TEPKINLY has been approved as a monotherapy to treat adults with relapsed or refractory diffuse large B-cell lymphoma. Credit: Komsan Loonprom/Shutterstock.com.

Genmab has received conditional marketing authorisation from the European Commission (EC) for TEPKINLY (epcoritamab) as a monotherapy to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) following two or more lines of systemic therapy.

It is the first and only subcutaneous T-cell-engaging bispecific antibody that has gained approval to treat these patients in the EU, Iceland, Liechtenstein and Norway.

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The IgG1-bispecific antibody epcoritamab has been created utilising the company’s DuoBody technology, which selectively directs cytotoxic T-cells to evoke an immune response towards target cell types.

It induces T-cell mediated killing of CD20+ cells by simultaneously binding to CD3 on T-cells and CD20 on B-cells.

The approval was based on data from the pivotal EPCORE NHL-1 Phase I/II multi-cohort, multi-centre, single-arm, open-label study.

It was designed to assess the safety and preliminary efficacy of TEPKINLY in patients with R/R large B-cell lymphoma (LBCL), including its subtype DLBCL.

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DLBCL patients who received treatment with TEPKINLY attained an overall response rate of 62% and a complete response rate of 39% with a median duration of response of 15.5 months.

TEPKINLY showed a manageable safety profile across the LBCL patient cohort, which included patients with DLBCL.

Genmab CEO Jan van de Winkel stated: “With TEPKINLY, people in Europe living with relapsed or refractory diffuse large B-cell lymphoma who are in need of additional treatment options now have a readily available, innovative therapeutic option for this aggressive cancer.”