AbbVie Announces Submissions of Regulatory Applications for Epcoritamab (DuoBody-CD3xCD20) for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Large B-Cell Lymphoma (LBCL)

AbbVie announced that the European Medicines Agency (EMA) has validated a Marketing Authorization Application (MAA) for epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Additionally, Genmab has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for epcoritamab for the treatment of adult patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

The regulatory submissions are supported by previously announced results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-center Phase 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), including DLBCL.

LBCL and its major subtype, DLBCL, are fast-growing types of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell.1 DLBCL is the most common type of NHL worldwide and accounts for approximately 30 percent of all NHL cases globally.1 Because NHL affects B-cell lymphocytes, the disease and its subtypes are classified as B-cell malignancies.

“The regulatory submissions for epcoritamab exemplify our pursuit to deliver innovative care for people living with large B-cell lymphoma and diffuse large B-cell lymphoma who have limited treatment options,” said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. “This achievement represents an initial step in our commitment to scientific research and providing an important treatment option with the potential to become a core therapy for people living with B-cell malignancies such as LBCL and DLBCL.”

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, including an ongoing Phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494).