Isatuximab meets primary endpoint in Phase III multiple myeloma trial

Written by Jade Parker, Editor

It has been reported that isatuximab has met its primary endpoint of prolonging progression free survival in relapsed/refractory multiple myeloma patients treated with isatuximab in combination with pomalidomide and lowdose dexamethasone versus pomalidomide and low-dose dexamethasone alone (standard of care).

The multi-center, randomized, open label Phase III study, known as ICARIA-MM, enrolled 307 patients with relapsed/refractory multiple myeloma across 96 centers spanning 24 countries.

All study participants received two or more prior anti-myeloma therapies, including at least two consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination.

During the trial, isatuximab, which is an anti-CD38 treatment, was administered through an intravenous infusion at a dose of 10mg/kg once weekly for 4 weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment. The safety profile was evaluated as a secondary endpoint.

The results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year.

Find out more about the ICARIA-MM study here.


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Isatuximab in relapsed/refractory multiple myeloma: ICARIA Phase III study design