Epcoritamab receives approval from the Japanese Ministry of Health, Labour and Welfare for R/R follicular lymphoma

On February 20, 2025, the Japanese Ministry of Health, Labour and Welfare approved epcoritamab, a T-cell-engaging bispecific antibody, for the treatment of relapsed/refractory follicular lymphoma (Grades 1 to 3A) in patients who have received ≥2 prior lines of therapy.¹ This approval is based on results from the open-label, multicenter phase I/II  EPCORE NHL-1 (global) and EPCORE NHL-3 (Japan only) trials.¹

EPCORE NHL-1¹

• Of 128 evaluable patients, the overall response rate was 82%, with a complete response of 62.5%.
• Of 91 patients evaluated for minimal residual disease (MRD), 67% were MRD-negative.
• In patients receiving epcoritamab in a 2-step step-up dosing schedule, adverse events were seen in 93% of patients; the most common treatment-emergent adverse events were cytokine release syndrome (66.4%) and injection site reactions (36.7%).

EPCORE NHL-3¹

• Of 21 evaluable patients, with a median follow-up of 21.2 months, the overall response rate was 95.2%, with a complete response of 76.2%.
• Of these patients, 88.9% were MRD-negative after treatment.
• In patients receiving epcoritamab in a 2-step step-up dosing schedule, the most common treatment-emergent adverse events were cytokine release syndrome (90.5%), rash (28.6%), neutropenia (28.6%), increased alanine aminotransferase (23.8%), and increased aspartate aminotransferase (23.8%).