Latest data from the Epcore DLBCL-1 clinical study indicates that Epkinly did not meet its primary endpoint of overall survival (OS) when measured against standard chemoimmunotherapy. The trial involved 483 adult participants diagnosed with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with 73% of the cohort having received two or more prior lines of medical intervention.
While the primary survival goal was missed, the study reported positive outcomes in several secondary metrics. Notably, there was a 26% reduction in the risk of disease worsening or mortality. Improvements were also observed in complete response rates and the duration of clinical effectiveness compared to the control group. Investigators are currently evaluating external variables, including the impact of the global pandemic and the availability of alternative lymphoma treatments during the study period (starting in 2021), to contextualize these findings.
Epkinly maintains its existing FDA authorizations for third-line DLBCL and second-line follicular lymphoma (FL). AbbVie and Genmab plan to engage with global health authorities to determine future steps while awaiting data from another Phase 3 trial (Epcore DLBCL-2) focused on first-line DLBCL treatment, expected later this year. From a financial perspective, the medication generated $190 million in the first nine months of 2025, surpassing its total performance for the entire previous year.