Takeda protease inhibitor Ninlaro Phase 3 test reached the main end of the test

Today, Takeda announced that its protease inhibitor Ninlaro (ixazomib) as a first-line maintenance therapy, in the treatment of adult patients with multiple myeloma (MM) who have not received stem cell transplant therapy in phase 3 trials, the patient's progression-free survival (PFS) has been significantly improved to reach the main end of the trial.

about the NinlaroNinlaro is the first FDA-approved oral protease inhibitor that selectively binds to PSMB5 sub-base of proteases and inhibits its activity. Previously, it had been approved by the FDA in combination with two other drugs to treat MM patients who had received at least one treatment.Currently, Ninlaro also treats MM patients in a number of critical clinical trials in a joint with other drugs.In this randomized, double-blind, placebo-controlled group of 3 clinical trials, TOURMALINE-MM4, 706 newly diagnosed adult patients who had not received stem cell transplant therapy had completed initial treatment for 6 to 12 months before participating in the trial and received Ninlaro or placebo treatment, respectively, after receiving partial remission.The results showed that PFS in patients treated with Ninlaro showed a statistically significant improvement compared to the placebo group, reaching the main endpoint of the trial. The study aims to validate the concept of switch maintenance therapy, where the maintenance therapy drugs used in the trial are different from those used in the initial induction therapy. Detailed data on the trial will be presented at a future medical conference.
(Drug Information Network)