Regeneron Pharmaceuticals Inc. has announced that regulatory applications for their PD-1 inhibitor, Libtayo® (cemiplimab), have been submitted in both the United States and the European Union. This submission follows the promising results from the Phase 3 C-POST trial, which demonstrated a significant reduction in the risk of disease recurrence or death in patients with high-risk cutaneous squamous cell carcinoma after surgery. The detailed analyses indicated a 68% reduction in disease recurrence or death and further reductions in locoregional and distant recurrences. These findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in the New England Journal of Medicine. Libtayo is poised to potentially become a new standard of care in the adjuvant treatment setting for this type of cancer. Regeneron is actively working with global regulatory authorities to expedite the availability of this treatment to patients.
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