Libtayo (Cemiplimab) Receives FDA Priority Review for Advanced Cervical Cancer Based on 31% Reduction in Death Risk

On September 28, 2021, Regeneron announced that the U.S. FDA has granted priority review to the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab), a PD-1 inhibitor co-developed by the company and Sanofi, for the treatment of patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after chemotherapy.

Cervical cancer is the fourth leading cause of cancer-related death among women worldwide and most commonly occurs in women aged 35–44. Almost all cases are associated with human papillomavirus (HPV) infection. According to statistics, over 570,000 women globally are newly diagnosed with cervical cancer each year. When detected early, cervical cancer is typically curable or can be effectively controlled; however, treatment options for patients with advanced-stage disease are limited.

Libtayo is a PD-1 inhibitor co-developed by Sanofi and Regeneron. It enhances the anti-tumor immune response of T lymphocytes by blocking the binding of PD-1 to its ligands. It is the first immunotherapy approved for the treatment of advanced basal cell carcinoma and metastatic cutaneous squamous cell carcinoma, and has received FDA approval for the first-line treatment of non-small cell lung cancer.

This application is supported by the results of a Phase 3 clinical trial, demonstrating that regardless of tumor PD-L1 expression status, Libtayo significantly improved overall survival (OS) compared with chemotherapy. The median OS was 12 months in the Libtayo group versus 8.5 months in the chemotherapy group (HR=0.69, p<0.001). In the squamous cell carcinoma subgroup, Libtayo reduced the risk of death by 27%, while in the adenocarcinoma subgroup, Libtayo reduced the risk of death by 44%.

The FDA is expected to respond to this application by January 30, 2022.

References:

[1] FDA Accepts Libtayo® (cemiplimab-rwlc) for Priority Review for Advanced Cervical Cancer. Retrieved September 28, 2021, from https://www.prnewswire.com/news-releases/fda-accepts-libtayo-cemiplimab-rwlc-for-priority-review-for-advanced-cervical-cancer-301386422.html

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