Cemiplimab for Unresectable Cutaneous Squamous Cell Carcinoma: Experience From a Tertiary Center

The aim of this study was to evaluate outcomes of treatment with cemiplimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) not amenable to surgery or radiotherapy in a single tertiary center. Demographic, histologic, and clinical data were retrospectively collected for patients treated with cemiplimab between November 2018 and March 2023. The primary objective was overall response rate (ORR), with secondary objectives including progression-free survival (PFS), overall survival (OS), and adverse events (AEs). Among 31 patients, 20 (64.5%) achieved a complete response, 6 (19.4%) achieved a partial response, and 2 (6.5%) experienced disease progression. Our findings yielded an ORR of 83.9%, which exceeded the 46.1% reported in the EMPOWER-CSCC 1 trial. The 2-year OS was 73.5%, comparable to the 73.3% reported in EMPOWER-CSCC 1. Adverse events occurred in 24 patients (77.4%). These findings provide additional real-world evidence supporting the efficacy of cemiplimab in advanced cSCC, with a substantial proportion of patients achieving complete response, including after limited treatment exposure; further studies are needed to better define optimal treatment duration and dosing strategies.