Odronextamab

Odronextamab is a hinge-stabilized, fully human immunoglobulin G4 (IgG4)-based CD20×CD3 bispecific antibody currently evaluated for the treatment of relapsed/refractory (R/R) B-Cell non-Hodgkin lymphoma (NHL). Preliminary studies have shown that in patients with R/R NHL, the use of odronextamab does not lead to the development of neurologic toxicity; however, it can lead to the development of cytokine release syndrome (CRS), a serious condition associated with the use of immunotherapy. In December 2020, the FDA placed a partial clinical hold and requested the drug developer, Regeneron Pharmaceuticals, to amend clinical protocols to reduce the incidence of CRS. The partial clinical hold was later lifted in May 2021.

A phase I clinical study (NCT02290951) showed that in heavily pre-treated patients with B-cell non-Hodgkin lymphoma, odronextamab elicited a durable response with a manageable safety profile.