European Commission’s approval brings a chemotherapy-free option to patients and develops AbbVie’s oncology and antibody portfolio.
The European Commission (EC) has approved AbbVie’s Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (R2), as the first bispecific-based therapy for relapsed/refractory follicular lymphoma in the EU.
The EC’s decision, based on data from the Phase III EPCORE FL-1 trial, provides a chemotherapy-free fixed-duration treatment option for this indication in the second-line setting.
Results show that Tepkinly + R2 reduced the risk of disease progression or death by 79 percent compared to R2 monotherapy. Additionally, the combination enabled an overall response rate of 96 percent compared to 81 percent in the R2 arm. Furthermore, a complete response was observed in 74 percent of patients given the epcoritamab-based regimen, compared with 43 percent given R2 only.
Dr Catherine Thieblemont, PhD, Head of the Haemato-Oncology Department at Paris Cité University and Hôpital Saint-Louis, Assistance-Publique-Hôpitaux de Paris, said: “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.”
Tepkinly + R2 [has the potential to] change the treatment paradigm for patients [with relapsed/refractory follicular lymphoma], offering the chance at a durable response with a chemotherapy-free option”
Dr Catherine Thieblemont
Dr Roopal Thakkar, Executive Vice President, Research and Development and Chief Scientific Officer at AbbVie, added: “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.”
This latest development from AbbVie builds on its earlier decision to expand its bispecific pipeline. In January, the firm agreed a major $5 billion settlement to license a novel bispecific antibody from Chinese biotech RemeGen. The deal adds a new class of cancer therapeutics AbbVie’s inventory, strengthening its oncology portfolio.
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