The FDA breakthrough drug designation for epcoritamab in follicular lymphoma was supported by findings from the phase 1/2 EPCORE NHL-1 study.
Epcoritamab, an investigational T-cell-engaging bispecific antibody, has received a BTD from the FDA in R/R FL. The BTD is supported by findings from the phase 1/2 EPCORE NHL-1 trial (NCT03625037).1
“Despite recent treatment advances in relapsed or refractory follicular lymphoma, a need still exists for more treatment options,” said Jan van de Winkel, PhD, chief executive officer of Genmab, EPCORE NHL-1 study sponsor, in a press release. “We are encouraged by these recent decisions from the regulatory authorities, and we are hopeful that this may help accelerate the process of delivering epcoritamab to people living with this disease.”
The phase 1/2 is a global, multicenter, open-label safety and efficacy trial of epcoritamab in patients with a documented CD20-positive mature B-cell neoplasm.2 The trial has an estimated enrollment of 786 patients with R/R disease following treatment with an anti-CD20 monoclonal antibody.
The primary end points for the dose-escalation portion are dose-limiting toxicities and incidence of adverse events. The primary end point for the dose-expansion portion is objective response rate (ORR). The primary end points for the dose-optimization portion are number of patients with cytokine release syndrome (CRS) and percentage of patients with grade 2 or higher CRS events. Secondary end points include ORR, partial response rate, complete response rate, time to response, duration of response, progression-free survival, and overall survival.
To be eligible to participate, patients cannot have primary central nervous system (CNS) lymphoma or CNS involvement, a known past or current malignancy other than inclusion diagnosis, clinically significant cardiovascular disease, a history of autoimmune disease or immunosuppression, or active hepatitis B, hepatitis C, or HIV infection. Patients must also have acceptable renal and liver functions and an ECOG performance status of 0-2 to be included in the study.
The study has an estimated completion date of April 2024. Updated findings from the EPCORE NHL-1 study will be presented at the 2023 American Society of Hematology annual meeting on December 9-12 in San Diego, California.1