October 09, 2025
1 min read
The FDA has approved cemiplimab-rwlc for adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk for recurrence after surgery and radiation.
Cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals), a PD-1 inhibitor, is the first approved immunotherapy for this specific patient population, according to the manufacturer.
The FDA has approved cemiplimab-rwlc for adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk for recurrence after surgery and radiation.
“Patients whose [cutaneous squamous cell carcinoma] is at a high risk of recurrence following surgery and radiation often have the poorest outcomes. Until now, we lacked options to help prevent a devastating recurrence and immunotherapy was only available for patients with advanced [cutaneous squamous cell carcinoma] who were no longer candidates for curative surgery or curative radiation,” Vishal A. Patel, MD, FAAD, director of cutaneous oncology and associate professor of dermatology at The George Washington University School of Medicine & Health Sciences, said in a press release.
“Many patients who undergo surgical resection of their [cutaneous squamous cell carcinoma] are later found, on full pathological evaluation, to be at high risk of recurrence,” Patel continued. “As the first and only immunotherapy approved in the adjuvant setting, Libtayo represents a practice-changing opportunity for this patient population, backed by compelling data showcasing its ability to significantly improve disease-free survival.”
The FDA based the approval on data from the randomized, placebo-controlled C-POST trial, which included 415 patients with cutaneous cell squamous carcinoma at high risk for recurrence after surgery and radiation.
Patients randomly assigned to the investigational regimen received 350 mg IV cemiplimab-rwlc every 3 weeks for four cycles followed by 700 mg IV cemiplimab-rwlc every 6 weeks for 36 weeks. The other trial participants received placebo. Patients were required to complete adjuvant radiation therapy within 2 to 10 weeks of randomization.
Results showed median DFS of 49.4 months with placebo, but was not yet reached with cemiplimab-rwlc (HR = 0.32; 95% CI, 0.2-0.51).
The FDA-recommended dose for cemiplimab-rwlc is 350 mg IV every 3 weeks for 12 weeks, followed by 700 mg every 6 weeks, or 350 mg every 3 weeks until disease recurrence, unacceptable toxicity or up to 48 weeks.
