Success for ixazomib in TOURMALINE-MM1 pivotal Phase III trial for Multiple Myeloma- Takeda

Takeda Pharmaceutical Company Limited 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 (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 (Celgene's Revlimid) 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.

Comment:Ixazomib is a succesor to Takeda's Velcade (bortezomib) and may be the first oral proteasome inhibitor to reach the market. In this formulation it, offers a more convenient administration compared with the established proteasome inhibitors, which also include Kyprolis (carfilzomib). Velcade and Kyprolis are given intravenously or subcutaneously, and the new Takeda drug having oral delivery route, might lead to fewer side-effects, such as peripheral neuropathy.