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.