Refractory Grade 3a Follicular Lymphoma

Nineteen abstracts accepted, including multiple presentations on the safety and efficacy of investigational epcoritamab (DuoBody®-CD3xCD20) in a variety of treatment settings and hematologic malignancies Four oral presentations highlighting data evaluating epcoritamab for the treatment of relapsed/refractory (R/R) large B-cell lymphoma (LBCL), R/R follicular lymphoma (FL), previously untreated FL, and Richter's syndrome New data evaluating investigational medicines in Genmab’s early portfolio of cancer immunotherapies will also be presented Genmab to host 2022 R&D Update and ASH Data Review meeting December 12 COPENHAGEN, Denmark--(BUSINESS WIRE)-- Genmab A/S (Nasdaq: GMAB) announced today that 19 abstracts evaluating various investigational medicines in its pipeline have been accepted for presentation at the 64th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held at the Ernest N. Morial Convention Center in New Orleans, Louisiana, and virtually, December 10-13. The presentations will include four oral and six poster presentations highlighting data from several clinical trials evaluating the safety and efficacy of epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology, alone or in combination for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), previously untreated FL and Richter’s syndrome. Additionally, abstracts evaluating two investigational medicines in Genmab’s early pipeline have been accepted for presentation, including the first-in-human data from the phase 1/2 trial evaluating GEN3014 (HexaBody®-CD38), an investigational novel human CD38 monoclonal antibody, in patients with R/R multiple myeloma (MM). In addition, preclinical data from a novel drug candidate GEN3017 (DuoBody®-CD3xCD30) will also be presented. All abstracts accepted for presentation have been published on the ASH website. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies are committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of B-cell malignancies, including an ongoing phase 3, open-label, randomized clinical trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory LBCL, including DLBCL (NCT: 04628494) and a phase 3, open-label randomized clinical trial evaluating epcoritamab in combination in patients with relapsed/refractory follicular lymphoma (FL) (NCT: 05409066). “As part of our commitment to the blood cancer community, we continue to advance our research and innovative technologies in an effort to develop differentiated therapies with the goal of transforming the future of treatment for patients,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “The robust data being presented at this year’s American Society of Hematology meeting are encouraging and support the potential of epcoritamab to become a core therapy for B-cell malignancies.” 2022 R&D Update and ASH Data Review On Monday, December 12, at 8:00 PM EST (7:00 PM CST / 1:00 AM GMT), Genmab will host its 2022 R&D Update and ASH Data Review. The event will be conducted and webcast live. Details, including the webcast link and registration can be found here. This meeting is not an official program of the ASH Annual Meeting. Abstracts accepted at ASH: Epcoritamab (DuoBody®-CD3xCD20) Abstract Number Abstract Title Type of Presentation Date/Time of Presentation 348 Subcutaneous Epcoritamab in Patients with Richter’s Syndrome: Early Results from Phase 1b/2 Trial (EPCORE CLL-1). Kater et. al. Oral Saturday, December 10, 4:00 PM - 5:30 PM 443 Subcutaneous Epcoritamab + R-DHAX/C in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Eligible for Autologous Stem Cell Transplant: Updated Phase 1/2 Results. Abrisqueta et. al. Oral Sunday, December 11, 9:30 AM - 11:00 AM 609 Subcutaneous Epcoritamab with Rituximab + Lenalidomide in Patients with Relapsed or Refractory Follicular Lymphoma: Phase 1/2 Trial Update. Falchi et. al. Oral Sunday, December 11, 4:30 PM - 6:00 PM 611 Subcutaneous Epcoritamab in Combination with Rituximab + Lenalidomide (R2) for First-Line Treatment of Follicular Lymphoma: Initial Results from Phase 1/2 Trial. Falchi et. al. Oral Sunday, December 11, 4:30 PM - 6:00 PM 4251 Epcoritamab Monotherapy Provides Deep and Durable Responses Including Minimal Residual Disease (MRD) Negativity: Novel Subgroup Analyses in Patients with Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL). Phillips et. al. Poster Monday, December 12, 6:00 PM - 8:00 PM 3580 Improvements in Lymphoma Symptoms and Health-related Quality of Life in Patients with Relapsed or Refractory Large B-cell Lymphoma Treated with Epcoritamab. Phillips et. al. Poster Sunday, December 11, 6:00 PM - 8:00 PM 4912 Indirect Comparison of the Efficacy of Subcutaneous Epcoritamab Dose Expansion (EPCORE NHL-1 Trial) in Patients With Relapsed or Refractory Large B-cell Lymphoma. Salles et. al. Poster Monday, December 12, 6:00 PM - 8:00 PM 2874 Deep peripheral T cell subset immune-profiling in relapse/refractory non-Hodgkins lymphoma (NHL): Evaluation of baseline samples from the Epcoritamab 3013-01 trial. Blum et. al. Poster Sunday, December 11, 6:00 PM - 8:00 PM 2859 Transcriptomic Comparison of Non-Hodgkin Lymphomas in Relapsed/Refractory versus Newly Diagnosed Patients with Single Slides. Jabado et. al. Poster Sunday, December 11, 6:00 PM - 8:00 PM 1663 Phase 1b Trial of Subcutaneous Epcoritamab Among Pediatric Patients With Relapsed or Refractory Aggressive Mature B-Cell Neoplasms. Cairo et. al. Poster Saturday, December 10, 5:30 PM - 7:30 PM 4182 Evaluation of Epcoritamab and Rituximab Combination in Preclinical Models of B-cell non-Hodgkin’s Lymphoma (NHL). Epling-Burnette et. al. Poster Monday, December 12, 6:00 PM - 8:00 PM 4206 Phase 3 Trial of Subcutaneous Epcoritamab in Combination With Rituximab and Lenalidomide (R2) vs R2 Without Epcoritamab Among Patients With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1). Falchi et. al. Poster Monday, December 12, 6:00 PM - 8:00 PM 4271 Phase 2 Trial to Evaluate Safety of Subcutaneous Epcoritamab Monotherapy in the Outpatient Setting Among Patients With Relapsed or Refractory Diffuse Grade 1–3a Large B-Cell and Follicular Lymphoma. Sharman et. al. Poster Monday, December 12, 6:00 PM - 8:00 PM 5524 Assessing Safety, Tolerability, and Efficacy of Subcutaneous Epcoritamab in Novel Combinations with Anti-Neoplastic Agents in Patients with Non-Hodgkin Lymphoma in a Phase 1b/2, Open-Label Study. Sehn et. al. Publication NA GEN3014 (HexaBody®-CD38) Abstract Number Abstract Title Type of Presentation Date/Time of Presentation 3254 Preliminary Dose-Escalation Results From a First-in-Human Phase 1/2 Study of GEN3014 (HexaBody®-CD38) in Patients (pts) With Relapsed or Refractory (R/R) Multiple Myeloma (MM). Spencer et. al. Poster Sunday, December 11 6:00-8:00 PM GEN3017 (DuoBody®-CD3xCD30) Abstract Number Abstract Title Type of Presentation Date/Time of Presentation 1366 DuoBody®-CD3xCD30 shows potent preclinical anti-tumor activity in vitro in CD30+ hematologic malignancies. Oostindie et. al. Poster Sunday, December 11, 6:00 PM - 8:00 PM Real-World Evidence Abstract Number Abstract Title Type of Presentation Date/Time of Presentation 2978 Real-World Outcomes in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Treated with Standard of Care: a COTA Database Analysis. Ip et. al. Poster Sunday, December 11, 6:00 PM - 8:00 PM 2296 Treatment Patterns and Outcomes in Patients With Follicular Lymphoma Receiving at Least 3 Lines of Therapy: a Real-World Evaluation in the United States. Phillips et. al. Poster Saturday, December 10, 5:30 PM - 7:30 PM 2215 Health Care Resource Utilization and Costs of CAR T Therapy in Patients With Large B-Cell Lymphoma: A Retrospective US Claims Database Analysis. Davies et. al. Poster Saturday, December 10, 5:30 PM - 7:30 PM About Epcoritamab Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.i CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.ii,iii About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer. For more than 20 years, Genmab’s vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that make an impact on people’s lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab’s proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab. This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at . Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. _______________________ i Engelberts et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625 ii Rafiq, Butchar, Cheney, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties." J. Immunol. 2013;190(6):2702-2711. DOI: 10.4049/jimmunol.1202588 iii Singh, Gupta, Almasan. "Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response." J Cancer Sci Ther. 2015;7(11):347-358. DOI: 10.4172/1948-5956.1000373

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 01, 2022 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it has initiated a bridging study of tazemetostat in China. The first patient received their first dose on July 29, 2022. The bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma (“R/R FL”). The primary objective is to evaluate the efficacy of tazemetostat for treatment of patients with R/R FL who have mutations in EZH21 (Cohort 1). The secondary objectives are to evaluate the efficacy of tazemetostat for treatment of patients with R/R FL who have EZH2 wild-type (Cohort 2) and to evaluate the safety and the pharmacokinetics of tazemetostat for treatment of patients with R/R FL. The lead principal investigator is Dr Junning Cao of Shanghai Fudan University Cancer Center. Additional details may be found at clinicaltrials.gov, using identifier NCT05467943. Tazemetostat is a methyltransferase inhibitor of EZH2 developed by Epizyme, Inc. (“Epizyme”). It is approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of certain patients with advanced epithelioid sarcoma (“ES”) and certain patients with R/R FL under the FDA accelerated approval granted in January and June 2020, respectively. In August 2021, HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan. In May 2022, tazemetostat was approved by the Health Commission and Medical Products Administration of Hainan Province of China to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (“Hainan Pilot Zone”), under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with ES and FL consistent with the label as approved by the FDA. About FL and ES FL is a subtype of non-Hodgkin’s lymphoma (“NHL”). FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively. 2,3,4 ES is a rare, slow-growing type of soft tissue cancer. Radical tumor resection is the primary treatment for patients with ES. However, ES is known for its high propensity for locoregional recurrence and distant metastases. The survival of patients with ES is often unsatisfactory with very limited treatment options.5 About TAZVERIK® (tazemetostat) TAZVERIK® is a methyltransferase inhibitor indicated in the United States for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies. Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval by the U.S. FDA based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain. View the U.S. Full Prescribing Information here: www.tazverik.com TAZVERIK® is a registered trademark of Epizyme, Inc. About Tazemetostat Clinical Development in China HUTCHMED and Epizyme are developing tazemetostat in various hematological and solid tumors in Greater China, with HUTCHMED leading the China portion of Epizyme’s SYMPHONY-1 study. HUTCHMED and Epizyme also intend to conduct additional global studies jointly. SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with R2 in patients with relapsed or refractory FL after at least one prior line of therapy (clinicaltrials.gov identifier: NCT04224493). We intend to initiate several combination studies of tazemetostat with HUTCHMED assets. About HUTCHMED HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,900 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/​immunology. Since inception it has advanced 13 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.