Regeneron announces data on trial of odronextamab to treat R/R FL

Regeneron Pharmaceuticals announced positive first data from a cohort of a pivotal Phase 2 trial evaluating investigational odronextamab in patients with heavily pre-treated, relapsed/refractory R/R follicular lymphoma grades 1 to 3a. The data were presented in an oral session at the 64th American Society of Hematology Annual Meeting and Exposition in New Orleans, LA, and follow the first Phase 2 results for odronextamab in R/R diffuse large B-cell lymphoma DLBCL from the same trial that were presented yesterday. The results will form the basis of planned submissions to regulatory authorities in 2023, including to the U.S. Food and Drug Administration . Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing."There is high unmet need for follicular lymphoma treatments that can improve tumor control and extend survival, given that there is no cure for this cancer and patients will experience multiple relapses," said Tae Min Kim, M.D., Ph.D., Department of Internal Medicine, Seoul National University Hospital in Seoul, South Korea, and a trial investigator. "These positive pivotal Phase 2 results investigating odronextamab in heavily pre-treated, relapsed/refractory follicular lymphoma patients showed deep and durable response – confirming earlier findings in this program – with the highest complete response rates seen in this patient population to date. We look forward to seeing the data continue to mature."