European Commission Grants Second Indication Approval for TEPKINLY® (epcoritamab) for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma
AbbVie announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy.
TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved to treat both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL) in the European Union (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland.
Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.
Epcoritamab is approved under the brand name EPKINLY® in the United States and TEPKINLY® in the European Union.
The conditional marketing authorization is supported by data from Phase 1/2 EPCORE® NHL-1 clinical trial: an open-label, multi-cohort, multicenter, single-arm trial that evaluated TEPKINLY as monotherapy in patients with R/R FL after two or more lines of prior systemic therapy.
The study included patients who were refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent (70% having double refractory disease), patients who were refractory to last prior treatment (82%), and patients whose disease progressed within two years of initiating any first systemic therapy (52%). The results published in the Lancet Haematology showed that patients treated with TEPKINLY (n=128) had an overall response rate (ORR) of 83% and a complete response (CR) rate of 63%. At a median follow-up of 16.2 months, the median duration of response was 21.4 months (13.7, NR). Duration of complete response (DOCR) was not reached.
The study included a planned separate optimization cohort, which evaluated 86 patients with the recommended 3-step-up doses for cytokine release syndrome (CRS) mitigation. Hospitalization was not mandatory in the cycle 1 optimization cohort. With the optimized regimen, 40% of patients experienced Grade 1 CRS and 9% experienced Grade 2 (no Grade 3 or higher CRS were reported). No immune effector cell-associated neurotoxicity syndrome (ICANS) cases were reported in this cohort.
The safety profile of epcoritamab in the pivotal cohort was similar to reports of epcoritamab monotherapy in the pivotal EPCORE NHL-1 DLBCL cohort. In the pooled safety population (n=382), the most common adverse reactions (≥ 20%) with TEPKINLY were CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia, and diarrhea. The most frequent serious adverse reaction (≥ 10%) was CRS (34%). Fourteen patients (3.7%) experienced a fatal adverse reaction [pneumonia in 9 (2.4%) patients, viral infection in 4 (1.0%) patients, and ICANS in 1 (0.3%) patient].