Regeneron Submits BLA for Odronextamab in R/R DLBCL and FL with Priority Review Granted by FDA

On September 29, Regeneron announced that the Biologics License Application (BLA) for Odronextamab, used to treat relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and relapsed or refractory follicular lymphoma (R/R FL) in patients who have received at least two systemic therapies, has been accepted by the FDA and granted Priority Review, with a PDUFA date of March 31, 2024.

Odronextamab is a CD3/CD20 bispecific antibody developed by Regeneron, which can simultaneously bind to CD20 on cancer cells and CD3 on T cells, thereby promoting localized T cell activation and cancer cell killing.

This BLA is primarily based on the positive results from the Phase I ELM-1 study and Phase II ELM-2 study.

ELM-1 Study is an ongoing multi-center, open-label Phase I clinical trial aimed at evaluating the safety and tolerability of Odronextamab in patients with CD20-positive (CD20+) B-cell malignancies who have previously received CD20-targeted antibody therapy, including an expansion cohort of DLBCL patients whose disease progressed after receiving CAR-T therapy.

ELM-2 is an ongoing multi-center, open-label pivotal Phase II clinical trial that has enrolled 375 patients, including five independent disease-specific cohorts: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and other subtypes of B-cell non-Hodgkin lymphoma (B-NHL). The primary endpoint of the study is the objective response rate (ORR).

Results from the ELM-2 study showed that, in 90 evaluable patients with DLBCL who had received at least second-line treatment, the ORR and complete response (CR) rates were 53% (48/90) and 37% (33/90), respectively, at 17.1 months of follow-up, with a 9-month sustained CR rate of 73%; in 85 evaluable patients with FL who had received at least second-line treatment, the ORR and CR rates were 81% (69/85) and 75% (64/85), respectively, at 17.3 months of follow-up, with a median duration of CR of 18.2 months and a median progression-free survival of 20.2 months.

If approved, Odronextamab will become the first CD3/CD20 antibody to be approved for both DLBCL and FL indications. Currently, there are three CD3/CD20 antibodies approved globally: epcoritamab-bysp (AbbVie/Genmab), mosunetuzumab (Roche/Biogen), and glofitamab (Roche). Among them, epcoritamab-bysp is currently only approved for DLBCL and large B-cell lymphoma (LBCL), mosunetuzumab is currently only approved for FL, and glofitamab is currently only approved for primary mediastinal B-cell lymphoma and DLBCL.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account or send a message, and specify the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.