{"entity":{"id":"paper-keynote-859-lancet-oncol-2023","kind":"paper","name":"KEYNOTE-859: pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer","aka":[],"tldr":"Adding pembrolizumab to platinum-fluoropyrimidine chemotherapy lengthened survival in HER2-negative advanced gastric cancer, with the largest gain in tumours with a PD-L1 combined positive score of 10 or more, confirming chemo-immunotherapy as first-line standard.","summary":"Phase 3 placebo-controlled trial of 1,579 patients with untreated HER2-negative locally advanced or metastatic gastric or junctional adenocarcinoma randomised to pembrolizumab or placebo with fluoropyrimidine-platinum chemotherapy.\n\nMedian overall survival was 12.9 versus 11.5 months overall (hazard ratio 0.78), 13.0 versus 11.4 months in combined positive score 1 or more (hazard ratio 0.74) and 15.7 versus 11.8 months in score 10 or more (hazard ratio 0.65).","asOf":"2026-09-17","links":[{"label":"Lancet Oncol 2023","url":"https://doi.org/10.1016/S1470-2045(23)00515-6"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37875143/"}],"tags":[],"related":[],"cancers":["gastric-pdl1-high"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["keynote-859"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["lancet-oncology"],"dependsOn":[],"notes":[],"journal":"The Lancet Oncology","year":2023,"doi":"10.1016/S1470-2045(23)00515-6","pmid":"37875143","authors":"Rha SY, Oh DY, Yañez P, et al.","paperType":"rct","findings":["Median overall survival 12.9 vs 11.5 months overall; hazard ratio 0.78.","Combined positive score 10 or more: 15.7 vs 11.8 months; hazard ratio 0.65."],"whatItMeans":"Pembrolizumab plus chemotherapy is approved for HER2-negative advanced gastric cancer, alongside nivolumab plus chemotherapy from CheckMate 649, with strongest evidence at higher PD-L1 scores.","caveats":["Benefit in PD-L1-low tumours is small, and European approval is restricted to combined positive score 1 or more."],"changedPractice":true,"participants":1579},"route":"/key-papers/paper-keynote-859-lancet-oncol-2023/","neighbours":{"cancer":[{"id":"gastric-pdl1-high","kind":"cancer","name":"PD-L1-high gastric cancer","route":"/cancers/gastric-pdl1-high/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"trial":[{"id":"keynote-859","kind":"trial","name":"KEYNOTE-859","route":"/trials/keynote-859/"}],"journal":[{"id":"lancet-oncology","kind":"journal","name":"The Lancet Oncology","route":"/journals/lancet-oncology/"}]}}