The first and only FDA-approved immunotherapy
for this patient population
October 8, 2025 (Sacramento, California) The FDA has approved the PD-1 inhibitor cemiplimab-rwlc (Libtayo®) for the adjuvant treatment of adult patients with high-risk cutaneous squamous-cell carcinoma (CSCC) after surgery and radiation.
Cutaneous squamous cell carcinoma is the second most common type of skin cancer. Although most cases are not life-threatening, advanced cutaneous squamous cell carcinoma is quite deadly. Unfortunately, patients with metastatic disease have 10-year survival rates between 10-20%. Surgery and radiotherapy have been the cornerstones of treatment for high-risk cutaneous squamous cell carcinoma, but there is an unmet need for systemic therapies to help prevent relapse and metastasis. Patients with CSCC at a high risk of recurrence following surgery and radiation often have the poorest outcomes. This approval has the potential to be practice-changing and improve disease-free survival in this patient population.
Cemiplimab is an immunotherapy drug that binds to the PD-1 receptor. By binding to the PD-1 receptor, it interferes with the immune checkpoint and therefore allows the immune system to recognize and attack cancer cells.
Cemiplimab was first approved in 2018 for patients with metastatic CSCC or locally advanced CSCC who are not eligible for curative surgery or curative radiation. Cemiplimab is also approved for patients with advanced non-small cell lung cancer and advanced basal cell carcinoma.
The new approval is based on results from the randomized, placebo-controlled, double-blind, multicenter, global Phase 3 C-POST trial. The trial compared cemiplimab versus placebo as adjuvant treatment for patients with features associated with a high-risk of CSCC recurrence and who had completed surgery and post-operative radiation therapy. In total, 415 patients received either cemiplimab (n=209) or placebo (n=206) for up to 48 weeks. A 68% reduction in the risk of disease recurrence or death was observed with cemiplimab compared to placebo in patients with CSCC at high risk of recurrence after surgery and radiation. The safety profile of cemiplimab as adjuvant treatment in this patient population is consistent with the known safety profile for cemiplimab monotherapy in advanced cancers.
For questions, contact
Samantha Guild
President, AIM with Immunotherapy
916-206-6100
About AIM with Immunotherapy
AIM with Immunotherapy is a professional education initiative of AIM at Melanoma, a nonprofit foundation dedicated to advancing research and improving outcomes in melanoma and other skin cancers. Developed in response to the expanding role of immunotherapy across oncology, the initiative provides evidence-based, tumor-specific resources for healthcare professionals involved in the care of patients receiving immune checkpoint inhibitors and related agents.
AIM with Immunotherapy offers practical guidance on the identification, management, and patient education of immune-related adverse events (irAEs)—a class of toxicities distinct from those seen with chemotherapy or radiation. Materials are developed by a multidisciplinary faculty of advanced practice providers and other oncology experts with deep clinical experience in immunotherapy.
The initiative aims to support optimal treatment delivery and improve therapeutic outcomes through targeted education, decision support tools, and communication strategies that empower clinicians and patients alike.
