AbbVie and development partner Genmab announced that epcoritamab failed its primary goal in the Phase 3 EPCORE DLBCL-1 trial. The study evaluated the drug in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The trial did not demonstrate a statistically significant improvement in overall survival, the primary U.S. endpoint. Researchers compared epcoritamab as a monotherapy against the investigator's choice of standard chemotherapy.
Epcoritamab, marketed as Epkinly, currently holds accelerated approval in the U.S. for this patient population. This Phase 3 study was the pivotal trial intended to confirm clinical benefits for full regulatory approval.
The companies will continue discussions with global regulatory authorities regarding the next steps for the treatment.