European Commission grants marketing authorisation for AbbVie’s TEPKINLY combined with lenalidomide and rituximab in relapsed or refractory follicular lymphoma

The European Commission has granted marketing authorisation for TEPKINLY in combination with lenalidomide and rituximab for the treatment of adults with relapsed or refractory follicular lymphoma. The decision is grounded in findings from the pivotal Phase 3 EPCORE FL-1 trial, which set fixed-duration TEPKINLY in combination with lenalidomide and rituximab against the standard of care lenalidomide and rituximab regimen.

“Follicular lymphoma is a persistent form of cancer that remains incurable, which means patients need more treatment options. Patients often relapse and experience shorter remissions and have fewer treatment options each time the disease returns,” said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris Cité University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris in Paris. “The results shown in the EPCORE FL-1 trial are clinically meaningful, demonstrating the potential for TEPKINLY + R2 to change the treatment paradigm for patients, offering the chance at a durable response with a chemotherapy-free option.”

Data from the Phase 3 EPCORE FL-1 trial, an open-label interventional study assessing the safety and efficacy of the TEPKINLY combination against lenalidomide and rituximab alone, underpin the authorisation. Patients receiving the TEPKINLY combination saw their risk of disease progression or death fall by 79% relative to those on lenalidomide and rituximab alone. The overall response rate among those on the TEPKINLY combination reached 96%, against 81% in the comparator group. Complete responses were achieved in 74% of patients receiving the TEPKINLY combination, compared to 43% among those treated with lenalidomide and rituximab alone.

Throughout the EPCORE FL-1 study, the safety profile of the TEPKINLY combination remained aligned with what is already known about each component individually. Among the most frequently occurring adverse reactions, those arising in at least 20% of patients, were neutropenia, rash, upper respiratory tract infections, fatigue, diarrhoea, injection site reactions, anaemia, constipation, thrombocytopenia, cytokine release syndrome, hypogammaglobulinaemia, COVID-19, pyrexia, and pneumonia. Serious adverse reactions were recorded in 44% of patients, with cytokine release syndrome, pneumonia, COVID-19, and febrile neutropenia each occurring in at least 5% of the patient population.

“There remains a critical need for new treatment options to improve outcomes for patients with relapsed or refractory follicular lymphoma, particularly in earlier lines of therapy,” said Roopal Thakkar, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. “This approval is important because it brings an effective treatment option to patients across Europe, representing meaningful progress for patients with follicular lymphoma.”

Follicular lymphoma is a typically slow-growing blood cancer arising from B-cell lymphocytes and ranks as the second most prevalent form of non-Hodgkin lymphoma, accounting for between 20 and 30% of all cases. Its incidence runs considerably higher in European populations than in those from other parts of the world. No cure exists for follicular lymphoma, and no universally accepted standard of care has been established for patients in the third line or beyond. Even among those who achieve remission, relapse remains a frequent and challenging reality.

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Related Topics and Keywords

AbbVie, Lenalidomide, lymphoma, refractory follicular lymphoma, tepkinly