A once-weekly regimen of selinexor, bortezomib, and dexamethasone slows the progression of relapsed or refractory multiple myeloma, according to a study published in the Nov. 14 issue of The Lancet.
Sebastian Grosicki, M.D., from the Medical University of Silesia in Katowice, Poland, and colleagues conducted a randomized, phase 3, open-label trial at 123 sites in 21 countries to examine the clinical benefit of weekly selinexor, bortezomib, and dexamethasone versus standard bortezomib and dexamethasone in 402 patients with previously treated multiple myeloma. Overall, 195 and 207 patients were randomly assigned to the selinexor, bortezomib, and dexamethasone group and the bortezomib and dexamethasone group, respectively.
The researchers found that the median progression-free survival was 13.93 and 9.46 months in the selinexor, bortezomib, and dexamethasone group and the bortezomib and dexamethasone group, respectively (hazard ratio, 0.70). Thrombocytopenia (39 versus 17 percent), fatigue (13 versus 1 percent), anemia (16 versus 10 percent), and pneumonia (11 versus 11 percent) were the most frequent grade 3 to 4 adverse events reported in the treatment groups. Peripheral neuropathy of grade 2 or greater occurred less often among patients treated with selinexor, bortezomib, and dexamethasone (21 versus 34 percent; odds ratio, 0.50).
“Encouragingly, the efficacy of [this] regimen was consistent and noteworthy across several key subgroups, including patients who were frail or 65 years and older, patients with high-risk cytogenetics, patients with moderate renal impairment, and patients who had either prior bortezomib or lenalidomide treatment,” a coauthor said in a statement.
Several authors disclosed financial ties to biopharmaceutical companies, including Karyopharm Therapeutics, which manufactures selinexor and funded the study.