Summary of Clinical Use

Odronextamab (REGN1979) is in clinical evaluation to determine efficacy as a treatment for advanced B cell malignancies. Early evidence of activity against heavily pretreated B cell non-Hodgkin lymphoma was reported from a phase 1 study, in 2022 [1]. It was designated as an orphan medicine for the treatment of diffuse large B cell lymphoma in the European Union in July 2022. Full EMA authorisation was granted in September 2024, as a monotherapy to treat pretreated relapsed/refractory follicular lymphoma [2]

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT02290951	Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies	Phase 1 Interventional	Regeneron Pharmaceuticals		1
NCT05685173	A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Participants With Aggressive B-cell Non-Hodgkin Lymphomas	Phase 1 Interventional	Regeneron Pharmaceuticals
NCT03888105	A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated	Phase 2 Interventional	Regeneron Pharmaceuticals
NCT06091865	A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma	Phase 3 Interventional	Regeneron Pharmaceuticals		1
NCT06149286	A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma	Phase 3 Interventional	Regeneron Pharmaceuticals
NCT06091254	A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma	Phase 3 Interventional	Regeneron Pharmaceuticals