Michael R. Migden, MD
Among patients with locally advanced cutaneous squamous cell carcinoma (CSCC) who were enrolled in the pivotal EMPOWER-CSCC-1 phase II study, cemiplimab (Libtayo) exhibited substantial antitumor activity and induced durable responses similar to those experienced in patients with metastatic CSCC who were enrolled in the same study.
The Kaplan-Meier estimated progression-free probability at 12 months was 58.1% (95% CI, 43.7%-70%), and the estimated probability of survival at 12 months was 93.2% (95% CI, 84.4%-97.1%).
The 43.6% ORR in this group is similar to that observed in patients with metastatic CSCC, who had a response rate of 47%. The results in the latter cohort were published last year in the New England Journal of Medicine
Results of the study led to FDA approval of cemiplimab for patients with metastatic CSCC, or those with locally advanced disease who are not candidates for curative surgery or radiation. The recommended dosage is at 350 mg intravenously every 3 weeks until disease progression or unacceptable toxicity.3
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