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news.The European Commission (EC) has granted marketing authorisation for AbbVie’s Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (Tepkinly + R²) for adult patients with relapsed or refractory follicular lymphoma.
Epcoritamab is co-developed by AbbVie and Genmab. Credit: © AbbVie Inc. All rights reserved.
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The decision is based on data from the pivotal Phase III EPCORE FL-1 trial, which assessed the efficacy and safety of the fixed-duration Tepkinly plus lenalidomide and rituximab regimen compared to the standard R² treatment.
These results showed that the combination reduced the risk of disease progression or death by 79% versus R² alone. Patients treated with the Tepkinly-based therapy achieved an overall response rate of 96%, compared to 81% for those receiving R².
Complete response (CR) rates reached 74% for patients receiving the combination, with 181 out of 243 patients achieving this outcome. For those treated with R² alone, the CR rate was 43%, with 106 out of 245 patients achieving a CR.
The safety profile observed in the trial was consistent with the known characteristics of the individual treatments.
The most frequent adverse reactions, occurring in 20% or more of patients, included anaemia, constipation, Covid-19, cytokine release syndrome (CRS), diarrhoea, fever, hypogammaglobulinaemia, neutropenia, pneumonia and thrombocytopenia.
Serious adverse reactions were reported in 44% of patients receiving the combination. CRS, pneumonia, Covid-19, and febrile neutropenia were among the events affecting at least 5% of participants.
AbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar said: “This approval is important because it brings an effective treatment option to patients across Europe, representing meaningful progress for patients with follicular lymphoma.”
Epcoritamab is a subcutaneous IgG1-bispecific antibody developed using Genmab’s DuoBody technology.
It is being co-developed by AbbVie and Genmab and is approved for certain lymphoma indications in more than 65 territories, under the names Epkinly in Japan and the US, and Tepkinly in the European Union.
The companies are investigating further uses of epcoritamab, alone and in combination, for various haematological malignancies in clinical trials.
Last month, AbbVie agreed to acquire Apogee Therapeutics for $10.9bn, potentially further fortifying its legacy in the immunology space and marking another sizeable investment into the disease area as it garners notable big pharma interest.
