Cambridge, Mass. and Osaka, Japan, February 10, 2015 – Takeda Pharmaceutical Company Limited (TSE:4502) 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.
"We are very pleased with the outcome of this interim analysis of the pivotal trial, and are excited about the potential that investigational ixazomib holds for patients with multiple myeloma," said Dixie-Lee Esseltine, MD, FRCPC, Vice President, Oncology Clinical Research, Takeda. "We thank the patients and investigators for their engagement and continued participation in this ongoing clinical evaluation of ixazomib."
About the TOURMALINE-MM1 Study
The study (n=722) is an international, randomized, double-blind, placebo controlled clinical trial designed to compare the efficacy and safety of two treatment regimens administered until progression – ixazomib plus lenalidomide and dexamethasone versus placebo plus lenalidomide and dexamethasone – in adult patients with relapsed and/or refractory MM.
Subjects included in the study had a confirmed diagnosis of MM, received one to three prior therapies and meet other outlined eligibility criteria. Patients who were refractory to lenalidomide or proteasome inhibitor-based therapy were excluded.
Ixazomib (MLN9708) is an investigational oral proteasome inhibitor, which is being studied in multiple myeloma (MM), systemic light-chain (AL) amyloidosis and other malignancies. Ixazomib was granted orphan drug designation in MM in both the U.S. and Europe in 2011, and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Breakthrough Therapy status by the U.S. Food and Drug Administration (FDA) for relapsed and/or refractory AL amyloidosis in 2014. It is also the first oral proteasome inhibitor to enter Phase 3 clinical trials. Four global Phase 3 trials are ongoing: TOURMALINE-MM1, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in relapsed and/or refractory MM; TOURMALINE-AL1, investigating ixazomib plus dexamethasone in patients with relapsed or refractory AL amyloidosis; TOURMALINE-MM2, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in patients with newly diagnosed MM; and TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed MM following induction therapy and autologous stem cell transplant. For additional information on the ongoing Phase 3 studies please visit www.clinicaltrials.gov.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
Takeda Pharmaceutical Company Limited
Corporate Communications Dept.