{"entity":{"id":"keynote-024-189","kind":"trial","name":"KEYNOTE-024 & KEYNOTE-189","aka":[],"tldr":"The two trials that made immunotherapy, alone or with chemotherapy, the first treatment for most advanced lung cancers.","summary":"KEYNOTE-024 (305 patients, TPS ≥50%): 5-year OS 31.9% vs 16.3% with chemotherapy. KEYNOTE-189 (616 patients): 5-year OS 19.4% vs 11.3%. Together with KEYNOTE-407 (squamous) they define first-line care for driver-negative disease and are the control arms every new agent (ivonescimab, ADC combinations) must beat.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02142738","url":"https://clinicaltrials.gov/study/NCT02142738"},{"label":"ClinicalTrials.gov NCT02578680","url":"https://clinicaltrials.gov/study/NCT02578680"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","pdl1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["tps"],"trials":[],"people":["martin-reck"],"bottlenecks":[],"keyPapers":["paper-keynote-024-nejm-2016","paper-keynote-024-189-j-clin-oncol-2021-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02142738","phase":"3","setting":"First-line metastatic NSCLC without EGFR/ALK: pembrolizumab alone (PD-L1 TPS ≥50%, KEYNOTE-024) or pembrolizumab + platinum-pemetrexed (any PD-L1, non-squamous, KEYNOTE-189)","sponsor":"Merck","result":"5-year OS 31.9% vs 16.3% (024); 19.4% vs 11.3% (189).","started":"2014-08-25","startedType":"actual","yearReported":2016,"enrolled":921,"enrolledBasis":"registry","outcomes":[{"endpoint":"KEYNOTE-024: overall survival at 5 years, PD-L1 ≥50%","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":154,"value":31.9},{"name":"Chemotherapy","n":151,"value":16.3}],"hr":0.62,"ci":[0.48,0.81],"source":"https://ascopubs.org/doi/10.1200/JCO.21.00174"},{"endpoint":"KEYNOTE-189: overall survival, non-squamous","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","n":410,"value":22},{"name":"Placebo + chemotherapy","n":206,"value":10.6}],"hr":0.6,"ci":[0.5,0.72],"source":"https://ascopubs.org/doi/10.1200/JCO.22.00975"}],"replication":"Replicated by KEYNOTE-042 (PD-L1 ≥1%), KEYNOTE-407 (squamous), IMpower150, and CheckMate 227/9LA; the most replicated result in lung immunotherapy."},"route":"/trials/keynote-024-189/","neighbours":{"cancer":[{"id":"her2-mutant-nsclc","kind":"cancer","name":"HER2-mutant non-small-cell lung cancer","route":"/cancers/her2-mutant-nsclc/"},{"id":"kras-g12c-nsclc","kind":"cancer","name":"KRAS G12C-mutant non-small-cell lung cancer","route":"/cancers/kras-g12c-nsclc/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-nsclc/"}],"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":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"term":[{"id":"control-arm","kind":"term","name":"Control arm and comparator (investigator's choice)","route":"/terms/control-arm/"},{"id":"landmark-survival","kind":"term","name":"Landmark and milestone survival (5-year survival, median follow-up)","route":"/terms/landmark-survival/"},{"id":"tps","kind":"term","name":"Tumour proportion score (TPS)","route":"/terms/tps/"}],"person":[{"id":"martin-reck","kind":"person","name":"Martin Reck","route":"/people/martin-reck/"}],"paper":[{"id":"paper-keynote-024-189-j-clin-oncol-2021-update","kind":"paper","name":"Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50","route":"/key-papers/paper-keynote-024-189-j-clin-oncol-2021-update/"},{"id":"paper-keynote-024-nejm-2016","kind":"paper","name":"KEYNOTE-024: pembrolizumab alone beats chemotherapy in PD-L1-high lung cancer","route":"/key-papers/paper-keynote-024-nejm-2016/"}],"pairing":[{"id":"pd1-plus-chemo-pdl1-low","kind":"pairing","name":"PD-1 blockade + chemotherapy in PD-L1-low NSCLC","route":"/pairings/pd1-plus-chemo-pdl1-low/"}],"trial":[{"id":"checkmate-026","kind":"trial","name":"CheckMate 026","route":"/trials/checkmate-026/"},{"id":"impower110","kind":"trial","name":"IMpower110","route":"/trials/impower110/"},{"id":"impower150","kind":"trial","name":"IMpower150","route":"/trials/impower150/"},{"id":"keynote-010","kind":"trial","name":"KEYNOTE-010","route":"/trials/keynote-010/"}],"bottleneck":[{"id":"b-immunotherapy-response","kind":"bottleneck","name":"No one can predict who responds to immunotherapy","route":"/bottlenecks/b-immunotherapy-response/"}],"idea":[{"id":"idea-tr1-low-dose-immunotherapy-for-lmic","kind":"idea","name":"Confirm ultra-low-dose immunotherapy so it can be afforded where most patients live","route":"/ideas/idea-tr1-low-dose-immunotherapy-for-lmic/"}],"roadmap":[{"id":"chemotherapy-roadmap","kind":"roadmap","name":"Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs","route":"/roadmaps/chemotherapy-roadmap/"}]}}