Takeda Pharmaceutical announced their Phase 3 TOURMALINE-MM-4 study examining the safety and efficacy of ixazomib to treat multiple myeloma has begun.
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. The primary endpoint is progressive free survival (PFS). Overall survival and safety are secondary endpoints.
Ixazomib (MLN9708) is an oral proteasome inhibitor being examined in a number of studies involving multiple myeloma and systemic light-chain (AL) amyloidosis. Ixazomib was granted orphan drug designation for multiple myeloma and systemic light-chain (AL) amyloidosis in both the U.S. and Europe in 2011.
The TOURMALINE-MM-4 study is the fourth Phase 3 study the company has sponsored for ixazomib. In total, 5 global Phase 3 trials are underway:
TOURMALINE-MM1, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in relapsed and/or refractory MM;
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;
TOURMALINE-AL1, investigating ixazomib plus dexamethasone in patients with relapsed or refractory AL amyloidosis.
The TOURMALINE-MM4 study involves patients with newly diagnosed multiple myeloma who have responded to initial therapy and have not undergone an ASCT. The study complements the Phase 3 TOURMALINE-MM3 study involving patients who do receive ASCT.
Michael Vasconcelles, M.D., Global Head of the Takeda Oncology Therapeutic Unit (formerly known as Millennium Pharmaceutics) said, “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.”
Multiple myeloma is a hematologic cancer caused by the production and growth of abnormal cells within the plasma, which multiply and build up in the bone marrow. Multiple myeloma is an incurable disease with a high rate of relapse (cancer returns) and patients often become refractory (unresponsive to therapy), despite currently available treatments.
Currently, the only proteasome inhibitors available for treating multiple myeloma are bortezomib (Velcade) and carfilzomib (Kyprolis) which are administered intravenously or by subcutaneous injection.
Takeda Announces First Patient Enrolled in Global Phase 3 Study of Ixazomib as Maintenance Therapy for Newly Diagnosed Multiple Myeloma [press release]. Cambridge, MA and Osaka, Japan: Takeda Pharmaceutical Company Limited; May 12, 2015. http://www.businesswire.com/news/home/20150511006534/en/Takeda-Announces-Patient-Enrolled-Global-Phase-3#.VVHjFGb1h9I