{"entity":{"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","aka":[],"tldr":"Later report from the EMPOWER-CSCC-1 trial registered as NCT02760498, in Journal of the American Academy of Dermatology (2025); its title describes an updated or longer-term analysis.","summary":"Background: In the phase 2 EMPOWER-CSCC-1 study (NCT02760498), cemiplimab demonstrated antitumor activity against metastatic cutaneous squamous cell carcinoma (mCSCC) and locally advanced cutaneous squamous cell carcinoma (laCSCC).\n\nObjectives: To report final analysis of weight-based cemiplimab in mCSCC and laCSCC (groups 1 and 2), fixed-dose cemiplimab in mCSCC (group 3), and primary analysis of fixed-dose cemiplimab in mCSCC/laCSCC (group 6).\n\nMethods: Patients received cemiplimab (3 mg/kg intravenously every 2 weeks [groups 1 and 2]) or cemiplimab (350 mg intravenously [groups 3 and 6]) every 3 weeks. The primary end point was objective response rate (ORR). Duration of response (DOR) and progression-free survival (PFS) are presented per protocol, according to post-hoc sensitivity analyses that only include the period of protocol-mandated imaging assessments.\n\nResults: At 42.5 months, ORR for groups 1-3 (n = 193) was 47.2%, estimated 12-month DOR was 88.3%, and median PFS was 26.0 months. At 8.7 months, ORR for group 6 (n = 165 patients) was 44.8%; median DOR and median PFS were not reached. Serious treatment-emergent adverse event rates (grade ≥3) were groups 1-3: 31.1% and group 6: 34.5%.\n\nLimitations: Nonrandomized study, nonsurvival primary end point.\n\nConclusion: EMPOWER-CSCC-1 provides the largest prospective data on long-term efficacy and safety for anti-programmed cell death-1 therapy in advanced CSCC.\n\nIndexed on Europe PMC as PubMed record 39245360 (DOI 10.1016/j.jaad.2024.06.108). Its abstract cites the registry id NCT02760498, which is how it was matched to this trial; no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"J Am Acad Dermatol 2025","url":"https://doi.org/10.1016/j.jaad.2024.06.108"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/39245360/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/39245360"},{"label":"ClinicalTrials.gov NCT02760498","url":"https://clinicaltrials.gov/study/NCT02760498"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["empower-cscc-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"Journal of the American Academy of Dermatology","year":2025,"doi":"10.1016/j.jaad.2024.06.108","pmid":"39245360","authors":"Hughes BGM, Guminski A, Bowyer S, et al.","paperType":"observational","findings":[],"whatItMeans":"A second publication from the EMPOWER-CSCC-1 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.","caveats":["Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.","Chosen as a later report by words in its title (updated, long-term, final, overall survival or a year count), not by reading the paper."]},"route":"/key-papers/paper-empower-cscc-1-j-am-acad-dermatol-2025-update/","neighbours":{"trial":[{"id":"empower-cscc-1","kind":"trial","name":"EMPOWER-CSCC-1","route":"/trials/empower-cscc-1/"}]}}