Cemiplimab extends DFS in high-risk cutaneous squamous cell carcinoma
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Key takeaways:
- Patients who received cemiplimab exhibited significantly reduced risk for recurrence or death compared with those who received placebo.
- More follow-up is needed to assess OS outcomes.
Adjuvant cemiplimab prolonged DFS compared with placebo for certain patients with cutaneous squamous cell carcinoma, according to the agent’s manufacturer.
Cemiplimab (Libtayo, Regeneron Pharmaceuticals) — a fully human PD-1-blocking antibody — is approved in the United States for treatment of people with cutaneous squamous cell carcinoma that spread or cannot be cured by radiation or surgery. It also is approved for treatment of certain patients with basal cell carcinoma or non-small cell lung cancer.
The randomized phase 3 C-POST trial included 415 patients with high-risk cutaneous squamous cell carcinoma who had undergone surgery and postoperative radiation therapy.
Patients randomly assigned to the investigational regimen received 350 mg cemiplimab via IV every 3 weeks for four cycles followed by 700 mg cemiplimab via IV every 6 weeks for 36 weeks. The other trial participants received placebo.
DFS served as the primary endpoint. Secondary endpoints included freedom from locoregional recurrence, freedom from distant recurrence, OS, cumulative incidence of second primary cutaneous squamous cell carcinoma tumors and safety.
Researchers performed the first prespecified interim analysis after median follow-up of 24 months (range, 2-64).
Results showed cemiplimab reduced risk for recurrence or death by 68% (HR = 0.32; 95% CI, 0.2-0.51) compared with placebo.
“[Although] surgery is curative for most people living with cutaneous squamous cell carcinoma, many are burdened with a higher risk [for] recurrence that can lead to death or disfiguration,” Danny Rischin, MD, MBBS, FRACP, research lead of head and neck cancer and cutaneous squamous cell carcinoma in the department of medical oncology at Peter MacCallum Cancer Centre in Melbourne, Australia, said in a Regeneron-issued press release.
“At the first prespecified interim analysis, Libtayo achieved a remarkably high bar in improving disease-free survival in high-risk cutaneous squamous cell carcinoma,” Rischin added. “With no currently approved options in the adjuvant setting, these landmark results demonstrate Libtayo could represent a major advance in delaying recurrence in these vulnerable patients.”
A comparable percentage of patients in the cemiplimab and placebo groups experienced adverse events (91% vs. 89%). A higher percentage of those assigned cemiplimab experienced grade 3 or higher adverse events (24% vs. 14%).
Two patients in each group experienced adverse events that led to death.
The C-POST study remains ongoing, with additional follow-up planned to evaluate OS.
Complete results from the trial will be presented at a medical meeting.
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