{"entity":{"id":"keynote-062","kind":"trial","name":"KEYNOTE-062","aka":[],"tldr":"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.\n\nPembrolizumab 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.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02494583","url":"https://clinicaltrials.gov/study/NCT02494583"}],"tags":["subtype-trials"],"related":[],"cancers":["gastric-pdl1-high","gastric-msi-high","gastric"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","cisplatin","fluorouracil","capecitabine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["shitara-kohei"],"bottlenecks":[],"keyPapers":["paper-keynote-062-shitara-jama-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"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)","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.","yearReported":2020,"enrolled":763,"outcomes":[]},"route":"/trials/keynote-062/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"gastric-msi-high","kind":"cancer","name":"Microsatellite-unstable (MSI-high) gastric cancer","route":"/cancers/gastric-msi-high/"},{"id":"gastric-pdl1-high","kind":"cancer","name":"PD-L1-high gastric cancer","route":"/cancers/gastric-pdl1-high/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"person":[{"id":"shitara-kohei","kind":"person","name":"Kohei Shitara","route":"/people/shitara-kohei/"}],"paper":[{"id":"paper-keynote-062-shitara-jama-oncol-2020","kind":"paper","name":"KEYNOTE-062: pembrolizumab or pembrolizumab plus chemotherapy versus chemotherapy in PD-L1-positive advanced gastric cancer","route":"/key-papers/paper-keynote-062-shitara-jama-oncol-2020/"}]}}