Source: Myeloma – Hematology Advisor

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab for the treatment of adults with relapsed/refractory multiple myeloma.

The BLA is supported by data from the phase 1/2 LINKER-MM1 trial (ClinicalTrials.gov Identifier: NCT03761108), which evaluated linvoseltamab, a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody, in patients with relapsed/refractory multiple myeloma who have progressed after at least 3 prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. 

Data from 117 evaluable patients (27% of whom were over 75 years old) showed that at a median duration of follow-up of 11 months, the objective response rate was 71%, with 46% of patients achieving a complete response or better. Patients who achieved a very good partial response or better after at least 24 weeks of treatment were allowed to switch from every 2 week dosing to every 4 week dosing. 

As for safety, 85% of patients treated with linvoseltamab experienced a grade 3 or higher adverse event. The most common adverse event reported was cytokine release syndrome (46%). Adjudicated immune effector cell-associated neurotoxicity syndrome (ICANS) events occurred in 9 patients (8% all grades), of which 3 patients experienced grade 3 ICANS.

A Prescription Drug User Fee Act target date of August 22, 2024 has been set for this application.

Regeneron is currently enrolling patients with relapsed/refractory multiple myeloma in the confirmatory phase 3 LINKER-MM3 trial (ClinicalTrials.gov Identifier: NCT05730036), which is comparing the efficacy and safety of linvoseltamab to a combination therapy consisting of elotuzumab, pomalidomide, and dexamethasone.

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