Dr Phillips on the FDA Approval of Epcoritamab in R/R DLBCL

Tycel Phillips, MD, associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, discusses the significance of the FDA approval of the bispecific antibody epcoritamab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

On May 19, 2023, the FDA approved epcoritamab in patients with relapsed/refractory DLBCL who have received at least 2 prior lines of systemic therapy. This regulatory decision was based on findings from the single-arm, phase 2 EPCORE NHL-1 trial (NCT03625037), which enrolled patients with aggressive non-Hodgkin lymphoma, such as DLBCL, primary mediastinal large B-cell lymphoma (LBCL), grade IIIB follicular lymphoma, or high-grade B-cell lymphoma. At baseline, patients had received a median of 3 prior lines of therapy, 61.1% of patients had primary refractory disease, and 75.8% of patients were refractory to at least 2 consecutive lines of therapy.

At a median follow-up of 10.7 months, patients achieved an overall response rate of 61% and a complete response (CR) rate of 38%. Moreover, the median duration of response was 15.6 months.

The most common any-grade treatment-emergent adverse effects included cytokine release syndrome, pyrexia, and fatigue. In addition, 6.4% of patients experienced immune effector cell–associated neurotoxicity syndrome.

Many patients with relapsed/refractory DLBCL have limited treatment options to generate durable responses, Phillips says. The FDA approval of epcoritamab provides an alternative treatment option for patients who are unable to or reluctant to travel to a CAR T-cell infusion center, Phillips notes. Since epcoritamab uses T cells, it is also an alternative for patients who did not have durable responses to CAR T-cell therapy, as it may help them recapture or improve upon the responses they previously achieved with prior CAR T-cell infusion, Phillips explains. Epcoritamab gives patients with DLBCL an additional treatment option post–CAR T-cell therapy, as well as an accessible alternative for those who are unable to travel to CAR T-cell infusion centers, Phillips concludes.