Millennium: The Takeda Oncology Company has announced the start of an international Phase 3 clinical trial evaluating its compound to treat patients with cancer of blood plasma in bone marrow.
The Cambridge company and its parent, Takeda Pharmaceutical Company Limited in Japan, will conduct the multi-center study with MLN9708, an investigational, oral proteasome inhibitor.
The study, known as Tourmaline-MM1, is a randomized, double-blind study to be conducted in centers in Europe, North America, Latin America and the Asia-Pacific region. It will compare oral MLN9708 plus lenalidomide and dexamethasone to a placebo (plus lenalidomide and dexamethasone) in patients with relapsed and/or refractory multiple myeloma. The primary endpoint is progression-free survival, while secondary endpoints include safety, survival in high-risk patients, overall response rate, duration of response and time to progression.
Earlier in June, the company announced "encouraging? results of three studies - two Phase 1, and one Phase 1/2 - of the same compound. The Phase 2 portion of the MLN9708 study found that of the 46 patients who completed four or more cycles of therapy, 26 percent achieved a complete response (disappearance of all signs of cancer), and 46 percent achieved a very good partial response rate or better.
?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, M.D., Chief Medical Officer of Millennium, in a statement. ?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.?
Millennium is also conducting a Phase 3 trial in conjunction with Seattle Genetics Inc. of Bothell, Wash. to evaluate Adcetris, a drug candidate for patients with CD30-expressing relapsed cutaneous T-cell lymphoma. The company announced the start of the trial in May.
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