• TEPKINLY^® (epcoritamab) plus lenalidomide and rituximab (R²) is the first and only bispecific-based therapy approved in Europe for the treatment of relapsed or refractory follicular lymphoma in the second-line setting, offering a chemotherapy-free option
• In the Phase 3 EPCORE^® FL-1 trial, fixed-duration TEPKINLY + R² achieved statistically significant improvement of progression-free survival and overall response rates compared to R², with approximately three out of four patients achieving a complete response

AbbVie announced that the European Commission (EC) granted marketing authorization for TEPKINLY^® (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R²) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE^® FL-1 trial, which evaluated fixed-duration TEPKINLY in combination with R² compared to standard of care R².

"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 (APHP) 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."

The marketing authorization is supported by data from the Phase 3 EPCORE FL-1 trial, an open-label interventional trial to evaluate the safety and efficacy of TEPKINLY + R² compared to R² alone in patients with R/R FL. The study demonstrated TEPKINLY + R² reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.13 - 0.33, p<0.0001) compared to R² alone. The overall response rate (ORR) in patients treated with TEPKINLY + R² was 96% (95% CI: 90.2, 98.6) compared to 81% in patients treated with R² (95% CI: 72.7, 87.7; p<.0001). Among patients who were treated with TEPKINLY + R², 74% achieved a complete response (CR) (n=181/243, 95% CI: 68.5, 79.8) compared to a 43% CR rate among patients treated with R² (n=106/245, 95% CI: 37.0, 49.7).

The safety profile of TEPKINLY + R² in the EPCORE FL-1 study was consistent with the known safety profiles of the individual regimens (epcoritamab and R²). In the trial, the most common (≥ 20%) adverse reactions were neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection site reactions, anemia, constipation, thrombocytopenia, cytokine release syndrome (CRS), hypogammaglobulinemia, COVID-19, pyrexia, and pneumonia. Serious adverse reactions occurred in 44% of patients who received epcoritamab in combination with lenalidomide and rituximab. Serious adverse reactions in ≥ 5% of patients included CRS, pneumonia, COVID-19, and febrile neutropenia.

"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, 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." 

FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL) that arises from B-cell lymphocytes. FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases.¹ FL incidence is significantly higher in European populations, 11-29 percent, compared to non-European populations, 2-18 percent.² FL is considered incurable, and there is no standard of care treatment for third-line or later FL.^1,3 Patients who achieve remission also often experience relapse.^4,5,6

"A diagnosis of follicular lymphoma can bring a relentless cycle of disease recurrence and treatment," said Mitchell Smith, M.D., Ph.D., Chief Medical Officer of the Follicular Lymphoma Foundation. "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."