Daily Newsletter

05 February 2024

Daily Newsletter

05 February 2024

Regeneron’s linvoseltamab application accepted for review

The latest submission is based on findings from the Phase I/II LINKER-MM1 trial of linvoseltamab in relapsed/refractory (r/r) multiple myeloma (MM) patients.

Vishnu Priyan February 05 2024

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.

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.

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