Healthcare
AbbVie Announces Positive Phase 3 Results for Epcoritamab Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
AbbVie (NYSE: ABBV) today announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of epcoritamab, a T-cell engaging bispecific antibody, and lenalidomide, compared to rituximab plus gemcitabine plus oxaliplatin (R-GemOx) in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of therapy. Based on topline results from the prespecified primary analysis, the trial met its primary endpoint, demo
About this update from Abbvie Inc.
NORTH CHICAGO, Ill., June 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of epcoritamab, a T-cell engaging bispecific antibody, and lenalidomide, compared to rituximab plus gemcitabine plus oxaliplatin (R-GemOx) in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of therapy. Based on topline results from the prespecified primary analysis, the trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS). The risk of disease progression and death was reduced by 60% (HR 0.40 [95% CI 0.30, 0.55]; p-value <0.0001) and 56% (HR 0.44 [95% CI 0.33, 0.60]; p-value <0.0001), based on different censoring rules in the U.S. and outside the U.S., respectively. The safety profile of epcoritamab when administered in combination with lenalidomide was consistent with the known safety profiles of the individual agents (epcoritamab and lenalidomide). "Despite recent advances, there remains a critical need for innovative therapies to improve outcomes for those battling DLBCL, an aggressive and often difficult-to-treat cancer," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "Today's encouraging topline results highlight the potential of epcoritamab, a fixed-treatment therapy, in combination with lenalidomide, as a meaningful treatment option after initial disease progression." AbbVie and Genmab will engage global regulatory authorities to discuss next steps. Data will be submitted for presentation at a future medical meeting. About the EPCORE ® DLBCL-4 Trial EPCORE DLBCL-4 ( NCT06508658 ) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) in combination with lenalidomide compared to chemoimmunotherapy, rituximab plus gemcitabine plus oxaliplatin (R-GemOx), in adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including patients with diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), high-grade B-Cell lymphoma (HGBL) with MYC and B-cell/lymphoma 2 (BCL2) and/or BCL6 rearrangements, follicular lymphoma grade 3B (FL3B), T-cell/histiocyte-rich large B-Cell lymphoma (TCHR LBLC), and Epstein-Barr Virus-positive diffuse large B-cell lymphoma (EBV+ DLBCL). Patients in the trial were previously treated with at least one line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy, and failed or relapsed after, or were not a candidate for autologous stem cell transplantation (ASCT) and ineligible for or unable to receive CAR-T since DLBCL diagnosis. Patients received subcutaneous epcoritamab (cycles 1–3, once weekly; cycles 4–12, once every 4 weeks) and oral lenalidomide (25 mg/day on days 1–21) for a total of twelve 28-day cycles or intravenously infused R-GemOx for up to four cycles (each cycle lasting 28 days). The trial started on August 13, 2024, and is ongoing.