Drug: odronextamab
Odronextamab is a bispecific antibody targeting CD20 and CD3; the U.S. Food and Drug Administration (FDA) previously denied an application for the use of odronextamab in diffuse large B-cell lymphoma.
Developer: Regeneron
Indication: relapsed or refractory (R/R) follicular lymphoma (FL)
Expected PDUFA Date: July 30, 2025
Summary of Key Studies
The phase II ELM-2 study enrolled 128 patients with R/R FL who had exposure to two or more prior lines of therapy. All patients received intravenous odronextamab in 21-day cycles with step-up dosing used in cycle one. The primary endpoint was objective response rate.
Eighty percent of patients achieved objective response, with more than 90% of responders achieving a complete response (CR of 73.4%). Median duration of response was longer than two years at 25.1 months.
Common adverse events (AEs) included cytokine release syndrome (CRS), which occurred in 56% of patients; grade 3 CRS occurred in 1.7% of patients. Other common AEs included neutropenia (39%) and pyrexia (38%).
All information was current as of press time.
A Chat with Joshua Brody, MD
Joshua Brody, MD, director of the Lymphoma Immunotherapy Program at the Icahn School of Medicine at Mount Sinai in New York, told ASH Clinical News that “the potential FDA approval of odronextamab for R/R FL will create another highly effective chemo-free option for these patients.”
However, he noted that the immediate effect of this approval would be moderate given the prior approval of two other CD20xCD3 bispecific antibodies for R/R FL: mosunetuzemab and epcoritamab.
“However, the future impact may be great, as all of these bispecifics are now being tested as first-line FL therapies in large, randomized trials and will likely lead to approvals in that setting in the not-too-distant future,” Dr. Brody said.
Information compiled by and interview conducted by Leah Lawrence, a freelance health writer and editor based in Delaware.
Reference
Kim TM, Taszner M, Novelil S, et al. Safety and efficacy of odronextamab in patients with relapsed or refractory follicular lymphoma. Ann Oncol. 2024;35(11):1039-1047.
