$AbbVie and Genmab's Epkinly Combination Meets Primary Endpoint in Phase 3 Trial for Relapsed/Refractory DLBCL$

AbbVie and Genmab's Epkinly Combination Meets Primary Endpoint in Phase 3 Trial for Relapsed/Refractory DLBCL

Jun 29, 2026

AbbVie and Genmab announce positive topline results from the Phase 3 EPCORE DLBCL-4 trial, where the combination of Epkinly (epcoritamab) and lenalidomide met its primary endpoint. The chemotherapy-free regimen significantly improves progression-free survival in patients with relapsed or refractory diffuse large B-cell lymphoma, reducing the risk of disease progression or death by up to 60% compared to standard chemoimmunotherapy. The companies plan to engage global regulatory authorities to discuss potential label expansion.

EPCORE DLBCL-4 trial results

▪The EPCORE DLBCL-4 trial is a global, open-label, randomized Phase 3 trial comparing subcutaneous epcoritamab plus oral lenalidomide against rituximab plus gemcitabine and oxaliplatin in adult patients.
▪The Phase 3 EPCORE DLBCL-4 trial evaluating epcoritamab in combination with lenalidomide met its primary endpoint of progression-free survival in patients with relapsed or refractory diffuse large B-cell lymphoma.

Epcoritamab-lenalidomide combination efficacy

▪The combination of epcoritamab and lenalidomide reduced the risk of disease progression or death by 60% under US censoring rules (HR, 0.40; 95% CI, 0.30-0.55; P < .0001).
▪The safety profile of the epcoritamab and lenalidomide combination was consistent with the previously reported safety profiles of the individual agents.

Relapsed/refractory DLBCL treatment

▪In the United States, approximately 25,000 new cases of diffuse large B-cell lymphoma are diagnosed each year.
▪Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma worldwide, accounting for approximately 25% to 30% of all cases.

Epcoritamab regulatory approvals

▪Epcoritamab is approved under the brand name Epkinly in the United States and Japan, and Tepkinly in the European Union.
▪Epcoritamab has received regulatory approval in certain lymphoma indications in more than 65 territories.

Epcoritamab development pipeline

▪AbbVie and Genmab are evaluating epcoritamab in an ongoing Phase 3 trial in combination with R-CHOP in adult patients with newly diagnosed diffuse large B-cell lymphoma.
▪AbbVie and Genmab are evaluating epcoritamab in an ongoing Phase 3 trial in combination with lenalidomide and rituximab compared to chemoimmunotherapy in patients with previously untreated follicular lymphoma.

Genmab-AbbVie collaboration

▪AbbVie is responsible for the global commercialization of epcoritamab outside of the United States and Japan.
▪Epcoritamab is being co-developed by Genmab and AbbVie as part of an oncology collaboration, sharing commercial responsibilities in the United States and Japan.