Promising Results in Third-Phase Trial of Epcoritamab and Lenalidomide for DLBCL Patients

Encouraging Phase 3 Trial Results for Epocritamab and Lenalidomide in DLBCL

AbbVie, a biopharmaceutical company based in North Chicago, Illinois, has announced promising findings from its Phase 3 clinical trial evaluating the combination therapy of epcoritamab and lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The results, provided on June 29, 2026, indicate a statistically significant and clinically meaningful improvement in progression-free survival (PFS) among these patients compared to standard treatments.

Study Details and Results

The study, known as EPCORE DLBCL-4 (NCT06508658), assessed the efficacy of epcoritamab, a bispecific T-cell engaging antibody, when paired with lenalidomide against a conventional combination therapy of rituximab, gemcitabine, and oxaliplatin (R-GemOx). The primary endpoint was met in the predefined analysis, demonstrating a significant reduction in the risk of disease progression and death. This risk was found to be reduced by 60% (HR 0.40; 95% CI 0.30-0.55; p<0.0001) in the US and by 56% (HR 0.44; 95% CI 0.33-0.60; p<0.0001) in other international regions.

Furthermore, the safety profile of epcoritamab in combination with lenalidomide was consistent with previously known safety information about both drugs. "Despite recent advancements, there remains a crucial need for innovative therapies to enhance the outcomes for patients battling DLBCL, a cancer known for its aggressive progression and treatment challenges," stated Daejin Abidoye, M.D., AbbVie's Vice President and Head of the Oncology Therapeutic Area.

Future Prospects

AbbVie and Genmab, the company behind epcoritamab, plan to collaborate with regulatory agencies globally to discuss the findings from the trial. Future presentations of the data at medical conferences are being anticipated, which can potentially shed more light on the therapeutic implications of this combination therapy.

Insights into the EPCORE DLBCL-4 Trial

Conducted as a randomized, open-label, and multicenter Phase 3 trial, the EPCORE DLBCL-4 study targets adult patients who are relapsed or refractory to previous treatments. The patient population included those who had received at least one line of systemic anti-cancer therapy, and those who had lymphoma types like high-grade B-cell lymphomas (including DLBCL), follicular lymphoma grades 3B, and others. Participants were assigned to receive epcoritamab subcutaneously (weekly during cycles 1-3 and biweekly thereafter for a total of 12 cycles) combined with oral lenalidomide or the R-GemOx regimen for up to four cycles.

The trial commenced on August 13, 2024, and is currently ongoing to continue assessing the outcomes for patients with this challenging form of cancer.

About Epcoritamab

Epcoritamab, a product of Genmab’s DuoBody® technology, is a bispecific IgG1 antibody designed for subcutaneous administration, selectively targeting CD3 on T-cells and CD20 on B-cells to induce immune responses. Approval for epcoritamab has been received in over 65 countries for specific lymphoma indications, with AbbVie and Genmab working in collaboration for further marketing and regulatory avenues across the globe.

AbbVie's Commitment to Oncology

AbbVie is dedicated to advancing innovative therapies to enhance the treatment landscape for patients facing difficult-to-treat cancers. Their extensive portfolio encompasses a wide range of therapies currently under development aimed at targeting blood cancers and solid tumors, integrating various treatment modalities including small molecule drugs and biologics. The goal remains to provide impactful solutions to enhance patient outcomes in oncology.

For additional information on AbbVie and its ongoing oncology initiatives, visit AbbVie Oncology.