U.S. FDA Accepts for Priority Review Biologics License Application for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma

  • The application is supported by data from the Phase 1/2 EPCORE™ NHL-1 trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in patients with non-Hodgkin’s B-cell lymphoma mature relapsed, progressive or refractory CD20+, including large B-cell lymphoma

  • If approved for relapsed/refractory large B-cell lymphoma after two or more lines of systemic therapy, epcoritamab could become the first subcutaneous bispecific antibody available for the treatment of large B-cell lymphoma

NORTH CHICAGO, Illinois., November 21, 2022 /PRNewswire/ — AbbVie (NYSE:ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application for epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

The application is supported by previously announced results from the LBCL cohort of the multicenter, open-label, Phase 1/2 EPCORE™ NHL-1 trial evaluating the safety and preliminary efficacy of investigational epcoritamab in adult patients with CD20+ relapsed, progressing, or refractory mature B-cell non-Hodgkin’s lymphoma (NHL).

“We are committed to the research and development of innovative therapies to provide important treatment options for people with blood cancers, such as large B-cell lymphoma, which has limited treatment options under the relapsed/refractory,” said mohamed zaki, MD, Ph.D., Vice President and Head of Global Oncology Development, AbbVie. “This milestone marks a first step in our hope to develop a core therapy for people with malignant B-cell tumors.”

Additionally, the European Medicines Agency recently validated a marketing authorization application for epcoritamab for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) – a major subtype of LBCL – after two or more lines of systemic therapy.

Epcoritamab is co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the United States and Japan, with AbbVie responsible for continued global commercialization. The companies are committed to evaluating epcoritamab as monotherapy and in combination, across treatment lines in a range of hematological malignancies. This includes an ongoing Phase 3 open-label randomized clinical trial evaluating epcoritamab monotherapy in patients with relapsed/refractory DLBCL (NCT: 04628494) and an open-label Phase 3 clinical trial evaluating epcoritamab in combination in patients with relapsed/refractory DLBCL. refractory follicular lymphoma (NCT: 05409066).

About Large B-Cell Lymphoma (LBCL)
LBCL is a fast-growing type of NHL, a cancer that grows in the lymphatic system and affects B cells, a type of white blood cell.1 There are an estimated 150,000 new cases of LBCL each year worldwide.1 LBCL includes DLBCL, which is the most common type of NHL in the world and accounts for approximately 30% of all NHL cases.1

About the EPCORE™ NHL-1 Trial
EPCORE™ NHL-1 is an open-label multicenter preliminary safety and efficacy trial of epcoritamab, including a first-in-man phase 1, dose escalation portion; a part of expansion of phase 2; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-cell NHL, including LBCL and DLBCL. Data from the dose escalation portion of the study, which determined the recommended Phase 2 dose, has been published in The Lancet in 2021. In the Phase 2 expansion, additional patients are being treated with epcoritamab to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of NHL at relapsed/refractory B cells who had limited treatment options.

The primary endpoint for the expansion portion of Phase 2 was the overall response rate as assessed by an independent review board. Secondary endpoints included duration of response, complete response rate, progression-free survival, overall survival, time to response, time to next therapy, and minimal residual disease negativity rate.

About Epcoritamab
Epcoritamab is an investigational IgG1 bispecific antibody created using Genmab’s proprietary DuoBody® Technology. Genmab DuoBody®-CD3 technology is designed to selectively direct cytotoxic T cells to trigger an immune response against target cell types. Epcoritamab is designed to simultaneously bind CD3 on T cells and CD20 on B cells, and induce T cell-mediated killing of CD20+ cells.2 CD20 is expressed on B cells and is 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.3,4 Epcoritamab is co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration.

About AbbVie in Oncology
At AbbVie, we are committed to transforming the standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies for a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially game-changing medicines. We’re evaluating more than 20 investigational drugs in more than 300 clinical trials for some of the world’s most common and debilitating cancers. As we strive to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients gain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology and our Blood Cancer Press Kit page.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve the serious health problems of today and meet the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives in several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition products and services from its Allergan Aesthetics portfolio. For more information about AbbVie, visit www.abbvie.com. Follow @abbvie on TwitterFacebook, Instagram, YouTube and LinkedIn.

AbbVie Forward-Looking Statements
Certain statements in this press release are, or may be deemed to be, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe”, “expect”, “anticipate”, “project and similar expressions, among other things, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated in the forward-looking statements. These risks and uncertainties include, but are not limited to, the failure to realize the expected benefits of the acquisition of Allergan plc by AbbVie (“Allergan”), the failure to quickly and effectively integrate the businesses of Allergan, competition from other products, intellectual property challenges, difficulties inherent in the research and development process, adverse litigation or government action, changes in laws and regulations applicable to our industry and the impact public health epidemics, epidemics or pandemics, such as COVID-19. Additional information about economic, competitive, governmental, technological and other factors that could affect AbbVie’s operations is set forth in Section 1A, “Risk Factors,” of AbbVie’s 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent quarterly reports on Form 10-Q. AbbVie undertakes no obligation to publicly release any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Sehn, Salles. “Diffuse Large B-Cell Lymphoma.” N Engl J Med. 2021;384:842-858. DOI: 10.1056/NEJMra2027612.
2 Engelberts et al. “DuoBody-CD3xCD20 induces potent T-cell killing of malignant B cells in preclinical models and offers possibilities for subcutaneous dosing.” EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625
3 Rafiq, Butchar, Cheney et al. “Comparative evaluation of antibodies against CD20 used clinically in chronic lymphocytic leukemia cells reveals divergent properties of NK cells, monocytes and macrophages.” J. Immunol. 2013;190(6):2702-2711. DOI: 10.4049/jimmunol.1202588
4 Singh, Gupta, Almasan. “Development of new anti-Cd20 monoclonal antibodies and modulation of Cd20 levels at the cell surface: seeks to improve the immunotherapeutic response.” J Cancer Sci Ther. 2015;7(11):347-358. DOI: 10.4172/1948-5956.1000373


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