{"entity":{"id":"empower-cscc-1","kind":"trial","name":"EMPOWER-CSCC-1","aka":[],"tldr":"EMPOWER-CSCC-1 showed that cemiplimab shrinks almost half of advanced skin squamous cell cancers, most of them for years, and it gave this cancer its first approved drug.","summary":"EMPOWER-CSCC-1 was a single-arm phase 2 trial of the PD-1 antibody cemiplimab in cutaneous squamous cell carcinoma that was metastatic or locally advanced and beyond cure with surgery or radiotherapy. Cutaneous squamous cell carcinoma carries one of the highest mutation burdens of any cancer because of ultraviolet damage, and it is commoner in immunosuppressed people, both of which pointed to immunotherapy.\n\nIn the first report (NEJM 2018) the objective response rate in the metastatic group was 47 percent, and in the pooled analysis of 193 patients across the three groups (2021) it was 46 percent with complete responses in 16 percent; the median duration of response had not been reached. Toxicity was that of PD-1 blockade generally.\n\nCemiplimab was approved for advanced cutaneous squamous cell carcinoma in September 2018, the first systemic therapy for the disease, and the trial opened the way to pembrolizumab (KEYNOTE-629), cosibelimab, neoadjuvant cemiplimab and the adjuvant C-POST trial.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02760498","url":"https://clinicaltrials.gov/study/NCT02760498"},{"label":"NEJM 2018","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1805131"},{"label":"Pooled analysis, JITC 2021","url":"https://doi.org/10.1136/jitc-2020-002757"}],"tags":[],"related":[],"cancers":["advanced-cutaneous-scc","cutaneous-scc","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["cemiplimab"],"companies":["regeneron","sanofi"],"institutions":[],"pathways":[],"terms":["tmb","skin-cancer-after-organ-transplant","radiotherapy-for-skin-cancer"],"trials":["c-post","neoadjuvant-cemiplimab-cscc","trog-05-01","cemiplimab-kidney-transplant-cscc"],"people":[],"bottlenecks":[],"keyPapers":["paper-empower-cscc-1-lancet-oncol-2020","paper-empower-cscc-1-j-am-acad-dermatol-2025-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02760498","phase":"2","setting":"Locally advanced or metastatic cutaneous squamous cell carcinoma not suitable for curative surgery or radiotherapy: cemiplimab in three dose groups","sponsor":"Regeneron / Sanofi","result":"Objective response 47% in the metastatic group; 46% in the pooled analysis of 193 patients with 16% complete responses.","started":"2016-04-07","startedType":"actual","yearReported":2018,"enrolled":193,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (metastatic group)","primary":true,"unit":"%","arms":[{"name":"Cemiplimab","n":59,"value":47}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1805131"},{"endpoint":"Objective response rate (pooled analysis)","unit":"%","arms":[{"name":"Cemiplimab","n":193,"value":46}],"source":"https://doi.org/10.1136/jitc-2020-002757"}],"replication":"KEYNOTE-629 (pembrolizumab) and the cosibelimab pivotal study found response rates of the same order with other PD-1 pathway antibodies."},"route":"/trials/empower-cscc-1/","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/"},{"id":"lip-cancer","kind":"cancer","name":"Lip cancer","route":"/cancers/lip-cancer/"},{"id":"skin-cancer","kind":"cancer","name":"Skin cancer (all types)","route":"/cancers/skin-cancer/"}],"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":"cemiplimab","kind":"drug","name":"Cemiplimab","route":"/drugs/cemiplimab/"}],"company":[{"id":"regeneron","kind":"company","name":"Regeneron","route":"/companies/regeneron/"},{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"term":[{"id":"radiotherapy-for-skin-cancer","kind":"term","name":"Radiotherapy for skin cancer","route":"/terms/radiotherapy-for-skin-cancer/"},{"id":"skin-cancer-after-organ-transplant","kind":"term","name":"Skin cancer after an organ transplant","route":"/terms/skin-cancer-after-organ-transplant/"},{"id":"tmb","kind":"term","name":"Tumour mutational burden (TMB)","route":"/terms/tmb/"}],"trial":[{"id":"c-post","kind":"trial","name":"C-POST (cemiplimab after surgery and radiotherapy for high-risk skin squamous cell carcinoma)","route":"/trials/c-post/"},{"id":"cemiplimab-kidney-transplant-cscc","kind":"trial","name":"Cemiplimab for kidney transplant recipients with advanced skin squamous cell carcinoma","route":"/trials/cemiplimab-kidney-transplant-cscc/"},{"id":"ck-301-101","kind":"trial","name":"CK-301-101","route":"/trials/ck-301-101/"},{"id":"neoadjuvant-cemiplimab-cscc","kind":"trial","name":"Neoadjuvant cemiplimab for resectable stage II to IV skin squamous cell carcinoma","route":"/trials/neoadjuvant-cemiplimab-cscc/"},{"id":"trog-05-01","kind":"trial","name":"TROG 05.01 (chemotherapy added to radiotherapy after surgery for high-risk skin squamous cell carcinoma)","route":"/trials/trog-05-01/"}],"paper":[{"id":"paper-empower-cscc-1-j-am-acad-dermatol-2025-update","kind":"paper","name":"A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6","route":"/key-papers/paper-empower-cscc-1-j-am-acad-dermatol-2025-update/"},{"id":"paper-empower-cscc-1-lancet-oncol-2020","kind":"paper","name":"Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial","route":"/key-papers/paper-empower-cscc-1-lancet-oncol-2020/"},{"id":"paper-empower-cscc-1-cemiplimab-migden-nejm-2018","kind":"paper","name":"PD-1 blockade with cemiplimab in advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1)","route":"/key-papers/paper-empower-cscc-1-cemiplimab-migden-nejm-2018/"}]}}