Phase III TOURMALINE-MM1 results for Ninlaro (ixazomib) in multiple myeloma published in NEJM- Takeda

Takeda has announced that results from the international, randomized, double-blind, placebo-controlled TOURMALINE-MM1 Phase III clinical study, evaluating once-weekly oral Ninlaro (ixazomib) capsules plus lenalidomide and dexamethasone versus placebo plus lenalidomide-dexamethasone in patients with relapsed and/or refractory multiple myeloma, have been published in the New England Journal of Medicine (NEJM).

As reported in NEJM, the trial results demonstrated a statistically significant and clinically meaningful (35%) extension of PFS (HR 0.74; p = 0.01; median PFS: 20.6 months vs. 14.7 months in control group; median follow-up 14.7 months). A benefit in PFS was observed with the ixazomib regimen across pre-specified patient subgroups, including patients with poor prognosis, such as elderly patients, those who have received two or three prior therapies, those with advanced stage disease, and those with high-risk cytogenetic abnormalities.

Overall response rates were 78% in the ixazomib arm versus 72% in the placebo group and at least very good partial response rates were 48% versus 39%. The median time to response was 1.1 months in the ixazomib arm versus 1.9 months in the placebo group, and median duration of response was 20.5 versus 15.0 months, respectively. In the ixazomib and placebo groups, frequencies of serious adverse events (47% vs. 49%) and on-study deaths (4% vs. 6%) were similar.