Regeneron Pharmaceuticals marketing authorisation application (MAA) for linvoseltamab has received acceptance for review from the European Medicines Agency (EMA) to treat adults with r/r MM.
Linvoseltamab is a bispecific antibody designed to target and destroy cancer cells by bridging the B cell maturation antigen on MM cells with CD3 (cluster of differentiation 3, a protein complex)-expressing T cells.
The MAA submission is based on findings from the Phase I/II LINKER-MM1 clinical trial of linvoseltamab in r/r MM patients.
The open-label, multicentre, dose-escalation and dose-expansion study is designed to evaluate the investigational drug in patients who have undergone multiple prior treatments.
All 282 enrolled trial subjects had received a minimum of three lines of therapy or were considered triple refractory. They subsequently received linvoseltamab through an initial step-up dosing regimen, followed by a full dose.
The completed Phase I portion of the trial evaluated the tolerability, safety and dose-limiting toxicities of linvoseltamab at nine dose levels and on varying administration regimens.
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The Phase II portion aims to analyse the anti-tumour activity and safety of linvoseltamab, with the primary objective being the objective response rate.
In addition to the EMA submission, a biologics licence application for linvoseltamab was submitted to the US Food and Drug Administration (FDA) in December 2023.
The comprehensive linvoseltamab clinical development programme includes the Phase III LINKER-MM3 confirmatory trial, which is currently enrolling patients.
Further trials are planned or underway in earlier lines of therapy and disease stages, including a Phase I/II study in the first-line setting, a Phase II trial in high-risk smouldering MM, and a Phase II trial in monoclonal gammopathy of undetermined significance.
A Phase I trial of linvoseltamab and a CD38xCD28 costimulatory bispecific in MM is planned.
Linvoseltamab’s safety and efficacy are yet to be fully evaluated by any regulatory authority.
In December 2023, the company formed Regeneron Cell Medicines, a new research and development unit focused on advancing cell therapies in oncology and immunology.
