AbbVie announced that the European Commission (EC) has granted Marketing Authorisation (MA) 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.

Catherine Thieblemont, MD, PhD, Head of the Hemato-Oncology Department, Paris Cité University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP), Paris, said, "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. 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 MA 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 percent (HR 0.21, 95 percent 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 percent (95 percent CI: 90.2, 98.6) compared to 81 percent in patients treated with R2 (95 percent CI: 72.7, 87.7; p<.0001). Among patients who were treated with TEPKINLY + R2, 74 percent achieved a Complete Response (CR) (n=181/243, 95 percent CI: 68.5, 79.8) compared to a 43 percent CR rate among patients treated with R2 (n=106/245, 95 percent CI: 37, 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 percent) 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 percent of patients who received epcoritamab in combination with lenalidomide and rituximab. Serious adverse reactions in ≥ 5 percent of patients included CRS, pneumonia, COVID-19, and febrile neutropenia.

Roopal Thakkar, MD, Executive Vice President (EVP), Research and Development (R&D), Chief Scientific Officer (CSO), AbbVie, said, "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. 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. FL incidence is significantly higher in European populations, 11-29 percent, compared to non-European populations, 2-18 percent. FL is considered incurable, and there is no Standard of Care (SoC) treatment for third-line or later FL. Patients who achieve remission also often experience relapse.

Mitchell Smith, MD, PhD, Chief Medical Officer (CMO), Follicular Lymphoma Foundation, said, "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."