{"entity":{"id":"paper-keynote-811-janjigian-lancet-2023","kind":"paper","name":"KEYNOTE-811: pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma","aka":[],"tldr":"Adding pembrolizumab to trastuzumab and chemotherapy improved response and progression-free survival in HER2-positive advanced gastric cancer, with the benefit concentrated in tumours that also express PD-L1.","summary":"Phase 3 placebo-controlled trial of 698 patients with untreated HER2-positive advanced gastric or junctional adenocarcinoma randomised to pembrolizumab or placebo with trastuzumab and fluoropyrimidine-platinum chemotherapy.\n\nMedian progression-free survival was 10.0 versus 8.1 months (hazard ratio 0.72) overall and 10.8 versus 7.2 months in PD-L1 combined positive score 1 or more (hazard ratio 0.70); response was 73 versus 60 percent, and the final analysis showed an overall survival benefit in the PD-L1-positive population (20.0 versus 15.7 months).","asOf":"2026-09-17","links":[{"label":"Lancet 2023","url":"https://doi.org/10.1016/S0140-6736(23)02033-0"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37871604/"}],"tags":[],"related":[],"cancers":["gastric-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","trastuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["keynote-811"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["lancet"],"dependsOn":[],"notes":[],"journal":"The Lancet","year":2023,"doi":"10.1016/S0140-6736(23)02033-0","pmid":"37871604","authors":"Janjigian YY, Kawazoe A, Bai Y, et al.","paperType":"rct","findings":["Median progression-free survival 10.0 vs 8.1 months; hazard ratio 0.72.","Combined positive score 1 or more: overall survival 20.0 vs 15.7 months at final analysis."],"whatItMeans":"Pembrolizumab with trastuzumab and chemotherapy is the first-line standard for HER2-positive gastric cancer with a PD-L1 combined positive score of 1 or more.","caveats":["No benefit in PD-L1-negative tumours (about 15 percent), leading to a label restriction."],"changedPractice":true,"participants":698},"route":"/key-papers/paper-keynote-811-janjigian-lancet-2023/","neighbours":{"cancer":[{"id":"gastric-her2-positive","kind":"cancer","name":"HER2-positive gastric cancer","route":"/cancers/gastric-her2-positive/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"trial":[{"id":"keynote-811","kind":"trial","name":"KEYNOTE-811","route":"/trials/keynote-811/"}],"journal":[{"id":"lancet","kind":"journal","name":"The Lancet","route":"/journals/lancet/"}]}}