Officials are Takeda Pharmaceutical Company Limited recently released the results from its randomized, international, placebo-controlled, double-blind, phase-three trial for Ninlaro, the first oral proteasome inhibitor.
The results, available in The New England Journal of Medicine (NEJM), showed that Ninlaro can lengthen the progression-free survival of patients who have relapsed or refractory multiple myeloma.
The new treatment accomplished this with limited additional toxicity.
“NEJM has published the results of the first phase-three study supporting an all-oral triplet regimen containing a proteasome inhibitor in multiple myeloma,” Philippe Moreau, study co-author and lead investigator from the University of Nantes, France, said. “With the emergence of long-term treatment as a preferred approach for multiple myeloma, it is crucial that we investigate more ways to improve treatment sustainability for patients. The Tourmaline-MM1 results demonstrated that ixazomib in combination with lenalidomide and dexamethasone is an effective and tolerable oral regimen with a manageable safety profile for patients with relapsed and/or refractory multiple myeloma.”
The study involved once-weekly oral Ninlaro capsules along with dexamethasone and lenalidomide. The treatments were compared to a placebo that included lenalidomide-dexamethasone for the patients.
“The publication of the phase-three Tourmaline-MM1 trial results is another important milestone for patients and physicians,” Dixie-Lee Esseltine, vice president of Takeda's oncology clinical research, said. “This reflects invaluable efforts from our researchers, the study investigators, the patients and their families. The publication concluded that the addition of ixazomib to lenalidomide and dexamethasone was associated with significantly longer progression-free survival; the additional toxic effects with this all-oral regimen were limited. We look forward to sharing additional ixazomib data from our ongoing Tourmaline studies over the next few years.”
