FDA Approves Libtayo as First Adjuvant Immunotherapy for High-Risk CSCC Following Surgery and Radiation

The FDA has approved Regeneron’s Libtayo as the first and only immunotherapy for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following curative surgery and radiation. This regulatory milestone significantly expands the use of the programmed cell death protein 1 (PD-1) inhibitor, providing a new, evidence-based option for clinicians and patients aiming to reduce the likelihood of cancer relapse in this challenging population.

The approval is based on data from the pivotal randomized phase 3 C-POST clinical trial, which enrolled 415 patients with CSCC at high risk for post-surgical and post-radiation recurrence. Patients receiving cemiplimab experienced a 68% reduction in the risk of recurrence or death compared to placebo, with median disease-free survival not reached in the active treatment arm versus 49.4 months for placebo (hazard ratio 0.32, p<0.0001). The safety profile was consistent with known side effects of PD-1 inhibitors, including potential immune-mediated reactions and infusion-related events.

Libtayo was previously approved for several indications, including:

• Treatment of patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or radiation.
• First-line treatment (in combination with chemotherapy) for advanced non-small cell lung cancer (NSCLC) with PD-L1 expression.
• Advanced basal cell carcinoma in certain settings.
• Advanced cervical cancer after prior chemotherapy.

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