Takeda Pharmaceutical has reported results from the Phase III TOURMALINE-MM2 clinical trial of Ninlaro (ixazomib) plus lenalidomide and dexamethasone to treat multiple myeloma.
The combination was compared to lenalidomide and dexamethasone plus placebo in newly diagnosed patients who are ineligible for autologous stem cell transplant.
According to the results, the Ninlaro combination led to a 13.5 month increase in median progression-free survival (PFS). The median PFS was 35.3 months in the study drug arm versus 21.8 months in the placebo group.
Takeda said that the trial failed to meet the threshold for statistical significance and the primary endpoint of PFS was not achieved.
Other endpoints of the trial include complete response (CR) rate, overall survival (OS), and median time to progression (TTP). The safety profile of the study drug was found to be generally consistent with the existing prescribing information.
Treatment emergent adverse events (TEAEs) were reported in 96.6% of patients in the study drug group compared to 92.6% of those in the placebo arm.
Takeda Pharmaceutical Oncology Therapeutic Area Unit head Christopher Arendt said: “We hope the findings from the TOURMALINE-MM2 trial will encourage constructive conversations and help progress future research efforts, particularly for patients who could benefit from an all-oral, proteasome inhibitor-based combination that helps preserve quality of life.
“As a company, we remain committed to the multiple myeloma community and look forward to sharing mature data from our ongoing Phase III multiple myeloma maintenance studies in the future.”
Ninlaro is an oral proteasome inhibitor that is indicated for use with lenalidomide and dexamethasone to treat multiple myeloma patients who have had at least one prior therapy.
The international, randomised, double-blind, multi-centre, placebo-controlled TOURMALINE-MM2 trial assessed the drug combination in a total of 705 adult patients.
Last month, Takeda and Ovid Therapeutics reported positive top-line data from the Phase II ELEKTRA trial of soticlestat in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS).