FDA Accepts for Priority Review Libtayo® (cemiplimab-rwlc) for Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%

TARRYTOWN, NY, USA I October 29, 2020 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The target action date for the FDA decision is February 28, 2021.

The sBLA is supported by results from a Phase 3 open-label, randomized, multi-center trial that investigated the first-line treatment of Libtayo monotherapy compared to platinum-doublet chemotherapy in patients with locally advanced or metastatic NSCLC whose tumor cells expressed PD-L1, including those whose cancers had confirmed PD-L1 expression of ≥50% using the PD-L1 IHC 22C3 pharmDx kit. Results were recently presented at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress in September.

The European Medicines Agency (EMA) is also assessing Libtayo in advanced NSCLC with ≥50% PD-L1 expression and a decision is expected in the second quarter of 2021. Libtayo is the first systemic treatment approved in the U.S. and European Union (EU) for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Libtayo is being jointly developed and commercialized by Regeneron and Sanofi under a global collaboration agreement. The use of Libtayo to treat advanced NSCLC is investigational and has not been fully evaluated by any regulatory authority.

About Non-small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide, with more than 2.2 million new cases expected globally, and 228,000 new cases expected in the U.S. in 2020. Approximately 85% of all lung cancers are NSCLC, and an estimated 25% to 30% of these cases are expected to test positive for PD-L1 in ≥50% of tumor cells. While immunotherapies have transformed advanced NSCLC treatment in recent years, there remains an unmet need to optimize the identification and treatment of patients with high PD-L1 expression and offer additional treatment options.

About Libtayo

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

Libtayo was invented using Regeneron's proprietary VelocImmune® technology that utilizes a genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. VelocImmune technology has been used to create multiple antibodies including Dupixent® (dupilumab), Praluent® (alirocumab) and Kevzara® (sarilumab), which are approved in multiple countries around the world. Regeneron previously used these technologies to rapidly develop a treatment for Zaire ebolavirus infection, which is approved by the FDA, and to create a potentially preventative and therapeutic investigational medicine for COVID-19 that was recently submitted to the FDA for an Emergency Use Authorization (EUA).

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes trials in adjuvant and neoadjuvant CSCC in addition to a pivotal trial in advanced basal cell carcinoma. Libtayo is also being investigated in pivotal trials in NSCLC (in combination with chemotherapy) and cervical cancer, as well as in trials combining Libtayo with either conventional or novel therapeutic approaches for both solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

About Regeneron Pharmaceuticals, Inc.

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

SOURCE: Regeneron Pharmaceuticals

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