The U.S. Food and Drug Administration (FDA) has granted accelerated approval to epcoritamab-bysp (Epkinly), developed by Genmab, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This approval marks a significant advancement in the treatment options for FL, a type of non-Hodgkin lymphoma.
Image Source: Vinoth Khandelwal
Epcoritamab-bysp has received accelerated approval from the FDA, highlighting its potential to address an unmet medical need for patients with relapsed or refractory FL. This approval was supported by data from clinical trials demonstrating significant efficacy and manageable safety profiles.
Epcoritamab-bysp is a bispecific CD20-directed CD3 T-cell engager. This innovative therapeutic approach harnesses the body’s immune system by directing T-cells to target and eliminate B-cells expressing the CD20 antigen, a common feature in FL.
The efficacy and safety of epcoritamab-bysp were evaluated in the EPCORE NHL-1 trial (Study GCT3013-01; NCT03625037), an open-label, multi-cohort, multicenter, single-arm trial involving 127 patients with relapsed or refractory FL after at least two lines of systemic therapy. The study focused on the primary efficacy and safety outcomes based on these patients who received a two-step dosing regimen. Additionally, a dose optimization cohort of 86 patients assessed a recommended three-step dosage schedule aimed at mitigating cytokine release syndrome (CRS).
The main efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), evaluated by an Independent Review Committee using the Lugano 2014 criteria. Among the 127 patients in the primary efficacy population, the ORR was 82%, with 60% achieving complete responses. With a median follow-up of 14.8 months, the estimated median DOR was not reached, but the 12-month Kaplan-Meier estimate for DOR was 68.4%. Similar efficacy results were observed in the cohort receiving the three-step dosage schedule.
To confirm the clinical benefit of epcoritamab-bysp, a Phase 3 randomized trial (NCT05409066) is ongoing, nearly fully enrolled. This trial is evaluating the combination of rituximab and lenalidomide with or without epcoritamab-bysp in patients with relapsed or refractory FL.
The accelerated approval of epcoritamab-bysp represents a promising new option for patients with relapsed or refractory follicular lymphoma. Its novel mechanism of action and encouraging trial results underscore the potential for improved patient outcomes in this challenging condition. Further data from ongoing Phase 3 trials will provide additional insights into its long-term efficacy and safety.
Dr. Vinoth Khandelwal, Ph.D.
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