FDA Approves Libtayo for Cutaneous Squamous Call Carcinoma

The U.S. Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc) for the adjuvant, or postsurgical, treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

Approval of the drug was based on results of the C-POST randomized, double-blind, multicenter, placebo-controlled trial of 415 patients with CSCC who were at a high risk of recurrence following surgery and radiation. In the trial, patients were required to complete postsurgical radiation therapy within two to 10 weeks of randomization, and the study excluded patients with autoimmune disease who required systemic immunosuppressant agents within five years, a history of solid organ transplant, prior allogenic or autologous stem cell transplantation, uncontrolled HIV, hepatitis B or C infection or an ECOG performance status of two or higher. Patients in the trial were evenly randomized to receive Libtayo or placebo.

Results showed median disease-free survival, or the time from randomization until the first documented disease recurrence or death due to any cause, was not reached in the Libtayo arm and 49.4 months in the placebo arm. The prescribing information of Libtayo includes warnings and precautions for immune-mediated side effects, infusion-related reactions, complications of allogenic hematopoietic stem cell transplantation and embryo-fetal toxicity.

“When we looked at the C-POST study, we actually discovered that those patients who, for example, got anti-PD-1 therapy — in the case of the C-POST study, it was Libtayo — and they also compared it to an arm of patients who got placebo, they actually found statistical significance in terms of disease recurrence,” Vincent Ma, MD, a faculty member in the Division of Hematology, Medical Oncology and Palliative Care at the University of Wis. “Overall, I think the conclusion from the study is that because we saw a disease-free survival benefit from patients who received adjuvant Libtayo for one year in the C-POST study, it is likely to eventually become standard of care in the future for patients who have high-risk squamous cell carcinoma of the skin following surgery and radiation.”