Phase 3 clinical trial outcomes for Epkinly in lymphoma treatment

Latest findings from the Epcore DLBCL-1 clinical trial for Epkinly (epcoritamab), a bispecific antibody developed through the partnership between AbbVie and Genmab, have revealed a complex data profile.

The study evaluated the efficacy of Epkinly as a monotherapy against standard chemoimmunotherapy options. The trial involved 483 adult participants diagnosed with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with 73% of the cohort having previously undergone two or more lines of medical intervention.

Regarding the primary objective, the medication did not demonstrate a statistically significant advantage in overall survival (OS). Nevertheless, secondary clinical markers indicated positive trends. Specifically, there was a 26% reduction in the risk of disease progression or mortality among the treated group. Improvements were also observed in complete response rates and the duration of clinical benefit compared to the control group.

The developers indicated that various external factors are being analyzed for their potential impact on the data, including disruptions caused by the global pandemic and the introduction of alternative anti-lymphoma therapies during the trial period.

Currently, Epkinly maintains its regulatory status for third-line DLBCL treatment. Financial reports show the drug generated $190 million in global revenue during the first three quarters of 2025, surpassing the $146 million recorded for the entirety of 2024. A separate phase 3 study (Epcore DLBCL-2), focusing on first-line treatment, is anticipated to release data later this year.

Source: https://www.fiercepharma.com/pharma/after-abbvie-and-genmabs-ph-3-survival-miss-epkinly-dlbcl-whats-next

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