The Lancet publishes Libtayo® (cemiplimab) data showing extended overall survival in patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ³50%

Libtayo was superior in extending overall survival compared to chemotherapy even with a high crossover rate
Data are the basis for multiple ongoing regulatory submissions, including in the U.S. and European Union

PARIS and TARRYTOWN, N.Y. – February 12, 2021 – The Lancet today published results from a pivotal trial designed to evaluate the investigational use of the PD-1 inhibitor Libtayo® (cemiplimab) compared to platinum-doublet chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ?50% PD-L1 expression in tumor cells.

The data were shared during a late-breaking presentation at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress and formed the basis of regulatory submissions in the U.S. and European Union (EU). The U.S. Food and Drug Administration (FDA) granted a Priority Review with a target action date of February 28, 2021. A European Commission decision is expected by mid-2021.

“These clinical results published in The Lancet support regulatory submissions for Libtayo as a potential new treatment option for patients with advanced NSCLC with PD-L1 expression of ?50%,” said Ahmet Sezer, M.D., Professor in the Department of Medical Oncology at Ba?kent University in Adana, Turkey and a trial investigator. “Libtayo was superior in extending overall survival compared to chemotherapy, even with 74% of patients crossing over to the Libtayo arm following progression on chemotherapy. Libtayo reduced the risk of death by 32% in all patients in the pivotal trial and by 43% among those with confirmed PD-L1 expression of 50% or higher. In addition, the data included more advanced patient populations usually underrepresented in advanced NSCLC trials – including 12% with pretreated and stable brain metastases and 16% with locally advanced NSCLC who were not candidates for definitive chemoradiation. As a result, the medical community now has valuable new clinical evidence that could enhance our understanding of how to treat this deadly cancer.”

The safety of Libtayo in the trial was generally consistent with previous Libtayo pivotal trials, and according to the publication, consistent with the safety profiles of other PD-1 or PD-L1 inhibitors in NSCLC and other tumor types. Grade 3 or 4 adverse events occurred in 28% and 39% of patients in the Libtayo and chemotherapy arms, respectively. Immune-mediated AEs were reported in 17% of patients in the Libtayo arm, compared to 2% in the chemotherapy arm, and included hypothyroidism (6% versus 0%), hyperthyroidism (4% versus <1%), pneumonitis (2% versus 0%), hepatitis (2% versus 0%), skin adverse reaction (2% versus <1%), colitis (1% versus <1%), nephritis (<1% versus <1%), arthritis, increased blood thyroid stimulating hormone, thyroiditis, and peripheral neuropathy (all <1% versus 0%).

Libtayo is currently approved as the first systemic treatment in the U.S., EU and other countries 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 also approved in the U.S. as the first immunotherapy treatment indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, and is under regulatory review in the EU for the treatment of locally advanced BCC previously treated with an HHI.

Libtayo is being jointly developed and commercialized by Sanofi and Regeneron 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 the Phase 3 Trial

The open-label, randomized, multi-center Phase 3 trial, called EMPOWER-Lung 1, was designed to investigate the first-line treatment of Libtayo monotherapy compared to platinum-doublet chemotherapy in patients with squamous or non-squamous advanced NSCLC that tested positive for PD-L1 in ?50% of tumor cells, but not for ALK, EGFR or ROS1. PD-L1 expression was confirmed using the PD-L1 IHC 22C3 pharmDx kit. The trial randomized 710 patients with either locally advanced NSCLC (stage IIIB/C) who were not candidates for surgical resection or definitive chemoradiation or had progressed after treatment with definitive chemoradiation, or previously untreated metastatic NSCLC (stage IV). Of the 710 patients randomized to receive treatment, 563 patients had confirmed PD-L1 expression of ?50%.

Patients were randomized 1:1 to receive either Libtayo 350 mg administered intravenously every three weeks for up to 108 weeks or an investigator-selected, standard-of-care, platinum-based, doublet chemotherapy regimen for 4 to 6 cycles (with or without histology relevant maintenance pemetrexed chemotherapy). The co-primary endpoints were overall survival and progression-free survival, and secondary endpoints included overall response rate, duration of response and quality of life.

The trial was designed to reflect current and emerging treatment paradigms. Inclusion criteria allowed patients with NSCLC who had: pre-treated and stable brain metastases; locally advanced disease that was not a candidate for, or which had progressed after, definitive chemoradiation; or controlled hepatitis B, hepatitis C or HIV. Patients whose disease progressed in the trial were able to change their therapy: those in the chemotherapy arm were allowed to cross over into the Libtayo arm following disease progression on chemotherapy; and those in the Libtayo arm were allowed to combine Libtayo treatment with 4 to 6 cycles of chemotherapy.

About Non-small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide. In 2020, an estimated 2.2 million and 225,000 new cases were diagnosed worldwide and in the U.S, respectively. Approximately 84% 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. Additionally, an estimated 75% of patients are diagnosed with advanced NSCLC and have a poor survival prognosis. 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.

In the U.S., the generic name for Libtayo in its approved indication is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Outside of the U.S., the generic name for Libtayo in its approved indication is cemiplimab.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes trials in adjuvant and neoadjuvant CSCC. 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 nine FDA-approved treatments and numerous product candidates in development, almost 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.

About Sanofi
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