Phase III TOURMALINE-MM1 Study for for ixazomib; first and only once-weekly oral proteasome inhibitor recently approved for multiple myeloma

Results from the TOURMALINE-MM1 trial were presented at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH 2015), showing that treatment with ixazomib capsules is effective in extending progression free survival with a manageable tolerability profile in patients with relapsed and/or refractory multiple myeloma.

The TOURMALINE-MM1 trial is an international, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate once-weekly oral ixazomib plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone.

Ixazomib was recently approved by the U.S. Food and Drug Administration (FDA) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

The approval was based on the Phase III TOURMALINE-MM1 data, which were highlighted at today’s ASH press briefing.

Ixazomib data was featured in 18 presentations at this year’s ASH meeting, including an oral presentation on Phase II data from an investigational study evaluating the all-oral combination of ixazomib plus cyclophosphamide and low-dose dexamethasone (ICd) in newly diagnosed multiple myeloma patients.

“The data presented at ASH this year are the first major output from the comprehensive ixazomib clinical trial program, TOURMALINE, demonstrating Takeda’s ongoing commitment to providing effective and convenient treatment options for patients with multiple myeloma,” said Andy Plump, M.D., Ph.D, Takeda Chief Medical and Scientific Officer.

“The breadth and depth of the TOURMALINE program allows us to gather important data across a broad range of patients that live with multiple myeloma and to expand on the efficacy and safety profile of our oral proteasome inhibitor, ixazomib. We will continue this and other important clinical trials and look forward to sharing results over the next few years.”

“Research has shown that the combination of a proteasome inhibitor with cyclophosphamide and dexamethasone is active in patients with multiple myeloma. As treatment practices for multiple myeloma can vary across regions, it is important that we gain an understanding of the utility of ixazomib in a number of combination settings,” said Meletios A. Dimopoulos, M.D., National and Kapodistrian University of Athens, School of Medicine. “Preliminary data suggest that this may be a viable all-oral triplet regimen. We are committed to gathering additional data of ixazomib in this investigational setting.”

Watch the press conference and video interview for more information.

Source: ASH / Takeda