{"entity":{"id":"keynote-775","kind":"trial","name":"KEYNOTE-775 / Study 309","aka":[],"tldr":"A pill that blocks tumour blood vessels plus immunotherapy extended survival after chemotherapy, including in tumours that immunotherapy alone does not touch.","summary":"OS 18.3 vs 11.4 months in all comers (HR 0.62) and 17.4 vs 12.0 months in pMMR (HR 0.68); PFS 7.2 vs 3.8 months (NEJM 2022). Full approval 2021 for pMMR disease after platinum. Toxicity is substantial: hypertension, hypothyroidism, diarrhoea, and dose reductions in two-thirds of patients. Now largely used after first-line chemo-immunotherapy.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03517449","url":"https://clinicaltrials.gov/study/NCT03517449"},{"label":"NEJM 2022","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2108330"}],"tags":[],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer","endometrial-nsmp"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":["vegf","pd1"],"drugs":["lenvatinib","pembrolizumab"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03517449","phase":"3","setting":"Advanced endometrial cancer after platinum: lenvatinib + pembrolizumab vs doxorubicin or weekly paclitaxel","sponsor":"Eisai / Merck","result":"OS 18.3 vs 11.4 months (HR 0.62).","started":"2018-06-11","startedType":"actual","yearReported":2021,"enrolled":827,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (all comers)","primary":true,"unit":"months","arms":[{"name":"Lenvatinib + pembrolizumab","n":411,"value":18.3},{"name":"Chemotherapy","n":416,"value":11.4}],"hr":0.62,"ci":[0.51,0.75],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2108330"},{"endpoint":"Progression-free survival (all comers)","primary":true,"unit":"months","arms":[{"name":"Lenvatinib + pembrolizumab","value":7.2},{"name":"Chemotherapy","value":3.8}],"hr":0.56,"ci":[0.47,0.66],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2108330"}]},"route":"/trials/keynote-775/","neighbours":{"cancer":[{"id":"advanced-recurrent-endometrial-cancer","kind":"cancer","name":"Advanced or recurrent endometrial cancer","route":"/cancers/advanced-recurrent-endometrial-cancer/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"endometrial-nsmp","kind":"cancer","name":"Endometrial cancer with no specific molecular profile","route":"/cancers/endometrial-nsmp/"},{"id":"endometrial-p53-abnormal","kind":"cancer","name":"p53-abnormal endometrial cancer, including uterine serous carcinoma","route":"/cancers/endometrial-p53-abnormal/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"},{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"drug":[{"id":"lenvatinib","kind":"drug","name":"Lenvatinib","route":"/drugs/lenvatinib/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"eisai","kind":"company","name":"Eisai","route":"/companies/eisai/"}],"pairing":[{"id":"lenvatinib-plus-pembrolizumab","kind":"pairing","name":"Lenvatinib + pembrolizumab (pMMR endometrial cancer after platinum)","route":"/pairings/lenvatinib-plus-pembrolizumab/"}],"paper":[{"id":"paper-keynote-775-nejm-2022","kind":"paper","name":"KEYNOTE-775: lenvatinib plus pembrolizumab versus chemotherapy for previously treated advanced endometrial cancer","route":"/key-papers/paper-keynote-775-nejm-2022/"}]}}