Phase III TOURMALINE-MM3 study of Ninlaro meets primary endpoint in multiple myeloma.- Takeda Pharma.

Takeda Pharmaceutical announced that the randomized, Phase III TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral Ninlaro (ixazomib) as a maintenance therapy in multiple myeloma resulted in a statistically significant improvement in progression-free survival (PFS) versus placebo. The trial evaluated the effect of Ninlaro as a maintenance therapy in adult patients diagnosed with multiple myeloma who responded to high-dose therapy (HDT) and autologous stem cell transplant (ASCT). There were no new safety signals found in TOURMALINE-MM3. The safety profile of Ninlaro in the maintenance setting is consistent with previously reported results of single-agent Ninlaro use.

Full data results will be submitted for presentation at the 60th American Society of Hematology Annual Meeting in December. Takeda plans to submit data from the trial to regulatory agencies around the world. Ninlaro is currently not approved as a maintenance therapy for multiple myeloma following ASCT.

Comment: Ninlaro was approved by the FDA in November 2015 following a priority review and by the European Commission in November 2016. In the U.S. and Europe, Ninlaro is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.