The European Commission (EC) has granted conditional marketing authorisation for AbbVie’s TEPKINLY (epcoritamab), an IgG1-bispecific antibody, for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

The approval marks TEPKINLY as the first subcutaneous T-cell engaging bispecific antibody for this indication in the EU and European Economic Area (EEA) countries, as well as Northern Ireland.

Epcoritamab, developed using Genmab's DuoBody technology, is designed to direct T cells to CD20+ B cells, inducing targeted cell killing. It has already received approval in several countries for certain lymphoma indications.

The latest authorisation is based on results from the Phase I/II EPCORE NHL-1 open-label, multi-cohort, multicentre, single-arm trial which demonstrated significant efficacy in patients with relapsed or refractory follicular lymphoma.

The trial showed an overall response rate of 83% and a complete response rate of 63% among patients treated with TEPKINLY. The median duration of response was reported to be 21.4 months.

The EPCORE NHL-1 trial included a separate optimisation cohort to evaluate a 3-step-up dosing regimen for cytokine release syndrome mitigation.

This cohort showed reduced rates of Grade 1 and 2 cytokine release syndrome, with no cases of Grade 3 or higher, or immune effector cell-associated neurotoxicity syndrome reported.

TEPKINLY’s safety profile was consistent with previous studies, with the most common adverse reactions being cytokine release syndrome, injection site reactions and fatigue.

The Phase I/II EPCORE NHL-1 trial is a comprehensive study designed to assess the safety and preliminary efficacy of subcutaneous epcoritamab in various types of non-Hodgkin's lymphoma, including follicular lymphoma.

AbbVie haematology therapeutic area head, vice-president Mariana Cota Stirner, stated: “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 haematological cancer treatment.”

AbbVie and Genmab are co-developing epcoritamab and will share commercial responsibilities in the US and Japan, with AbbVie handling global commercialisation.

The companies are pursuing additional regulatory approvals internationally for both the relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma indications.