▎WuXiEdited by Kant Content Team

Regeneron Pharmaceuticals recently announced positive results from the Phase 3 clinical trial C-POST. The trial showed that the PD-1 inhibitor Libtayo (cemiplimab) provided a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the primary endpoint, as an adjuvant treatment in high-risk patients with cutaneous squamous cell carcinoma (CSCC) who had undergone surgery. The press release noted,Libtayo is the first immunotherapy to show statistically significant and clinically meaningful benefit in adjuvant treatment for high-risk CSCC patients.

The C-POST trial enrolled 415 high-risk CSCC patients who were randomly assigned to receive either Libtayo or placebo treatment for up to 48 weeks. The primary endpoint was DFS, defined as the time from randomization to the first documented disease recurrence or death from any cause.In the first pre-specified interim analysis with a median follow-up time of 24 months, Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo (HR: 0.32; 95% CI: 0.20-0.51; p<0.0001).

In the safety evaluation, 91% and 89% of patients in the Libtayo group and placebo group, respectively, experienced adverse events (AEs) of any grade. The incidence of grade 3 or higher AEs was 24% in the Libtayo group and 14% in the placebo group. Treatment discontinuation due to adverse reactions occurred in 10% of the Libtayo group and 1.5% of the placebo group. Two patients in each group died due to AEs.

Based on these interim results, the C-POST trial will continue with additional follow-up, including analysis of the key secondary endpoint—overall survival. Detailed results will be presented at an upcoming medical conference and shared with regulatory authorities.Regeneron Plans to Submit Regulatory Application to U.S. FDA in the First Half of 2025

Libtayo is a fully humanized monoclonal antibody that targets the immune checkpoint receptor PD-1 on T cells.By binding to PD-1, Libtayo is able to prevent cancer cells from using the PD-1 signaling pathway to suppress T-cell activity. Libtayo has received regulatory approvals in over 30 countries and regions for multiple indications, including advanced basal cell carcinoma (BCC), advanced CSCC, advanced non-small cell lung cancer (NSCLC), and advanced cervical cancer.

References:

[1] Adjuvant Libtayo® (cemiplimab) Significantly Improves Disease-Free Survival (DFS) After Surgery in High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) in Phase 3 Trial. Retrieved January 14, 2025, from https://investor.regeneron.com/news-releases/news-release-details/adjuvant-libtayor-cemiplimab-significantly-improves-disease-free

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