Libtayo (Cemiplimab) Combination Therapy Moves Closer to Approval for First-Line Treatment of Advanced NSCLC

On January 19, 2022, Regeneron announced that the U.S. FDA had accepted the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab) in combination with platinum-based doublet chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Lung cancer is the leading cause of cancer death. In 2020, there were an estimated 2.2 million new cases globally. In China, more than 780,000 people are diagnosed with lung cancer each year, and over 620,000 die from it. Approximately 84% of all lung cancers are NSCLC, with 75% diagnosed at an advanced stage. It is estimated that 25%-30% of patients have high PD-L1 expression.

Libtayo is a PD-1 inhibitor jointly developed by Sanofi and Regeneron. It enhances the anti-cancer 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 as a monotherapy for first-line treatment of NSCLC patients with high PD-L1 expression (tumor proportion score ≥50%).

This sBLA submission is based on positive results from a Phase 3 clinical trial. The enrolled patients (n=466) had locally advanced or metastatic squamous or non-squamous NSCLC, regardless of PD-L1 expression levels or tumor histology, and without ALK, EGFR, or ROS1 mutations. Libtayo in combination with platinum-based doublet chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone. The median OS for patients in the Libtayo + chemotherapy group was 22 months, while the median OS in the control group was only 13 months.

In terms of safety, 5% of patients in the Libtayo plus chemotherapy group (n=312) and 3% of patients in the chemotherapy alone group (n=154) discontinued treatment due to adverse events (AEs). Immune-mediated AEs occurred in 19% of patients in the Libtayo plus chemotherapy group.

References:

[1] FDA Accepts For Review Libtayo® (Cemiplimab-Rwlc) In Combination With Chemotherapy For First-Line Treatment Of Advanced Nsclc. Retrieved January 19, 2022, from https://investor.regeneron.com/news-releases/news-release-details/fda-accepts-review-libtayor-cemiplimab-rwlc-combination

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