Evaluation of Clinical Parameters Associated with Response and Resistance to Cemiplimab in Locally Advanced and Metastatic Cutaneous Squamous Cell Carcinoma: A Multi-Institutional Retrospective Cohort Study

Abstract

Cutaneous squamous cell carcinoma (cSCC) is a common cancer with increasing incidence and 5% of patients develop incurable disease, often resistant to chemotherapy. The anti-PD-1 therapy cemiplimab has shown high efficacy in clinical trials. This retrospective study evaluated the real-world effectiveness of cemiplimab in incurable cSCC and examined factors influencing response and toxicity. Data from 86 patients across three UK healthcare providers were analysed. Median progression-free survival (PFS) and overall survival (OS) were not reached, with 38% showing durable responses beyond 12 months. The overall response rate was 60.8% (95% CI 49-71), and the clinical benefit rate was 74.3% (95% CI 63-83). A head and neck primary site was associated with improved PFS (p = 0.008) and OS (p = 0.023), while concurrent immunosuppression was associated with worse PFS (p < 0.001). These findings align with clinical trials, suggesting cemiplimab is effective and safe in the recurrent/metastatic setting.

Keywords: cemiplimab; cutaneous squamous cell carcinoma; primary site.

Figure 1

Kaplan–Meier plots of the progression-free survival (A) and overall survival (B) from treatment initiation for the entire study population (n = 86). The black dashed lines mark 12 months and 24 months. The median was not reached in either plot.

Figure 2

Kaplan–Meier plots of the progression-free survival with univariate comparisons of patient characteristics by log-rank, including site of primary disease (A), presence of immunosuppression (B), presence of haematological malignancy (C), presence of autoimmune comorbidity (D), differentiation on histology (E), and ECOG performance status (F). The black dashed line shows median survival if reached, and the purple dashed lines mark 12 months and 24 months.

Figure 3

Kaplan–Meier plots of the overall survival with univariate comparisons of patient characteristics by log-rank, including site of primary disease (A), presence of immunosuppression (B), presence of haematological malignancy (C), presence of an autoimmune comorbidity (D), differentiation on histology (E), and ECOG performance status (F). The black dashed line shows median survival if reached, and the purple dashed lines mark 12 months and 24 months.