Genmab Submits Applications for Bispecific Therapy for Large B-cell Lymphoma

Genmab has submitted a biologics license application (BLA) to the FDA for subcutaneous epcoritamab to treat patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. Large B-cell lymphoma (LBCL) is a fast-growing type of non-Hodgkin’s lymphoma (NHL), a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally.

Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology, which is designed to direct cytotoxic T cells selectively to elicit an immune response toward 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. CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies.

“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,” Jan van de Winkel, Ph.D., chief executive officer of Genmab, said in a press release.

Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. AbbVie has submitted a marketing authorization application (MAA) for epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), which has been validated by the European Medicines Agency (EMA).

The regulatory submissions are supported by previously announced results from the LBCL cohort of the pivotal EPCORE NHL-1 phase 2 clinical trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL), including DLBCL. These results were presented at the 27th Annual Meeting of the European Hematology Association (EHA2022), on June 11, 2022.