European Commission grants second indication approval for Tepkinly (epcoritamab) for the treatment of adults with r/r follicular lymphoma

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.

The European approval of Tepkinly for the treatment of follicular lymphoma after two or more prior treatments is yet another step forward in our aspiration to develop Tepkinly as a potential core therapy across multiple B-cell malignancies. First approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, its expansion into follicular lymphoma underscores its utility as a hematological cancer treatment," said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. "Together with our partner, Genmab, we are thrilled with this approval which advances our commitment to elevating care for people living with cancer."

FL is typically a slow-growing form of non-Hodgkin's lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30% of all cases. FL is considered incurable, and there is no standard of care treatment for third-line or later FL. Patients often relapse and with each relapse, the remission and time to next treatment is shorter. Over time, transformation to DLBCL, an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.

The conditional marketing authorization is supported by data from Phase 1/II 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.

See-"Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase II cohort of a single-arm, multicentre study"- Kim M Linton MBChB, PhD , Umberto Vitolo MD , Wojciech Jurczak MD , Pieternella J Lugtenburg MD , Emmanuel Gyan MD , Anna Sureda MD , Jacob Haaber Christensen MD , et al,. https://doi.org/10.1016/S2352-3026(24)00166-2. The Lancet Haematology. Volume 11, Issue 8 August 2024, Pages e593-e605'