{"entity":{"id":"keynote-119","kind":"trial","name":"KEYNOTE-119","aka":[],"tldr":"KEYNOTE-119 tested pembrolizumab on its own against chemotherapy as second- or third-line treatment for metastatic triple-negative breast cancer. It did not lengthen life, even in tumours with high PD-L1, which is why immunotherapy in this disease is given with chemotherapy or an antibody-drug conjugate and only in the first line.","summary":"KEYNOTE-119 (NCT02555657) randomised 622 patients with centrally confirmed metastatic triple-negative breast cancer, one or two prior systemic treatments and prior anthracycline or taxane, 1 to 1 to pembrolizumab 200 mg every 3 weeks for up to 35 cycles or single-agent chemotherapy of the investigator's choice (capecitabine, eribulin, gemcitabine or vinorelbine). The primary endpoint was overall survival tested hierarchically in CPS 10 or more, CPS 1 or more and all patients. At a median follow-up of 31.4 months median overall survival in CPS 10 or more was 12.7 versus 11.6 months (hazard ratio 0.78, 95 percent confidence interval 0.57 to 1.06, p 0.057), in CPS 1 or more 10.7 versus 10.2 months (0.86, 0.69 to 1.06, p 0.073) and overall 9.9 versus 10.8 months (0.97, 0.82 to 1.15). Grade 3 to 4 treatment-related adverse events were far less common with pembrolizumab (for example neutropenia below 1 versus 10 percent). The trend with rising PD-L1 expression fed the CPS 10 threshold used in KEYNOTE-355, but the trial itself was negative, pembrolizumab has no monotherapy indication in breast cancer, and NICE discontinued its appraisal of pembrolizumab for previously treated metastatic triple-negative disease (GID-TA10295).","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02555657","url":"https://clinicaltrials.gov/study/NCT02555657"},{"label":"Winer et al., Lancet Oncology 2021: pembrolizumab versus investigator-choice chemotherapy for metastatic TNBC (KEYNOTE-119)","url":"https://doi.org/10.1016/S1470-2045(20)30754-3"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["pembrolizumab","capecitabine","eribulin","gemcitabine","vinorelbine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["cps"],"trials":["keynote-355","ascent"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02555657","phase":"3","setting":"Metastatic triple-negative breast cancer after one or two prior systemic treatments: pembrolizumab monotherapy versus investigator's choice of capecitabine, eribulin, gemcitabine or vinorelbine, 150 centres in 31 countries","sponsor":"Merck Sharp & Dohme","result":"OS in CPS 10 or more 12.7 vs 11.6 months (HR 0.78, p 0.057); CPS 1 or more 10.7 vs 10.2 (HR 0.86); all patients 9.9 vs 10.8 (HR 0.97). Negative.","yearReported":2021,"enrolled":622,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, PD-L1 CPS 10 or more","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","value":12.7},{"name":"Chemotherapy","value":11.6}],"hr":0.78,"ci":[0.57,1.06],"p":"0.057","source":"https://doi.org/10.1016/S1470-2045(20)30754-3"},{"endpoint":"Overall survival, PD-L1 CPS 1 or more","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","value":10.7},{"name":"Chemotherapy","value":10.2}],"hr":0.86,"ci":[0.69,1.06],"p":"0.073","source":"https://doi.org/10.1016/S1470-2045(20)30754-3"},{"endpoint":"Overall survival, all patients","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","n":312,"value":9.9},{"name":"Chemotherapy","n":310,"value":10.8}],"hr":0.97,"ci":[0.82,1.15],"source":"https://doi.org/10.1016/S1470-2045(20)30754-3"}],"replication":"The PD-L1 gradient was confirmed by KEYNOTE-355, where pembrolizumab with chemotherapy improved survival only at CPS 10 or more."},"route":"/trials/keynote-119/","neighbours":{"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"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/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"eribulin","kind":"drug","name":"Eribulin","route":"/drugs/eribulin/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"vinorelbine","kind":"drug","name":"Vinorelbine","route":"/drugs/vinorelbine/"}],"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/"}],"trial":[{"id":"ascent","kind":"trial","name":"ASCENT","route":"/trials/ascent/"},{"id":"keynote-355","kind":"trial","name":"KEYNOTE-355","route":"/trials/keynote-355/"}]}}