Takeda's Ninlaro clears Phase 3 endpoint as maintenance therapy in multiple myeloma


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After making headlines with its mammoth deal to acquire Shire earlier this year, Takeda has emerged with new Phase 3 data for its oral proteasome inhibitor Ninlaro (ixazomib).

The findings showed that the drug met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus placebo as a maintenance therapy for multiple myeloma in adult patients who responded to high-dose therapy (HDT) and autologous stem cell transplant (ASCT).  

Additionally, no new safety signals were found during the trial, with Ninlaro’s safety and efficacy profile remaining consistent with the findings of previous studies.

“Within the maintenance setting, it is critical that we find agents that are efficacious, tolerable and convenient,” commented Dr Jesús Gomez Navarro, Vice President, Head of Oncology Clinical Research and Development at Takeda. “The results of the TOURMALINE-MM3 trial represent an important step toward the goal of expanding the use of Ninlaro as a maintenance therapy. This is the first and only Phase 3 placebo-controlled study evaluating a proteasome inhibitor in this setting and we look forward to discussions with Health Authorities around the world.”

Ninlaro is not currently approved anywhere in the aforementioned indication, but Takeda has confirmed it will present full details of the study at the 60th American Society of Hematology Annual Meeting in December in support of regulatory submissions in the near future.

Matt Fellows