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科学家完成PD-1和HER2双重阻断治疗HER2阳性胃癌的KEYNOTE-811试验
2021-12-19 23:51

美国威尔·康奈尔医学院Yelena Y. Janjigian等研究人员完成PD-1和HER2双重阻断治疗HER2阳性胃癌的KEYNOTE-811试验。该项研究成果于2021年12月15日在线发表在《自然》杂志上。

研究人员表示,人类表皮生长因子受体2(HER2,又称ERBB2)扩增或过度表达发生在大约20%的晚期胃癌或胃食管交界处腺癌。十多年前,抗HER2抗体曲妥珠单抗和化疗的联合治疗成为这些类型肿瘤患者的标准一线治疗方法。虽然在化疗中加入抗程序化死亡1(PD-1)抗体pembrolizumab并不能明显改善晚期HER2阴性胃癌的疗效,但在HER2阳性疾病中加入pembrolizumab有其临床前和临床的理由。
 
研究人员描述了随机、双盲、安慰剂对照的KEYNOTE-811期研究的第一次中期分析结果,该研究是关于pembrolizumab加曲妥珠单抗和化疗治疗不可切除或转移的、HER2阳性的胃或胃食管连接处腺癌(https://clinicaltrials.gov,NCT03615326)。结果表明,在曲妥珠单抗和化疗的基础上加入pembrolizumab可以明显减少肿瘤大小,在一些参与者中诱发完全反应,并显著提高客观反应率。
 
附:英文原文
 
Title: The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer

Author: Janjigian, Yelena Y., Kawazoe, Akihito, Yaez, Patricio, Li, Ning, Lonardi, Sara, Kolesnik, Oleksii, Barajas, Olga, Bai, Yuxian, Shen, Lin, Tang, Yong, Wyrwicz, Lucjan S., Xu, Jianming, Shitara, Kohei, Qin, Shukui, Van Cutsem, Eric, Tabernero, Josep, Li, Lie, Shah, Sukrut, Bhagia, Pooja, Chung, Hyun Cheol

Issue&Volume: 2021-12-15

Abstract: Human epidermal growth factor receptor 2 (HER2, also known as ERBB2) amplification or overexpression occurs in approximately 20% of advanced gastric or gastro-oesophageal junction adenocarcinomas1,2,3. More than a decade ago, combination therapy with the anti-HER2 antibody trastuzumab and chemotherapy became the standard first-line treatment for patients with these types of tumours4. Although adding the anti-programmed death 1 (PD-1) antibody pembrolizumab to chemotherapy does not significantly improve efficacy in advanced HER2-negative gastric cancer5, there are preclinical6,7,8,9,10,11,12,13,14,15,16,17,18,19 and clinical20,21 rationales for adding pembrolizumab in HER2-positive disease. Here we describe results of the protocol-specified first interim analysis of the randomized, double-blind, placebo-controlled phase III KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for unresectable or metastatic, HER2-positive gastric or gastro-oesophageal junction adenocarcinoma22 (https://clinicaltrials.gov, NCT03615326). We show that adding pembrolizumab to trastuzumab and chemotherapy markedly reduces tumour size, induces complete responses in some participants, and significantly improves objective response rate.

DOI: 10.1038/s41586-021-04161-3

Source: https://www.nature.com/articles/s41586-021-04161-3

Nature:《自然》,创刊于1869年。隶属于施普林格·自然出版集团,最新IF:69.504
官方网址:http://www.nature.com/
投稿链接:http://www.nature.com/authors/submit_manuscript.html


本期文章:《自然》:Online/在线发表

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