Overall response rates were 78.3% in the ixazomib group and 71.5% in the placebo group (P = .04); complete response plus good partial response rates were 48% and 39%, respectively. “The responses were rapid and durable and deepened with increasing duration of treatment,” the researchers noted.
Among patients with del(17p)—36 in the ixazomib group and 33 in the placebo group—progression-free survival was 21.4 months and 9.7 months, respectively (HR, 0.60; 95% CI, 0.29 – 1.24). Median overall survival had not been reached in either the ixazomib or placebo groups.
Rates of serious adverse events were 47% in the ixazomib group and 49% in the placebo group, and 4% and 6% of the patients died, respectively. Grade 3 or higher adverse events were 74% in the ixazomib group and 69% in the placebo group. Adverse events (all grades) that occurred more frequently in the ixazomib group were rash (36% vs 23% for the placebo arm), gastrointestinal (diarrhea, 45% vs 39%; constipation, 35% vs 26%; vomiting, 23% vs 12%), and peripheral neuropathy (27% vs 22%; grade 3, 2% in each group).
Patients self-reported health-related quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 module (EORTC QLQ-C30) and the myeloma-specific module (EORTC QLQ-MY20). At 23 months, scores on both instruments indicated similar quality of life in the ixazomib and placebo groups.
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“In consideration of its adverse-event profile and efficacy, this all-oral regimen provides an additional therapeutic option for patients with relapsed, refractory, or relapsed and refractory multiple myeloma,” the authors concluded.
Patients with hepatic or renal impairment require ixazomib dose reductions, and lactating women should discontinue nursing. Concomitant use of strong CYP3A inducers should be avoided.2
- Moreau P, Masszi T, Grzasko N, et al. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;374:1621-1634.
- U.S. Food and Drug Administration. Ninlaro [prescribing information]. Cambridge, MA: Millennium Pharmaceuticals, Inc.; 2015. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208462lbl.pdf. Accessed May 23, 2016.