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Takeda Begins Phase III Trial of Multiple Myeloma Drug

-- First oral proteasome inhibitor investigated in newly diagnosed patients –

CAMBRIDGE, Mass., May 23, 2013 – Takeda Pharmaceutical Company Limited (TSE:4502)  today announced the initiation of an international phase 3 clinical trial evaluating once a week MLN9708 in combination with lenalidomide and dexamethasone in patients with  newly diagnosed multiple myeloma who are not candidates for transplant. The multi-center study with MLN9708, an investigational, oral proteasome inhibitor, will be conducted in Europe and North America.

“The initiation of this front line myeloma trial represents another first in the development of MLN9708, an oral proteasome inhibitor, and is a major achievement in advancing the Takeda Oncology pipeline,” said Karen Ferrante, M.D, Head of the Takeda Oncology Therapeutic Unit. “The TOURMALINE-MM2 study is the first all oral triplet combination regimen including both a proteasome inhibitor and an IMiD to be investigated in newly diagnosed myeloma patients.”

Study Design

The study, known as TOURMALINE-MM2, is a phase 3, randomized, double-blind, multi-center, international study comparing oral MLN9708 plus lenalidomide and dexamethasone to placebo plus lenalidomide and dexamethasone in patients with newly diagnosed  multiple myeloma who are not candidates for transplant. The primary endpoint is progression-free survival (PFS). Key secondary endpoints include safety, rate of complete response (CR), pain response and overall survival (OS).

About MLN9708

MLN9708 is an investigational oral proteasome inhibitor that is being studied in multiple myeloma, various other hematologic malignancies and solid tumors. It is the first oral proteasome inhibitor to enter clinical trials. Two global phase 3 trials, TOURMALINE-MM1, to investigate MLN9708 in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma and TOURMALINE-AL1, to investigate MLN9708 plus dexamethasone in patients with relapsed or refractory light chain AL amyloidosis were initiated in 2012. For additional information on the ongoing phase 3 studies please visit  and

Editor’s Note: This press release is also available under the Media section of the Company’s website at:

About Takeda

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 patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website,

Manisha Pai

David Albaugh

Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
Tel: +81-3-3278-2037

Posted: May 2013