Menarini Group Reports Data from the Phase 3 SENTRY Trial of Selinexor Plus Ruxolitinib in Myelofibrosis at The European Hematology Association (EHA) 2026 Congress

The combination of selinexor plus ruxolitinib has shown a statistically significant improvement in spleen volume reduction (SVR35) in a pivotal Phase 3 trial. Results from the trial indicate a SVR35 of 49.8% for the combination arm compared to 28% for the control arm at week 24.

The phase 3 SENTRY trial's post-hoc analysis suggests that SVR35 may serve as a predictor for overall survival (OS). Early findings from a phase 1 SENTRY trial also support this indication.

Data from the SENTRY trial, conducted in collaboration with Karyopharm Therapeutics, will be presented during a late-breaking oral session at The European Hematology Association (EHA) 2026 Congress. The trial (NCT04562389) enrolled 353 patients and was designed to evaluate two co-primary endpoints: SVR35 and absolute total symptom score (Abs-TSS).

Dr. Claire Harrison, a professor specializing in Myeloproliferative Neoplasms, noted that spleen reduction is a critical goal for myelofibrosis treatment and emphasized the significant and rapid reductions achieved with the combination therapy. Although the trial met the first co-primary endpoint regarding SVR35, it did not meet the second co-primary endpoint for Abs-TSS.

Overall survival data from the trial indicated a promising trend, showing a more than 50% reduction in the risk of death for patients receiving the selinexor combination therapy. Consistent SVR35 benefits were observed across predefined subgroups, suggesting potential disease-modifying properties of the combination therapy.

The combination therapy demonstrated a manageable safety and tolerability profile consistent with the known profiles of selinexor and ruxolitinib. No new safety signals were reported, indicating that the therapy may be a viable new treatment option for patients suffering from myelofibrosis.