Dr Nowakowski on the FDA Approval of Epcoritamab in R/R Follicular Lymphoma

Grzegorz S. Nowakowski, MD, consultant, Division of Hematology; enterprise deputy director, Clinical Research, Mayo Clinic Comprehensive Cancer Center, discusses the significance of the FDA approval of epcoritamab-bysp (Epkinly) as a third-line treatment option in relapsed/refractory follicular lymphoma.

On June 16, 2024, the FDA approved this bispecific antibody for patients with relapsed/refractory follicular lymphoma following 2 or more lines of systemic therapy. This approval was supported by results from the phase 1/2 EPCORE NHL-1 trial (NCT03625037), in which epcoritamab produced a median overall response rate (ORR) of 82.0% (95% CI, 74.1%-88.2%) and a complete response (CR) rate of 60.0% among 127 patients with relapsed/refractory follicular lymphoma.

Additionally, prior data reported from the EPCORE NHL-1 trial showed that patients with relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma achieved an ORR of 61.0% (95% CI, 52.5%-68.7%) and a 38.0% CR rate with the bispecific CD20-directed CD3 T-cell engager. This led to the agent’s accelerated FDA approval for this population in May 2023.

Despite advancements in the management of follicular lymphoma, the majority of patients will relapse and they will require subsequent lines of therapy, Nowakowski says. Effective frontline and second-line therapeutics are available, but treatment options in the third line and beyond tend to yield poorer outcomes and are limited, he explains. Accordingly, the approval of epcoritamab offers a new treatment avenue for these patients, especially in the third-line setting, Nowakowski states.

This approval provides patients with a different treatment modality compared with other available agents in this space, Nowakowski adds. For example, treatment with PI3K inhibitors has been associated with infection issues in the past, he says. Consequently, epcoritamab provides a highly effective and novel option for patients with relapsed or refractory follicular lymphoma, Nowakowski emphasizes. He speculates that the agent's activity in the relapsed/refractory setting could also support efforts to move it up into earlier treatment lines.