AbbVie and Genmab reported positive Phase 3 results for epcoritamab in newly diagnosed diffuse large B-cell lymphoma (DLBCL), with the EPCORE DLBCL-2 study meeting its primary endpoint. The trial showed that adding epcoritamab to standard R-CHOP therapy reduced the risk of disease progression or death by 51% compared with R-CHOP alone. The readout delivers a major Phase 3 win for the companies' bispecific antibody program in frontline lymphoma care. The announcement came after AbbVie shares (ABBV) closed 1.12% higher at $265.76, and the findings could strengthen the company's position in frontline treatment for the disease.

Phase 3 Trial Meets Key Lymphoma Goal

The companies tested epcoritamab alongside standard R-CHOP therapy in patients with newly diagnosed DLBCL whose International Prognostic Index scores ranged from two to five. Researchers compared the combination directly against R-CHOP treatment alone.

The study met its progression-free survival goal with results the companies described as statistically significant and clinically meaningful. Epcoritamab plus R-CHOP reduced the risk of progression or death by 51% compared with standard therapy, corresponding to a hazard ratio of 0.49 and a p-value below 0.0001.

The combination also showed a generally manageable safety profile, with findings that researchers said were consistent with earlier results observed for epcoritamab and R-CHOP separately. The outcome provides AbbVie with stronger Phase 3 evidence supporting epcoritamab in earlier stages of lymphoma treatment, where newly diagnosed patients begin therapy.

Epcoritamab and the Frontline Treatment Landscape

DLBCL is an aggressive form of non-Hodgkin lymphoma and its most common subtype, which is why any change to the frontline standard carries weight across a broad patient population. R-CHOP has remained a core frontline therapy for many patients for more than two decades, yet some patients still experience disease progression or relapse after initial treatment — the exact outcome the EPCORE DLBCL-2 regimen was designed to reduce.

Epcoritamab takes a bispecific antibody approach that engages T cells against cancer cells. AbbVie and Genmab designed the treatment to target CD3 on T cells and CD20 on B cells, an approach aimed at increasing immune activity against malignant B cells.

If regulators approve the combination, the latest results could expand epcoritamab's use beyond later treatment settings. For the bispecific field, the result marks a step in the broader effort to move T-cell engaging therapies from later lines into the first line of care. AbbVie already considers bispecific antibodies an important part of its hematology development strategy, and the Phase 3 outcome gives the company additional clinical data supporting that direction.

AbbVie and Genmab Prepare Regulatory Discussions

AbbVie and Genmab plan to present detailed EPCORE DLBCL-2 results at a future medical meeting. The companies will also discuss the findings with regulatory authorities across major global markets, and those talks will help determine the next development and filing steps. The data presentation and the responses from regulators are the near-term milestones that will show whether the combination advances toward approval for newly diagnosed patients.

The combination remains investigational and currently lacks regulatory approval for patients with newly diagnosed DLBCL. Regulators will assess the complete efficacy and safety data before making any authorization decision, and AbbVie must complete further regulatory work before the treatment can be used commercially in this setting.

Epcoritamab forms part of a broader AbbVie and Genmab collaboration in blood cancer treatment. Both companies continue to study the medicine across several lymphoma settings and treatment stages, and the latest Phase 3 result adds frontline DLBCL to that growing clinical development program.

Source: Blockonomi