By VETTAPHARMA reporter – Derek Roche: AbbVie announced that epcoritamab in combination with lenalidomide achieved the primary endpoint in the pivotal Phase 3 EPCORE® DLBCL-4 trial, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with rituximab plus gemcitabine and oxaliplatin (R-GemOx) in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The chemotherapy-free regimen reduced the risk of disease progression or death by up to 60%, supporting discussions with global regulatory authorities regarding potential next steps.
The EPCORE DLBCL-4 study (NCT06508658) is a global, open-label, multicenter, randomized Phase 3 trial evaluating epcoritamab, a subcutaneous CD3×CD20 bispecific antibody, combined with lenalidomide versus the standard chemoimmunotherapy regimen R-GemOx in adults with relapsed or refractory large B-cell lymphoma who had received at least one prior line of systemic therapy. Eligible patients had relapsed after or were ineligible for autologous stem cell transplantation or CAR-T cell therapy.
At the prespecified primary analysis, the study met its primary endpoint, with the epcoritamab combination reducing the risk of disease progression or death by 60% under U.S. censoring rules (HR 0.40; 95% CI 0.30–0.55; p<0.0001) and by 56% under non-U.S. censoring rules (HR 0.44; 95% CI 0.33–0.60; p<0.0001). AbbVie reported that the safety profile of epcoritamab plus lenalidomide was consistent with the known safety profiles of the individual agents, with no unexpected safety findings. Detailed study results will be presented at a future scientific meeting.
Diffuse large B-cell lymphoma is the most common aggressive subtype of non-Hodgkin lymphoma. Although frontline therapy can cure many patients, a substantial proportion experience relapse or refractory disease, creating a continued need for effective, chemotherapy-free treatment approaches. Epcoritamab is already approved in more than 65 countries and territories for certain lymphoma indications under the brand names EPKINLY® and TEPKINLY®, while AbbVie and Genmab continue to evaluate the molecule across multiple hematologic malignancies.
Quick FAQs
1. What Is Epcoritamab?
Epcoritamab is a subcutaneous CD3×CD20 bispecific IgG1 antibody that redirects T cells to eliminate CD20-positive B cells. It is co-developed by AbbVie and Genmab for the treatment of B-cell malignancies.
2. What Happened?
AbbVie announced that epcoritamab plus lenalidomide met the primary endpoint of the Phase 3 EPCORE DLBCL-4 trial, significantly improving progression-free survival versus R-GemOx in relapsed or refractory diffuse large B-cell lymphoma.
3. What Is The EPCORE DLBCL-4 Study?
EPCORE DLBCL-4 (NCT06508658) is a global, randomized, open-label Phase 3 trial evaluating epcoritamab plus lenalidomide against rituximab, gemcitabine, and oxaliplatin (R-GemOx) in adults with relapsed or refractory large B-cell lymphoma following at least one prior systemic therapy. The primary endpoint is progression-free survival.
4. What Is Relapsed or Refractory Diffuse Large B-Cell Lymphoma?
Relapsed or refractory diffuse large B-cell lymphoma is an aggressive form of non-Hodgkin lymphoma in which the disease either returns after treatment or fails to respond adequately to previous therapy, often requiring additional treatment options.
5. What Were The Key Results?
The combination reduced the risk of disease progression or death by 60% under U.S. censoring rules and 56% under non-U.S. censoring rules, with statistically significant improvements in progression-free survival. The safety profile was consistent with the known profiles of epcoritamab and lenalidomide.
6. Why Is This Important?
The positive Phase 3 results support a chemotherapy-free treatment approach for relapsed or refractory diffuse large B-cell lymphoma and may expand the clinical use of epcoritamab if regulatory authorities approve this indication.
