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Takeda Initiates TOURMALINE-MM2 Pivotal Phase 3 Trial of MLN9708 in Patients with Newly Diagnosed Multiple Myeloma

  Takeda Initiates TOURMALINE-MM2 Pivotal Phase 3 Trial of MLN9708 in Patients
  with Newly Diagnosed Multiple Myeloma

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

Business Wire

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
www.tourmalinetrialal1.com and www.tourmalinetrialmm1.com

Editor’s Note: This press release is also available under the Media section of
the Company’s website at: www.millennium.com/InTheNews.aspx.

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, www.takeda.com.

Contact:

Manisha Pai, +1-617-551-7877
Manisha.pai@mpi.com
or
David Albaugh, +1-617-444-4456
david.albaugh@mpi.com
or
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
+81-3-3278-2037
 
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