FDA tacks on third-line follicular lymphoma indication to Epkinly’s label
26 Jun 2024
Phase 3Clinical ResultPriority ReviewDrug ApprovalAccelerated Approval
A year after first scoring a green light in the US for diffuse large B-cell lymphoma (DLBCL), AbbVie and Genmab’s bispecific T-cell engager Epkinly (epcoritamab-bysp) has now won accelerated approval in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior treatments.
The FDA clearance, granted following priority review, was based on data from the Phase I/II EPCORE NHL-1 study in 127 patients with relapsed or refractory FL.
The CD20xCD3 bispecific led to an overall response rate (ORR) of 82%, with 60% of patients achieving a complete response. While median duration of response (DOR) was not reached after nearly 14 months, the 12-month Kaplan-Meier estimate for DOR was about 68%.
Epkinly will carry a boxed warning for Immune Effector Cell-Associated Neurotoxicity (ICANS), which occurred in about 6% of patients, as well as serious or fatal cytokine release syndrome (CRS). In EPCORE NHL-1, 66.4% of patients experienced CRS, with 1.6% of cases being Grade 3 or higher.
In a separate 86-patient dose optimisation cohort testing a three-step dosage regimen of Epkinly, CRS occurred in 49% of patients, with the majority being Grade 1. BMO Capital Markets analysts had previously called the high incidence of CRS "a concern."
The partners are conducting a Phase III confirmatory study of Epkinly in combination with Rituxan (rituximab) and Revlimid (lenalidomide), compared with the two other treatments alone, in patients with relapsed or refractory FL. The trial is 95% enrolled.
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