Takeda announced the 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 addition of ixazomib to lenalidomide and dexamethasone improved median progression-free survival of 13.5 months (35.3 months versus 21.8 months); however, it did not meet the threshold for statistical significance. The safety was generally consistent with the existing Ninlaro prescribing information.
TOURMALINE-MM2 is an international, randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial, designed to evaluate Ninlaro (ixazomib) plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone, in 705 adults with newly diagnosed multiple myeloma who are not candidates for transplant. The primary endpoint is progression-free survival (PFS). Key secondary endpoints include rate of complete response (CR), pain response and overall survival (OS).
According to Takeda, investigators have been informed of the results and have been advised to discuss the potential impact with study participants. For patients currently enrolled in this study, it will be at the discretion of physicians to continue their current treatment.
Results from the TOURMALINE-MM2 study will be submitted to an upcoming medical congress.
About Ninlaro (ixazomib)
Ninlaro (ixazomib) is an oral proteasome inhibitor.
Ninlaro was approved by the U.S. FDA in November 2015 for use in combination with lenalidomide and dexamethasone for 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.