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Copenhagen, Denmark, May 12, 2022
Multiple epcoritamab (DuoBody®-CD3xCD20) studies will be presented showcasing preliminary efficacy and safety findings in a variety of patient populations in need of treatment options
Several abstracts evaluating Genmab owned and partnered programs accepted for presentation
Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, will be presented at the European Hematology Association (EHA) Annual Congress, being held in Vienna, Austria, and virtually, June 9-12. The presentations will include data from various clinical trials, including multiple arms of the phase 1b/2 EPCORE™ NHL-2 trial, evaluating the safety and preliminary efficacy of epcoritamab in combination with standard-of-care therapies for the treatment of B-cell non-Hodgkin lymphoma (NHL), including first-line, high-risk diffuse large B-cell lymphoma (DLBCL), relapsed or refractory DLBCL, and relapsed or refractory follicular lymphoma (FL). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV).
Additionally, results from several clinical trials evaluating Janssen Biotech, Inc. (Janssen’s)’s subcutaneous formulation of daratumumab, and Janssen’s bispecific programs leveraging Genmab’s DuoBody technology platform will be presented. Daratumumab is being developed by Janssen under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab, and the companies have a research and license agreement to create and develop bispecific antibodies using Genmab’s DuoBody technology platform.
All abstracts accepted for presentation have been published on the EHA website.
“We are looking forward to presenting the results from a variety of clinical trials evaluating the safety and efficacy of epcoritamab at this year’s EHA, which shows the significant progress we have made developing epcoritamab,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “Together with AbbVie, we continue to evaluate epcoritamab in a variety of clinical settings and patient populations, with the shared commitment of potentially delivering a new treatment option to patients in need.”
Abstracts accepted for presentation at EHA include:
Abstract #: P1214. Subcutaneous epcoritamab + R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma: phase 1/2 data update; Clausen et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1135. Subcutaneous epcoritamab in combination with rituximab + lenalidomide in relapsed or refractory follicular lymphoma: phase 1/2 trial update; Belada et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1215 Preliminary phase 1/2 results of subcutaneous epcoritamab + R-DHAX/C in patients with relapsed or refractory diffuse large B-cell lymphoma eligible for autologous stem cell transplant; Cordoba et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1213. Subcutaneous epcoritamab with GemOx induced high response rates in patients with relapsed/refractory diffuse large B-cell lymphoma ineligible for autologous stem cell transplant; Wahlin et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Publication: 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
Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) Alone in Chinese Patients With Relapsed or Refractory Multiple Myeloma (RRMM): Updated Analysis of LEPUS; Fu et al
Efficacy and safety of daratumumab (DARA) in pediatric and young adult patients (pts) with relapsed/refractory T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL): results from the phase 2 DELPHINUS study; Hogan et al
Daratumumab (DARA) in combination with bortezomib plus dexamethasone (D-Vd) or lenalidomide plus dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): subgroup analysis of the phase 3 CASTOR and POLLUX studies in patients (pts) with early or late relapse after initial therapy; Spencer et al
Time to response, duration of response, and patient-reported outcomes (PROs) with daratumumab (DARA) plus lenalidomide and dexamethasone (D-Rd) vs lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of the phase 3 MAIA study; Facon et al
Daratumumab (DARA) + lenalidomide, bortezomib, and dexamethasone (RVd) in transplant-eligible newly diagnosed multiple myeloma (NDMM): a post hoc analysis of sustained minimal residual disease (MRD) negativity from GRIFFIN; Rodriguez et al
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 Epcoritamab was developed with selective, silencing mutations that may limit systemic, non-specific activity.ii 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.iii,iv Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.
About DARZALEX® (daratumumab)
DARZALEX® (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat certain multiple myeloma indications. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of certain multiple myeloma indications and the first and only approved treatment for certain patients with light-chain (AL) amyloidosis.v,vi,vii
Please see local country prescribing information for all labeled indication and safety information.
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.
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This Media Release 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 www.genmab.com 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 www.sec.gov. 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®. EPCORE™ is a trademark of AbbVie Biotechnology Ltd.; DARZALEX® and DARZALEX FASPRO® are trademarks of Johnson & Johnson.
iEngelbert 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 Feb;52: 102625. doi: 10.1016/j.ebiom.2019.102625. Epub 2020 Jan 23. PMID: 31981978; PMCID: PMC6992935.
ii Van der Horst, et al. “Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment.” Blood Cancer Journal, 18 February 2021; https://doi.org/10.1038/s41408-021-00430-6.
iiiRafiq, Sarwish, et al. “Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties.” Journal of Immunology (Baltimore, Md. 1950), U.S. National Library of Medicine, 15 Mar. 2013, www.ncbi.nlm.nih.gov/pmc/articles/PMC3631574/.
ivSingh, Vijay, et al. “Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response.” Journal of Cancer Science & Therapy, U.S. National Library of Medicine, Nov. 2015, www.ncbi.nlm.nih.gov/pmc/articles/PMC4939752/.
vDARZALEX Prescribing information, available at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761036 Last accessed July 2021.
viDARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 2021.
viiDARZALEX FASPRO Prescribing information, available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145 Last accessed June 2021.
Media Release no. 07
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Kalvebod Brygge 43
1560 Copenhagen V