Regeneron's Bispecific Antibody Linvoseltamab Receives FDA Priority Review with 71% ORR in Heavily Pretreated Relapsed/Refractory Multiple Myeloma

Feb 22, 2024 08:40 CST Updated 08:41

Regeneron

Biopharmaceutical Manufacturer

▎WuXiEdited by Kant Content Team

Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted the Biologics License Application (BLA) for its bispecific antibody therapy linvoseltamab, which targets B-cell maturation antigen (BCMA) and CD3, and granted it Priority Review for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have progressed following at least three prior lines of therapy.The PDUFA date for this application is August 22, 2024.

Linvoseltamab is aA bispecific antibody designed to bridge BCMA on multiple myeloma cells with CD3-expressing T cells, promoting T-cell activation and cancer cell killing.。

The submission of this application is based on the results of the pivotal Phase 1/2 clinical trial, LINKER-MM1. The trial results, published in December last year, showed that at a median follow-up time of 11 months,In the Phase 1/2 clinical trial (n=117), patients treated with a dose of 200 mg linvoseltamab showed an objective response rate of 71%, with 46% achieving complete response or better.

‍

As of the latest data cutoff date, all patients receiving 200 mg of treatment experienced adverse events (AEs), with 85% of patients experiencing Grade ≥3 adverse events (AEs). The most frequently reported AE was cytokine release syndrome (CRS;‍46%）。In CRS cases, the majority (35%) were Grade 1, 10% were Grade 2, and one case (1%) was Grade 3 CRS.

LinvosEltamab has been granted Fast Track designation by the U.S. FDA for the treatment of multiple myeloma.

The ability of bispecific antibodies to target two different antigens provides these molecules with significant flexibility. Approved therapies include not only T-cell redirection therapies that recruit T cells to tumor cells expressing specific antigens, but also treatment modalities that enhance specificity and potency by targeting two different antigens. Bispecific antibodies can also target different epitopes of the same antigen, assist large molecules in crossing the blood-brain barrier, and act as cofactors to activate signaling pathways, among other mechanisms of action. This innovative treatment modality holds great promise for benefiting more patients in the future.

▲Potential Mechanisms of Action of Bispecific Antibodies (Image Source: Reference [2])

Everyone is watching

▲ To learn more about the application of cutting-edge technologies in the biopharmaceuticals industry, please long press and scan the QR code above to access "WuXi Live Studio" and watch live discussions and exciting replays on related topics.

References:

[1] Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review. Retrieved February 21, 2024 fromhttps://www.globenewswire.com/news-release/2024/02/21/2832630/0/en/Linvoseltamab-BLA-for-Treatment-of-Relapsed-Refractory-Multiple-Myeloma-Accepted-for-FDA-Priority-Review.html

[2] Labrijn et al., (2019). Bispecific antibodies: a mechanistic review of the pipeline. Nature Reviews Drug Discovery, https://doi.org/10.1038/s41573-019-0028-1

Disclaimer:WuXi AppTec Content Team Focuses on Introducing Global Biomedical and Health Research Progress.This article is for informational exchange purposes only. The views expressed in the article do not represent the position of WuXi AppTec, nor does WuXi AppTec support or oppose the views mentioned in the article.This article is not a recommendation for treatment options.For guidance on treatment options, please visit a正规 hospital.

Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media platforms, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain the reprint guidelines.

Share，PointLike，In view, Focus on Global Biomedical Health Innovation