The European Commission granted conditional approval to ixazomib in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma (MM) who have received at least one prior therapy.
The decision was based on the results of the randomized, double-blind, placebo-controlled, phase III TOURMALINE-MM1 study that compared the safety and efficacy of lenalidomide and dexamethasone plus placebo or ixazomib in 722 patients (median age = 66 years; range = 30-91 years) with relapsed/refractory MM. Read more about the TOURMALINE-MM1 trial from our previous reports.
At the time of data cutoff on October 30, 2014, the median follow-up was 14.8 months in the ixazomib combination group and 14.6 months in the placebo group. Progression-free survival (the study’s primary endpoint) was significantly longer in the ixazomib-treated group: 20.6 months versus 14.7 months (hazard ratio [HR] = 0.74; 95% CI 0.59-0.94; p=0.01).
Ixazomib also lengthened median PFS in patients with high-risk cytogenetic abnormalities (75 patients in the ixazomib group and 62 patients in the placebo group): 21 months versus 9.7 months (HR=0.54; 95% CI 0.32-0.92; p=0.02).
The most common any-grade hematologic adverse events (AEs) occurring in both study cohorts included:
- neutropenia (n=118; 33% vs. n=111; 31%)
- thrombocytopenia (n=112; 31% vs. n=57; 16%)
- anemia (n=103; 29% vs. n=48; 13%)
The most common any-grade, non-hematologic AEs that occurred in both cohorts included:
- diarrhea (n=164; 45% vs. n=139; 39%)
- rash (n=131; 36% vs. n=82; 23%)
- constipation (n=126; 35% vs. n=94; 26%)
Europe’s Committee for Medicinal Products for Human Use rejected ixazomib earlier this year, citing insufficient clinical benefit, but went on to recommend the drug due to the results of this trial.
Source: Takeda press release, November 28, 2016.