Takeda Pharmaceutical Company Limited has announced that the double-blind, placebo-controlled TOURMALINE-MM1 pivotal Phase 3 study assessing the efficacy and safety of ixazomib for the treatment of patients with relapsed or refractory multiple myeloma achieved its primary endpoint of improving progression-free survival at an interim analysis. Ixazomib is an investigational oral proteasome inhibitor being studied in various malignancies.
For the study, researchers enrolled 722 adult patients with relapsed or refractory multiple myeloma and randomly assigned them to receive ixazomib plus lenalidomide and dexamethasone or placebo plus lenalidomide and dexamethasone.
All participants had received between one and three prior therapies, and no patients refractory to lenalidomide or proteasome inhibitor-based therapy were included.
Ixazomib is the first oral proteasome inhibitor, but is in the same class of drugs as bortezomib and carfilzomib. It is currently being evaluated in four Phase 3 studies for the treatment of relapsed or refractory multiple myeloma, relapsed or refractory systemic light-chain amyloidosis, newly diagnosed multiple myeloma, and as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplantation.
Ixazomib for the treatment of relapsed or refractory multiple myeloma achieved its primary endpoint.
Takeda announces that the first interim analysis of the Phase 3 study of oral ixazomib in patients with relapsed or refractory multiple myeloma met the primary endpoint of improvement in progression-free survival.