AbbVie announces results for epcoritamab from Phase 3 EPCORE DLBCL-1 trial

AbbVie (ABBV) announced topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, compared to investigator’s choice of chemoimmunotherapy in adult patients with relapsed/refractory diffuse large B-cell lymphoma. The study demonstrated an improvement in progression-free survival. Improvements were observed in complete response rates, duration of response, and time to next treatment among patients treated with epcoritamab. The study did not demonstrate a statistically significant improvement in overall survival. EPCORE DLBCL-1 is the first Phase 3 study to demonstrate improvement in PFS in patients with R/R DLBCL who were treated with a CD3xCD20 T-cell engaging bispecific monotherapy. The global study enrolled 483 patients with R/R DLBCL with at least one prior line of therapy who were ineligible for high-dose chemotherapy and autologous stem cell transplant. The adverse events observed in this study appear consistent with known safety of epcoritamab. AbbVie and Genmab (GMAB) are working to assess the potential impact of various factors, including the COVID-19 pandemic and the increased availability of novel anti-lymphoma therapies during the study timeline. The data will be submitted for presentation at a future medical meeting, and AbbVie and Genmab will engage global regulatory authorities to determine next steps.