Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited has initiated an international phase III clinical trial evaluating MLN9708 in patients with relapsed and/or refractory multiple myeloma. The multi-centre study with MLN9708, an investigational, oral proteasome inhibitor, will be conducted in Europe, North America, Latin America and the Asia-Pacific region.

“As the leader in the area of protein homeostasis Millennium continually strives to develop new therapies and new options to meet the needs of patients dealing with cancer,” said Karen Ferrante, MD, chief medical officer, Millennium. “This is the first all oral combination regimen, which includes a proteasome inhibitor and IMiD being studied in multiple myeloma. The initiation of this trial represents another major achievement in advancing the Millennium pipeline.”

The study, known as TOURMALINE-MM1, is a phase III, randomized, double-blind, multi-center, international study comparing oral MLN9708 plus lenalidomide and dexamethasone to placebo plus lenalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma. The primary endpoint is progression-free survival (PFS). Secondary endpoints include safety, overall survival (OS), OS in high-risk patients, overall response rate (ORR), duration of response (DOR) and time to progression (TTP).

MLN9708 is an investigational oral, potent, proteasome inhibitor, which is being studied in multiple myeloma, various hematologic malignancies and solid tumors. It is the first oral proteasome inhibitor to enter clinical trials in patients.

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in oncology.

Takeda is a research-based global company with its main focus on pharmaceuticals. It is committed to strive towards better health for patients worldwide through leading innovation in medicine.