Interim analysis during a phase 3 study of Ixazomib in patients with relapsed or refractory multiple myeloma found that the drug improved the primary endpoint of progression-free survival.
Takeda Pharmaceutical Company Limited today announced that the randomized, double-blind, placebo-controlled TOURMALINE-MM1 pivotal Phase 3 trial evaluating the safety and efficacy of ixazomib, the first oral proteasome inhibitor, conducted in patients with relapsed or refractory multiple myeloma (MM) achieved its primary endpoint of improving progression-free survival at the first pre-specified interim analysis. In the trial, patients treated with investigational ixazomib plus lenalidomide and dexamethasone lived without their disease worsening for a significantly longer time compared to patients who received placebo plus lenalidomide/dexamethasone.
Efficacy and safety data were reviewed by an Independent Data Monitoring Committee (IDMC). Takeda intends to submit these data to health authorities globally for marketing authorizations.
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