Refractory Marginal Zone Lymphoma

WILMINGTON, Del.--( BUSINESS WIRE )--Incyte (Nasdaq:INCY) today announced additional results from the pivotal Phase 3 inMIND trial evaluating treatment with tafasitamab (Monjuvi ® ), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL). These data are featured today in the Late-breaking Session (LBA-1) at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego. The late-breaking results, which build on previously announced topline data, show that the study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in 548 patients with FL. Patients treated with tafasitamab achieved a median PFS by investigator assessment of 22.4 months compared to 13.9 months in the control arm (Hazard Ratio [HR]: 0.43; 95% Confidence Interval [CI] (0.32—0.58); P <0.0001), representing a 57% reduction in risk of progression, relapse, or death. The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results, with a HR of 0.41 (95% CI 0.29, 0.56, P <0.0001). Median PFS by IRC was not reached in the tafasitamab group versus 16.0 months in the control arm, [95% CI (19.3-NE) and (13.9, 21.1), respectively; P <0.0001]. The PFS benefit was consistent across all patient subgroups regardless of the number of previous lines of therapy. “In the Phase 3 inMIND trial, tafasitamab demonstrated impressive efficacy and safety for treating certain patients with follicular lymphoma, the most common type of B-cell non-Hodgkin lymphoma,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “These data, the first to evaluate the novel approach of combining CD19 and CD20 immunotherapies, show the potential of tafasitamab in combination with lenalidomide and rituximab to become a new standard of care for these patients. We look forward to working with regulatory authorities to potentially bring this treatment forward to patients with FL.” The trial also showed improvement across secondary endpoints, including: Complete response (CR), overall response rate (ORR) and duration of response (DOR) each showed improvement in the tafasitamab group versus the control arm (CR of 49.4% vs. 39.8% [95% CI (43.1, 55.8) and (33.7, 46.1), respectively; OR=1.5, P =0.0286); (ORR of 83.5% vs. 72.4% [95% CI (78.6, 87.7) and (66.7, 77.6), respectively]); (DOR of 21.2 months vs. 13.6 months [95% CI (19.5—NE) and (12.4—18.6), respectively]). Median overall survival (OS) was not reached in either group, but a positive trend was observed with the tafasitamab group versus the control arm (HR=0.59 [95% CI (0.31, 1.13)]). Additionally, median time to next treatment (TTNT) was not reached in the tafasitamab group and was 28.8 months in the control arm (HR [95% CI], 0.45 [0.31, 0.64], nominal P <0.0001). Tafasitamab was generally well-tolerated, and safety was consistent with other CD19 and immunotherapy combination regimens. The most common treatment-emergent adverse events (TEAEs) in the tafasitamab and immunotherapy combination group were neutropenia (48.5%), diarrhea (37.6%), COVID-19 (31.4%) and constipation (29.2%). “Patients with follicular lymphoma have a high risk of relapse, yet there are limited treatment options in the relapsed and refractory setting,” said Dr. Laurie Sehn, British Columbia Cancer Centre for Lymphoid Cancer. “The goal of therapy is primarily to prolong remission, while maintaining quality of life. The inMIND trial demonstrated a meaningful improvement in disease control with the addition of the anti-CD19 monoclonal antibody tafasitamab to lenalidomide and rituximab, providing patients with a new, well tolerated, immunotherapy combination.” About inMIND A global, double-blind, randomized, controlled Phase 3 study, inMIND (NCT04680052) evaluated the clinical benefit of tafasitamab and lenalidomide as an add-on to rituximab compared with lenalidomide alone as an add-on to rituximab in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years). The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population. For more information about the study, please visit https://clinicaltrials.gov/study/NCT04680052 . About Tafasitamab (Monjuvi ® ) Tafasitamab (Monjuvi ® ) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb ® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In the United States, Monjuvi ® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. XmAb ® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are registered trademarks of Incyte. IMPORTANT SAFETY INFORMATION What are the possible side effects of MONJUVI? MONJUVI may cause serious side effects, including: Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI. Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding. Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection. The most common side effects of MONJUVI include: Feeling tired or weak Diarrhea Cough Fever Swelling of lower legs or hands Respiratory tract infection Decreased appetite These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects. Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you: Have an active infection or have had one recently. Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby. You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI. Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI. You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation. Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch . You may also report side effects to Incyte Medical Information at 1-855-463-3463 . Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information. About Incyte A global biopharmaceutical company on a mission to Solve On. , Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn , X , Instagram , Facebook , YouTube . Incyte Forward-looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding tafasitamab, the inMIND clinical trial, the potential for tafasitamab to become an approved treatment option for FL, Incyte’s plans to share data with the scientific community and Incyte’s expectations with respect to filing an sBLA or otherwise engaging with regulators, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the U.S. FDA and other regulatory authorities outside of the United States; the efficacy or safety of Incyte and its partners' products; the acceptance of Incyte and its partners' products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte's reports filed with the Securities and Exchange Commission, including its annual report on Form 10-K and its report on Form 10-Q for the quarter ended September 30, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements.

BEIJING--( BUSINESS WIRE )--Latest data of InnoCare’s (HKEX: 09969; SSE: 688428) orelabrutinib were presented at the ongoing 66th American Society of Hematology (ASH) Annual Meeting. Poster Presentation 1. Orelabrutinib in Patients with Indolent Non-Hodgkin Lymphoma (iNHL) Who Are Intolerant to Prior Bruton Tyrosine Kinase Inhibitors (BTKi): Updated Results from a Phase 2 Study (Abstract No.: 4399) Orelabrutinib improved outcomes of prior BTKi-intolerant adverse events (AEs), particularly the off-target toxicities. Patients who switched experienced minimal and low levels of intolerance recurrences and all achieved disease control. These updated results show promising efficacy and safety data of orelabrutinib in prior BTKi-intolerant iNHL patients. As data cutoff (July 9, 2024), 66 patients were enrolled and 64 patients were available for AE and efficacy analysis. At a median follow-up of 6.8 months, the median progression-free survival (PFS) and overall survival (OS) were not reached. Both PFS and OS rates remained 100%. 2. Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (cwCLL-001 Study) (Abstract No.: 3244) This is a multicenter, open-label, non-randomized phase II study for previously untreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) without restriction by del(17p)/TP53 aberrations and/or immunoglobulin heavy⁃chain variable region gene (IGHV) mutation status. The Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab regimen leads to a rapid and deep molecular remission with a manageable safety profile in previously untreated CLL patients including those with unfavorable characteristics. After cycle 6, the rates of peripheral blood (PB) undetectable minimal residual disease (uMRD) and bone marrow (BM) uMRD by flow cytometry (FCM) were 95% and 86%, respectively, and the rate of complete response (CR)/CR with incomplete hematologic recovery (CRi ) was 59%. After cycle 12, the rates of PB-uMRD by FCM, BM-uMRD by FCM, and CR/CRi were 95%, 91% and 77% respectively. 3. A Prospective, Multicenter, Single-Arm Study on the Combination of Orelabrutinib and Rituximab in the Second-Line Treatment of Relapsed/Refractory Marginal Zone Lymphoma (Abstract No.: 4391) This is a prospective, multicenter, single-arm, phase II clinical trial, aiming to evaluate the efficacy and safety of orelabrutinib in combination with rituximab in patients with relapsed or refractory Marginal Zone Lymphoma (MZL). The preliminary results of this study suggest that the combination therapy of orelabrutinib and rituximab is effective in patients with rrMZL and has manageable safety, with tolerable maintenance therapy. Of the 12 enrolled patients, 6 have completed the interim efficacy assessment, achieving an overall response rate (ORR) of 100%. 3 patients completed the combination therapy and entered the maintenance phase, keeping the ORR at 100%. All patients chose orelabrutinib for maintenance therapy. 4. Orelabrutinib, Rituximab, and Thiotepa (ORT) in Combination with or without High-Dose Methotrexate in Untreated Primary Central Nervous System Lymphoma (Abstract No.: 4487) The orelabrutinib, rituximab, and thiotepa (ORT) regimen, with or without high-dose methotrexate (HD-MTX), has shown initial efficacy and a manageable safety profile in treating Primary Central Nervous System Lymphoma (PCNSL), particularly in elderly patients with MCD subtypes. Autologous stem cell transplantation (ASCT) following ORT with or without HD-MTX induction therapy further improves patient response. Patients with complete response (CR) did not relapse and were well-tolerated on orelabrutinib maintenance therapy. The median follow-up was 8.27 months. The best CR rate was 85.71%, and the longest CR duration was 22.53 months. The objective response rate (ORR) was 85.71%. 5. Preliminary Data of a Single-Arm, Phase II Study of Orelabrutinib with/without Rituximab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma after BTK Inhibitor Therapy (Abstract No.: 3240) Despite the currently limited follow-up period, orelabrutinib combined with or without rituximab, demonstrated favorable efficacy in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with detectable MRD post-BTK inhibitor treatment, and MRD decreased significantly after 9 months. This treatment holds the potential to emerge as a new therapeutic option for CLL/SLL patients. At 9 months, 66.7% achieved undetectable peripheral blood MRD, with a 9-month complete response rate (CRR) of 77.8% and a 1-year overall survival (OS) of 100%, and no patient has progressed thus far. 6. Preliminary Data on the Efficacy and Safety of Orelabrutinib Combined with Rituximab and Methotrexate (ORM Regimen) As First-Line Treatment for Primary Central Nervous System Lymphoma, and the Exploration of Cerebrospinal Fluid ctDNA Dynamic Monitoring (Abstract No.: 4500) The Orelabrutinib Combined with Rituximab and Methotrexate regimen demonstrates high overall response rate (ORR) and complete response (CR) in the treatment of Primary Central Nervous System Lymphoma (PCNSL), with acceptable safety. Our results suggest that dynamic monitoring of cerebrospinal fluid circulating tumor DNA (ctDNA) is of significant importance for the early evaluation of therapeutic efficacy and prognosis prediction in PCNSL. During treatment the best response evaluation showed an ORR of 86.4% and a disease control rate (DCR) of 100%; Among the 21 patients who completed all induction therapies, the ORR was 85.71% with a CR rate of 76.19%. Among 19 patients with detectable ctDNA in baseline CSF, 13 patients had undetectable ctDNA in C5D1 CSF, of which 12 patients achieved CR. Patients with undetectable CSF ctDNA at C5D1 showed longer progression-free survival (PFS), indicating that early clearance of CSF ctDNA can predict favorable prognosis. 7. Preliminary Efficacy of Orelabrutinib Targeted Therapy in Induction Therapy of Primary Central Nervous System Diffuse B-Cell Lymphoma (Abstract No.: 4496) The Orelabrutinib, Rituximab and High-dose MTX regimen is an effective and safe induction therapy for primary central nervous system diffuse B-cell lymphoma, with a total response rate of 83.3% and a median onset time of 1 course for partial response (PR) and 2 courses for complete response (CR). It is a promising induction therapy for primary central nervous system diffuse B-cell lymphoma. 8. The Primary Results of R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) As the First-Line Induction Therapy Followed By Autologous Stem Cell Transplantation in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: 1742) This is a prospective designed, ongoing, single-center, single-arm, open-label study. The Rituximab, Methotrexate, Thiotepa, and Orelabrutinib induction treatment has demonstrated notable efficacy in achieving higher response rates among patients with newly diagnosed Primary Central Nervous System Lymphoma (PCNSL), and a tolerable safety profile. A total of 26 patients with newly diagnosed PCNSL were enrolled in this study. The overall response rate (ORR) was 96.15%, and the complete response (CR) rate was 92.30% after 4 cycles of treatment. Among ten patients who underwent autologous hematopoietic stem cell transplantation (HSCT), all of them (100%) remained in CR. The progression-free survival (PFS) and overall survival (OS) rate at 12 months were 82.24%, and 87.00% respectively. 9. Efficacy and Safety of Orelabrutinib in Relapsed/Refractory Idiopathic Multicentric Castleman Disease: A Single-Center, Retrospective Study (Abstract No.: 1656) Orelabrutinib, with its high response rate, durable response time, and improved safety profile can be a viable alternative for the treatment of patients with relapsed/refractory (r/r) idiopathic multicentric Castleman disease (iMCD). Ten patients with r/r iMCD were included in the study, Seven patients (70%) were assessed as responders, two of whom achieved complete response. The median time to remission for responders was 9.8 months (range: 5.9–20.5 months). In the non-responder group, despite not achieving response criteria, these patients still showed a continuous improvement in median hemoglobin, albumin, C-reactive protein (CRP) and creatine levels with treatment at month 12. No grade 3 or above adverse reactions occurred. Except poster presentation, more than 10 studies were also selected as online publications at the meeting. For more detailed clinical data, please refer to ASH website. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

Oral presentation shares head-to-head results for investigational combination pozelimab plus cemdisiran vs. ravulizumab in paroxysmal nocturnal hemoglobinuria Initial results for odronextamab in first-line follicular lymphoma showcase compelling monotherapy potential and progress in the confirmatory trial Additional oral presentations explore odronextamab in areas of high unmet need, including the primary analysis in diffuse large B-cell lymphoma progressing after CAR-T therapy and first results in relapsed/refractory marginal zone lymphoma TARRYTOWN, N.Y., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data from its hematology pipeline will be shared across 23 abstracts at the American Society of Hematology (ASH) 2024 Annual Meeting, taking place from December 7-10 in San Diego, CA. The latest research advances demonstrate the potential of Regeneron’s diverse pipeline, which aims to address unmet needs in ten types of blood cancers and disorders. These innovative and differentiated approaches include CD3 bispecific antibodies, costimulatory bispecific antibodies, and a pioneering combination of a monoclonal antibody and small interfering RNA (siRNA). “Our presentations at ASH demonstrate the progress we are making toward transforming care for a range of blood cancers and disorders where advancements are desperately needed,” said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President and Hematology Clinical Development Unit Head at Regeneron. “These include new head-to-head data exploring a novel combination that aims to maximize disease control in paroxysmal nocturnal hemoglobinuria compared to a standard-of-care treatment, as well as initial results from our confirmatory odronextamab trial in first-line follicular lymphoma. Together, our presentations underscore our commitment to work towards translating scientific breakthroughs to differentiated medicines for hematology patients.” At ASH, abstracts in blood disorders include an oral presentation from an exploratory cohort of a Phase 3 trial investigating a novel combination of pozelimab with cemdisiran compared to ravulizumab in patients with paroxysmal nocturnal hemoglobinuria (PNH) who were naïve to complement inhibition at baseline. Notably, the presentation will detail interim results from patients who were initially randomized to ravulizumab but crossed over to the combination in an open label extension portion of the trial. Progress on the odronextamab development program will be featured in twelve abstracts. Among them are initial results in patients with previously untreated follicular lymphoma (FL) from Part 1 of the Phase 3 OLYMPIA-1 confirmatory trial, which consists of a non-randomized safety run-in (Part 1) followed by a randomized efficacy portion (Part 2) comparing odronextamab monotherapy to rituximab plus standard-of-care chemotherapies. Two oral presentations on the ELM-1 and pivotal ELM-2 trials will feature new analyses in settings with significant unmet needs: one in patients with diffuse large B-cell lymphoma (DLBCL) who progressed after CAR-T therapy and the other in relapsed/refractory (R/R) marginal zone lymphoma (MZL). Other notable abstracts include the latest linvoseltamab efficacy and safety results from the pivotal LINKER-MM1 study in R/R multiple myeloma (MM), preclinical data evaluating a CD38xCD28 costimulatory bispecific antibody in combination with linvoseltamab, and preclinical data on TMPRSS6 inhibition in beta-thalassemia. The full list of Regeneron presentations at ASH includes: Abstract TitleAbstractPresenterSession Date/Time (PT)Odronextamab Efficacy and Safety of Odronextamab Monotherapy in Patients (Pts) with Diffuse Large B-Cell Lymphoma (DLBCL) Progressing after CAR T-Cell Therapy: Primary Analysis from the ELM-1 StudyAbstract #866Oral PresentationSessionMatthew MatasarMonday, December 9, at 2:45-4:15 pmMarriott Marquis San Diego Marina, Pacific Ballroom Salons 15-17Efficacy and Safety of Odronextamab in Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL): Data from the R/R MZL Cohort in the ELM-2 StudyAbstract #862Oral PresentationSessionTae Min KimMonday, December 9, at 2:45-4:15 pmMarriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13Odronextamab Monotherapy in Previously Untreated Patients with High-Risk Follicular Lymphoma (FL): Results of the Safety Lead-in of the Phase 3 OLYMPIA-1 StudyAbstract #4411Poster PresentationSessionElizabeth BremMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HEfficacy and Safety of Odronextamab in Rare Subtypes of Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (B-NHL): Data from a Dedicated Cohort of Other B-NHLs in the ELM-2 StudyAbstract #4502Poster PresentationSessionEmmanuel BachyMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HTreatment Duration and Risk of Fatal Infections in Patients with B-Cell Non-Hodgkin Lymphoma Achieving Complete Response with OdronextamabAbstract #3080Poster PresentationGottfried von KeudelMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HDynamics of Complete Responses in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma Treated with Odronextamab in the ELM-2 StudyAbstract #4486Poster PresentationSessionSabarish AyyappanMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HLong-Term Efficacy and Safety of Odronextamab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Pooled Analysis from ELM-1 and ELM-2 StudiesAbstract #3118Poster PresentationSessionJohn N. AllanSunday, December 8, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HEvaluation of CAR-HEMATOTOX Scoring as a Predictor of Infection Risk following Treatment with Odronextamab (a CD20×CD3 Bispecific Antibody) in Relapsed/Refractory Diffuse Large B-Cell LymphomaAbstract #3076Poster PresentationSessionMathew MatasarSunday, December 8, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HEvaluation of Baseline CAR-HEMATOTOX Scores to Predict Increased Severe Infection Risk in Patients with Relapsed/Refractory Follicular Lymphoma Treated with OdronextamabAbstract #1650Poster PresentationSessionMatthew MatasarSaturday, December 7, at 5:30-7:30 pmSan Diego Convention Center, Halls G-HDynamics of Complete Responses in Patients with Relapsed or Refractory Follicular Lymphoma Treated with Odronextamab in the ELM-2 StudyAbstract #1628Poster PresentationSessionStefano LuminariSaturday, December 7, at 5:30-7:30 pmSan Diego Convention Center, Halls G-HTrial in Progress: Odronextamab for the Treatment of Patients with Relapsed/Refractory Mantle Cell Lymphoma following Prior BTK Inhibitor Therapy - A Cohort of the ELM-2 StudyAbstract Publication OnlySrikanth AmbatiN/AMatching-Adjusted Indirect Comparisons (MAICs) of Odronextamab Versus Mosunetuzumab and Epcoritamab for the Treatment of Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL) after Two or More Lines of Systemic TherapyAbstract Publication OnlyDeepa JagadeeshN/ALinvoseltamabLinvoseltamab in Patients with Relapsed/Refractory Multiple Myeloma: Longer Follow-Up and Selected High-Risk Subgroup Analyses of the LINKER-MM1 StudyAbstract #3369Poster PresentationMansi R. ShahSunday, December 8, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HSoluble BCMA Dynamics in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Linvoseltamab in LINKER-MM1Abstract #3310Poster PresentationAnasuya HazraSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HCharacterization of Linvoseltamab’s BCMA Binding Epitope and Efficacy Against BCMA Mutations in Relapsed/Refractory Multiple MyelomaAbstract #3265Poster PresentationKen Lee & Yi ZhouSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HA CD38xCD28 Costimulatory Bispecific Antibody Demonstrates Potent Preclinical Combinatorial Activity with a BCMAxCD3 T Cell-EngagerAbstract #3283Poster PresentationKara Olson & David J. DiLilloSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HReducing Time Toxicity for Anti-B-Cell Maturation Antigen (BCMA) Bispecific Treatment: Evidence from Pivotal Single-Arm Trial Data on Teclistamab, Elranatamab, and Linvoseltamab for Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)Abstract #2271Poster Presentation SessionSikander AilawadhSaturday, December 7, at 5:30-7:30 pmSan Diego Convention, Halls G-HExposure-Response Analyses of Various Efficacy and Safety Endpoints in Support of Registrational Dose Selection of Linvoseltamab in Patients with Relapsed/Refractory Multiple MyelomaAbstract Publication OnlyOleg MilbergN/AComparative Effectiveness of Linvoseltamab Versus Current Real-World Standard-of-Care Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma Treated at IMWG SitesAbstract Publication OnlyShaji KumarN/AComparative Effectiveness of Linvoseltamab Versus Current Real-World (RW) Standard-of-Care (SOC) Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma (RRMM): Key Subgroups AnalysisAbstract Publication OnlyShaji KumarN/AAdditional PresentationsEfficacy and Safety of Pozelimab Plus Cemdisiran vs Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria who are Naïve to Complement Inhibition* Abstract #306Oral Presentation SessionChristopher PatriquinSaturday, December 7, at 4 – 5:30 pmSan Diego Convention Center, Room 11TMPRSS6 Inhibition Rapidly Reverses Liver Iron Overload and Prevents an Increase of Splenic Pro-Inflammatory Macrophages in a Mouse Model of Beta-Thalassemia Abstract #2473Poster Presentation SessionHeinrich E. LobSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HThe Reality of Beta Thalassemia and Iron Chelation Therapy – A Qualitative Study Unveiling the Patient BurdenAbstract Publication OnlyChris Hartford *Agreement with Alnylam Pharmaceuticals, Inc. Linvoseltamab as well as the combination of pozelimab and cemdisiran are investigational, and the potential uses of odronextamab in R/R MZL and rare subtypes of R/R aggressive B-cell non-Hodgkin lymphoma are also investigational and have not been approved by any regulatory authority. Odronextamab is approved in the European Union as Ordspono™ to treat R/R FL or DLBCL after two or more lines of systemic therapy, but the safety and efficacy of odronextamab have not been fully evaluated by any other regulatory authority. About Regeneron in Hematology At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite® technologies to develop medicines for patients with diverse blood cancers and rare blood disorders. Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments. Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling. 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 a substantial proportion 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), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). About Regeneron  Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most 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, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.  Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. 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 nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “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 pozelimab in combination with cemdisiran, odronextamab, linvoseltamab, and the other programs discussed or referenced in this press release; 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 odronextamab for the treatment of follicular lymphoma in the United States, linvoseltamab for the treatment of relapsed/refractory multiple myeloma in the United States and/or European Union, and the other programs discussed or referenced in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) 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 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; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) 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 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 (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; 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, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; 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), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), 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, 2023 and its Form 10-Q for the quarterly period ended September 30, 2024. 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. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Contacts:Media RelationsTammy AllenTel: +1 914-306-2698tammy.allen@regeneron.comInvestor RelationsMark HudsonTel: +1 914-847-3482mark.hudson@regeneron.com