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Use of Cemiplimab-rwlc After Hedgehog Inhibitor Therapy in Locally Advanced Basal Cell Carcinoma

By: Jenna Carter, PhD
Posted: Thursday, February 1, 2024

Extended follow-up data from a phase II primary analysis were published in the Journal of the American Academy of Dermatology. The clinical benefits of cemiplimab-rwlc (an anti–PD-1 inhibitor) were examined in patients with locally advanced basal cell carcinoma after Hedgehog signaling pathway inhibitor treatment. Alexander J. Stratigos, MD, PhD, of the Andreas Sygros Hospital–National and Kapodistrian University of Athens, Greece, and colleagues reported the objective response rate improved from 31% in the primary analysis to 32.1% in the follow-up study.

“An unmet need exists among patients with advanced basal cell carcinoma…. Surgery and Hedgehog signaling pathway inhibitors…are proven treatments, but…challenges [exist] (eg, resistance, recurrence, or intolerance),” stated Dr. Stratigos and colleagues.

A total of 84 patients were included in this study. Patients received cemiplimab at 350 mg intravenously every 3 weeks for up to 93 weeks. Tumor assessments were performed at the end of each treatment cycle, and the data cutoff was May 2021. The primary endpoint was objective response rate, and the median duration of follow-up was 15.9 months (range, 0.5–39.7 months), whereas the median duration of treatment was 47.2 weeks (range, 2.1–97.9 weeks), with patients receiving a median of 15 doses (range, 1–31 doses).

According to the World Health Organization criteria, a best percentage change in tumor size from baseline of greater than 50% was seen in 70.4% of patients. Additional findings revealed that durable disease control (the proportion of patients without disease progression for at least 182 days) occurred in 59.5% (95% CI = 48.3%–70.1%). Based on these findings, the authors confirmed the extended efficacy of cemiplimab for management of this disease.  

Disclosure: For full disclosures of the study authors, visit

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