On October 8, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation therapy.
C-POST
Efficacy was evaluated in C-POST (ClinicalTrials.gov identifier NCT03969004), a randomized, double-blind, multicenter, placebo-controlled trial in 415 patients with CSCC at high risk of recurrence after surgery and radiation therapy. Patients were required to complete adjuvant radiation therapy within 2 to 10 weeks of randomization. The study excluded patients with autoimmune disease requiring systemic immunosuppressants within 5 years, a history of solid organ transplant, prior allogeneic or autologous stem cell transplantation, uncontrolled human immunodeficiency virus, hepatitis B or hepatitis C infection, or an Eastern Cooperative Oncology Group performance status of ≥ 2. Patients were randomly assigned 1:1 to receive cemiplimab-rwlc or placebo.
The major efficacy outcome measure was disease-free survival (defined as the time from randomization to the first documented disease recurrence by investigator assessment or death due to any cause). Median disease-free survival was not reached in the cemiplimab-rwlc arm (95% confidence interval [CI] = not evaluable to not evaluable) and 49.4 months (95% CI = 48.5 months to not evaluable) in the placebo arm (hazard ratio = 0.32, 95% CI = 0.20–0.51, P < .0001).
The prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryofetal toxicity.
Recommended Dosage
The recommended dose of cemiplimab is 350 mg intravenously 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.
Expedited Programs
This review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted Priority Review designation.
