{"entity":{"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)","aka":[],"tldr":"Cemiplimab shrank tumours in about half of patients with metastatic or locally advanced cutaneous squamous cell carcinoma, a highly mutated skin cancer with almost no previous treatment options, leading to the first approval for the disease.","summary":"Phase 1 expansion cohort (26 patients) and phase 2 study (59 patients) of cemiplimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma not amenable to curative surgery or radiotherapy.\n\nObjective response was 50 percent in the phase 1 cohort and 47 percent in the phase 2 metastatic cohort, with most responses durable beyond six months and typical immune-related toxicity.","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2018","url":"https://doi.org/10.1056/NEJMoa1805131"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/29863979/"}],"tags":[],"related":[],"cancers":["lip-cancer","advanced-cutaneous-scc"],"sections":[],"technologies":[],"targets":[],"drugs":["cemiplimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["empower-cscc-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2018,"doi":"10.1056/NEJMoa1805131","pmid":"29863979","authors":"Migden MR, Rischin D, Schmults CD, et al.","paperType":"observational","findings":["Objective response 50 percent (phase 1) and 47 percent (phase 2 metastatic cohort).","Durable responses exceeding six months in the majority of responders."],"whatItMeans":"PD-1 blockade is the first-line systemic treatment for advanced cutaneous squamous cell carcinoma, including on the lip, and cemiplimab has since moved into neoadjuvant and adjuvant use.","caveats":["Single-arm; transplant recipients and immunosuppressed patients were excluded."],"changedPractice":true,"participants":85},"route":"/key-papers/paper-empower-cscc-1-cemiplimab-migden-nejm-2018/","neighbours":{"cancer":[{"id":"advanced-cutaneous-scc","kind":"cancer","name":"Advanced cutaneous squamous cell carcinoma","route":"/cancers/advanced-cutaneous-scc/"},{"id":"lip-cancer","kind":"cancer","name":"Lip cancer","route":"/cancers/lip-cancer/"}],"drug":[{"id":"cemiplimab","kind":"drug","name":"Cemiplimab","route":"/drugs/cemiplimab/"}],"trial":[{"id":"empower-cscc-1","kind":"trial","name":"EMPOWER-CSCC-1","route":"/trials/empower-cscc-1/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}