Genmab reports positive Phase 3 results for epcoritamab plus lenalidomide in DLBCL

Genmab A/S announced on June 29, 2026 that its Phase 3 EPCORE DLBCL-4 trial met its primary objective. The trial met its primary objective, demonstrating statistically significant and clinically meaningful improvement in progression-free survival.¹

The study compared fixed duration epcoritamab combined with lenalidomide against a chemoimmunotherapy regimen in adult patients with relapsed or refractory diffuse large B-cell lymphoma who had received at least one prior line of treatment. Patients saw a 60% reduction in the risk of disease progression and death, with a hazard ratio of 0.40 (95% CI 0.30 to 0.55, p<0.0001), under the U.S. censoring approach, and a 56% reduction, with a hazard ratio of 0.44 (95% CI 0.33 to 0.60, p<0.0001), under the censoring rules used outside the U.S.¹

On safety, the combination showed a safety profile in line with what has previously been reported for epcoritamab and lenalidomide when used separately.¹

Trial enrollment required patients to have received prior anti-CD20-containing chemotherapy and to have either failed or relapsed after stem cell transplant, or been unsuitable candidates for it, while also being ineligible for or unable to receive CAR-T therapy since their DLBCL diagnosis, according to the company. The trial began on August 13, 2024, and remains ongoing.¹

Genmab and AbbVie will engage global regulatory authorities, and data will be submitted for presentation at a future medical meeting.¹ Epcoritamab is approved under the brand name EPKINLY in the U.S. and Japan, and as TEPKINLY in the EU.¹ The drug is co-developed by Genmab and AbbVie as part of their oncology collaboration, with the companies sharing commercial responsibilities in the U.S. and Japan while AbbVie handles further global commercialization.¹