AbbVie’s TEPKINLY approved for follicular lymphoma

UK—The European Commission (EC) has granted AbbVie conditional marketing authorization for TEPKINLY (epcoritamab) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).

This approval is a significant step forward in cancer treatment for patients who have received two or more lines of treatment, giving people fighting this difficult form of non-Hodgkin’s lymphoma (NHL) new hope.

TEPKINLY , also known as EPKINLY in the United States, is a bispecific antibody that engages subcutaneous T-cells.

With this approval, it becomes the first and only treatment of its sort licensed for R/R FL and R/R diffuse large B-cell lymphoma (DLBCL) in the European Union (EU), European Economic Area (EEA) countries (Iceland, Liechtenstein, and Norway), and Northern Ireland.

The approval of TEPKINLY was supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial, an open-label, multi-cohort, multicenter, single-arm study that examined TEPKINLY as monotherapy in patients with R/R FL after two or more lines of systemic treatment.

The EPCORE NHL-1 trial included patients with challenging treatment histories, such as those who were refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent.

Approximately 70% of patients in the experiment had twice refractory sickness, 82% were refractory to their most recent treatment, and 52% showed disease progression within two years of starting any initial systemic therapy.

The findings, published in The Lancet Haematology, showed that TEPKINLY had a remarkable overall response rate (ORR) of 83%, with a complete response (CR) rate of 63% among the 128 patients treated.

Epcoritamab’s safety profile in the trial’s pivotal cohort was similar to that of prior data from the EPCORE NHL-1 DLBCL cohort.

In response to the EC’s approval, Mariana Cota Stirner, M.D., Ph.D., Vice President and Therapeutic Area Head for Hematology at AbbVie, expressed her enthusiasm.

She highlighted that the approval of TEPKINLY marks a significant step toward establishing TEPKINLY as a core therapy across multiple B-cell malignancies.

Furthermore, she noted that the therapy’s expansion into FL, following its initial approval for treating relapsed or refractory diffuse large B-cell lymphoma, underscores its potential as a critical treatment option for haematological cancers.

Echoing this sentiment, Kate Rogers, CEO of the Follicular Lymphoma Foundation, described the approval as a promising development for the lymphoma community.

She emphasised the importance of providing additional treatment options for patients and physicians, especially given the challenging nature of relapsed or refractory follicular lymphoma, particularly in later lines of therapy.

Follicular lymphoma, which accounts for 20-30% of all non-Hodgkin’s lymphoma cases, is typically a slow-growing cancer that arises from B-lymphocytes.

 However, it remains incurable, and there is no standard treatment for patients in the third line of therapy or beyond.

Over time, more than 25% of patients with FL may experience transformation to DLBCL, an aggressive form of NHL associated with poor survival outcomes, making the approval of TEPKINLY a crucial step forward in improving patient care.

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