Regulatory Decision Summary for Libtayo

The submission included an integrated analysis of data from two clinical trials. The pivotal trial was a Phase 2, uncontrolled study of 82 patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC). Data from 26 patients with CSCC from a Phase I study were pooled with the pivotal trial to form the primary efficacy set. The patients in both clinical studies received cemiplimab 3 mg/kg every 2 weeks for up to 96 weeks. The primary efficacy endpoint was objective response rate (ORR) as assessed by an independent review committee. An overall ORR of 47.2% was considered clinically meaningful. Libtayo may cause serious (potentially life-threatening or fatal) adverse reactions. The most common adverse reactions (ADRs) reported in at least 10% of patients were rash, pruritus, diarrhea, and fatigue. Immune-mediated adverse reactions were common, but the majority were low-grade and/or manageable with close monitoring, the use of corticosteroids, and dose delays, as detailed in the product monograph (PM). The recommended dose of the drug is 350 mg intravenously every 3 weeks. In low body weight individuals, an alternative dose of 3 mg/kg every 2 weeks may be considered. View the PM for details. Overall, the benefit-risk assessment of Libtayo is considered favourable for this indication.

For more information on Health Canadas decision, please view the Summary Basis of Decision.