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

Menarini Group and partner Karyopharm Therapeutics (KPTI) announced positive Phase 3 SENTRY trial data for selinexor combined with ruxolitinib in treating myelofibrosis. The combination therapy achieved a statistically significant 49.8% spleen volume reduction (SVR35) versus 28% for control at week 24, meeting the trial's first co-primary endpoint. This 78% relative improvement represents clinically meaningful efficacy in a disease with limited treatment options.

Post-hoc analysis suggests SVR35 may serve as a predictive biomarker for overall survival—a critical finding for regulatory and clinical utility. Corroborating evidence from Phase 1 SENTRY data strengthens the mechanistic case, indicating the benefit profile is not isolated to early-stage cohorts. Selection for late-breaking oral presentation at the European Hematology Association Congress signals the Scientific Program Committee's recognition of the data's significance within the hematology community.

The dual-mechanism approach—combining selinexor's XPO1 inhibition with ruxolitinib's JAK1/2 targeting—addresses unmet needs in myelofibrosis management. Regulatory pathways for accelerated approval may be viable given the magnitude of improvement and biomarker correlation. Commercial potential extends to both newly diagnosed and treatment-resistant patient populations.

Sector implication: Health Care biotech benefits from positive late-stage clinical validation, particularly in specialized hematologic malignancies where pricing power remains strong. KPTI de-risks its pipeline and enhances partnership value, positioning selinexor for potential label expansion and sustained revenue growth in oncology.