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

Author

Listed:
  • 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)

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.

Suggested Citation

  • 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 , 2021. "The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer," Nature, Nature, vol. 600(7890), pages 727-730, December.
    • Handle: RePEc:nat:nature:v:600:y:2021:i:7890:d:10.1038_s41586-021-04161-3
    DOI: 10.1038/s41586-021-04161-3
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    Cited by:

    1. Funda Meric-Bernstam & Sun Young Rha & Erika Hamilton & Yoon-Koo Kang & Diana L. Hanna & Syma Iqbal & Keun-Wook Lee & Jeeyun Lee & Muralidhar Beeram & Do-Youn Oh & Jorge Chaves & Rachel A. Goodwin & J, 2025. "Zanidatamab monotherapy or combined with chemotherapy in HER2-expressing gastroesophageal adenocarcinoma: a phase 1 trial," Nature Communications, Nature, vol. 16(1), pages 1-10, December.

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