TEPKINLY’s safety profile was consistent with previous studies. Credit: Kateryna Kon/Shutterstock.

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.

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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.

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

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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.