Clinical efficacy of ixazomib

IxazomibNinlaro (ixazomib) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib in combination with lenalidomide and dexamethasone is not recommended for maintenance therapy or in newly diagnosed multiple myeloma outside of controlled clinical trials.

USFDA approval of ixazomib in combination with lenalidomide and dexamethasone was evaluated in a randomized, double-blind, placebo-controlled, multicenter study of 722 patients with relapsed and/or refractory multiple myeloma who had received at least one prior therapy. Patients who were resistant to lenalidomide or proteasome inhibitors were excluded from the study. Subjects were randomized 1:1 to receive the combination of ixazomib, lenalidomide, and dexamethasone or placebo, the combination of lenalidomide, and dexamethasone (N=362; placebo regimen) until disease progression or unacceptable toxicity. The efficacy of ixazomib was assessed by progression-free survival (PFS). The group treated with ixazomib showed a statistically significant improvement - the group lived longer without worsening of the disease (an average of 20.6 months) compared with subjects who received a placebo (14.7 months).

For multiple myeloma patients with high-risk cytogenetic abnormalities, ixazomib combination therapy has also shown certain efficacy and can extend the progression-free survival of these patients.

It should be noted that although ixazomib has shown significant efficacy in clinical trials, patients' specific responses may vary due to individual differences. Therefore, when using ixazomib for treatment, a reasonable treatment plan should be formulated based on the patient's specific situation and the doctor's recommendations.