The US Food and Drug Administration (FDA) has accepted for priority review the biologics license application for elranatamab to be used as a treatment for patients with relapsed or refractory multiple myeloma (MM).
Elranatamab is a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody. It is designed to elicit T-cell-mediated anti-myeloma activity by binding to BCMA on the surface of MM cells and CD3 receptors on the surface of T cells.
The application is supported by data from cohort A of the single-arm, phase 2 MagnetisMM-3 study (ClinicalTrials.gov Identifier: NCT04649359), which enrolled patients with relapsed/refractory MM who had received at least 3 prior lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The primary endpoint was objective response rate.
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At a median follow-up of 10.4 months, the objective response rate was 61%, and 55% of patients had a very good partial response or better. The probability of patients maintaining a response at 9 months was 84%.
The rate and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were mitigated with a 2-step-up priming dose regimen. All cases of CRS were grade 1-2, and the majority of cases occurred after the first or second dose. All cases of ICANS were grade 1-2 as well.
The FDA is expected to make a decision on the application in 2023.
Reference
Pfizer’s elranatamab receives FDA and EMA filing acceptance. News release. Pfizer. Accessed February 22, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-elranatamab-receives-fda-and-ema-filing-acceptance.
This article originally appeared on MPR
