Regeneron Announces Approval of Cemiplimab-rwlc for Adjuvant Treatment of Cutaneous Squamous-Cell Carcinoma with a High Risk of Recurrence After Surgery and Radiation    

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.

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For questions, contact
Samantha Guild
President, AIM at Skin Cancer
📞 916-206-6100
✉️ Info@AIMatSkinCancer.org

AIM at Skin Cancer

AIM at Skin Cancer is a global foundation focused on nonmelanoma skin cancers such as basal cell carcinoma and cutaneous squamous cell carcinoma. Our mission: By educating patients, healthcare professionals, and the public, and by advocating for survivors and their families, AIM at Skin Cancer’s goal is to reduce the incidence of nonmelanoma skin cancer while improving the lives of those it affects.  Follow our groundbreaking initiatives on Facebook and YouTube.

About Skin Cancer

Skin cancer, such as cutaneous squamous cell carcinoma and basal cell carcinoma, is the most common form of cancer worldwide. Each year, more people are diagnosed with skin cancer in the U.S. than all other cancers combined. Recent data suggest over 2 million people were treated for nonmelanoma skin cancer in the U.S. in a single year. Skin cancers occur more frequently in males than females. Ultraviolet radiation exposure is estimated to cause 83.0% of squamous cell skin cancer and 80.5% of basal cell carcinoma among specific populations with high susceptibility to damage from ultraviolet radiation in a short amount of time.