Phase III trial with Ninlaro meets primary endpoint as first line maintenance treatment of multiple myeloma.- Takeda

Takeda Pharmaceutical will present positive results from TOURMALINE-MM4, a Phase III, randomized clinical trial evaluating the effect of single-agent oral Ninlaro (ixazomib) as a first-line maintenance therapy in adult patients diagnosed with multiple myeloma who had not been treated with stem cell transplantation. The TOURMALINE-MM4 trial achieved its primary endpoint, with treatment with Ninlaro resulting in a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation (hazard ratio [HR] 0.659; CI: 95; p <0.001). this corresponds to a 34 reduction in risk of progression or death in patients treated with ninlaro. the safety profile of ninlaro was consistent with previously reported results of single-agent ninlaro use and there were no new safety signals identified. takeda is also presenting key insights from the us mm-6 trial which investigates the effectiveness and safety of an in-class transition to oral ninlaro in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who have previously received a parenteral bortezomib-based triplet induction therapy. the trial revealed the in-class transition from treatment with parenteral bortezomib to a ninlaro-based treatment taken by patients at home allowed for prolonged proteasome inhibitor administration and resulted in an increase in overall response rate from 62 to 70 and an increase in complete response from 4 to 26. these data suggest promising efficacy without impacting patients quality of life. the safety profile of ninlaro treatment in this setting is favorable with no unexpected safety signals identified in us mm-6. the results of two studies will be presented at the 25th congress of the european hematology association eha.>