There was a 47% decrease in the risk of death or progression when isatuximab was added to carfilzomib and dexamethasone (PFS HR=0.531, p=0.0007)
PFS benefit of adding isatuximab was consistent across subgroups, including difficult-to-treat populations such as the elderly, renally impaired patients, and those with high-risk cytogenetic status
6% of participants on isatuximab plus carfilzomib and dexamethasone achieved minimal residual disease negativity (29.6% with Isa-Kd vs. 13.0% with Kd, p=0.0004)
Median time to next treatment (TNT) was not reached in both arms, yet adding isatuximab further delayed TNT (HR=0.566, 95% CI: 0.380-0.841)
Although grade ≥3 treatment emergent adverse events (TEAEs) occurred at a higher incidence with isatuximab plus carfilzomib and dexamethasone, no significant difference in mortality and incidence of serious TEAEs was observed when compared to the carfilzomib and dexamethasone group
Moreau P, et al. Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA phase III study design. Future Oncol. 2020 Jan;16(2):4347-58.
Moreau P, et al. Isatuximab plus carfilzomib and dexamethasone vs carfilzomib and dexamethasone in relapsed/refractory multiple myeloma (IKEMA): interim analysis of a phase 3, randomized, open-label study. EHA25, Abstract LB2603.