{"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":["checkpoint-inhibitor"],"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.","started":"2015-07-31","startedType":"actual","yearReported":2020,"enrolled":763,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, PD-L1 CPS >=1 (non-inferiority)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","n":256,"value":10.6,"note":"99.2% CI; median follow-up 29.4 months"},{"name":"Chemotherapy","n":250,"value":11.1}],"hr":0.91,"ci":[0.69,1.18],"source":"https://doi.org/10.1001/jamaoncol.2020.3370"},{"endpoint":"Overall survival, PD-L1 CPS >=10","unit":"months","arms":[{"name":"Pembrolizumab","value":17.4,"note":"Not statistically tested"},{"name":"Chemotherapy","value":10.8}],"hr":0.69,"ci":[0.49,0.97],"source":"https://doi.org/10.1001/jamaoncol.2020.3370"},{"endpoint":"Overall survival, PD-L1 CPS >=1","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","n":257,"value":12.5},{"name":"Chemotherapy","n":250,"value":11.1}],"hr":0.85,"ci":[0.7,1.03],"p":"0.05","source":"https://doi.org/10.1001/jamaoncol.2020.3370"},{"endpoint":"Progression-free survival, PD-L1 CPS >=1","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","n":257,"value":6.9},{"name":"Chemotherapy","n":250,"value":6.4}],"hr":0.84,"ci":[0.7,1.02],"p":"0.04","source":"https://doi.org/10.1001/jamaoncol.2020.3370"}]},"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/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"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/"}]}}