AbbVie and Genmab are celebrating their second accelerated approval for Epkinly, this time in follicular lymphoma.
The bispecific antibody, also known as epcoritamab, was approved on Wednesday for relapsed or refractory follicular lymphoma patients who’ve received at least two prior therapies. Follicular lymphoma is a common, slow-growing form of non-Hodgkin’s lymphoma, accounting for 10% to 20% of “all lymphomas in the western world,” according to AbbVie and Genmab.
AbbVie put down $750 million upfront in 2020 to partner on certain Genmab cancer treatments, including Epkinly, which is being tested as both a monotherapy and in combinations. That partnership led to an accelerated approval for Epkinly last year in relapsed/refractory diffuse large B cell lymphoma, based on a Phase 1/2 trial in a variety of non-Hodgkin’s lymphoma patients.
The latest approval was based on data from a different cohort of that same trial, showing an overall response rate of 82% in follicular lymphoma patients. The complete response rate, also called complete remission, was 60%, according to the FDA.
“Often by the time patients get to third-line plus, they’re running out of options,” Jackie Nielsen, AbbVie’s therapeutic area head of hematologic oncology medical affairs, told Endpoints News.
AbbVie and Genmab tested an optimized step-up dosing regimen for follicular lymphoma patients to reduce the risk of cytokine release syndrome (CRS), a common side effect of immunotherapies in which the immune system overreacts to treatment.
As a result, no patients had grade 3 or higher CRS. About 40% of patients experienced grade 1 CRS, while 9% had grade 2 CRS, the partners said. The label includes a boxed warning for serious or fatal CRS and immune effector cell-associated neurotoxicity syndrome (ICANS).
Epkinly will compete with Roche’s bispecific Lunsumio, which was approved in 2022 to treat adults with relapsed or refractory follicular lymphoma. Genmab CMO Tahi Ahmadi said Epkinly’s subcutaneous administration will be a differentiator, as Lunsumio is given intravenously.