Dr Nowakowski on the Implications of the FDA Approval of Epcoritamab in Follicular Lymphoma

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

On June 26, 2024, the FDA approved the bispecific antibody for patients with relapsed or refractory follicular lymphoma who have undergone 2 or more lines of systemic therapy. This approval was based on findings from the phase 1/2 EPCORE NHL-1 trial (NCT03625037), where epcoritamab generated an overall response rate of 82.0% (95% CI, 74.1%-88.2%) and a complete response rate of 60.0% among 127 patients with relapsed or refractory follicular lymphoma.

Nowakowski states that patients with relapsed or refractory follicular lymphoma have a significant unmet need, citing remaining treatment challenges in light of previous advancements. For instance, PI3K inhibitors were once promising treatment options, but setbacks occurred when randomized studies revealed a negative effect on overall survival with these agents, primarily due to increased infection risk, he reports. As a result, these inhibitors were withdrawn from the market, and enthusiasm for their use as third-line therapy diminished, according to Nowakowski. The other currently approved agents for relapsed or refractory follicular lymphoma tend to have lower response rates, leaving patients with few effective options, Nowakowski emphasizes.

Although some treatments, such as bispecific antibodies, show promise for these patients, the unmet need persists, he expands. The approval of epcoritamab in the third-line follicular lymphoma setting provides a new option for managing relapsed or refractory cases and helps address the limitations of earlier therapies, Nowakowski notes.

Additionally, epcoritamab has already been FDA approved for treating patients with aggressive relapsed or refractory lymphomas, such as diffuse large B-cell lymphoma and high-grade B-cell lymphoma, he continues. Familiarity with the agent among health care providers managing these aggressive lymphomas makes it easier to adopt and implement epcoritamab for patients with follicular lymphoma as well, Nowakowski explains. Many oncologists and treatment teams are already experienced with the drug’s use, which simplifies its integration into the care of patients with relapsed follicular lymphoma, he concludes.