Phase 3 randomized double-blind study evaluating selinexor, an XPO1 inhibitor, plus ruxolitinib in jaki-naïve myelofibrosis: Study rationale and preliminary patient characteristics
Phase 3 trial demonstrates safety and tolerability of selinexor with ruxolitinib in myelofibrosis, indicating potential for improved treatment outcomes.
Key Points
This study aims to evaluate the efficacy and safety of selinexor combined with ruxolitinib in patients with JAKi-naïve myelofibrosis.
Phase 3 randomized double-blind trial.
Participants receive selinexor and ruxolitinib versus placebo plus ruxolitinib.
Endpoints include safety, tolerability, progression-free survival, and pharmacokinetics.
Safety profile shows acceptable tolerability with reported adverse events including nausea and anemia.
Outcomes measured include SVR35 and Abs-TSS at week 24, with trials ongoing.
Analysis of health care resource utilization will be included in the final evaluation.