The FDA has approved Libtayo (cemiplimab-rwlc) for adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. Approval was based on the phase 3 C-POST trial of 415 patients, which showed significantly improved disease-free survival with Libtayo versus placebo. Median disease-free survival was not reached in the Libtayo group compared with 49.4 months for placebo.
Libtayo is given intravenously at 350 mg every three weeks for 12 weeks, then either 700 mg every six weeks or 350 mg every three weeks, for up to 48 weeks. Common warnings include immune-mediated side effects, infusion reactions, transplant complications, and embryo-fetal toxicity.
Experts note the C-POST results support Libtayo as a potential new standard of care for high-risk CSCC after surgery and radiation. Libtayo, a PD-1–blocking monoclonal antibody, enhances immune response against cancer and is also approved for certain cases of basal cell carcinoma, CSCC, and non-small cell lung cancer.