# KEYNOTE-062

Source: https://onco.cc/trials/keynote-062/  
OnCo record `keynote-062` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

KEYNOTE-062 found that pembrolizumab on its own was no worse than chemotherapy for survival in PD-L1-positive stomach cancer, but adding it to chemotherapy did not clearly beat chemotherapy alone; the tumours with the most PD-L1, and those with mismatch-repair deficiency, gained the most.

## Summary

KEYNOTE-062 randomised 763 patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (combined positive score of 1 or more) to pembrolizumab alone, pembrolizumab plus cisplatin and a fluoropyrimidine, or chemotherapy plus placebo. The primary endpoints were overall and progression-free survival in the PD-L1-positive and high-PD-L1 (score of 10 or more) populations.

Pembrolizumab alone was non-inferior to chemotherapy for overall survival, with a larger apparent advantage at a score of 10 or more, but pembrolizumab plus chemotherapy was not superior to chemotherapy alone. Patients with microsatellite-unstable tumours, a small subgroup, did strikingly well with pembrolizumab. The trial did not change first-line practice by itself, but its subgroup findings shaped how later chemo-immunotherapy trials and approvals were read.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT02494583
- Phase: 3
- Setting: Untreated PD-L1-positive (combined positive score of 1 or more), HER2-negative advanced gastric or gastro-oesophageal junction adenocarcinoma: pembrolizumab alone, pembrolizumab plus chemotherapy, or chemotherapy
- Sponsor: Merck & Co. (MSD)
- Enrolled: 763
- Result: Pembrolizumab alone was non-inferior to chemotherapy for overall survival in PD-L1-positive disease; pembrolizumab plus chemotherapy was not superior to chemotherapy; large benefit in the microsatellite-unstable subgroup.

## Sources

- ClinicalTrials.gov NCT02494583: https://clinicaltrials.gov/study/NCT02494583

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Microsatellite-unstable (MSI-high) gastric cancer](https://onco.cc/cancers/gastric-msi-high/), [PD-L1-high gastric cancer](https://onco.cc/cancers/gastric-pdl1-high/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- people: [Kohei Shitara](https://onco.cc/people/shitara-kohei/)
- key papers: [KEYNOTE-062: pembrolizumab or pembrolizumab plus chemotherapy versus chemotherapy in PD-L1-positive advanced gastric cancer](https://onco.cc/key-papers/paper-keynote-062-shitara-jama-oncol-2020/)

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