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

  • The application is supported by data from EPCORE™ NHL-1 Phase 1/2 trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma, 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, IL, USA I November 21, 2022 I 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 EPCORE™ NHL-1 open-label, multi-center Phase 1/2 trial evaluating the safety and preliminary efficacy of investigational epcoritamab in adult patients with relapsed, progressive or refractory CD20+ 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 living with blood cancer such as large B-cell lymphoma, which has limited treatment options in the relapsed/refractory setting," said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. "This milestone signals an early step in our hope to develop a core therapy for people living with B-cell malignancies."

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

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

About the EPCORE™ NHL-1 Trial
EPCORE™ NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab including a Phase 1 first-in-human, dose escalation part; a Phase 2 expansion part; 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 part of the study, which determined the recommended Phase 2 dose, were published in The Lancet in 2021. In the Phase 2 expansion part, additional patients are treated with epcoritamab to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-cell NHLs who had limited therapeutic options.

The primary endpoint of the Phase 2 expansion part was overall response rate as assessed by an Independent Review Committee. Secondary efficacy endpoints included duration of response, complete response rate, progression-free survival, overall survival, time to response, time to next therapy, and rate of minimal residual disease negativity.

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.2 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.3,4 Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain 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 serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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-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
3 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
4 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

SOURCE: AbbVie

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