Efficacy and Safety of Cemiplimab in Cutaneous Squamous Cell Carcinoma: A Systematic Review of Clinical Trials

Abstract

Background: One prevalent kind of skin cancer is cutaneous squamous cell carcinoma (CSCC), with advanced stages historically having limited treatment options and poor outcomes. A possible treatment is cemiplimab, an inhibitor of programmed cell death-1 (PD-1). This systematic review aims to consolidate evidence from clinical trials on the efficacy and safety of cemiplimab across the spectrum of advanced CSCC.

Methods: Using PubMed/MEDLINE, Embase, Web of Science, and Cochrane Central from the beginning to the present, a thorough literature search was carried out in accordance with PRISMA standards. Included were prospective clinical studies examining cemiplimab in adult patients with resectable, metastatic, or locally advanced CSCC. Objective reaction rate (ORR) and pathological complete response (pCR) were the main results. Safety and survival were secondary outcomes.

Results: Seven studies (one Phase 3 RCT, six Phase 2 trials) were included. Cemiplimab showed significant and long-lasting effectiveness in advanced CSCC, with ORRs ranging from 41.1% to 62%. In a critical examination, 87.8% of respondents continued to answer after a year, failing to meet the median duration of response. High pCR rates (51–73%) in the neoadjuvant context allowed for less involved surgery. Adjuvant cemiplimab was found to be a new standard of treatment in the Phase 3 C-POST study, which reduced the risk of mortality or illness recurrence by 68% (Hazard Ratio 0.32) when compared to placebo. With 23.9% to 44% of patients experiencing Grade ≥3 treatment-emergent side events, the safety profile was reasonable and in line with the PD-1 inhibitor class.

Conclusion: Cemiplimab is a highly effective and indispensable therapy for CSCC, demonstrating robust and durable efficacy across metastatic, locally advanced, neoadjuvant, and adjuvant settings. Its manageable safety profile solidifies its role as a cornerstone treatment, marking a paradigm shift in the management of this disease.