AbbVie and Genmab announced that the US Food and Drug Administration (FDA) has approved Epkinly (epcoritamab-bysp) to treat a type of follicular lymphoma (FL) in adults.
Epkinly is an IgG1-bispecific antibody developed using Genmab’s in-house DuoBody-CD3 technology, which directs cytotoxic T cells selectively to elicit an immune response.
The drug is already approved in the US for the treatment of R/R diffuse large B-cell lymphoma (DLBCL).
The current FDA approval expands its indication to include adults with relapsed or refractory (R/R) FL after two or more lines of prior therapy.
Epkinly is the first and only T-cell-engaging bispecific antibody in the current indication.
US FDA approved the drug under its Accelerated Approval program, based on overall response rate (ORR) and durability of response.
AbbVie and Genmab expect continued approval for Epkinly in this indication, contingent upon verification of clinical benefit in confirmatory trials.
AbbVie vice president and haematology therapeutic area head Mariana Cota Stirner said: “The FDA approval of Epkinly offers a new treatment option for relapsed or refractory follicular lymphoma, particularly following the failure of other therapies.
“Epkinly treatment has shown deep and durable responses for many patients. Subcutaneous dosing offers convenience, and Epkinly can be given to patients without mandatory hospitalization using a 3-step-up dosing regimen.
“We believe that Epkinly has the potential to be a core therapy in the treatment of multiple B-cell malignancies and furthers our company mission to advance research to raise standards of care for patients with cancer.”
The FDA approval is based on results from the Phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of the drug in 127 adult patients with R/R FL.
In the study, Epkinly showed 82% of ORR, the study’s primary endpoint, a 60% complete response (CR) rate and 22% partial response (PR) rate.
The most common adverse reactions include injection site reactions, cytokine release syndrome (CRS), fatigue, rash, diarrhoea, fever, cough, and headache, among others.
Epkinly prescribing information includes a Boxed Warning for serious CRS and immune effector cell-associated neurotoxicity syndrome (ICANS).
AbbVie and Genmab will continue to evaluate the drug as a monotherapy and in combination across lines of therapy in a range of hematologic malignancies.
