COPENHAGEN, Denmark and NORTH CHICAGO, Ill. — October 5, 2026
Genmab A/S and AbbVie announced positive topline results from the Phase 3 EPCORE DLBCL-2 trial evaluating fixed-duration subcutaneous epcoritamab in combination with R-CHOP versus R-CHOP alone in newly diagnosed diffuse large B-cell lymphoma (DLBCL). The study demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, reducing the risk of disease progression or death by 51% in patients with an International Prognostic Index (IPI) score of 2 to 5 (HR 0.49; p<0.0001). The companies said they will engage global regulatory authorities based on the topline findings.
Epcoritamab Adds T-Cell Engagement to Frontline R-CHOP
Epcoritamab is a subcutaneous T-cell-engaging bispecific antibody designed to bind CD3 on T cells and CD20 on B cells. The investigational frontline combination adds epcoritamab to the established R-CHOP regimen, which includes rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. In EPCORE DLBCL-2, the primary endpoint population with an IPI score of 3 to 5 experienced a 51% reduction in the risk of disease progression or death (HR 0.49; 95% CI 0.35–0.69; p<0.0001). The companies reported that the safety profile of epcoritamab plus R-CHOP was generally well tolerated and consistent with the known safety profiles of the individual agents.
EPCORE DLBCL-2 Supports Potential Frontline Treatment Expansion
The global Phase 3 EPCORE DLBCL-2 trial randomized patients 2:1 to fixed-duration epcoritamab plus R-CHOP or R-CHOP alone. Patients in the experimental arm received epcoritamab plus R-CHOP for six cycles followed by epcoritamab alone for two cycles, while the control group received R-CHOP for six cycles followed by rituximab for two cycles. The trial enrolled patients with newly diagnosed large B-cell lymphoma and IPI scores of 2 to 5, including DLBCL, high-grade B-cell lymphoma with specified MYC/BCL2 and/or BCL6 rearrangements, follicular lymphoma grade 3B and other specified subtypes. The primary endpoint was PFS in patients with IPI scores of 3 to 5, with total-participant PFS as a key secondary endpoint.
Advertisement
Genmab and AbbVie Prepare for Regulatory Discussions
The positive results expand the development potential of epcoritamab into the frontline DLBCL setting, where the companies are now preparing to engage regulatory authorities. Epcoritamab is already approved under the brand name EPKINLY in the United States and Japan and TEPKINLY in the European Union for certain lymphoma indications. Genmab and AbbVie continue to evaluate epcoritamab as monotherapy and in combination with other treatments across hematologic malignancies. The EPCORE DLBCL-2 results provide clinical evidence supporting a potential new use of epcoritamab with R-CHOP in newly diagnosed DLBCL, while the companies continue to pursue additional regulatory approvals and clinical development opportunities for the bispecific antibody.
Source:Genmab, press release
