– Data Featured as Oral Presentation at ASH 2014 –
San Francisco, CA, December 7, 2014 and Osaka, Japan, December 8, 2014– Takeda Pharmaceutical Company Limited (TSE:4502) today announced results from an open-label, Phase 2 study evaluating the safety and efficacy of oral, single-agent ixazomib (MLN9708) as maintenance therapy in patients with multiple myeloma (MM) who had received ixazomib, lenalidomide and dexamethasone as induction therapy. The data from this trial demonstrate the potential feasibility of single-agent ixazomib maintenance therapy following 12 cycles of ixazomib-lenalidomide-dexamethasone, with deepening responses and an acceptable tolerability profile. These data were presented today at the 56th American Society of Hematology (ASH) annual meeting in San Francisco, CA.
“These findings suggest that treatment with single-agent ixazomib, an investigational oral proteasome inhibitor, in the maintenance setting has the potential to extend depth of response for patients following induction therapy,” said Shaji K. Kumar, MD, Mayo Clinic, Rochester, NY. “The future availability of such an agent in the maintenance setting could represent an important addition to the treatment of patients with multiple myeloma.”
“These data suggest that as an oral proteasome inhibitor, ixazomib may be an important new agent for further clinical investigation in the maintenance therapy of multiple myeloma," said Michael Vasconcelles, M.D., Head, Oncology Therapeutic Area Unit, Takeda. “Indeed, we have recently initiated enrollment into our Phase 3 TOURMALINE-MM3 study to assess the potential benefit of single-agent ixazomib following autologous stem cell transplant. We look forward to this study completing enrollment and follow up, so that important new information about the use of ixazomib in the maintenance setting may be learned.”
The abstract, titled “Long-Term ixazomib maintenance is tolerable and improves depth of response following ixazomib-lenalidomide-dexamethasone induction in patients (pts) with previously untreated multiple myeloma (MM): Phase 2 study results [Abstract #82]” was delivered as an oral presentation by Shaji K. Kumar, MD, Mayo Clinic, Rochester, MN.
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. It is the first oral proteasome inhibitor to enter Phase 3 clinical trials. Four 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; and TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed MM following induction therapy and autologous stem cell transplant. For additional information on the ongoing Phase 3 studies please visit www.tourmalinetrials.com or 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.
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