AbbVie has announced positive topline results from the Phase 3 EPCORE DLBCL-4 clinical trial, demonstrating that a chemotherapy-free combination of epcoritamab and lenalidomide significantly improved progression-free survival (PFS) in adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) compared with the current standard-of-care regimen.
The global, randomized, open-label Phase 3 study enrolled patients with aggressive large B-cell lymphoma who had received at least one prior line of therapy. Participants treated with the fixed-duration combination of subcutaneous epcoritamab and lenalidomide experienced a statistically significant and clinically meaningful reduction in the risk of disease progression or death when compared with the standard chemoimmunotherapy regimen consisting of rituximab, gemcitabine, and oxaliplatin (R-GemOx).
According to the companies, the investigational regimen reduced the risk of disease progression or death by approximately 60% under U.S. censoring rules and 56% under non-U.S. censoring rules, highlighting the potential of a chemotherapy-free treatment approach for patients whose disease has returned or failed to respond to previous therapy.
Diffuse large B-cell lymphoma is the most common subtype of non-Hodgkin lymphoma and remains difficult to treat after relapse. Despite recent therapeutic advances, many patients eventually experience disease progression, emphasizing the need for more effective and less toxic treatment options. AbbVie stated that the encouraging findings reinforce the potential of fixed-duration epcoritamab-based therapy to address this unmet medical need.
The EPCORE DLBCL-4 trial evaluated subcutaneous epcoritamab, a CD3×CD20 bispecific antibody that redirects T cells to attack malignant B cells, in combination with lenalidomide. The study included patients with several aggressive large B-cell lymphoma subtypes, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, follicular lymphoma grade 3B, T-cell/histiocyte-rich large B-cell lymphoma, and Epstein-Barr virus-positive DLBCL.
AbbVie and its development partner Genmab plan to discuss the Phase 3 results with global regulatory authorities to determine the next steps for potential regulatory submissions. Additional efficacy and safety data from the study will be presented at a future scientific medical meeting.
