{"entity":{"id":"checkmate-057","kind":"trial","name":"CheckMate 057","aka":[],"tldr":"Showed that a PD-1 antibody also beats chemotherapy in the commoner, non-squamous form of lung cancer, and that PD-L1 staining predicts how much.","summary":"CheckMate 057 randomised 582 patients with non-squamous non-small-cell lung cancer that had progressed during or after platinum doublet chemotherapy to nivolumab 3 mg/kg every two weeks (292) or docetaxel 75 mg/m2 every three weeks (290).\n\nMedian overall survival was 12.2 months (95 percent confidence interval 9.7 to 15.0) with nivolumab against 9.4 months (8.1 to 10.7) with docetaxel (hazard ratio for death 0.73, 96 percent confidence interval 0.59 to 0.89, p=0.002). One-year survival was 51 against 39 percent and 18-month survival 39 against 23 percent. Response was 19 against 12 percent (p=0.02). Median progression-free survival favoured docetaxel (2.3 against 4.2 months), but the one-year progression-free rate favoured nivolumab (19 against 8 percent): the crossing curves are the classic signature of immunotherapy, where a minority does very well and the median hides it. The benefit was greater at higher PD-L1 expression thresholds of 1, 5 and 10 percent, unlike in the squamous population of CheckMate 017.\n\nThe FDA approved nivolumab for non-squamous disease later in 2015. In England NICE TA713 (7 July 2021) recommends nivolumab for advanced non-squamous disease after chemotherapy.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01673867","url":"https://clinicaltrials.gov/study/NCT01673867"},{"label":"CheckMate 057 (New England Journal of Medicine 2015)","url":"https://doi.org/10.1056/NEJMoa1507643"},{"label":"NICE TA713: nivolumab for advanced non-squamous non-small-cell lung cancer after chemotherapy","url":"https://www.nice.org.uk/guidance/ta713"}],"tags":[],"related":[],"cancers":["lung-adenocarcinoma","nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":["pd1","pdl1"],"drugs":["nivolumab","docetaxel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["immune-checkpoint","tps","pd-l1-testing"],"trials":["checkmate-017","oak"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01673867","phase":"3","setting":"Advanced non-squamous non-small-cell lung cancer progressing during or after platinum doublet chemotherapy: nivolumab 3 mg/kg every two weeks versus docetaxel 75 mg/m2 every three weeks, with overall survival as the primary endpoint","sponsor":"Bristol-Myers Squibb","result":"Median overall survival 12.2 against 9.4 months (hazard ratio 0.73, p=0.002); progression-free survival crossed, favouring docetaxel at the median and nivolumab at one year.","yearReported":2015,"enrolled":582,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab","n":292,"value":12.2},{"name":"Docetaxel","n":290,"value":9.4}],"hr":0.73,"ci":[0.59,0.89],"p":"0.002","source":"https://doi.org/10.1056/NEJMoa1507643"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Nivolumab","n":292,"value":2.3},{"name":"Docetaxel","n":290,"value":4.2}],"source":"https://doi.org/10.1056/NEJMoa1507643"}],"replication":"OAK and KEYNOTE-010 reproduced the second-line survival benefit with atezolizumab and pembrolizumab."},"route":"/trials/checkmate-057/","neighbours":{"cancer":[{"id":"lung-adenocarcinoma","kind":"cancer","name":"Adenocarcinoma of the lung","route":"/cancers/lung-adenocarcinoma/"},{"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/"}],"technology":[{"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":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"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":"oak","kind":"trial","name":"OAK","route":"/trials/oak/"}]}}