COPENHAGEN, Denmark and NORTH CHICAGO, Ill., July 23, 2026
Genmab and AbbVie have issued a clarification regarding the Phase 3 EPCORE DLBCL-1 clinical trial evaluating epcoritamab (DuoBody®-CD3xCD20) in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who were ineligible for autologous stem cell transplantation. The companies confirmed that overall survival (OS) was the sole primary endpoint for the United States, and the study did not demonstrate a statistically significant improvement in OS, meaning it did not meet the U.S. primary endpoint. The clarification follows the earlier release of topline results in January 2026 and additional findings presented at the European Hematology Association (EHA) 2026 Congress, providing greater transparency regarding the regional regulatory endpoints used in the global study.
Phase 3 Trial Clarifies Regional Primary Endpoints
The EPCORE DLBCL-1 study is a global, randomized, open-label, multicenter Phase 3 trial comparing epcoritamab monotherapy, a subcutaneous CD3xCD20 bispecific T-cell engaging antibody, with investigator’s choice of standard chemoimmunotherapy, including rituximab plus gemcitabine and oxaliplatin (R-GemOx) or bendamustine plus rituximab (BR). While the study incorporated different pre-specified primary endpoints across global regions, overall survival served as the only primary endpoint in the United States. According to the companies, this endpoint was not achieved, resulting in the trial missing its primary U.S. objective. Genmab and AbbVie stated that the complete results from the study will be submitted for publication in a peer-reviewed medical journal to further inform the scientific and medical communities.
Epcoritamab Development Continues Across Multiple Studies
Despite the Phase 3 outcome, epcoritamab remains FDA-approved under the accelerated approval pathway for adults with relapsed or refractory DLBCL after two or more prior lines of systemic therapy. The therapy, marketed as EPKINLY® in the United States and Japan and TEPKINLY® in the European Union, has received regulatory approvals in more than 65 territories for specific lymphoma indications. Genmab and AbbVie emphasized that development of epcoritamab continues through an extensive clinical program evaluating the therapy both as monotherapy and in combination regimens across multiple hematologic malignancies. Ongoing late-stage studies include EPCORE DLBCL-2, investigating epcoritamab with R-CHOP in newly diagnosed DLBCL patients, and EPCORE DLBCL-4, evaluating a chemotherapy-free combination with lenalidomide for relapsed or refractory disease.
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Bispecific Antibody Platform Supports Ongoing Lymphoma Research
Epcoritamab is an IgG1 bispecific antibody developed using Genmab’s proprietary DuoBody® technology, designed to simultaneously bind CD3 receptors on T cells and CD20 on malignant B cells, triggering T-cell-mediated destruction of CD20-positive cancer cells. The therapy represents an important component of the long-standing oncology collaboration between Genmab and AbbVie, with both companies continuing to explore its potential across multiple treatment settings. Diffuse large B-cell lymphoma remains the most common form of non-Hodgkin lymphoma, accounting for approximately 25–30% of all NHL cases worldwide, and many patients eventually experience relapsed or refractory disease despite available therapies. While the EPCORE DLBCL-1 study did not meet the U.S. primary endpoint, the companies remain committed to advancing innovative bispecific antibody therapies aimed at improving treatment options for patients with challenging blood cancers.
Source: Genmab press release
