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ASH 2015: Updated Results of Phase III Tourmaline-MM1 Study of Ixazomib in Multiple Myeloma

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Key Points

  • Patients who received ixazomib lived a median of 20.6 months without their disease progressing. Patients who received placebo instead of ixazomib demonstrated progression-free survival of 14.7 months.
  • Toxicity was similar among both treatment groups, as 68% of patients in the ixazomib arm suffered severe but not life-threatening adverse events compared to 61% of patients in the placebo group.
  • The U.S. Food and Drug Administration approved this drug combination for treatment of patients with multiple myeloma who have received at least one prior therapy on November 20, 2015.

In a study presented by Moureau et al at the 57th American Society of Hematology (ASH) Annual Meeting, ixazomib (Ninlaro), a recently approved oral proteasome inhibitor, significantly extended progression-free survival for patients with relapsed and/or refractory multiple myeloma (Abstract 727).

One of the current global standards of care for patients with relapsed or treatment-resistant multiple myeloma is a combination of lenalidomide (Revlimid) and dexamethasone. Both of these drugs can be taken orally.

Proteasome inhibitors can often be used in combination with dexamethasone or added to lenalidomide and dexamethasone to improve treatment for relapsed or treatment-resistant multiple myeloma. Until now, proteasome inhibitors have only been available for use intravenously or subcutaneously. Ixazomib is the first of these drugs to be available in pill form.

Study Details

In this phase III study (NCT01564537), 722 patients with relapsed or treatment-resistant multiple myeloma were randomized to receive either the standard treatment regimen of lenalidomide and dexamethasone or a combination of the standard treatment with weekly doses of ixazomib. The median age of patients participating in the trial was 66 years.

Patients repeated treatment cycles until their disease progressed or side effects became intolerable.

Study Findings

At the first interim analysis, the patients who received ixazomib lived a median of 20.6 months without their disease progressing. Patients who received placebo instead of ixazomib demonstrated progression-free survival of 14.7 months.

Toxicity was similar among both treatment groups, as 68% of patients in the ixazomib arm suffered severe but not life-threatening adverse events compared to 61% of patients in the placebo group.

Notably, ixazomib plus lenalidomide and dexamethasone represents the first all-oral combination treatment for multiple myeloma. The U.S. Food and Drug Administration approved this drug combination for treatment of patients with multiple myeloma who have received at least one prior therapy on November 20, 2015. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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