Top-line Ph III results of Takeda’s oral ixazomib met primary endpoint

Japan’s largest drugmaker Takeda Pharmaceutical (TYO; 4502) announced that the randomized, double-blind, placebo-controlled TOURMALINE-MM1 pivotal Phase III trial evaluating the safety and efficacy of ixazomib, the first oral proteasome inhibitor, conducted in patients with relapsed or refractory multiple myeloma 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.