NORTH CHICAGO, Ill., June 29, 2026
AbbVie has announced positive topline results from the Phase 3 EPCORE® DLBCL-4 clinical trial, demonstrating that epcoritamab, a T-cell engaging bispecific antibody, in combination with lenalidomide, achieved a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The study successfully met its primary endpoint, with the investigational chemotherapy-free treatment regimen reducing the risk of disease progression or death by up to 60% compared with the standard chemoimmunotherapy regimen of rituximab, gemcitabine, and oxaliplatin (R-GemOx). The encouraging findings strengthen the clinical profile of epcoritamab, reinforcing its potential to become an important treatment option for patients with aggressive B-cell lymphoma who have experienced disease progression following prior therapy. AbbVie and Genmab plan to discuss the Phase 3 results with global regulatory authorities while preparing detailed data for presentation at an upcoming international scientific congress.
Phase 3 Trial Demonstrates Significant Improvement in Progression-Free Survival
The global Phase 3 EPCORE DLBCL-4 study evaluated the efficacy and safety of subcutaneous epcoritamab combined with oral lenalidomide versus standard R-GemOx chemoimmunotherapy in adults with relapsed or refractory large B-cell lymphoma, including patients with diffuse large B-cell lymphoma and several aggressive lymphoma subtypes. Participants had previously received at least one line of systemic therapy and were either ineligible for or unable to undergo autologous stem cell transplantation (ASCT) or CAR-T cell therapy. According to the prespecified primary analysis, the investigational regimen significantly improved progression-free survival, demonstrating a 60% reduction in disease progression or death under U.S. censoring criteria and a 56% reduction using international analysis criteria.
The combination therapy also maintained a safety profile consistent with the established safety characteristics of epcoritamab and lenalidomide, with no unexpected safety findings reported. These results highlight the potential of a fixed-duration, chemotherapy-free treatment strategy capable of improving outcomes while reducing reliance on conventional cytotoxic chemotherapy for patients with difficult-to-treat blood cancers.
Bispecific Antibody Strategy Expands Treatment Options for Blood Cancers
Advertisement
Epcoritamab is a subcutaneous IgG1 bispecific antibody developed using Genmab’s DuoBody® technology, engineered to simultaneously bind CD3-positive T cells and CD20-positive B cells, thereby directing the patient’s immune system to selectively eliminate malignant B cells. The therapy is already approved under the brand names EPKINLY® and TEPKINLY® in more than 65 countries and territories for selected lymphoma indications and continues to be evaluated across multiple hematologic malignancies through an extensive global clinical development program. AbbVie and Genmab are jointly advancing epcoritamab across earlier treatment settings and combination regimens to further improve outcomes for patients with aggressive lymphomas.
Diffuse large B-cell lymphoma remains the most common form of non-Hodgkin lymphoma, and although treatment advances have improved survival, many patients experience relapse or become resistant to available therapies, creating an urgent need for innovative immunotherapies. The positive Phase 3 EPCORE DLBCL-4 results represent an important milestone in the evolution of bispecific antibody therapy, demonstrating the potential of immune-based approaches to deliver meaningful clinical benefit while reducing dependence on conventional chemotherapy. If supported by regulatory authorities, epcoritamab combined with lenalidomide could establish a new chemotherapy-free treatment option for relapsed or refractory DLBCL, further strengthening AbbVie’s expanding oncology portfolio and advancing the future of precision immunotherapy for patients with aggressive blood cancers worldwide.
Source: AbbVie press release
