Prospective real-world outcomes with cemiplimab for locally advanced or metastatic cutaneous squamous cell carcinoma

The DRUG Access Protocol (DAP) in The Netherlands provides patients with cancer access to registered anticancer drugs that are awaiting reimbursement, and simultaneously collects prospective real-world data. DAP patients with locally advanced or metastatic cutaneous squamous cell carcinoma received the PD-1 blocker cemiplimab 350 mg every three weeks. The clinical benefit rate at 16 weeks was 54.3% (95% CI 46.0- 62.4) while the objective response rate was 35.1% (27.5-43.3). Median duration of response was not reached after median follow-up of 15.2 months. Median progression-free survival was 12.2 months (95% CI 7.0-NR) and median overall survival was 24.2 months (18.8-NR). Grade 3 or higher treatment-emergent adverse events occurred in 29.8% of patients. The authors conclude that cemiplimab proved highly effective and safe in this real-world cohort of patients with locally advanced or metastatic cutaneaous squamous cell carcinoma.