Publication Date
3-11-2024
Journal
Journal for ImmunoTherapy of Cancer
Abstract
BACKGROUND: Cemiplimab (Libtayo
METHODS: In this open-label, phase II trial (ClinicalTrials.gov identifier NCT02760498), the cohort of patients ≥18 years old with advanced CSCC received cemiplimab 600 mg intravenously Q4W for up to 48 weeks. Tumor measurements were recorded every 8 weeks. The primary endpoint was objective response rate by independent central review.
RESULTS: Sixty-three patients with advanced CSCC were treated with cemiplimab. The median duration of follow-up was 22.4 months (range: 1.0-39.8). An objective response was observed in 39 patients (62%; 95% CI: 48.8% to 73.9%), with 22% of patients (n
CONCLUSIONS: Extended dosing of cemiplimab 600 mg intravenously Q4W exhibited substantial antitumor activity, rapid and durable responses, and an acceptable safety profile in patients with advanced CSCC. These results confirm that cemiplimab is a highly active therapy for advanced CSCC. Additional data would help ascertain the benefit-risk profile for the 600 mg intravenous dosing regimen compared with the approved regimen.
Keywords
Humans, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Carcinoma, Squamous Cell, Skin Neoplasms, Adult
Comments
Article has Corrections: Correction: High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma.