An investigational bispecific antibody, linvoseltamab is aimed at adults with relapsed/refractory (r/r) MM who have undergone treatment with a minimum of three previous therapies.
A decision on the regulatory approval from the FDA is anticipated by 22 August 2024.
The BLA for linvoseltamab is based on data from a current Phase I/II clinical trial known as LINKER-MM1. This open-label, multicentre trial enrolled 282 subjects.
The completed Phase I dose-escalation segment of the trial evaluated the tolerability, safety and dose-limiting toxicities linked to linvoseltamab at nine dose levels and on varying administration schedules.
The ongoing Phase II dose-expansion stage will analyse the anti-tumour efficacy and safety of the therapy.
The clinical development programme for linvoseltamab includes the LINKER-MM3 Phase III confirmatory trial for R/R MM patients, which is currently recruiting participants.
Plans are in place for further trials targeting earlier stages of the disease and different lines of therapy, such as a Phase I/II trial for first-line therapy, a Phase II trial for high-risk smouldering MM, and a Phase II trial for monoclonal gammopathy of undetermined significance.
A Phase I trial is also planned to explore the combination of linvoseltamab with a Regeneron CD38xCD28 costimulatory bispecific in MM treatment.
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