Regeneron Pharmaceuticals announced groundbreaking results from the Phase 3 C-POST trial, revealing that Libtayo® (cemiplimab) significantly reduces the risk of disease recurrence or death in patients with high-risk cutaneous squamous cell carcinoma (CSCC) following surgery. The study, presented at the 2025 ASCO Annual Meeting and published in the New England Journal of Medicine, positions Libtayo as a potential new standard in adjuvant therapy for CSCC.
Remarkable Reduction in Recurrence Risks
The C-POST trial demonstrated a 68% decrease in the likelihood of disease recurrence or death among patients treated with Libtayo compared to those receiving a placebo. Specifically, there was an 80% reduction in the risk of locoregional recurrence and a 65% decrease in distant recurrence. With a median follow-up of two years, 87% of patients on Libtayo remained disease-free versus 64% on placebo, showcasing the drug’s robust efficacy in maintaining long-term remission.
Safety Profile and Regulatory Progress
Safety assessments indicated that adverse events were comparable between the Libtayo and placebo groups, with manageable side effects such as fatigue and rash being the most common. Grade ≥3 adverse events occurred in 24% of the Libtayo group versus 14% in the placebo group, primarily involving hypertension. Regeneron has submitted regulatory applications in the United States and European Union, aiming to expedite the availability of this promising treatment to patients in need.
• Libtayo’s efficacy is consistent regardless of PD-L1 expression levels.
• The trial included a diverse patient population with high-risk features.
• Extended follow-up is necessary to fully understand overall survival benefits.
Libtayo’s success in the C-POST trial marks a significant advancement in CSCC treatment, addressing a critical unmet need for effective systemic therapies post-surgery. By substantially lowering recurrence rates, Libtayo not only enhances patient outcomes but also sets a precedent for immunotherapy applications in non-melanoma skin cancers.
The introduction of Libtayo as an adjuvant therapy represents a pivotal moment in oncological care, offering hope to patients with limited options. Its ability to maintain disease-free survival in high-risk CSCC patients underscores the potential of targeted immunotherapies in revolutionizing cancer treatment paradigms. As regulatory bodies review the data, the oncology community eagerly anticipates Libtayo’s integration into standard care protocols, potentially improving survival rates and quality of life for countless individuals battling CSCC.
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