Policy & Regulation
Menarini reports Phase 3 data for selinexor plus ruxolitinib in myelofibrosis
15 June 2026 -

The Menarini Group, an Italy-based international pharmaceutical and diagnostics company, and Stemline Therapeutics Inc, a subsidiary of the Menarini Group focused on oncology treatments, announced on Sunday the presentation of new data related to the pivotal Phase 3 SENTRY trial at The European Hematology Association (EHA) 2026 Congress.

The randomised, double-blind, placebo-controlled trial assessed 60 mg selinexor in combination with ruxolitinib in frontline myelofibrosis (MF), versus ruxolitinib monotherapy. Conducted by Karyopharm Therapeutics Inc in collaboration with the Menarini Group, SENTRY was designed to evaluate two co-primary endpoints: spleen volume reduction of 35% or more (SVR35) and absolute total symptom score (Abs-TSS).

According to Menarini, the trial met the first co-primary endpoint, demonstrating that patients who were treated with the combination of selinexor plus ruxolitinib achieved a clear and statistically significant improvement in SVR35, compared to patients who received ruxolitinib alone. These results highlight that the combination arm enabled rapid, deep and sustained spleen volume reductions.

Looking at Abs-TSS, the combination arm demonstrated a comparable benefit to ruxolitinib alone, with a 9.9 point improvement in Abs-TSS at week 24 in patients who received the combination, compared to a 10.9 point improvement in patients who received ruxolitinib alone. The difference across the two arms was not statistically significant, and the combination arm did not meet this second co-primary endpoint.

The combination demonstrated a manageable safety and tolerability profile consistent with the known profile of selinexor and ruxolitinib individually. No new safety signals were observed.

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