#Italy #Menarini #Florence #Myelofibrosis #SENTRY Trial

Menarini Group Presents Phase III SENTRY Trial Results

The Menarini Group has recently made headlines at the 2026 European Hematology Association (EHA) congress with the unveiling of the promising results from the SENTRY trial. This Phase III clinical trial evaluated the combination of selinexor and ruxolitinib for the treatment of myelofibrosis (MF), shedding light on a new potential direction in oncology treatments.

Key Findings from the SENTRY Trial

The SENTRY trial was a randomized, double-blind, placebo-controlled study that enrolled 353 patients to assess the efficacy and safety of the selinexor-ruxolitinib combination. The primary endpoint focused on achieving a spleen volume reduction of at least 35% (SVR35) at the 24-week mark. Remarkably, 49.8% of patients receiving the selinexor-ruxolitinib combination achieved this outcome compared to just 28% in the control group receiving ruxolitinib alone. This represents a statistically significant difference, marking an important advancement in the treatment landscape for MF.

Furthermore, an exploratory analysis of the data indicates that achieving SVR35 may correlate with improved overall survival (OS). Additional findings from the earlier Phase I trial of SENTRY align with this observation, implying robust potential benefits of the treatment combination.

Professional Insight

Dr. Claire Harrison, a leading expert in myeloproliferative neoplasms at Guy's and St. Thomas' NHS Foundation Trust, commented on the findings. She emphasized, "The reduction in spleen size is a crucial treatment goal in myelofibrosis. The rapid and sustained reduction of spleen volume observed in the SENTRY trial is noteworthy and carries the promise of better survival outcomes for patients receiving this combined therapy."

Other Noteworthy Outcomes

In addition to the primary endpoint, the SENTRY trial also evaluated the absolute change in total symptom scores (Abs-TSS). Although the results were comparable between the selinexor-ruxolitinib and the ruxolitinib-only groups, the combination did not meet this secondary objective, as the difference was not statistically significant.

Results showed that the selinexor combination group had a 50% reduction in the risk of death compared to those on ruxolitinib monotherapy, indicating an OS advantage. The consistent benefits of SVR35 across predefined subgroups were also highlighted, enhancing the significance of the treatment effects. Notably, patients receiving doses lower than 15mg of ruxolitinib per day experienced substantial spleen volume reductions when treated with selinexor as well.

Implications for Patients

Elcin Barker Ergun, CEO of Menarini Group, remarked on the positive implications of the study's findings: "The intensity of spleen response and preliminary data on short-term overall survival observed in the SENTRY trial give hope for a new therapeutic option for patients suffering from this challenging disease. Our dedication to providing groundbreaking treatments for cancer patients is stronger than ever."

About Myelofibrosis

Myelofibrosis is a form of blood cancer that falls within the category of myeloproliferative neoplasms (MPNs). It is characterized by an abnormal proliferation of hematopoietic cells in the bone marrow, leading to scarring that inhibits the production of healthy blood cells. With an annual incidence of only one or two cases per 100,000 individuals, this rare condition can negatively impact the quality of life due to symptoms like fatigue and spleen enlargement. Individuals diagnosed with MF can expect a median survival of approximately six years, underscoring the vital need for innovative treatment options.

In conclusion, the SENTRY trial results reveal a significant step forward in the treatment of myelofibrosis. By making strides in both efficacy and survival potential, the selinexor-ruxolitinib combination may eventually reshape the therapeutic landscape for patients battling this challenging disease.