Extended follow-up outcomes of patients with advanced cutaneous squamous cell carcinoma treated with cemiplimab on EMPOWER-CSCC-1: A retrospective cohort study
- Author(s)
- Bennett, C; McLean, LS; Lim, AM; Bressel, M; Guminski, A; Hughes, BGM; Bowyer, SE; Stein, B; Rischin, D;
- Journal Title
- Journal of the American Academy of Dermatology
- Publication Type
- Online publication before print
- Abstract
- BACKGROUND: The international phase II EMPOWER-CSCC-1 study established the PD-1 inhibitor cemiplimab as standard of care for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC), however long-term durability of responses are unknown. OBJECTIVE: This study aims to evaluate outcomes for patients in Australia treated on the EMPOWER-CSCC-1 study, beyond trial protocol follow-up. Outcomes for patients receiving cemiplimab re-treatment were evaluated for those who progressed after completing fixed duration treatment. METHODS: A retrospective multi-centre analysis was conducted at five Australian sites. Primary outcomes were duration of response (DoR), progression-free (PFS) and overall survival (OS). RESULTS: Fifty-four patients (91% male) were identified, median age 71 years. Median follow-up was 77 (IQR 72 - 86) months. Of 39 (72%) responders, 5-year DoR was 65% (95%CI: 47-78). The median PFS was 56.4 months (95%CI: 19.2-NR) and median OS not reached (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 re-treatment with cemiplimab, with three 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 CSCC in Australia treated on the EMPOWER-CSCC-1 trial.
- Keywords
- 80 and over; adult; aged; antagonists & inhibitors; antibodies; carcinoma; drug therapy; female; follow-up studies; immune checkpoint inhibitor; male; monoclonal; programmed cell disease 1 receptor; skin neoplasms; squamous cell; therapeutic use
- Department(s)
- Medical Oncology; Biostatistics and Clinical Trials
- Publisher's Version
- 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: 2026-01-06 02:47:11