Danish biotechnology company Genmab has announced top line results from the Phase III EPCORE DLBCL-1 trial, highlighting improved progression-free survival (PFS) for its subcutaneous bispecific antibody, epcoritamab, in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
The randomised, multi-centre, open-label trial showed a PFS hazard ratio of 0.74 for epcoritamab monotherapy, with observed improvements in time to next treatment, complete response rate, and duration of response.
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EPCORE DLBCL-1 is the first Phase III trial to show improved PFS in patients with r/r DLBCL who received CD3×CD20 T-cell engaging bispecific monotherapy. The hazard ratio for overall survival (OS) was 0.96, but this did not achieve statistical significance.
The global trial included 483 patients with r/r DLBCL who had undergone at least one previous treatment, with 73% having received two or more prior therapies.
Genmab said not all participants were eligible for high-dose chemotherapy or autologous stem cell transplant (HDT-ASCT). The trial evaluated epcoritamab as a monotherapy against rituximab combined with gemcitabine and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR).
Reported adverse events were consistent with the known safety profile of epcoritamab. Further analyses are underway, including assessment of variables such as the Covid-19 pandemic and availability of new anti-lymphoma therapies.
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By GlobalDataGenmab plans to present full results at an upcoming medical meeting and, in collaboration with AbbVie, will consult with global regulatory authorities regarding next steps.
Additional data from two ongoing Phase III trials evaluating fixed-duration epcoritamab regimens, EPCORE DLBCL-2 (combining epcoritamab with R-CHOP) and EPCORE DLBCL-4 (epcoritamab with lenalidomide versus chemo-immunotherapy), are anticipated in 2026.
Genmab CEO Jan van de Winkel said: “The EPCORE DLBCL-1 trial is the first Phase III study evaluating a bispecific antibody monotherapy to demonstrate improvements in progression-free survival in patients with relapsed or refractory DLBCL.
“The results from this global trial contribute to the growing body of evidence supporting epcoritamab and build upon the robust foundation established by epcoritamab, which has been used to treat thousands of patients in need of additional therapeutic options.”
Epcoritamab has regulatory approval for certain lymphoma indications in more than 65 countries under the names EPKINLY and TEPKINLY, with ongoing clinical studies planned across treatment settings and haematologic malignancies.
In June 2025, Genmab announced results from Arm 10 of the Phase Ib/II EPCORE NHL-2 trial, which investigated the T-cell-engaging bispecific antibody epcoritamab combined with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with r/r DLBCL.
