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. It can simultaneously bind to CD20 on cancer cells and CD3 on T cells, thereby promoting local 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 ongoingMultiple ChinaHeart,An open-label Phase I clinical trial aimed to evaluate the safety and tolerability of Odronextamab in CD20-positive (CD20+) B-cell malignancy patients who have received CD20-targeted antibody drug treatments, including an expanded cohort of DLBCL patients with disease progression after CAR-T therapy.ELM-2 is an ongoing multi-center, open-label pivotal Phase II clinical trial, enrolling a total of 375 patients, including those with DLBCL, FL, mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and others.B-cell Non-Hodgkin Lymphoma (B-NHL) Subtype5 IndependentTheDisease-Specific Cohort. The primary endpoint of the study is the objective response rate (ORR).The results of the ELM-2 study showed,Among 90 evaluable patients with DLBCL who had received at least second-line treatment, the ORR and complete response (CR) rates at 17.1 months of follow-up were 53% (48/90) and 37% (33/90), respectively, and the sustained CR rate at 9 months was 73%; among 85...Efficacy can be evaluated in the exampleAt leastAffectedOver TwoLine TherapyTheIn FL patients, the ORR and CR rates at 17.3 months of follow-up were 81% (69/85) and 75% (64/85), respectively. The median duration of response for CR was 18.2 months, and the median progression-free survival was 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, which areepcoritamab-bysp (AbbVie/Genmab),Mosunetuzumab (Roche/Biogen) andGefitumab (Roche). Among them,Epcoritamab-bysp is currently only approved for use in DLBCL and large B-cell lymphoma (LBCL).Mosunetuzumab is currently only applicable to FL.Gefitumab is currently only applicable inPrimary Mediastinal B-cell Lymphoma and DLBCL.Copyright © 2023 PHARMCUBE. All Rights Reserved.
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