GlobeNewswire Inc | Feb 12, 2021 01:00AM EST

February 12, 2021

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 50%

-- 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 clinicalresults 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 Bakent 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 valuablenew 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 proprietaryVelociSuitetechnologies, such asVelocImmune, 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

Sanofi is dedicated to supporting people through their health challenges. Weare a global biopharmaceutical company focused on human health. We preventillness with vaccines, provide innovative treatments to fight pain and easesuffering. We stand by the few who suffer from rare diseases and the millionswith long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transformingscientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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Words suchas ?anticipate,? ?expect,? ?intend,? ?plan,? ?believe,? ?seek,? ?estimate,?variations of such words, and similar expressions are intended to identify suchforward-looking statements, although not all forward-looking statements containthese identifying words.These statements concern, and these risks anduncertainties include, among others, the impact of SARS-CoV-2 (the virus thathas caused the COVID-19 pandemic) on Regeneron?s business and its employees,collaborators, and suppliers and other third parties on which Regeneron relies,Regeneron?s and its collaborators? ability to continue to conduct research andclinical programs, Regeneron?s ability to manage its supply chain, net productsales of products marketed or otherwise commercialized by Regeneron and/or itscollaborators (collectively, ?Regeneron?s Products?), and the global economy;the nature, timing, and possible success and therapeutic applications ofRegeneron?s Products and product candidates being developed by Regeneron and/orits collaborators (collectively, ?Regeneron?s Product Candidates?) and researchand clinical programs now underway or planned, including without limitationLibtayo^ (cemiplimab); the likelihood, timing, and scope of possibleregulatory approval and commercial launch of Regeneron?s Product Candidates andnew indications for Regeneron?s Products, such as Libtayo for the treatment oflocally advanced or metastatic non-small cell lung cancer, locally advancedbasal cell carcinoma previously treated with a hedgehog pathway inhibitor (inthe European Union and other potential jurisdictions), adjuvant and neoadjuvantcutaneous squamous cell carcinoma, and cervical cancer (as well as incombination with either conventional or novel therapeutic approaches for bothsolid tumors and blood cancers); uncertainty of market acceptance andcommercial success of Regeneron?s Products and Regeneron?s Product Candidatesand the impact of studies (whether conducted by Regeneron or others and whethermandated or voluntary), including the study discussed in this press release, onthe commercial success of Regeneron?s Products and Regeneron?s ProductCandidates; safety issues resulting from the administration of Regeneron?sProducts (such as Libtayo) and Regeneron?s Product Candidates in patients,including serious complications or side effects in connection with the use ofRegeneron?s Products and Regeneron?s Product Candidates in clinical trials;determinations by regulatory and administrative governmental authorities whichmay delay or restrict Regeneron?s ability to continue to develop orcommercialize Regeneron?s Products and Regeneron?s Product Candidates; ongoingregulatory obligations and oversight impacting Regeneron?s Products, researchand clinical programs, and business, including those relating to patientprivacy; the availability and extent of reimbursement of Regeneron?s Productsfrom third-party payers, including private payer healthcare and insuranceprograms, health maintenance organizations, pharmacy benefit managementcompanies, and government programs such as Medicare and Medicaid; coverage andreimbursement determinations by such payers and new policies and proceduresadopted by such payers; competing drugs and product candidates that may besuperior to, or more cost effective than, Regeneron?s Products and Regeneron?sProduct Candidates; the extent to which the results from the research anddevelopment programs conducted by Regeneron and/or its collaborators may bereplicated in other studies and/or lead to advancement of product candidates toclinical trials, therapeutic applications, or regulatory approval; the abilityof Regeneron to manufacture and manage supply chains for multiple products andproduct candidates; the ability of Regeneron?s collaborators, suppliers, orother third parties (as applicable) to perform manufacturing, filling,finishing, packaging, labeling, distribution, and other steps related toRegeneron?s Products and Regeneron?s Product Candidates; unanticipatedexpenses; the costs of developing, producing, and selling products; the abilityof Regeneron to meet any of its financial projections or guidance and changesto the assumptions underlying those projections or guidance; the potential forany license, collaboration, or supply agreement, including Regeneron'sagreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. 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