AbbVie and Genmab’s epcoritamab has shown promise as part of a combination treatment for relapsed or refractory follicular lymphoma (FL).
The phase 3 EPCORE FL-1 trial has been comparing subcutaneous epcoritamab plus rituximab and lenalidomide (R2) against R2 alone in adult patients.
The study achieved its dual primary endpoints of overall response rate and progression-free survival, lowering the risk of disease progression or death by 79%.
The safety profile of the combination was also found to be consistent with the known safety profiles of the individual regimens.
Approximately 15,000 people develop FL, a slow growing form of non-Hodgkin lymphoma, every year in the US. The disease is considered incurable, with patients frequently relapsing and the prognosis worsening after each subsequent relapse.
Epcoritamab, which already holds approvals in certain lymphoma indications under the brand names Epkinly and Tepkinly, is an IgG1-bispecific antibody designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induce T-cell-mediated killing of CD20-positive cells.
The US Food and Drug Administration (FDA) recently granted priority review to the drug in combination with R2 following at least one prior systemic therapy, setting a target review date of 30 November this year.
If approved, epcoritamab in combination R2 would be the first bispecific antibody combination regimen available in the US as a second-line treatment option for patients with relapsed or refractory FL.
Genmab’s chief executive officer, Jan van de Winkel, said: “While therapeutic options exist for patients with relapsed or refractory FL, response rates tend to decline and durability diminishes with each subsequent line of treatment, which can increase the risk of the disease transforming into aggressive large-cell lymphoma.
“The results from this trial, and the decision from the FDA to accept the supplemental Biologics License Application for priority review, demonstrate the potential of this epcoritamab combination therapy to reshape the treatment landscape…”
The announcement comes just over a year after the FDA granted accelerated approval to epcoritamab as a single agent for adults with relapsed or refractory FL who have received at least two lines of prior therapy.
Both AbbVie and Genmab share commercial responsibilities for epcoritamab in the US and Japan, while AbbVie is responsible for further global commercialisation.