Presentations include initial results for an investigational combination of fianlimab (LAG-3 inhibitor) and Libtayo (PD-1 inhibitor) in advanced non-small cell lung cancer
TARRYTOWN, N.Y., Dec. 1, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2022 from December 7 to 9 in Geneva, Switzerland. Presentation highlights include first clinical results and new exploratory analyses from trials investigating LAG-3 inhibitor fianlimab and/or PD-1 inhibitor Libtayo® (cemiplimab) in non-small cell lung cancer (NSCLC), melanoma and cervical cancer.
"Our ESMO IO presentations reflect our continued progress toward developing a differentiated oncology pipeline with the potential to treat a variety of cancers with unique combinations," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "Libtayo has already proven to be an effective immunotherapy across multiple tumor types and is poised to serve as a foundational therapy for our investigational combination approaches. Fianlimab combined with Libtayo has generated early-but-promising clinical activity in advanced melanoma and non-small cell lung cancer, demonstrating the potential of Regeneron's oncology pipeline to potentially advance the standard-of-care in various cancers."
Among the research published by ESMO IO today were initial results for an investigational combination of fianlimab and Libtayo in patients with unresectable stage IIIB-C or IV NSCLC. The results are from two expansion cohorts of a Phase 1 trial – one with anti-PD-1/PD-L1-naïve patients (naïve cohort) and the other with anti-PD-1/PD-L1-experienced patients (experienced cohort). Patients received fianlimab 1600 milligrams and Libtayo 350 milligrams intravenously every 3 weeks for 12 months, with a median follow up of 9 months and 5 months for the naïve and experienced cohorts, respectively.
Efficacy results demonstrated an investigator-assessed objective response rate (ORR) of 27% (4 of 15 patients; all partial responses [PR]) in the naïve cohort and 7% in the experienced cohort (1 of 15 patients with a PR). Additionally, exploratory analyses of the naïve cohort found the ORR was 50% (3 patients) among those who had not received any prior systemic therapy and 100% (3 patients) among those with tumors that had ≥50% PD-L1 expression. Median duration of response was not reached in the naïve cohort and was 5 months in the experienced cohort (95% confidence interval: not evaluable to not evaluable).
In terms of safety for the naïve and experienced cohorts, rates of ≥grade 3 adverse events (AE) were respectively 33% (5 patients) and 40% (6 patients), while rates of serious AEs were respectively 20% (3 patients) and 13% (2 patients). One patient in the naïve cohort and no patients in the experienced cohort discontinued treatment due to an AE; there were no treatment-related deaths reported in either cohort. Updated efficacy and safety data will be presented during a poster session (abstract #127P).
Other notable presentations at ESMO IO include:
Regeneron data at ESMO IO
Medicine | Abstract title | Abstract | Presentation date/time (all CET) |
Lung cancer | |||
Libtayo, | Phase 1 study of fianlimab: A human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced NSCLC | #127P | December 8 12:30-13:15 pm |
Libtayo | Cemiplimab (cemi) + platinum doublet chemotherapy (chemo) + ipilimumab (ipi) for first-line treatment of advanced non-small cell lung cancer (NSCLC): EMPOWER-Lung 3 part 1 | #122MO | December 8 9:35-9:40 am |
Libtayo | An observational study to assess the effectiveness and safety of cemiplimab in patients with advanced non-small cell lung cancer (NSCLC) in routine clinical practice within Europe (CEMI-LUNG) | #119TiP | December 8 12:30-13:15 pm |
Skin cancer | |||
Libtayo, | Phase 1 study of fianlimab, a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced melanoma (mel): subgroup analysis | #150P | December 8 12:30-13:15 pm |
Ovarian cancer | |||
Libtayo, | First-in-human (FIH) Phase 1/2 study of ubamatamab, a MUC16xCD3 bispecific antibody, administered alone or in combination with cemiplimab in patients with recurrent ovarian cancer (OC) | #197TiP | December 8 12:30-13:15 pm |
Advanced solid tumors | |||
Libtayo | Liver metastases (mets) and treatment effect of cemiplimab-based therapy: An analysis from three Phase 3 trials (EMPOWER-Lung 1, EMPOWER-Lung 3 part 2, and EMPOWER-Cervical 1) | #168P | December 8 12:30-13:15 pm |
The potential uses of Libtayo, fianlimab, ubamatamab and REGN6569 described above are investigational, and their safety and efficacy in these uses have not been fully evaluated by any regulatory authority. Fianlimab, ubamatamab and REGN6569 are not currently approved for use in any indication.
About Regeneron in Oncology
At Regeneron, we're applying more than three decades of scientific innovation with the goal of developing paradigm-changing therapies for patients with cancer. Our oncology portfolio is built around two foundational approaches – our approved PD-1 inhibitor Libtayo and investigational bispecific antibodies – which are being evaluated both as monotherapies and in combination with emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop potentially synergistic treatments for a wide range of solid tumors and blood cancers.
If you are interested in learning more about our clinical trials, please contact us ( clinicaltrials@regeneron.com or 844-734-6643) or visit our clinical trials website.
About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology. 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. and other countries Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced NSCLC, as well as in advanced cervical cancer in the European Union, Canada and Brazil. As of July 1, 2022, Libtayo is developed and marketed globally by Regeneron.
In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). Outside of the U.S., the generic name of Libtayo in its approved indication is cemiplimab.
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
U.S. FDA-approved Indications Libtayo is a prescription medicine used to treat:
It is not known if Libtayo is safe and effective in children.
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat certain cancers by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Libtayo if you have severe side effects.
Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Libtayo when used alone include muscle or bone pain, tiredness, rash, and diarrhea. The most common side effects of Libtayo when used in combination with platinum-containing chemotherapy include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, decreased appetite. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296.
Please see full Prescribing Information, including Medication Guide.
About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).
About Regeneron
Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 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, hematologic conditions, 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 more information, please visit www.Regeneron.com or follow @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has 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 and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation Libtayo® (cemiplimab) as monotherapy or in combination with fianlimab; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products and Regeneron's Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as fianlimab and/or Libtayo for the treatment of non-small cell lung cancer, melanoma, and cervical cancer as well as the other investigational programs studying Libtayo in combination with ipilimumab, ubamatamab, and REGN6569 referenced in this press release; safety issues resulting from the administration of Regeneron's Products (such as Libtayo) and Regeneron's Product Candidates (such as fianlimab, ubamatamab, and REGN6569) in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products (such as Libtayo) from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (including those discussed or referenced in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials or therapeutic applications; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection, Praluent® (alirocumab), and REGEN-COV® (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended September 30, 2022. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
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