Regeneron announces new, updated data for odronextamabn in R/R DLBCL

Regeneron Pharmaceuticals announced new and updated data for odronextamab in patients with relapsed/refractory diffuse large B-cell lymphoma, or DLBCL. The data from the pivotal Phase 2 trial and Phase 1 trial were shared in several presentations – including two orals – at the 65th American Society of Hematology Annual Meeting and Exposition. 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. “Diffuse large B-cell lymphoma has a high risk of relapse, which is why it is so critical to demonstrate continued disease control over the long term. The totality of the odronextamab data at ASH reinforces its potential as a promising treatment option for patients with this aggressive blood cancer,” said Sabarish Ram Ayyappan, M.D., medical director of hematologic malignancies, City of Hope Atlanta, and a trial investigator. “The primary analysis from the pivotal trial of odronextamab demonstrated impressive response rates, including in certain high-risk subgroups. Furthermore, these responses were durable and consistent with those seen in a Phase 1 trial in patients who had previously progressed on CAR-T therapy, a population with a very poor prognosis.” Odronextamab is currently under regulatory review for the treatment of R/R DLBCL and R/R FL by the U.S. Food and Drug Administration, with a target action date of March 31, 2024, as well as by the European Medicines Agency. In the U.S., odronextamab has been granted Fast Track Designation for DLBCL and FL by the FDA. In the European Union, odronextamab has been granted Orphan Drug Designation in DLBCL and FL by the EMA. The potential use of odronextamab in R/R DLBCL and R/R FL is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.