On July 23, 2026 Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) reported clarification on the primary endpoints from the Phase 3 EPCORE DLBCL-1 study evaluating monotherapy epcoritamab (DuoBody-CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, compared with investigator’s choice of chemoimmunotherapy (CIT) of either rituximab plus gemcitabine plus oxaliplatin (R-GemOx) or bendamustine plus rituximab (BR) in adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who were ineligible for autologous stem cell transplantation. Genmab and AbbVie previously announced topline results of the study on January 16, 2026, and additional study results were subsequently presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress on June 12, 2026.
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EPCORE DLBCL-1 is a global, Phase 3, open label, multi-center, randomized clinical trial with prespecified primary endpoints that differ by region. In the United States, where overall survival (OS) is the sole primary endpoint, the study did not demonstrate a statistically significant improvement in OS and therefore did not meet its primary endpoint.
Additional results of the EPCORE DLBCL-1 study will be submitted for publication in a peer-reviewed medical journal.
About Epcoritamab
Epcoritamab is approved under the FDA’s accelerated approval pathway for the treatment of adult patients with R/R DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapy.
Epcoritamab is being co-developed by Genmab and AbbVie 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. Genmab and AbbVie continue to evaluate the potential of epcoritamab, with ongoing clinical programs evaluating the therapy as a monotherapy and in combination regimens across treatment lines and a broad range of hematologic malignancies. Data from EPCORE DLBCL-2, evaluating fixed duration epcoritamab in combination with standard-of-care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), in patients with newly diagnosed DLBCL are anticipated in 2026. This follows the recent disclosure of topline results from the Phase 3 EPCORE DLBCL-4 study, evaluating fixed-duration epcoritamab in a chemotherapy-free combination with lenalidomide in patients with R/R DLBCL.
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology 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.i
Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in more than 65 territories. Where approved, epcoritamab is a readily accessible therapy.
Please see local country prescribing information for all labeled indication and safety information.
About the EPCORE DLBCL-1 Trial
EPCORE DLBCL-1 (NCT04628494) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody-CD3xCD20) compared to investigator’s choice of chemotherapy, either rituximab plus gemcitabine plus oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR), in patients with relapsed or refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The trial started on January 13, 2021, and is ongoing.
More information on this trial can be found at View Source
About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.ii,iii In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.iv DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.v,vi DLBCL 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. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.
(Press release, Genmab, JUL 23, 2026, View Source [SID1234669396])