#Italy #Florence #Myelofibrosis #Selinexor #Ruxolitinib

Menarini Group Unveils New Data on Myelofibrosis Treatment at EHA 2026

The Menarini Group, a leading international pharmaceutical company, made a significant impact at the European Hematology Association (EHA) 2026 Congress by presenting new insights from the Phase-3 SENTRY study. This research explored the efficacy of combining Selinexor with Ruxolitinib for treating patients diagnosed with Myelofibrosis (MF). The study's findings have the potential to reshape therapeutic approaches for this debilitating condition.

Study Overview

The SENTRY study was designed as a randomized, double-blind, placebo-controlled trial. It involved 353 patients who were administered 60 mg of Selinexor alongside Ruxolitinib, as opposed to only Ruxolitinib as the treatment. Researchers focused on two primary endpoints: a 35% reduction in spleen volume (SVR35) and the absolute total symptom score (Abs-TSS).

As the trial reached the 24-week mark, the results indicated that 49.8% of patients in the Selinexor-Ruxolitinib group experienced a significant reduction in spleen volume compared to 28% in the Ruxolitinib-only group. This improvement highlights the combination’s effectiveness in providing rapid and durable responses in MF treatment. Dr. Claire Harrison, a leading expert in myeloproliferative diseases, expressed optimism about the implications of these findings for patients in need of better treatment options.

Primary and Secondary Endpoints

The data presented indicate that the combination therapy not only achieved its primary endpoint but also showed promising early signs regarding overall survival (OS). Though OS data were still maturing at the time of the analysis, the combination therapy demonstrated a reduction in the risk of death by more than 50% compared to Ruxolitinib alone, showcasing a potential survival benefit for patients receiving Selinexor.

Moreover, the absolute total symptom score showed comparable benefits between the two groups. Patients receiving Selinexor showed a 9.9-point improvement in Abs-TSS, while the Ruxolitinib group saw a 10.9-point improvement. The difference was not statistically significant, suggesting the combination could be enriching the patient experience without adding substantial new risks.

Spleen Volume Reduction

Remarkably, SVR35 was consistent across pre-defined subgroups, signifying the robustness of the combination treatment. The study even observed significant spleen volume reductions irrespective of Ruxolitinib dosing. This speaks to the efficacy of Selinexor in leveraging the therapeutic potential of Ruxolitinib, even at lower doses.

Safety Profile

In terms of safety and tolerability, the combination treatment demonstrated a manageable profile consistent with therapies' known effects. No new safety signals were reported, which is encouraging for clinicians considering this treatment approach for Myelofibrosis.

The findings of the SENTRY study, particularly the efficacy of Selinexor combined with Ruxolitinib, may offer new hope for patients battling Myelofibrosis. Elcin Barker Ergun, CEO of the Menarini Group, highlighted the promise these results hold for patients facing the challenges of this disease, and the Group's commitment to delivering innovative cancer therapies remains unwavering.

Understanding Myelofibrosis

Myelofibrosis is classified as a myeloproliferative neoplasm characterized by aberrant blood cell production leading to fibrosis in the bone marrow. With an incidence rate of just 1-2 cases per 100,000 people annually, Myelofibrosis is rare, with a median survival rate of approximately six years post-diagnosis. Patients often suffer from debilitating symptoms affecting their quality of life, emphasizing the need for effective treatment options.

As the Menarini Group continues to spearhead research in hematology, the implications of the SENTRY study are expected to be influential for future clinical approaches towards Myelofibrosis and potentially enhance the wellbeing of patients navigating this complex disease.