Treatment with ixazomib (Ninlaro, Takeda) in the first-line maintenance therapy setting improved progression-free survival (PFS) in patients with multiple myeloma (MM) who have not undergone autologous stem cell transplant (ASCT), according to new clinical data.

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:
  • TOURMALINE-MM1: ixazomib versus placebo in combination with lenalidomide and dexamethasone in relapsed and/or refractory MM.
  • TOURMALINE-MM2: ixazomib versus placebo in combination with lenalidomide and dexamethasone in patients with newly diagnosed MM.
  • TOURMALINE-MM3: ixazoimib versus placebo as maintenance therapy in patients with newly diagnosed MM following induction therapy and ASCT.
  • TOURMALINE-MM4: ixazomib versus placebo as maintenance therapy in patients with newly-diagnosed MM who have not undergone ASCT.
“We are very encouraged by the results of the TOURMALINE-MM4 trial and continue our forward momentum in developing maintenance options for multiple myeloma patients,” Phil Rowlands, PhD, head of Oncology Therapeutic Area Unit, Takeda, said in a statement. “We remain committed to bringing this convenient and well-tolerated treatment option to patients.”

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]. Takeda’s 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.