Second lymphoma indication approval for Tepkinly in Europe

AbbVie and Genmab’s Tepkinly (epcoritamab) has been granted conditional marketing authorisation by the European Commission (EC) as a monotherapy for relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy. The approval makes Tepkinly the first 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 and Northern Ireland. Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology. It is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells. “Follicular lymphoma can be challenging to treat and today’s approval marks an important milestone for patients in the European Union who are in need of more options offering a balance of meaningful efficacy and favourable safety,” said Jan van de Winkel, President and Chief Executive Officer of Genmab. “Alongside our partner AbbVie, we are committed to exploring the continued development of epcoritamab as a potential core therapy across B-cell malignancies.” Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the US and Japan, with AbbVie responsible for further global commercialisation. The EPCORE NHL-1 clinical trial The conditional marketing authorisation is supported by data from Phase I/II EPCORE NHL-1 clinical trial. 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 showed that patients treated with Tepkinly 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. Duration of complete response (DOCR) was not reached. The study included a planned separate optimisation cohort, which evaluated 86 patients with the recommended three-step-up doses for cytokine release syndrome (CRS) mitigation. With the optimised 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 approval of epcoritamab by the European Commission is a promising update for the lymphoma community," said Kate Rogers, CEO of the Follicular Lymphoma Foundation. "Given that relapsed or refractory follicular lymphoma is a very challenging form of cancer to treat, especially in later lines of therapy, it is critical that patients and physicians have additional options when it comes to treating this type of cancer." Diana Spencer, Senior Digital Content Editor, DDW