#Italy #Menarini #Florence #Selinexor #Ruxolitinib

Menarini Group Highlights Phase 3 SENTRY Trial Results at EHA 2026

In a significant advancement for the treatment of myelofibrosis, the Menarini Group shared breakthrough data from its Phase 3 SENTRY trial during the European Hematology Association (EHA) 2026 Congress. This trial investigated the efficacy of combining selinexor with ruxolitinib, revealing promising results that could reshape therapeutic options for patients.

Key Findings from the SENTRY Trial

The SENTRY trial (NCT04562389) was designed as a randomized, double-blind, placebo-controlled study, assessing 60 mg of selinexor in conjunction with ruxolitinib in patients suffering from frontline myelofibrosis. The pivotal results exhibited a statistically significant reduction in spleen volume—one of the trial's primary endpoints. At week 24, the combination therapy achieved a spleen volume reduction (SVR35) of 49.8%, a notable improvement compared to the 28% observed in the control group receiving ruxolitinib alone.

Dr. Claire Harrison, a key researcher in the study, emphasized that achieving spleen reduction is critical for treating myelofibrosis. The rapid and durable responses seen in the SENTRY trial align with the emotional and physical needs of patients facing this debilitating disease.

Detailed Results

The data from the trial uncover crucial insights:

• - Spleen Volume Reduction: At week 12, the selinexor plus ruxolitinib cohort recorded an SVR35 of 49.4% compared to 20.3% for the ruxolitinib group.
• - Longitudinal Data: The results remained consistent through the study duration. At week 36, 46.9% of patients in the combination arm continued to show significant reduction compared to 23% in the ruxolitinib-only arm.
• - Safety Profile: The combination displayed a manageable safety profile, consistent with existing data on selinexor and ruxolitinib. No new safety issues emerged during the trial.

Overall Survival and Symptom Management

While the data regarding overall survival (OS) is still in its infancy, an encouraging trend was noted, indicating over a 50% reduction in the risk of death for patients treated with the combination therapy compared to ruxolitinib alone. Furthermore, the study highlighted that both treatment arms achieved improvements in Absolute Total Symptom Score (Abs-TSS), although the combinations did not significantly exceed the ruxolitinib-only group's results after 24 weeks.

Emerging Perspectives

The findings presented at EHA 2026 have stirred hope for healthcare providers and patients alike. The Menarini Group and its subsidiaries, like Stemline Therapeutics, are committed to developing transformative treatment options that address significant unmet medical needs in oncology.