Takeda Pharmaceutical Company Announces Positive Results for NINLARO in Relapsed and/or Refractory Multiple Myeloma Patients

Strategic Insights -

The Takeda Pharmaceutical Company Limited has announced positive results from the TOURMALINE-MM1 trial, a Phase 3 clinical trial evaluating the efficacy of NINLARO (ixazomib) capsules in combination with lenalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma. The trial demonstrated that treatment with NINLARO is effective in extending progression-free survival (PFS) with a manageable tolerability profile. These results were presented at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH). The TOURMALINE-MM1 trial is part of Takeda's comprehensive ixazomib clinical trial program, which aims to provide effective and convenient treatment options for patients with multiple myeloma. The data presented at ASH this year are the first major output from the TOURMALINE program, demonstrating Takeda's commitment to advancing multiple myeloma research.

Key Takeaways:

  • The TOURMALINE-MM1 trial, a Phase 3 clinical trial, evaluated the efficacy of NINLARO (ixazomib) capsules in combination with lenalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma.
  • The trial demonstrated that treatment with NINLARO extended progression-free survival (PFS) with a manageable tolerability profile.
  • NINLARO was recently approved by the U.S. Food and Drug Administration (FDA) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
  • The approval was based on the Phase 3 TOURMALINE-MM1 data.
  • Ixazomib data will be featured in 18 presentations at the 2015 ASH meeting, including an oral presentation on Phase 2 data from an investigational study evaluating the all-oral combination of ixazomib plus cyclophosphamide and low-dose dexamethasone (ICd) in newly diagnosed multiple myeloma patients.
  • The comprehensive ixazomib clinical development program, TOURMALINE, includes a total of five pivotal trials, four investigating every major multiple myeloma patient population, and one in light-chain amyloidosis.

Statistics:

  • The trial included 722 patients with relapsed and/or refractory multiple myeloma who were randomly assigned to receive NINLARO in combination with lenalidomide and dexamethasone (361 patients) or placebo in combination with lenalidomide and dexamethasone (361 patients).
  • The median progression-free survival (PFS) was 20.6 months in the NINLARO group, compared with 14.9 months in the placebo group.
  • The overall response rate (ORR) was 92.7% in the NINLARO group, compared with 71.9% in the placebo group.

Sources:

  • Takeda Pharmaceutical Company Limited (as stated in the press release)
  • 57th Annual Meeting and Exposition of the American Society of Hematology (ASH)
  • U.S. Food and Drug Administration (FDA)