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The efficacy and safety of Ixazomib in combination with lenalidomide and dexamethasone was evaluated in a randomized, double-blind, placebo-controlled, multicenter study in patients with relapsed and/or refractory multiple myeloma who had received at least one prior line of therapy. Patients who were refractory to lenalidomide or proteasome inhibitors were excluded from the study.
The efficacy of Ixazomib was evaluated by progression-free survival (PFS) according to the 2011 International Myeloma Working Group (IMWG) Consensus Uniform Response Criteria as assessed by a blinded independent review committee (IRC) based on central lab results. Response was assessed every four weeks until disease progression.
The median time to response was 1.1 months in the Ixazomib regimen and 1.9 months in the placebo regimen. The median duration of response was 20.5 months in the Ixazomib regimen and 15 months in the placebo regimen for responders in the response evaluable population.
A non-inferential PFS analysis was conducted at a median follow up of 23 months with 372 PFS events. Hazard ratio of PFS was 0.82 (95% confidence interval [0.67, 1.0]) for Ixazomib regimen versus placebo regimen, and estimated median PFS was 20 months in the Ixazomib regimen and 15.9 months in the placebo regimen. At the final analysis for OS at a median duration of follow up of approximately 85 months, median OS in the ITT population was 53.6 months for patients in the Ixazomib regimen and 51.6 months for patients in the placebo regimen (HR = 0.94 [95% CI: 0.78, 1.13]).
from FDA,2024.07
