Cambridge, MA, and Osaka, Japan, May 12, 2015 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the first patient has been enrolled in the Phase 3 TOURMALINE-MM4 study of investigational oral ixazomib. This is a superiority study designed to demonstrate whether sustained proteasome inhibition, delivered orally, improves the long term clinical outcomes of people living with multiple myeloma.
The Phase 3 TOURMALINE-MM-4 study will evaluate the role of ixazomib maintenance therapy compared with placebo on the primary endpoint of progression-free survival (PFS) in patients with newly diagnosed multiple myeloma who have responded to initial therapy and have not undergone an autologous stem cell transplant (ASCT). This study complements an actively enrolling Phase 3 maintenance study (TOURMALINE-MM3) in patients who do receive ASCT. Proteasome inhibition is an established mechanism of action and long-term therapy is emerging as a standard of care in multiple myeloma.
"We are excited to initiate our second Phase 3 maintenance study which will provide data for patients who do not receive transplant due to age, comorbities or other factors. The breadth of our ixazomib development program, which now has a pivotal trial in every major multiple myeloma patient population, demonstrates our commitment to patients battling this disease," said Michael Vasconcelles, M.D., Global Head of the Takeda Oncology Therapeutic Unit. "Takeda Oncology has deep experience in multiple myeloma and greatly appreciates the efforts of the patients and families who participate in our clinical programs."
The TOURMALINE-MM4 study is the fifth in ixazomib's Phase 3 clinical development program, which is evaluating the use of ixazomib in various multiple myeloma settings and in relapsed, refractory systemic light-chain (AL) amyloidosis, a rare but severe plasma cell disorder.
About the TOURMALINE-MM4 Study
The study is an international, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of maintenance ixazomib therapy – compared to placebo – in adult patients with newly diagnosed multiple myeloma. Eligible study participants have responded to initial multiple myeloma therapy and have not undergone ASCT. The study is investigating the effect of ixazomib on the primary endpoint of PFS, or the length of time that participants are free of disease progression or death. Overall survival and safety are secondary endpoints.
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. Five 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;
TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed MM following induction therapy and autologous stem cell transplant (ASCT);
TOURMALINE-MM4, investigating ixazomib vs. placebo as maintanence therapy in patients with newly diagnosed MM who have not undergone ASCT.
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.