EPKINLY® (epcoritamab) Approved by Japan Ministry of Health, Labour and Welfare for Additional Indication as a Treatment for Relapsed or Refractory Follicular Lymphoma

Core Viewpoint - Genmab A/S has received approval from the Japan Ministry of Health, Labour and Welfare for EPKINLY (epcoritamab) to treat patients with relapsed or refractory follicular lymphoma (FL) who have undergone two or more prior lines of therapy, marking it as the first and only T-cell engaging bispecific antibody administered subcutaneously approved in Japan for this indication [2][8][11]. Group 1: Product Approval and Indications - EPKINLY is now approved for both relapsed or refractory follicular lymphoma and relapsed or refractory large B-cell lymphomas in Japan after two or more prior lines of therapy [2][8]. - The approval is based on results from the global Phase 1/2 EPCORE NHL-1 and the Japanese Phase 1/2 EPCORE NHL-3 clinical trials, which demonstrated strong efficacy and safety profiles [4][8]. Group 2: Clinical Trial Results - In the EPCORE NHL-1 trial, among 128 evaluable patients with R/R FL, the overall response rate (ORR) was 82% and the complete response (CR) rate was 62.5% [5]. - The Japanese trial (EPCORE NHL-3) showed an ORR of 95.2% and a CR rate of 76.2% among 21 evaluable patients, with 88.9% achieving minimal residual disease (MRD) negativity [9]. Group 3: Safety and Adverse Events - In the EPCORE NHL-1 trial, 93% of patients experienced treatment-emergent adverse events (TEAEs), with the most common being cytokine release syndrome (CRS) at 66.4% [6]. - In the EPCORE NHL-3 trial, 90.5% of patients reported TEAEs, with CRS occurring in 90.5% and injection site reactions in 71.4% [10]. Group 4: Company Commitment and Future Development - Genmab is committed to making EPKINLY available to patients and is pursuing additional international regulatory approvals for the investigational R/R FL indication and R/R DLBCL indication [11][15]. - The company continues to evaluate epcoritamab in various clinical trials across different hematologic malignancies, including ongoing Phase 3 trials [16][17].