EU approves Genmab's Tepkinly combo for relapsed follicular lymphoma

Genmab A/S (Nasdaq: GMAB) announced that the European Commission granted marketing authorization for TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma.

The approval is based on results from the Phase 3 EPCORE FL-1 trial, which compared the fixed-duration TEPKINLY combination regimen, known as TEPKINLY + R2, against the standard of care R2 alone. The trial showed that TEPKINLY + R2 reduced the risk of disease progression or death by 79% compared to R2 alone (HR 0.21, 95% CI: 0.13–0.33, p<0.0001).

The overall response rate among patients treated with TEPKINLY + R2 was 96%, compared to 81% for patients receiving R2 alone. Among patients in the TEPKINLY + R2 group, 74% achieved a complete response, versus 43% in the R2-only group.

Serious adverse reactions occurred in 44% of patients who received the combination regimen. The most common adverse reactions, occurring in at least 20% of patients, included neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection site reactions, anemia, constipation, thrombocytopenia, cytokine release syndrome, hypogammaglobulinemia, COVID-19, pyrexia, and pneumonia. Serious adverse reactions occurring in at least 5% of patients included cytokine release syndrome, pneumonia, COVID-19, and febrile neutropenia.

Epcoritamab is co-developed by Genmab and AbbVie. The drug is marketed as EPKINLY in the U.S. and Japan and as TEPKINLY in the European Union. AbbVie is responsible for global commercialization outside the U.S. and Japan, where both companies share commercial responsibilities.

Follicular lymphoma is the second most common form of non-Hodgkin lymphoma, accounting for 20% to 30% of all cases. The disease is considered incurable, and there is no established standard of care for patients in the third line or later.

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