AbbVie has received marketing authorization from the European Commission (EC) for TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
The approval is based on results from the Phase 3 EPCORE FL-1 trial, which evaluated the safety and efficacy of TEPKINLY plus R2 against R2 alone in patients with R/R FL.
The study demonstrated that the TEPKINLY combination reduced the risk of disease progression or death by 79% compared with R2 alone. The overall response rate (ORR) was 96% in the TEPKINLY plus R2 arm, compared with 81% for R2 alone. Additionally, 74% of patients receiving the combination achieved a complete response (CR), versus 43% of patients treated with R2 alone.
The safety profile of TEPKINLY plus R2 was consistent with the established safety profiles of epcoritamab and the R2 regimen, with no new safety signals identified.
Roopal Thakkar, executive vice president, research and development, and chief scientific officer at AbbVie, said there is a critical need for new treatment options to improve outcomes for patients with relapsed or refractory follicular lymphoma, particularly in earlier lines of therapy.
“This approval is important because it brings an effective treatment option to patients across Europe, representing meaningful progress for patients with follicular lymphoma,” he added.
Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma (NHL) that arises from B-cell lymphocytes. It is the second most common form of NHL overall, accounting for 20-30% of all NHL cases. The disease is considered incurable, and patients frequently experience repeated relapses following remission. There is currently no standard of care for patients requiring third-line or later treatment.
Mitchell Smith, chief medical officer of the Follicular Lymphoma Foundation, said the approval offers renewed hope for patients living with recurrent disease.
“A diagnosis of follicular lymphoma can bring a relentless cycle of disease recurrence and treatment. 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,” Smith said.
Epcoritamab is a subcutaneously administered IgG1 bispecific antibody developed using Genmab’s proprietary DuoBody technology. It is designed to bind simultaneously to CD3 on T cells and CD20 on B cells, directing the body’s immune system to selectively destroy malignant CD20-positive B cells.
The therapy is marketed as EPKINLY in the United States and Japan and as TEPKINLY in the European Union. It has already received regulatory approvals for certain lymphoma indications in more than 65 countries and territories.
Epcoritamab is being co-developed by AbbVie and Genmab under their oncology collaboration. The companies jointly commercialize the therapy in the United States and Japan, while AbbVie is responsible for commercialization in the rest of the world.
Beyond this approval, the companies continue to investigate epcoritamab as both a monotherapy and combination treatment across multiple hematologic malignancies. Ongoing Phase 3 studies are evaluating the therapy in combination with R-CHOP for newly diagnosed diffuse large B-cell lymphoma (DLBCL), with lenalidomide for relapsed or refractory DLBCL, and with R2 compared with chemoimmunotherapy in previously untreated follicular lymphoma. These additional indications remain investigational, and their safety and efficacy have not yet been established.
