Regeneron Pharmaceuticals has announced that its investigational bispecific antibody odronextamab has been accepted for priority review by the US Food and Drug Administration (FDA) as a treatment option for certain non-Hodgkin lymphoma patients.
Odronextamab is specifically under review as a treatment for adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) who have progressed after at least two prior systemic therapies.
FL and DLBCL represent the two most common subtypes of B-cell non-Hodgkin lymphoma. FL is a slow-growing form of the disease, and despite many patients being responsive to initial treatment, around 20% are expected to relapse within two years and have shorter remissions with each successive line of therapy.
DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment. As these blood cancers progress, they become increasingly harder to treat, and therapy options become limited.
Regeneron’s odronextamab is designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
The Biologics License Application (BLA) for the candidate is supported by data from the ongoing ELM-1 trial, which is evaluating its safety and tolerability in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy, including an expansion group evaluating DLBCL patients who had progressed on CAR-T therapy.
Additionally, the filing is backed by results from the ongoing phase 2 ELM-2 study of the drug in 375 patients across five independent disease-specific cohorts, including FL, DLBCL, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-cell non-Hodgkin lymphoma.
Regeneron also outlined that it is initiating a “broad phase 3 development programme” to assess odronextamab in earlier lines of therapy and other B-cell non-Hodgkin lymphomas.
The FDA, which has set a target action date of 31 March 2024 for its decision on odronextamab, previously granted the drug Orphan Drug Designation and Fast Track Designation for FL and DLBCL.
A marketing authorisation application for the candidate has also been accepted for review by the European Medicines Agency as a treatment option for adults with R/R FL or R/R DLBCL who have progressed after at least two prior systemic therapies.