Effectiveness and safety of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma

TL;DR

This study shows cemiplimab is effective and safe for treating advanced skin cancer, with half of patients responding positively, though some experienced side effects.

Contribution

The study provides real-life evidence of cemiplimab's effectiveness and safety in treating locally advanced and metastatic cutaneous squamous cell carcinoma.

Findings

Cemiplimab achieved a 49.4% objective response rate in patients with advanced skin cancer.

Median overall survival was 19 months, and half of patients experienced adverse events.

Patients with head and neck tumors had longer survival after first progression.

Abstract

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.

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