BRIEF RESEARCH REPORT article
Front. Pharmacol.
Sec. Pharmacology of Anti-Cancer Drugs
This article is part of the Research TopicCutaneous Oncology and Management of Adverse EventsView all 3 articles
Effectiveness and safety of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma
Provisionally accepted
Gabriele Roccuzzo*
Eleonora BongiovanniGiovanni Actis-GiorgettoChiara AstruaMatteo Giovanni BrizioGiovanni Cavaliere
Paolo Fava
SIMONE RIBERO
Pietro Quaglino- University of Turin, Turin, Italy
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Cutaneous squamous cell carcinoma (cSCC) is a common skin cancer with increasing incidence. The anti-PD-1 therapy cemiplimab has shown its antitumor activity in locally advanced (lacSCC) and metastatic cSCC (mcSCC). This retrospective study assessed the real-life effectiveness and safety of cemiplimab in 83 patients with lacSCC (n=53) and mcSCC (n=30). The objective response rate (ORR) was 49.4%, with a complete response (CR) in 15.7% and a partial response (PR) in 33.7%. The median progression-free survival (PFS) was 14 months (95% CI 9-55) and the median overall survival (OS) 19 months (95% CI 10-39). Half of patients (50.6%) experienced adverse events (AE) of any grade, with 8.4% discontinuing therapy due to the severe AEs. The subset of patients who experienced progression during therapy displayed younger age (p=0.002), a higher disease stage at baseline (p=0.003), and a nodal disease (p=0.041). No differences in survival outcome emerged between patients with nodal vs distant metastases, previous radiotherapy recipient vs radiotherapy-naïve, and immunosuppressed vs immunocompetent patients. Head&neck tumor site was associated with a longer OS after first progression (OS2, HR 0.29, 95% CI 0.09-0.89). This study supports the safe and effective use of cemiplimab in real life clinical practice yet highlights the need for further identification of new predictors of clinical response.
Keywords: Cemiplimab, Checkpoint inhibitor therapy, Cutaneous squamous cell carcinoma, Immunosuppression, PD-1 inhibitors, real-life
Received: 28 Mar 2025; Accepted: 09 Feb 2026.
Copyright: © 2026 Roccuzzo, Bongiovanni, Actis-Giorgetto, Astrua, Brizio, Cavaliere, Fava, RIBERO and Quaglino. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Gabriele Roccuzzo
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