Media Release
COPENHAGEN, Denmark; October 28, 2022
- Genmab has Submitted Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) for epcoritamab
- European Medicines Agency (EMA) has validated Marketing Authorization Application (MAA) for epcoritamab submitted by AbbVie
- The submissions are supported by the EPCORE™ NHL-1 open-label, multi-center section 2 trial evaluating the security and preliminary efficacy of epcoritamab in grownup sufferers with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (B-NHL)
Genmab A/S (Nasdaq: GMAB) in the present day introduced that the corporate has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational bispecific antibody, for the remedy of sufferers with relapsed/refractory massive B-cell lymphoma (LBCL) after two or extra traces of systemic remedy. Additionally, Genmab introduced that AbbVie (NYSE: ABBV) submitted a Marketing Authorization Application (MAA) for epcoritamab for the remedy of sufferers with relapsed/refractory diffuse massive B-cell lymphoma (DLBCL) after two or extra traces of systemic remedy, which has been validated by the European Medicines Agency (EMA).
The regulatory submissions are supported by beforehand introduced outcomes from the LBCL cohort of the pivotal EPCORE™ NHL-1 open-label, multi-center section 2 medical trial evaluating the security and preliminary efficacy of epcoritamab in sufferers with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL), together with DLBCL. These outcomes had been offered in a late-breaking oral presentation as an element of the Presidential Symposium on the 27th Annual Meeting of the European Hematology Association (EHA2022), on June 11, 2022, in Vienna, Austria.
“Even with existing therapies to treat these lymphomas, there is a significant medical need for alternative and accessible treatment options for patients who are unable to tolerate current treatments or whose treatments have failed,” stated Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Together with our partner AbbVie, we believe epcoritamab has the potential to become a core therapy for patients with B-cell malignancies, and the submission of these regulatory applications to the FDA and EMA is an important step in potentially bringing epcoritamab to people living with relapsed/refractory B-cell lymphomas.”
Epcoritamab is being co-developed by Genmab and AbbVie as half of the businesses’ oncology collaboration. The corporations will share business tasks within the U.S. and Japan, with AbbVie accountable for additional world commercialization. The corporations are dedicated to evaluating epcoritamab as a monotherapy, and together, throughout traces of remedy in a variety of hematologic malignancies, together with an ongoing section 3, open-label, randomized medical trial evaluating epcoritamab as a monotherapy in sufferers with relapsed/refractory DLBCL (NCT: 04628494) and a section 3, open-label medical trial evaluating epcoritamab together in sufferers with relapsed/refractory follicular lymphoma (FL) (NCT: 05409066).
About Large B-cell Lymphoma (LBCL) and Diffuse Large B-cell Lymphoma (DLBCL)
Large B-cell lymphoma (LBCL) is a fast-growing sort of non-Hodgkin’s lymphoma (NHL), a most cancers that develops within the lymphatic system and impacts B-cell lymphocytes, a kind of white blood cell. There are an estimated 150,000 new LBCL circumstances annually globally.1,2 Diffuse massive B-cell lymphoma (DLBCL) is a fast-growing sort of NHL3 and the most typical sort of NHL worldwide, accounting for roughly 31 % of all NHL circumstances.2 DLBCL can come up in lymph nodes in addition to in organs exterior of the lymphatic system, happens extra generally within the aged and is barely extra prevalent in males.1
About the EPCORE™ NHL-1 Trial
EPCORE™ NHL-1 is an open-label, multi-center security and preliminary efficacy trial of epcoritamab together with a section 1 first-in-human, dose escalation half; a section 2 growth half; and an optimization half. The trial was designed to guage subcutaneous epcoritamab in sufferers with relapsed, progressive or refractory CD20+ mature B-NHL, together with LBCL and DLBCL. Data from the dose escalation half of the examine, which decided the really useful section 2 dose, had been printed in The Lancet in 2021. In the section 2 growth half, extra sufferers are handled with epcoritamab to additional discover the security and efficacy of epcoritamab in sufferers with differing kinds of relapsed/refractory B-NHLs who had restricted therapeutic choices.
The main endpoint of the section 2 growth half was total response price (ORR) as assessed by an IRC. Secondary efficacy endpoints included period of response, full response price, progression-free survival, total survival, time to response, time to subsequent remedy, and price of minimal residual illness negativity.
About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created utilizing Genmab’s proprietary DuoBody know-how. Genmab’s DuoBody-CD3 know-how is designed to direct cytotoxic T cells selectively to elicit an immune response in the direction of goal cell sorts. Epcoritamab is designed to concurrently bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.4 CD20 is expressed on B-cells and a clinically validated therapeutic goal in lots of B-cell malignancies, together with diffuse massive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and power lymphocytic leukemia.5,6
About Genmab
Genmab is a global biotechnology firm with a core objective to enhance the lives of folks with most cancers. For greater than 20 years, Genmab’s imaginative and prescient to remodel most cancers remedy has pushed its passionate, progressive and collaborative groups to invent next-generation antibody know-how platforms and leverage translational analysis and information sciences, fueling a number of differentiated most cancers therapies that make an affect on folks’s lives. To develop and ship novel therapies to sufferers, Genmab has shaped 20+ strategic partnerships with biotechnology and pharmaceutical corporations. Genmab’s proprietary pipeline consists of bispecific T-cell engagers, next-generation immune checkpoint modulators, effector perform enhanced antibodies and antibody-drug conjugates.
Genmab is headquartered in Copenhagen, Denmark with places in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For extra data, please go to Genmab.com and observe us on Twitter.com/Genmab.
Genmab Media Contact:
David Freundel, Director, Product Communications
T: +1 609 613 0504; E: [email protected]
Genmab Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
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Genmab Forward-Looking Statements
This Media Release incorporates ahead wanting statements. The phrases “believe”, “expect”, “anticipate”, “intend” and “plan” and comparable expressions establish ahead wanting statements. Actual outcomes or efficiency could differ materially from any future outcomes or efficiency expressed or implied by such statements. The necessary elements that would trigger our precise outcomes or efficiency to vary materially embrace, amongst others, dangers related to pre-clinical and medical improvement of merchandise, uncertainties associated to the end result and conduct of medical trials together with unexpected issues of safety, uncertainties associated to product manufacturing, the dearth of market acceptance of our merchandise, our incapacity to handle development, the aggressive setting in relation to our business space and markets, our incapacity to draw and retain suitably certified personnel, the unenforceability or lack of safety of our patents and proprietary rights, {our relationships} with affiliated entities, adjustments and developments in know-how which can render our merchandise or applied sciences out of date, and different elements. For an additional dialogue of these dangers, please seek advice from the chance administration sections in Genmab’s most up-to-date monetary stories, which can be found on www.genmab.com and the chance elements included in Genmab’s most up-to-date Annual Report on Form 20-F and different filings with the U.S. Securities and Exchange Commission (SEC), which can be found at www.sec.gov. Genmab doesn’t undertake any obligation to replace or revise ahead wanting statements on this Media Release nor to verify such statements to mirror subsequent occasions or circumstances after the date made or in relation to precise outcomes, until required by regulation.
Genmab A/S and/or its subsidiaries personal the next logos: Genmab®; the Y-shaped Genmab brand®; Genmab together with the Y-shaped Genmab brand®; HuMax®; DuoBody®; DuoBody together with the DuoBody brand®; HexaBody®; HexaBody together with the HexaBody brand®; DuoHexaBody® and HexElect®.
1 Sehn, Salles. “Diffuse Large B-Cell Lymphoma.” N Engl J Med. 2021;384:842-858. DOI: 10.1056/NEJMra2027612
2 Martelli, Ferreri, Agostinelli, et al. “Diffuse large B-cell lymphoma.” Crit Rev Oncol Hematol. 2013;87(2):146-71. DOI: 10.1016/j.critrevonc.2012.12.009
3 “Diffuse Large B-Cell Lymphoma.” Lymphoma Research Foundation, https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/. Date accessed: October 26, 2022.
4 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
5 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
6 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
Media Release no. 14
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
- GENMAB_BLA_MAA Submission Release_FINAL
