Genmab Presents Pivotal Phase 3 Data for Epcoritamab at ASH 2025, Expanding Treatment Options Across B-Cell Malignancies
核心洞察
Genmab will present more than 20 abstracts at ASH 2025, including seven oral presentations showcasing epcoritamab's expanding clinical profile across B-cell non-Hodgkin's lymphoma (搜索) subtypes.
The Phase 3 EPCORE FL-1 trial results evaluating epcoritamab in combination with rituximab and lenalidomide for relapsed or refractory follicular lymphoma (搜索) will be presented as an oral presentation.
New data demonstrate epcoritamab's potential in first and second-line settings for follicular lymphoma (搜索) and first-line treatment for diffuse large B-cell lymphoma (搜索).
Genmab A/S announced that more than 20 abstracts evaluating epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) in Orlando, Florida, December 6-9, 2025. The presentations will showcase the expanding clinical profile of epcoritamab across lines of therapy and B-cell non-Hodgkin's lymphoma (搜索) (NHL) subtypes.
Pivotal Phase 3 Results to Be Unveiled
The highlight of Genmab's ASH presentation will be the full pivotal results from the Phase 3 EPCORE FL-1 trial, which evaluated epcoritamab in combination with rituximab and lenalidomide (R2) in patients with relapsed or refractory follicular lymphoma (搜索) (FL). This oral presentation represents a significant milestone in the development of epcoritamab for broader B-cell malignancy applications.
"The breadth and depth of data evaluating epcoritamab at this year's American Society of Hematology meeting spotlight the growing body of clinical evidence supporting the potential of epcoritamab and underscore our commitment to developing epcoritamab as a potential core therapy across a range of B-cell malignancies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab.
Expanding Treatment Horizons
The data presentations will demonstrate epcoritamab's potential utility in earlier lines of therapy with a fixed treatment duration. Key presentations include three oral sessions supporting the potential of epcoritamab in the first- and second-line setting in patients with follicular lymphoma (搜索) and two oral presentations evaluating epcoritamab in the first-line setting in patients with diffuse large B-cell lymphoma (搜索) (DLBCL).
Notable oral presentations include results from the EPCORE DLBCL-3 trial showing fixed-duration epcoritamab monotherapy inducing high response and MRD-negativity rates in elderly patients with newly diagnosed large B-cell lymphoma (搜索) and comorbidities. Additionally, data from the EPCORE NHL-2 trial will demonstrate that epcoritamab combined with R-mini-CHOP results in 2-year remissions and high MRD negativity rates in elderly patients with newly diagnosed DLBCL.
Mechanism and Current Status
Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology. The DuoBody-CD3 (搜索) technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab simultaneously binds to CD3 on T cells and CD20 (搜索) on B cells, inducing T-cell-mediated killing of CD20+ cells.
The drug has received regulatory approval under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU for certain lymphoma indications. Epcoritamab is being co-developed by Genmab and AbbVie (搜索) as part of their oncology collaboration, with shared commercial responsibilities in the U.S. and Japan, while AbbVie handles further global commercialization.
Comprehensive Development Program
Genmab and AbbVie (搜索) continue to evaluate epcoritamab as both monotherapy and in combination across lines of therapy in various hematologic malignancies. The companies are currently conducting five ongoing Phase 3, open-label, randomized trials, including studies evaluating epcoritamab as monotherapy in patients with relapsed/refractory DLBCL, in combination with R-CHOP in newly diagnosed DLBCL patients, and in combination with rituximab and lenalidomide in both relapsed/refractory and previously untreated FL patients.
The ASH presentations will also include two oral presentations summarizing the efficacy and safety of epcoritamab as monotherapy and in combination for patients with Richter transformation (搜索), demonstrating the drug's potential across diverse B-cell malignancy subtypes.
Looking Forward
Genmab will host its 2025 R&D Update and ASH Data Review on December 11 at 11:00 a.m. ET, providing a comprehensive overview of the presented data and its implications for future development strategies. The virtual event will be webcast live and available on the company's website.