{"entity":{"id":"keynote-b96","kind":"trial","name":"KEYNOTE-B96 / ENGOT-ov65","aka":[],"tldr":"After a decade of failures, the first immunotherapy trial to extend survival in ovarian cancer, leading to the first checkpoint-inhibitor approval in the disease.","summary":"KEYNOTE-B96, also ENGOT-ov65, trial NCT05116189 sponsored by Merck and published in the Lancet in 2026, was, after a decade of failures, the first immunotherapy trial to extend survival in ovarian cancer, leading to the first checkpoint inhibitor approval in the disease. It randomised women with platinum-resistant recurrent disease to pembrolizumab or placebo with weekly paclitaxel, with or without bevacizumab, met its primary progression-free survival endpoint and improved overall survival in PD-L1-positive tumours, with a smaller survival benefit overall, and FDA approval followed in February 2026 for PD-L1-positive disease, including the subcutaneous formulation. OnCo links it to ovarian cancer, PD-1 and PD-L1 as targets, pembrolizumab, paclitaxel, bevacizumab and the CPS term. Why immunotherapy works in resistant but not first-line disease is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05116189","url":"https://clinicaltrials.gov/study/NCT05116189"},{"label":"FDA approval, ASCO Post","url":"https://ascopost.com/issues/february-25-2026/fda-approves-pembrolizumab-with-paclitaxel-for-platinum-resistant-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma/"}],"tags":[],"related":["src-asco-post"],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","pdl1"],"drugs":["pembrolizumab","paclitaxel","bevacizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["cps"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05116189","phase":"3","setting":"Platinum-resistant recurrent ovarian cancer, 1-2 prior lines: pembrolizumab + weekly paclitaxel ± bevacizumab vs placebo + paclitaxel ± bevacizumab","sponsor":"Merck","result":"OS 18.2 vs 14.0 months in CPS ≥1 (HR 0.76); ITT OS HR 0.82.","started":"2021-12-13","startedType":"actual","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (CPS ≥1)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + paclitaxel ± bev","value":8.3},{"name":"Placebo + paclitaxel ± bev","value":7.2}],"hr":0.72,"ci":[0.58,0.89],"source":"https://pubmed.ncbi.nlm.nih.gov/41974150/"},{"endpoint":"Overall survival (CPS ≥1)","unit":"months","arms":[{"name":"Pembrolizumab + paclitaxel ± bev","value":18.2},{"name":"Placebo + paclitaxel ± bev","value":14}],"hr":0.76,"ci":[0.61,0.94],"source":"https://pubmed.ncbi.nlm.nih.gov/41974150/"},{"endpoint":"Overall survival (all patients)","unit":"months","arms":[{"name":"Pembrolizumab + paclitaxel ± bev","value":17.7},{"name":"Placebo + paclitaxel ± bev","value":14}],"hr":0.82,"ci":[0.69,0.97],"source":"https://www.targetedonc.com/view/final-keynote-b96-analysis-confirms-survival-benefits-with-pembrolizumab-regimen-in-ovarian-cancer"}],"replication":"First positive phase 3; earlier trials (JAVELIN Ovarian 200, IMagyn050, DUO-O) were negative for OS."},"route":"/trials/keynote-b96/","neighbours":{"collection":[{"id":"src-asco-post","kind":"collection","name":"The ASCO Post","route":"/collections/src-asco-post/"}],"cancer":[{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"platinum-resistant-ovarian-cancer","kind":"cancer","name":"Platinum-resistant ovarian cancer","route":"/cancers/platinum-resistant-ovarian-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"},{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"drug":[{"id":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"term":[{"id":"cps","kind":"term","name":"Combined positive score (CPS)","route":"/terms/cps/"}],"pairing":[{"id":"caution-pd1-first-line-ovarian","kind":"pairing","name":"Caution: checkpoint inhibitors in first-line ovarian cancer","route":"/pairings/caution-pd1-first-line-ovarian/"}]}}