Market reaction
Shares of Genmab A/S (NASDAQ:GMAB) rose 3.4% in after-hours trading on Monday after the company announced positive topline outcomes from its Phase 3 EPCORE DLBCL-4 study. The move in the stock followed the release of headline efficacy data from the trial evaluating a chemotherapy-free regimen for relapsed or refractory diffuse large B-cell lymphoma.
Trial results and clinical details
The EPCORE DLBCL-4 trial tested epcoritamab administered subcutaneously in combination with lenalidomide versus standard-of-care treatment in adult patients with relapsed or refractory DLBCL who had received at least one prior line of therapy. The study met its primary objective, reporting a 60% reduction in the risk of disease progression and death (HR 0.40 [95% CI 0.30, 0.55]).
According to the topline statement, the combination produced a statistically significant and clinically meaningful improvement in progression-free survival. Epcoritamab is described by the sponsors as a T-cell engaging bispecific antibody given by subcutaneous injection.
Regulatory and data plans
Genmab and AbbVie said they plan to engage with global regulatory authorities regarding the Phase 3 results. The companies also indicated they will present more detailed data at a future medical meeting, with timing not specified in the topline release.
Trial design and enrollment criteria
The EPCORE DLBCL-4 program is a global, Phase 3, open-label, multi-center randomized study that began on August 13, 2024 and remains ongoing. It enrolled patients with relapsed or refractory large B-cell lymphoma who had previously received at least one line of systemic antineoplastic therapy, including combination chemotherapy containing an anti-CD20 monoclonal antibody.
Commercial status of epcoritamab
Epcoritamab already holds regulatory approvals for certain lymphoma indications in more than 65 territories under the trade names EPKINLY in the U.S. and Japan, and TEPKINLY in the EU. The therapy is being co-developed by Genmab and AbbVie. The companies share commercial responsibilities in the U.S. and Japan, while AbbVie is responsible for broader global commercialization.
Context on disease burden
Diffuse large B-cell lymphoma is noted as the most common form of non-Hodgkin lymphoma worldwide, accounting for roughly 25-30% of cases. In the United States, the disease accounts for about 25,000 new diagnoses each year.
What remains unresolved
While the topline results indicate a clear progression-free survival benefit for the chemotherapy-free combination, detailed efficacy and safety data have not yet been released. The trial remains ongoing and regulatory interactions are planned, leaving the timing and outcome of any submissions or approvals dependent on forthcoming data disclosures and regulatory review.
Note: The article reports the information provided in the companies' topline announcement and trial registry details; further specifics will be available when Genmab and AbbVie present full datasets.