Extended follow-up outcomes of patients with advanced cutaneous squamous cell carcinoma treated with cemiplimab on EMPOWER-CSCC-1: A retrospective cohort study

Bennett, C; McLean, LS; Lim, AM; Bressel, M; Guminski, A; Hughes, BGM; Bowyer, SE; Stein, B; Rischin, D

Author(s): Bennett, C; McLean, LS; Lim, AM; Bressel, M; Guminski, A; Hughes, BGM; Bowyer, SE; Stein, B; Rischin, D;
Details: Publication Year 2026-04,Volume 94,Issue #4,Page 1151-1157
Journal Title: Journal of the American Academy of Dermatology
Publication Type: Research article
Abstract: BACKGROUND: The international phase 2 EMPOWER-CSCC-1 study established the programmed cell death protein-1 inhibitor cemiplimab as standard of care for patients with locally advanced or metastatic cutaneous squamous cell carcinoma, however, long-term durability of responses are unknown. OBJECTIVE: This study aimed to evaluate outcomes for patients in Australia treated on the EMPOWER-CSCC-1 study, beyond trial protocol follow-up. Outcomes for patients receiving cemiplimab retreatment were evaluated for those who progressed after completing fixed-duration treatment. METHODS: A retrospective multicenter analysis was conducted at 5 Australian sites. Primary outcomes were duration of response, progression-free survival (PFS), and overall survival (OS). RESULTS: Fifty-four patients (91% men) were identified, median age 71 years. Median follow-up was 77 (interquartile range, 72-86 months) months. Of 39 (72%) responders, 5-year duration of response was 65% (95% confidence interval [CI], 47-78). The median PFS was 56.4 months (95% CI, 19.2-not reached [NR]) and median OS NR (95% CI, 52.8-NR), with 5-year PFS and OS of 48% (95% CI, 34-61) and 60% (95% CI, 45-72), respectively. Four patients received retreatment with cemiplimab, with 3 of these patients remaining progression-free at data cut-off. LIMITATIONS: Those inherent to small retrospective analyses. CONCLUSIONS: Long-term follow-up confirms durable responses with cemiplimab in patients with advanced cutaneous squamous cell carcinoma in Australia treated on the EMPOWER-CSCC-1 trial.
Publisher: Elsevier
Keywords: Humans; Male; Retrospective Studies; *Carcinoma, Squamous Cell/drug therapy/mortality/pathology/secondary; Female; *Skin Neoplasms/drug therapy/mortality/pathology; Aged; *Antibodies, Monoclonal, Humanized/therapeutic use/administration & dosage; Follow-Up Studies; Middle Aged; *Antineoplastic Agents, Immunological/therapeutic use; Aged, 80 and over; Progression-Free Survival; Australia; Retreatment; Treatment Outcome; adult; antibodies, monoclonal/therapeutic use; carcinoma, squamous cell/drug therapy; immune checkpoint inhibitor; programmed cell disease 1 receptor/antagonists and inhibitors; skin neoplasms/drug therapy
Department(s): Medical Oncology; Biostatistics and Clinical Trials
Publisher's Version: https://doi.org/10.1016/j.jaad.2025.11.080
Open Access at Publisher's Site: https://doi.org/10.1016/j.jaad.2025.11.080
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2026-01-06 02:46:48

Last Modified: 2026-04-02 12:29:59