AbbVie and Genmab’s Epkinly (epcoritamab-bysp) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL).
The regulator’s decision, which specifically applies to patients who have received at least two lines of prior therapy, makes Epkinly the first and only subcutaneous T-cell engaging bispecific antibody to be approved for this patient population.
Approximately 15,000 people develop FL, the second most common 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.
Epkinly, which is already approved in the US to treat certain cases of diffuse large B-cell lymphoma (DLBCL), 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 FDA’s latest decision on the therapy was supported by results from the phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of Epkinly in more than 120 adults with R/R FL who had received a median of three lines of therapy, 70% of whom had double refractory disease.
Results demonstrated an overall response rate of 82%, a complete response rate of 60% and a partial response rate of 22%, with more than half of patients who responded to treatment remaining responsive at a median follow-up of 14.8 months.
Mariana Cota Stirner, vice president, therapeutic area head for haematology at AbbVie, said: “The FDA approval of Epkinly offers a new treatment option for R/R FL, particularly following [the] failure of other therapies… Subcutaneous dosing offers convenience, and Epkinly can be given to patients without mandatory hospitalisation using a three-step-up dosing regimen.”
Both AbbVie and Genmab share commercial responsibilities for epcoritamab in the US and Japan, while AbbVie is responsible for further global commercialisation.
AbbVie announced earlier this year that epcoritamab, under the brand name Tepkinly, had been recommended by the National Institute for Health and Care Excellence (NICE) to treat adults with DLBCL.
The agency’s decision specifically applies to patients who have DLBCL that has returned or not responded to at least two previous treatments, including Roche’s CD79b-directed antibody-drug conjugate Polivy (polatuzumab vedotin), unless this is contraindicated or not tolerated.