Ixazomib Extends Survival in Multiple Myeloma for Patients Not Treated With Stem Cell Transplantation

The phase 3 TOURMALINE-MM4 study evaluated single-agent oral ixazomib as first-line maintenance therapy versus placebo in 706 adult patients diagnosed with MM not treated with stem cell transplantation, who have completed 6 to 12 months of initial therapy and achieved a partial response or better.

New data from the study have demonstrated statistically significant improvement in PFS, meeting the primary endpoint of the trial, Takeda announced. According to the press release, this is the first industry-sponsored phase 3 trial to investigate the concept of switch maintenance, the use of medications not included in initial induction therapy, in this setting.

First approved by the FDA in November 2015, ixazomib is an oral proteasome inhibitor being studied across several MM treatment settings, according to Takeda. It is currently indicated in combination with lenalidomide and dexamethasone for the treatment of patients with MM who have received at least 1 prior therapy.

The TOURMALINE clinical development program includes ongoing clinical trials involving ixazomib in MM:

Reference

Phase 3 Trial Ninlaro (ixazomib) as First Line Maintenance Therapy Met Primary Endpoint in Multiple Myeloma Patients not treated with Stem Cell Transplantation [news release]. Takedas website. https://www.takeda.com/newsroom/newsreleases/2019/phase-3-trial-of-ninlaro-ixazomib-as-first-line-maintenance-therapy-met-primary-endpoint-in-multiple-myeloma-patients-not-treated-with-stem-cell-transplantation/. Accessed November 7, 2019.

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Ixazomib Extends Survival in Multiple Myeloma for Patients Not Treated With Stem Cell Transplantation - Pharmacy Times