{"entity":{"id":"keynote-629","kind":"trial","name":"KEYNOTE-629","aka":[],"tldr":"KEYNOTE-629 showed that pembrolizumab shrinks about a third of recurrent or metastatic skin squamous cell cancers and half of locally advanced ones, giving a second immunotherapy option after cemiplimab.","summary":"KEYNOTE-629 was a single-arm phase 2 trial of pembrolizumab with two cohorts: recurrent or metastatic cutaneous squamous cell carcinoma, and locally advanced disease not curable by surgery or radiotherapy.\n\nIn the recurrent or metastatic cohort of 105 patients the objective response rate was 34 percent (JCO 2020); in the locally advanced cohort of 54 patients it was 50 percent, with responses in both cohorts lasting well beyond a year in most responders. Toxicity matched pembrolizumab in other cancers.\n\nPembrolizumab was approved for recurrent or metastatic cutaneous squamous cell carcinoma in June 2020 and for locally advanced disease in July 2021, making it the second PD-1 antibody available and confirming that the EMPOWER-CSCC-1 result was a class effect.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03284424","url":"https://clinicaltrials.gov/study/NCT03284424"},{"label":"JCO 2020","url":"https://ascopubs.org/doi/10.1200/JCO.19.03054"}],"tags":[],"related":[],"cancers":["advanced-cutaneous-scc","cutaneous-scc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03284424","phase":"2","setting":"Recurrent or metastatic, and separately locally advanced, cutaneous squamous cell carcinoma: pembrolizumab","sponsor":"Merck","result":"Objective response 34% in recurrent or metastatic disease and 50% in locally advanced disease.","yearReported":2020,"enrolled":159,"outcomes":[{"endpoint":"Objective response rate (recurrent or metastatic cohort)","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":105,"value":34}],"source":"https://ascopubs.org/doi/10.1200/JCO.19.03054"},{"endpoint":"Objective response rate (locally advanced cohort)","unit":"%","arms":[{"name":"Pembrolizumab","n":54,"value":50}],"source":"https://doi.org/10.1016/j.jaad.2021.04.008"}],"replication":"Consistent with EMPOWER-CSCC-1 (cemiplimab) and the cosibelimab pivotal study."},"route":"/trials/keynote-629/","neighbours":{"cancer":[{"id":"advanced-cutaneous-scc","kind":"cancer","name":"Advanced cutaneous squamous cell carcinoma","route":"/cancers/advanced-cutaneous-scc/"},{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}]}}