AbbVie has received European Commission marketing authorization for TEPKINLY, or epcoritamab, in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.
The approval allows the use of the fixed-duration, chemotherapy-free regimen, known as TEPKINLY plus R2, in patients whose follicular lymphoma has returned or failed to respond to prior treatment. It is supported by results from the pivotal Phase III EPCORE FL-1 trial, which compared the combination regimen with lenalidomide and rituximab alone.
Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma that develops from B-cell lymphocytes. Although it can often be managed over long periods, it is generally considered incurable. Patients commonly experience repeated relapses, and treatment options can become more limited as the disease returns.
The EPCORE FL-1 study found that TEPKINLY plus R2 reduced the risk of disease progression or death by 79% compared with R2 alone. The trial reported a hazard ratio of 0.21, indicating a substantial improvement in progression-free survival for patients receiving the epcoritamab-based regimen.
The overall response rate was 96% among patients treated with TEPKINLY plus R2, compared with 81% in the R2-only group. Complete responses were reported in 74% of patients receiving the combination, compared with 43% of patients treated with lenalidomide and rituximab alone.
Epcoritamab is a bispecific antibody designed to engage CD3 on T cells and CD20 on B cells, helping direct the immune system to attack malignant B cells. Its addition to the R2 regimen is intended to provide a more effective treatment option without the use of conventional chemotherapy.
The safety profile of the combination was consistent with the known profiles of epcoritamab and R2, according to AbbVie. Common adverse reactions included neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection-site reactions, anemia, constipation, thrombocytopenia, cytokine release syndrome, hypogammaglobulinemia, COVID-19, fever and pneumonia.
Serious adverse reactions occurred in 44% of patients treated with the combination. The most frequently reported serious events included cytokine release syndrome, pneumonia, COVID-19 and febrile neutropenia.
Catherine Thieblemont, head of the hemato-oncology department at Paris Cité University and Hôpital Saint-Louis, said the Phase III findings could represent a meaningful change in treatment for patients with relapsed or refractory disease.
AbbVie’s chief scientific officer, Roopal Thakkar, said the authorization addresses a continuing need for more effective therapies earlier in the treatment journey for follicular lymphoma patients.
The approval expands the availability of TEPKINLY in Europe and adds another treatment option for a patient population facing recurrent disease and limited long-term treatment choices.