COPENHAGEN, Denmark, June 29, 2026
Genmab A/S announced positive topline results from the Phase 3 EPCORE DLBCL-4 clinical trial evaluating epcoritamab in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The study successfully met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with the current standard-of-care regimen of rituximab, gemcitabine, and oxaliplatin (R-GemOx).
According to the trial results, the investigational chemotherapy-free combination reduced the risk of disease progression or death by 60% under U.S. censoring rules (HR 0.40; p<0.0001) and by 56% under non-U.S. censoring rules (HR 0.44; p<0.0001). The findings further strengthen the clinical profile of epcoritamab and highlight its potential to become an important treatment option for patients who have received at least one prior therapy for aggressive B-cell lymphoma.
Phase 3 Trial Demonstrates Strong Efficacy with Consistent Safety Profile
The EPCORE DLBCL-4 study evaluated a fixed-duration regimen of subcutaneous epcoritamab, a CD3xCD20 bispecific antibody, in combination with lenalidomide, compared with chemotherapy-based treatment in adults with relapsed or refractory large B-cell lymphoma. Eligible patients had previously received at least one systemic treatment, including anti-CD20 antibody-containing chemotherapy, and had either relapsed, failed therapy, or were ineligible for autologous stem cell transplantation or CAR-T cell therapy. Alongside its significant efficacy findings, the investigational regimen demonstrated a safety profile consistent with previously reported data for both epcoritamab and lenalidomide individually, with no unexpected safety concerns identified during the study. The favorable balance between efficacy and tolerability supports the continued clinical development of the chemotherapy-free regimen in patients with limited treatment options.
Epcoritamab Continues to Expand Across B-Cell Malignancies
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Genmab noted that the positive Phase 3 results reinforce the growing body of evidence supporting epcoritamab-based treatment combinations across multiple stages of B-cell malignancies. The therapy is currently approved under the brand names EPKINLY® in the United States and Japan and TEPKINLY® in Europe for certain lymphoma indications and has already secured regulatory approvals in more than 65 territories worldwide. Developed using Genmab’s proprietary DuoBody® technology, epcoritamab is designed to simultaneously bind CD3 on T cells and CD20 on B cells, directing the immune system to selectively eliminate malignant B cells. In addition to the DLBCL program, Genmab and AbbVie continue evaluating epcoritamab in several ongoing Phase 3 studies, including first-line diffuse large B-cell lymphoma and previously untreated follicular lymphoma, aiming to expand its therapeutic role across hematologic cancers.
Regulatory Discussions Planned Following Positive Topline Results
Following the successful completion of the primary endpoint, Genmab and AbbVie announced plans to engage with global regulatory authorities regarding potential regulatory submissions based on the Phase 3 findings. Detailed results from the EPCORE DLBCL-4 trial will be presented at a future scientific congress, providing the medical community with comprehensive efficacy and safety data. The ongoing study continues to monitor patients for additional long-term outcomes while supporting future regulatory filings. If approved for this indication, the chemotherapy-free combination of epcoritamab plus lenalidomide could offer an important new treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma, addressing a significant unmet clinical need by delivering improved progression-free survival with a targeted immunotherapy-based approach.
Source: Genmab press release
