FDA Grants Priority Review to Libtayo (cemiplimab-rwlc) for First-Line Treatment of Advanced NSCLC with PD-L1 Expression ≥50%

Today, Regeneron and Sanofi jointly announced that the U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for the PD-1 inhibitor Libtayo (cemiplimab-rwlc) and granted it Priority Review for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 ≥50%. The FDA is expected to respond by February 28 of next year.

Lung cancer is the leading cause of cancer-related deaths both globally and in China. Each year, more than 780,000 people in China are diagnosed with lung cancer, and over 620,000 die from it. Lung cancer can be broadly classified into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC being the most common type, accounting for 80%–85% of all lung cancer cases. Among patients with NSCLC, 25%–30% have squamous NSCLC, while 70%–75% have non-squamous NSCLC. Most NSCLC patients are diagnosed at an advanced stage, with a five-year survival rate of only 10%.

Libtayo is a fully human anti-PD-1 monoclonal antibody. It helps the human immune system kill tumor cells by blocking the PD-1 signaling pathway. Previously, it has been approved in the United States, the European Union, Canada, and Brazil for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or radiation therapy. In addition, Libtayo is being evaluated in clinical trials for the treatment of patients with cervical cancer, head and neck squamous cell carcinoma, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma, and non-Hodgkin lymphoma.

This application is supported by results from a Phase 3, open-label, randomized, multicenter trial evaluating the efficacy and safety of Libtayo monotherapy versus platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumor cells express PD-L1 (PD-L1 expression ≥50%). The findings were recently presented at the virtual 2020 European Society for Medical Oncology (ESMO) Congress held in September. In this patient population, Libtayo reduced the risk of death by 43%.

The European Medicines Agency (EMA) is also evaluating the use of Libtayo in advanced NSCLC with PD-L1 expression ≥50%, with a decision expected in the second quarter of next year.

References:

[1] FDA ACCEPTS FOR PRIORITY REVIEW LIBTAYO® (CEMIPLIMAB-RWLC) FOR ADVANCED NON-SMALL CELL LUNG CANCER WITH PD-L1 EXPRESSION OF ≥50%. Retrieved October 29, 2020, from https://investor.regeneron.com/news-releases/news-release-details/fda-accepts-priority-review-libtayor-cemiplimab-rwlc-advanced

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