A Study to Evaluate Single Agent Selinexor Versus Physician’s Choice in Participants With Previously Treated Myelofibrosis
Key claim: A Phase 2 randomized open-label study is evaluating selinexor monotherapy versus physician’s choice treatment in myelofibrosis patients who have received at least 6 months of JAK1/2 inhibitor therapy.
Abstract
This is a Phase 2, multicenter, two-arm, open-label study to evaluate the safety and efficacy of selinexor versus treatment per physician’s choice (PC) in participants with myelofibrosis (MF) who had at least 6 months of treatment with a Janus kinase (JAK)1/2 inhibitor. Study participants will be randomized in a 1:1 ratio to either receive selinexor or physicians’ choice of treatment.
Why this matters
Selinexor monotherapy has previously been tested in JAKi-refractory/intolerant MF only in single-arm designs, leaving its comparative benefit versus real-world salvage choices unquantified. This Phase 2 randomized head-to-head design against physician’s choice in the JAKi-pretreated PMF population directly addresses that gap and provides the first controlled efficacy readout for XPO1 inhibition as standalone salvage — a natural-history-relevant question given the dismal outcomes of PMF after JAKi failure and the crowded pipeline (AJ1-11095, flonoltinib, imetelstat, roginolisib+rux) competing for the same niche.