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Oral Ixazomib Improves Survival in Late-Stage Myeloma Trial
A pivotal phase III study evaluating the safety and efficacy of ixazomib (Takeda Pharmaceutical Company), the first oral proteasome inhibitor, in patients with relapsed or refractory multiple myeloma (MM) has achieved its primary endpoint of improving progression-free survival at the first pre-specified interim analysis.
In the study, patients treated with investigational ixazomib plus lenalidomide and dexamethasone lived without their disease worsening for a significantly longer period compared with patients who received placebo plus lenalidomide/dexamethasone.
The TOURMALINE-MM1 trial was an international, randomized, double-blind, placebo- controlled clinical study designed to compare the efficacy and safety of ixazomib plus lenalidomide/dexamethasone with that of placebo plus lenalidomide/dexamethasone in 722 adult patients with relapsed and/or refractory MM.
The subjects included in the study had a confirmed diagnosis of MM, had received one to three prior therapies, and met other eligibility criteria. Patients who were refractory to lenalidomide or proteasome inhibitor-based therapy were excluded from the trial.
Ixazomib (MLN9708) is being studied in MM, systemic light-chain (AL) amyloidosis, and other malignancies. The compound was granted an “orphan drug” designation for MM in 2011 and for AL amyloidosis in 2012. It also received “breakthrough therapy” status for relapsed and/or refractory AL amyloidosis in 2014.
Ixazomib is the first oral proteasome inhibitor to enter phase III clinical trials. In addition to TOURMALINE-MM1, the drug is being evaluated in TOURMALINE-AL1, which is studying ixazomib plus dexamethasone in patients with relapsed or refractory AL amyloidosis; in TOURMALINE-MM2, which is studying ixazomib versus placebo in combination with lenalidomide and dexamethasone in patients with newly diagnosed MM; and in TOURMALINE-MM3, which is studying ixazomib versus placebo as maintenance therapy in patients with newly diagnosed MM following induction therapy and autologous stem-cell transplant.
Source: Takeda; February 10, 2015.