EU approves AbbVie's Tepkinly for follicular lymphoma

In a significant announcement, AbbVie revealed that the European Commission has granted conditional marketing authorization for TEPKINLY® (epcoritamab) for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) following two or more lines of prior therapy. TEPKINLY is the first subcutaneous T-cell engaging bispecific antibody approved for both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL) in the European Union, including the European Economic Area countries and Northern Ireland.

"TEPKINLY's approval for follicular lymphoma is a landmark in our journey to develop it as a comprehensive treatment for various B-cell malignancies," stated Mariana Cota Stirner, M.D., Ph.D., Vice President of Hematology at AbbVie. She emphasized that this approval underscores TEPKINLY's utility in managing hematological cancers and advances AbbVie's commitment to enhancing cancer care.

Follicular lymphoma is a usually slow-growing type of non-Hodgkin's lymphoma (NHL) originating from B-lymphocytes and represents the second most common form of NHL, making up 20-30% of all cases. It is deemed incurable, with no consensus on third-line treatment, and patients often experience shorter remission periods with each relapse. Furthermore, over 25% of FL patients may develop DLBCL, an aggressive NHL type associated with poor survival outcomes.

Kate Rogers, CEO of the Follicular Lymphoma Foundation, expressed optimism, noting that the European Commission's approval of epcoritamab offers a promising treatment option for a particularly challenging cancer type. Given the difficulties in treating relapsed or refractory follicular lymphoma, especially in later therapy stages, having additional treatment options is crucial.

The conditional marketing authorization was based on data from the Phase 1/2 EPCORE® NHL-1 clinical trial. This open-label, multi-cohort, multicenter trial evaluated TEPKINLY as a monotherapy in patients with R/R FL after two or more prior systemic therapies. The trial included patients refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent. Published results in the Lancet Haematology highlighted an overall response rate of 83% and a complete response rate of 63% among 128 patients treated with TEPKINLY. The median follow-up was 16.2 months, with a median response duration of 21.4 months.

Additionally, the trial included an optimization cohort focusing on 86 patients. With an optimized regimen to mitigate cytokine release syndrome (CRS), 40% experienced Grade 1 CRS, and 9% experienced Grade 2 CRS, with no Grade 3 or higher CRS reported. There were no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) in this cohort.

The safety profile of epcoritamab in the pivotal cohort was consistent with previous reports, and the most common adverse reactions included CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia, and diarrhea. The most frequent serious adverse reaction was CRS, occurring in 34% of patients, and 3.7% experienced fatal adverse reactions.

Epcoritamab, administered subcutaneously, is an IgG1-bispecific antibody developed using Genmab's DuoBody® technology. It targets CD3 on T cells and CD20 on B cells, promoting T-cell-mediated killing of CD20+ cells. Epcoritamab (marketed as EPKINLY® in the United States and TEPKINLY® in the EU) has received regulatory approval for certain lymphoma indications in several countries and is being co-developed by AbbVie and Genmab.

Both companies are committed to further international regulatory submissions for R/R FL and R/R DLBCL indications and are exploring the use of epcoritamab in combination therapies across various hematologic malignancies.