Global pharma powerhouse AbbVie’s new therapy has got the European Commission's approval for relapsed or refractory follicular lymphoma, offering new chemotherapy-free treatment option for patients.

 

The approval for TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab (R2) for adults with relapsed or refractory follicular lymphoma (FL), marks the first and only bispecific antibody-based therapy approved in Europe for this setting.

 

The approval introduces a chemotherapy-free treatment option for patients whose follicular lymphoma has returned or failed to respond to previous therapy. It is supported by results from the Phase 3 EPCORE FL-1 trial, which showed that TEPKINLY plus R2 delivered a significant improvement in progression-free survival and response rates compared with R2 alone.

 

In the trial, TEPKINLY + R2 reduced the risk of disease progression or death by 79% compared with R2 alone. The combination achieved an overall response rate of 96%, with 74% of patients achieving a complete response, compared with 43% among patients treated with R2 alone.

 

"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, head of the hemato-oncology department, Paris Cité University.

 

"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."

 

Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma that develops from B-cell lymphocytes. Although many patients respond to treatment, the disease is considered incurable and patients often face repeated cycles of relapse and therapy.

 

The Phase 3 EPCORE FL-1 study evaluated the safety and effectiveness of fixed-duration epcoritamab combined with lenalidomide and rituximab compared with R2 alone in patients with relapsed or refractory FL following at least one prior treatment. The study enrolled 488 patients, with 243 receiving TEPKINLY + R2 and 245 receiving R2 alone.

 

"The approval of epcoritamab now in combination with R2 in Europe is a welcome advance that will bring an innovative treatment option and hope to the follicular lymphoma community," said Mitchell Smith, Chief Medical Officer of the Follicular Lymphoma Foundation.

 

AbbVie said the safety profile of TEPKINLY + R2 was consistent with the known safety profiles of the individual treatments. 

 

The most common adverse reactions included neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection site reactions, anemia, constipation, thrombocytopenia, cytokine release syndrome (CRS), hypogammaglobulinemia, COVID-19, fever and pneumonia.

 

Serious adverse reactions occurred in 44% of patients receiving the combination therapy, with CRS, pneumonia, COVID-19 and febrile neutropenia among the most common serious events.

 

"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, executive vice president, research and development, chief scientific officer, AbbVie. "This approval is important because it brings an effective treatment option to patients across Europe."