COPENHAGEN, Denmark, July 6, 2026
Genmab A/S announced that the European Commission (EC) has granted marketing authorization for TEPKINLY® (epcoritamab) in combination with lenalidomide and rituximab (R2) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). The approval makes TEPKINLY plus R2 the first and only bispecific antibody-based chemotherapy-free regimen approved in Europe for second-line follicular lymphoma, providing physicians and patients with a novel treatment option following disease relapse after at least one prior therapy.
Phase 3 EPCORE FL-1 Trial Delivered Superior Efficacy Over Standard Therapy
The European Commission’s decision is supported by data from the pivotal Phase 3 EPCORE FL-1 trial, an international, open-label study comparing fixed-duration TEPKINLY plus lenalidomide and rituximab against the current standard-of-care R2 regimen in patients with relapsed or refractory follicular lymphoma. The trial demonstrated a 79% reduction in the risk of disease progression or death compared with R2 alone (Hazard Ratio 0.21; p<0.0001). Patients treated with the TEPKINLY combination achieved an overall response rate of 96%, compared with 81% for R2, while 74% achieved a complete response, substantially higher than the 43% complete response rate observed with standard therapy. The results demonstrate the potential of fixed-duration bispecific antibody therapy to deliver deeper, more durable responses without the need for chemotherapy.
Safety Findings Consistent with the Established Profiles of Individual Therapies
The safety profile of TEPKINLY plus R2 was consistent with the known safety characteristics of epcoritamab, lenalidomide, and rituximab. The most commonly reported adverse reactions included 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 events occurred in 44% of treated patients, with the most frequent serious events including CRS, pneumonia, COVID-19, and febrile neutropenia. Investigators reported that the overall safety profile remained manageable and aligned with previous clinical experience involving the individual agents.
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Approval Expands Genmab’s Leadership in Bispecific Antibody Oncology
Follicular lymphoma is the second most common subtype of non-Hodgkin lymphoma, affecting patients with a chronic disease characterized by repeated relapses and progressively shorter treatment responses. The approval represents a significant milestone for Genmab and strengthens the role of TEPKINLY as a core therapy across B-cell malignancies. Developed using Genmab’s proprietary DuoBody® technology, epcoritamab is a subcutaneous IgG1 bispecific antibody designed to bind simultaneously to CD3-positive T cells and CD20-positive B cells, activating the immune system to eliminate malignant B cells. Co-developed with AbbVie, TEPKINLY is already approved in multiple lymphoma indications across more than 65 countries and territories. Both companies continue to advance the therapy through multiple ongoing Phase 3 studies evaluating its use in earlier treatment settings and additional B-cell malignancies, reinforcing its potential to reshape the treatment landscape for lymphoma patients worldwide.
Source: Genmab press release
