{"entity":{"id":"keynote-010","kind":"trial","name":"KEYNOTE-010","aka":[],"tldr":"The trial that validated PD-L1 staining as a way of choosing who gets immunotherapy, and gave pembrolizumab its first lung cancer approval.","summary":"KEYNOTE-010 enrolled 1,034 patients at 202 academic centres in 24 countries between August 2013 and February 2015, randomising them 1:1:1 to pembrolizumab 2 mg/kg (345), pembrolizumab 10 mg/kg (346) or docetaxel 75 mg/m2 (343) every three weeks. Entry required PD-L1 on at least 1 percent of tumour cells, and both survival endpoints were tested in the whole population and again in patients with PD-L1 on 50 percent or more.\n\nBy 30 September 2015, 521 patients had died. Median overall survival was 10.4 months with pembrolizumab 2 mg/kg, 12.7 months with 10 mg/kg and 8.5 months with docetaxel; the hazard ratios against docetaxel were 0.71 (95 percent confidence interval 0.58 to 0.88, p=0.0008) and 0.61 (0.49 to 0.75) respectively. The effect was larger in the PD-L1-high subgroup, which is the finding that made PD-L1 selection standard.\n\nThe FDA approved pembrolizumab for PD-L1-positive previously treated non-small-cell lung cancer in 2015 and broadened it on this trial. In England NICE TA428 (11 January 2017, updated 12 September 2017) recommends it after at least one chemotherapy, stopped at two years. The two doses performed similarly and the licensed dose became a flat 200 mg.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01905657","url":"https://clinicaltrials.gov/study/NCT01905657"},{"label":"KEYNOTE-010 (Lancet 2016)","url":"https://doi.org/10.1016/S0140-6736(15)01281-7"},{"label":"NICE TA428: pembrolizumab for PD-L1-positive non-small-cell lung cancer after chemotherapy","url":"https://www.nice.org.uk/guidance/ta428"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","companion-diagnostic"],"targets":["pd1","pdl1"],"drugs":["pembrolizumab","docetaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["tps","pd-l1-testing","immune-checkpoint"],"trials":["keynote-024-189","checkmate-017","oak"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01905657","phase":"2/3","setting":"Previously treated advanced non-small-cell lung cancer with PD-L1 on at least 1 percent of tumour cells: pembrolizumab 2 mg/kg or 10 mg/kg versus docetaxel 75 mg/m2, all every three weeks, with overall and progression-free survival in the whole population and in the PD-L1 50 percent or more population as co-primary endpoints","sponsor":"Merck Sharp & Dohme","result":"Median overall survival 10.4 months (pembrolizumab 2 mg/kg) and 12.7 months (10 mg/kg) against 8.5 months with docetaxel; hazard ratios 0.71 and 0.61.","yearReported":2016,"enrolled":1034,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab 2 mg/kg","n":345,"value":10.4},{"name":"Docetaxel","n":343,"value":8.5}],"hr":0.71,"ci":[0.58,0.88],"p":"0.0008","source":"https://doi.org/10.1016/S0140-6736(15)01281-7"},{"endpoint":"Overall survival, higher dose","unit":"months","arms":[{"name":"Pembrolizumab 10 mg/kg","n":346,"value":12.7},{"name":"Docetaxel","n":343,"value":8.5}],"hr":0.61,"ci":[0.49,0.75],"source":"https://doi.org/10.1016/S0140-6736(15)01281-7"}],"replication":"CheckMate 017, CheckMate 057 and OAK reproduced the second-line survival benefit with nivolumab and atezolizumab."},"route":"/trials/keynote-010/","neighbours":{"cancer":[{"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":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"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":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"term":[{"id":"immune-checkpoint","kind":"term","name":"Immune checkpoint","route":"/terms/immune-checkpoint/"},{"id":"pd-l1-testing","kind":"term","name":"PD-L1 expression testing (22C3, SP142, SP263)","route":"/terms/pd-l1-testing/"},{"id":"tps","kind":"term","name":"Tumour proportion score (TPS)","route":"/terms/tps/"}],"trial":[{"id":"checkmate-017","kind":"trial","name":"CheckMate 017","route":"/trials/checkmate-017/"},{"id":"keynote-024-189","kind":"trial","name":"KEYNOTE-024 & KEYNOTE-189","route":"/trials/keynote-024-189/"},{"id":"oak","kind":"trial","name":"OAK","route":"/trials/oak/"}]}}