Genmab A/S announced topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, which demonstrated an improvement in progression-free survival (PFS) (HR 0.74 95% CI 0.60 to 0.92)1 in patients treated with epcoritamab monotherapy. Additionally, improvements were observed in the complete response rate, duration of response, and time to next treatment among patients treated with epcoritAMab monotherapy. EPCORE DL BCL-1 is the first Phase 3 study to demonstrate an improvement in PFS in patients with relapsed or refractory (R R) diffuse large B-cell lymphoma (DLBCL) who were treated with a CD3xCD20 T-cell engaging bispespecific monotherapy.
The study demonstrated an overall survival (OS) of HR 0.96 95% CI 0.77 to 1.20, which did not reach statistical significance. The global study enrolled 483 patients with R R DLBCL with at least one prior line of therapy (73% had received two or more prior lines) who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The study evaluated the safety and efficacy of epcoritamab Monotherapy compared to investigator's choice of either rituximab plus gemcitabine and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR).
The adverse events observed in this study appear consistent with the known safety profile of epcoritamab. Further analysis of the results is ongoing, including the potential impact of various factors, such as the COVID-19 pandemic and increasing availability of novel anti-lymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting.
Genmab and AbbVie will engage with global regulatory authorities to discuss next steps. Data is anticipated in 2026 from two Phase 3 trials evaluating fixed duration epcoritamab in patients with relapsed or Refractory DLBCL, including EPCORE DLBCL, including E PCORE DLBCL-2, a front-line study evaluating epcoritamab in combination with standard-of-care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), and EPCORE DLBCL -4, evaluating epcoritamab In combination with lenalidomide versus chemo-immunotherapy in patients with relapsed orrefractory DLBCL. The EPCORE DLBCL1 trial is the first Phase 3 study evaluating a bispecific antibody monotherapy to demonstrate improvements in progression-free survival in patients with relapsed orRefractory DLBCL.
