{"entity":{"id":"paper-keynote-010-lancet-2016","kind":"paper","name":"KEYNOTE-010 (Herbst 2016): pembrolizumab versus docetaxel in previously treated PD-L1-positive lung cancer","aka":[],"tldr":"After chemotherapy had failed, pembrolizumab prolonged life compared with docetaxel in lung cancers expressing any PD-L1, with the largest gain in tumours where at least half the cells were positive, and caused fewer severe side effects.","summary":"KEYNOTE-010 randomised 1,034 patients with previously treated advanced non-small-cell lung cancer and a PD-L1 tumour proportion score of at least 1% to pembrolizumab at 2 mg/kg or 10 mg/kg or to docetaxel. Both pembrolizumab doses improved overall survival in the whole population and by a larger margin in the group with a score of 50% or more, with fewer grade 3 to 5 treatment-related adverse events than docetaxel. It secured pembrolizumab's regular approval in previously treated lung cancer and established PD-L1 of 1% as the entry threshold for that use.","asOf":"2026-09-08","links":[{"label":"Full text (DOI)","url":"https://doi.org/10.1016/S0140-6736(15)01281-7"},{"label":"ClinicalTrials.gov NCT01905657","url":"https://clinicaltrials.gov/study/NCT01905657"}],"tags":[],"related":["paper-keynote-001-pembrolizumab-nsclc-nejm-2015","paper-checkmate-057-nejm-2015","pd-l1-tps"],"cancers":["nsclc"],"sections":[],"technologies":["histopathology-ihc","checkpoint-inhibitor"],"targets":["pd1","pdl1"],"drugs":["pembrolizumab","docetaxel"],"companies":["merck"],"institutions":[],"pathways":["pd1-checkpoint"],"terms":["tps","os","ihc"],"trials":[],"people":["roy-herbst"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"The Lancet","year":2016,"doi":"10.1016/S0140-6736(15)01281-7","authors":"Herbst RS, Baas P, Kim DW, et al.","paperType":"rct","findings":["1,034 patients with previously treated NSCLC and PD-L1 tumour proportion score of at least 1%; pembrolizumab 2 mg/kg, 10 mg/kg or docetaxel.","Median overall survival 10.4 and 12.7 months with pembrolizumab vs 8.5 months with docetaxel; hazard ratios 0.71 and 0.61.","In tumours with a score of 50% or more: median overall survival 14.9 and 17.3 vs 8.2 months; hazard ratios 0.54 and 0.50.","Grade 3 to 5 treatment-related adverse events 13% and 16% vs 35%."],"whatItMeans":"Alongside the CheckMate trials this study replaced docetaxel with PD-1 blockade as second-line treatment for most lung cancers, and its PD-L1 threshold of 1% became the basis of pembrolizumab's label in previously treated disease.","caveats":["Open-label design.","Patients with PD-L1-negative tumours were excluded, so the trial says nothing about them.","Second-line setting; first-line immunotherapy has since reduced its relevance."],"changedPractice":true,"participants":1034},"route":"/key-papers/paper-keynote-010-lancet-2016/","neighbours":{"paper":[{"id":"paper-checkmate-057-nejm-2015","kind":"paper","name":"CheckMate 057: nivolumab beats docetaxel after chemotherapy in non-squamous lung cancer","route":"/key-papers/paper-checkmate-057-nejm-2015/"},{"id":"paper-keynote-001-pembrolizumab-nsclc-nejm-2015","kind":"paper","name":"KEYNOTE-001 (Garon 2015): pembrolizumab in non-small-cell lung cancer and the 50% PD-L1 cut-off","route":"/key-papers/paper-keynote-001-pembrolizumab-nsclc-nejm-2015/"}],"biomarker":[{"id":"pd-l1-tps","kind":"biomarker","name":"PD-L1 TPS (tumour proportion score)","route":"/biomarkers/pd-l1-tps/"}],"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"histopathology-ihc","kind":"technology","name":"Histopathology & immunohistochemistry","route":"/technologies/histopathology-ihc/"},{"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/"}],"pathway":[{"id":"pd1-checkpoint","kind":"pathway","name":"PD-1 / PD-L1 immune checkpoint & T-cell activation","route":"/pathways/pd1-checkpoint/"}],"term":[{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"},{"id":"tps","kind":"term","name":"Tumour proportion score (TPS)","route":"/terms/tps/"}],"person":[{"id":"roy-herbst","kind":"person","name":"Roy S. Herbst","route":"/people/roy-herbst/"}],"idea":[{"id":"idea-tr1-extended-interval-checkpoint-dosing","kind":"idea","name":"Extended-interval immunotherapy: give checkpoint inhibitors every 8-12 weeks once stable","route":"/ideas/idea-tr1-extended-interval-checkpoint-dosing/"},{"id":"idea-tr1-immunotherapy-stop-trials","kind":"idea","name":"Randomised trials of stopping immunotherapy after one year versus continuing","route":"/ideas/idea-tr1-immunotherapy-stop-trials/"}]}}