AbbVie Gets CHMP Nod for Epcoritamab in Relapsed/Refractory Follicular Lymphoma

AbbVie has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending conditional marketing authorization for epcoritamab (TEPKINLY®). Epcoritamab is a bispecific antibody designed to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more prior therapies. This recommendation marks a significant development in the treatment of FL, a type of non-Hodgkin's lymphoma (NHL).

Epcoritamab, developed in collaboration with Genmab, is administered subcutaneously and is the first T-cell engaging bispecific antibody of its kind. The European Commission is expected to make a final decision on the marketing authorization later this year.

Follicular lymphoma is a slow-growing type of NHL that originates from B-lymphocytes. It accounts for 20-30% of all NHL cases and is considered incurable with current standard therapies. In Western Europe, approximately 13,000 new cases were estimated in 2023. Patients with FL frequently face disease recurrence and diminishing response durations with each treatment line. This highlights the significant unmet medical need for innovative therapies.

The CHMP's positive opinion is based on data from the Phase 1/2 EPCORE® NHL-1 clinical trial, which involved 128 patients with R/R FL who had received at least two prior lines of therapy. The clinical trial demonstrated the efficacy and safety of epcoritamab, showing promising overall and complete response rates. Notably, the study included patients who were refractory to both anti-CD20 monoclonal antibody therapy and alkylating agents, as well as those whose disease progressed within two years of initial systemic therapy. The safety profile of epcoritamab in patients with R/R FL was consistent with previous reports from the EPCORE NHL-1 study on diffuse large B-cell lymphoma (DLBCL).

An additional cohort of 86 patients was evaluated using a three-step-up dosing schedule to minimize the incidence and severity of cytokine release syndrome (CRS), a common adverse effect associated with immune-engaging cancer treatments. The data from this cohort, recently published in the Lancet Haematology, showed a 49% incidence of CRS, with no grade 3 or higher events, indicating a manageable safety profile.

Dr. Catherine Thieblemont, head of the hemato-oncology department at Paris University, emphasized the need for new treatment options for FL patients, who often face relapse and refractory disease. The positive CHMP opinion is a crucial step toward making epcoritamab available to more patients in need.

Epcoritamab is part of AbbVie's and Genmab's collaborative oncology efforts. AbbVie will handle global commercialization outside the U.S. and Japan, where responsibilities will be shared. Both companies plan to seek additional regulatory approvals for epcoritamab in other regions and for other indications, including R/R DLBCL.

The EPCORE® NHL-1 trial is an open-label, multi-center study designed to evaluate the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-cell NHL, including FL. The trial consists of three parts: dose escalation, expansion, and optimization. The primary endpoint for the expansion part was the overall response rate (ORR), while secondary endpoints included duration and rate of complete response, progression-free survival, and time to response.

Epcoritamab, also known as TEPKINLY® in the European Union, utilizes Genmab's DuoBody® technology to engage T cells and target B cells expressing CD20. This mechanism is designed to induce T-cell-mediated killing of malignant B cells.

AbbVie remains committed to pursuing regulatory submissions for epcoritamab globally and continues to explore its potential as a monotherapy and in combination with other treatments for various hematologic malignancies. The company is dedicated to transforming cancer care and improving patient outcomes through innovative therapies.