没有显著益处.

结论:

布罗利祖马布加上trastuzumab和化疗是一种有效的第一线治疗HER2-阳性晚期胃/GEJ癌症.
治疗表明ORR和OS的统计学上显著改善.
在这个人群中,PD-L1表达 (CPS ≥1) 是治疗效益的预测生物标志物.

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