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Updated: Oct 10, 2025

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

Yelena Y Janjigian1, Akihito Kawazoe2, Patricio Yañez3

  • 1Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. janjigiy@mskcc.org.

Nature
|December 16, 2021
PubMed

Insights

Adding pembrolizumab to trastuzumab and chemotherapy significantly improves outcomes for patients with HER2-positive advanced gastric cancer. This combination therapy markedly reduces tumor size and improves objective response rates in this patient population.

Area of Science:

  • Oncology
  • Gastroenterology
  • Immunotherapy

Background:

  • HER2 amplification/overexpression is found in ~20% of advanced gastric/gastro-oesophageal junction adenocarcinomas.
  • Trastuzumab plus chemotherapy is the standard first-line treatment for HER2-positive advanced gastric cancer.
  • Rationale exists for combining immunotherapy with HER2-targeted therapy in HER2-positive gastric cancer.

Purpose of the Study:

  • To evaluate the efficacy of pembrolizumab plus trastuzumab and chemotherapy in patients with unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma.

Main Methods:

  • Phase III, randomized, double-blind, placebo-controlled study (KEYNOTE-811).
  • Patients received pembrolizumab, trastuzumab, and chemotherapy, or placebo, trastuzumab, and chemotherapy.
  • Protocol-specified first interim analysis.

Main Results:

  • Pembrolizumab combination therapy markedly reduced tumor size.
  • Complete responses were observed in some participants.
  • Significantly improved objective response rate compared to placebo.

Conclusions:

  • Adding pembrolizumab to trastuzumab and chemotherapy demonstrates significant efficacy in HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma.
  • This combination represents a promising therapeutic strategy for this patient group.

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