Takeda Oncology announced results from the TOURMALINE-MM2 study designed to evaluate the addition of Ninlaro (ixazomib) to lenalidomide and dexamethasone in newly diagnosed transplant ineligible multiple myeloma patients. The trial did not meet statistical significance for the primary endpoint of progression-free survival (PFS).
TOURMALINE-MM2 was an international, randomized, double-blind, multicenter, placebo-controlled trial conducted in 705 adult patients with newly diagnosed multiple myeloma who were not candidates for transplant. The addition of ixazomib to lenalidomide and dexamethasone resulted in an improvement in median progression-free survival (PFS) of 13.5 months (35.3 months versus 21.8 months); however, it did not meet the threshold for statistical significance. The safety profile was generally consistent with the existing prescribing information.
Results from the TOURMALINE-MM2 study will be submitted to an upcoming medical conference.
About Ninlar (ixazomib) capsules
Ninlaro is an oral proteasome inhibitor. Ninlaro was approved by the U.S. Food and Drug Administration (FDA) in November 2015 and is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ninlaro is currently approved in more than 60 countries, including the United States, Japan and in the European Union, with more than 10 regulatory filings currently under review.
About Multiple Myeloma
Multiple myeloma is a life-threatening rare blood cancer that arises from the plasma cells, a type of white blood cell that is made in the bone marrow. These plasma cells become abnormal, multiply and release a type of antibody known as a paraprotein, which causes symptoms of the disease, including bone pain, frequent or recurring infections and fatigue, a symptom of anemia. These malignant plasma cells have the potential to affect many bones in the body and can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count. The typical multiple myeloma disease course includes periods of symptomatic myeloma followed by periods of remission. Nearly 230,000 people around the world live with multiple myeloma, with approximately 114,000 new cases diagnosed globally each year.