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Danish biotech Genmab reported positive Phase III EPCORE DLBCL-1 results for its subcutaneous bispecific antibody epcoritamab in relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
The randomised, open-label trial compared epcoritamab monotherapy with R-GemOx or BR in 483 patients, 73% of whom had received ≥2 prior therapies. Epcoritamab improved progression-free survival (PFS) with a hazard ratio of 0.74, alongside longer time to next treatment, higher complete response rates, and improved duration of response. Overall survival (OS) showed a hazard ratio of 0.96 but did not reach statistical significance.
Adverse events aligned with the known safety profile. EPCORE DLBCL-1 is the first Phase III trial to show PFS improvement with CD3×CD20 bispecific monotherapy. Full data will be presented at a future medical meeting.
Genmab and AbbVie plan regulatory discussions, while additional Phase III trials, EPCORE DLBCL-2 and DLBCL-4, are ongoing, with results expected in 2026. Epcoritamab is approved in 65+ countries under EPKINLY and TEPKINLY.
19-01-2026