Regeneron(US:REGN) Globenewswire·2025-11-19 12:00Core Insights - The European Commission has approved Libtayo (cemiplimab) as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation, marking a significant advancement in treatment options for earlier-stage patients [1][2][4] - The approval is based on the results of the Phase 3 C-POST trial, which demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo, with a hazard ratio of 0.32 [1][2][6] Company Overview - Regeneron Pharmaceuticals, Inc. is a leading biotechnology company focused on developing innovative treatments for serious diseases, including various cancers [27][28] - The company has a strong pipeline, with nearly half of its investigational assets in oncology, including Libtayo, which serves as a backbone for many investigational combinations [9][27] Clinical Trial Details - The C-POST trial was a randomized, placebo-controlled, double-blind study involving 415 patients at high risk of CSCC recurrence, who had completed surgery and postoperative radiation therapy [6][7] - Participants received either Libtayo or placebo for up to 48 weeks, with specific dosing regimens outlined [7] Treatment Implications - Libtayo is currently the standard of care for advanced CSCC in Europe, and its approval for earlier-stage patients could significantly alter treatment paradigms [1][4] - The incidence of non-melanoma skin cancer (NMSC), including CSCC, is expected to increase by 40% in the EU over the coming decades, highlighting the need for effective treatments [4] Safety Profile - The safety profile of Libtayo in the adjuvant setting is consistent with its known profile in advanced cancers, with grade ≥3 adverse events occurring in 24% of patients receiving Libtayo [3] - Common adverse events included fatigue, pruritus, rash, and diarrhea, with treatment discontinuation due to adverse events occurring in 10% of Libtayo patients [3]