The addition of Ninlaro (ixazomib) to treatment combos is improving outcomes for relapsed/refractory myeloma patients, says a study published in the April 28 New England Journal of Medicine. When added to lenalidomide and dexamethasone, it significantly improved progression free survival. 

Philippe Moreau, M.D., from University Hospital Hôtel Dieu in Nantes, France, and colleagues conducted a double-blind trial involving 722 patients with relapsed, refractory, or relapsed and refractory multiple myeloma. Patients were randomized to receive ixazomib plus lenalidomide-dexamethasone (ixazomib group) or placebo plus lenalidomide-dexamethasone (placebo group).

The researchers found that at a median follow-up of 14.7 months, progression-free survival was significantly longer in the ixazomib group (median progression-free survival, 20.6 versus 14.7 months. In all prespecified patient groups, including patients with high-risk cytogenetic abnormalities, there was a benefit with respect to progression-free survival with the ixazomib regimen. The overall rates of response were 78 and 72 percent, respectively, in the ixazomib and placebo groups; the corresponding rates of complete response plus very good partial response were 48 and 39 percent. The two study groups had similar rates of serious adverse events (47 and 49 percent, respectively).

"The addition of ixazomib to a regimen of lenalidomide and dexamethasone was associated with significantly longer progression-free survival; the additional toxic effects with all-oral regimen were limited," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Millennium, a subsidiary of Takeda, which manufactures ixazomib and funded the study.

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