The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer

Yelena Y. Janjigian (), Akihito Kawazoe, Patricio Yañez, Ning Li, Sara Lonardi, Oleksii Kolesnik, Olga Barajas, Yuxian Bai, Lin Shen, Yong Tang, Lucjan S. Wyrwicz, Jianming Xu, Kohei Shitara, Shukui Qin, Eric Cutsem, Josep Tabernero, Lie Li, Sukrut Shah, Pooja Bhagia and Hyun Cheol Chung
Additional contact information
Yelena Y. Janjigian: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Akihito Kawazoe: National Cancer Hospital East
Patricio Yañez: Universidad de La Frontera, James Lind Cancer Research Center
Ning Li: Henan Cancer Hospital, the Affiliated Cancer Hospital of Zhengzhou University
Sara Lonardi: Istituto Oncologico Veneto IOV-IRCCS
Oleksii Kolesnik: Medical Center ‘Oncolife’
Olga Barajas: Arturo López Pérez Foundation
Yuxian Bai: Harbin Medical University Cancer Hospital
Lin Shen: Peking University Cancer Hospital & Institute
Yong Tang: Cancer Hospital Affiliated to Xinjiang Medical University
Lucjan S. Wyrwicz: Maria Sklodowska-Curie National Cancer Research Institute
Jianming Xu: Chinese PLA General Hospital
Kohei Shitara: National Cancer Hospital East
Shukui Qin: Cancer Center of People’s Liberation Army
Eric Cutsem: University Hospitals Gasthuisberg and KU Leuven
Josep Tabernero: Vall d’Hebron Hospital Campus and Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC
Lie Li: Merck & Co.
Sukrut Shah: Merck & Co.
Pooja Bhagia: Merck & Co.
Hyun Cheol Chung: Yonsei University College of Medicine

Nature, 2021, vol. 600, issue 7890, 727-730

Abstract: 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 adenocarcinomas1–3. 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 preclinical6–19 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.

Date: 2021
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DOI: 10.1038/s41586-021-04161-3

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