#Italy #Florence #Menarini Group #Myelofibrosis #SENTRY Trial

Menarini Group Unveils Phase 3 SENTRY Trial Data

On June 15, 2026, the Menarini Group, alongside Stemline Therapeutics, presented compelling data from the pivotal Phase 3 SENTRY trial at the European Hematology Association (EHA) Congress 2026. This trial investigated the combination of selinexor and ruxolitinib for treating myelofibrosis, a rare blood cancer marked by abnormal blood cell growth in the bone marrow.

The trial's findings revealed that patients receiving the selinexor and ruxolitinib combination achieved a significant reduction in spleen volume (RVS35) of 49.8% compared to 28% in the control group, demonstrating the treatment's efficacy at the 24-week mark.

Dr. Claire Harrison, a prominent expert in myeloproliferative neoplasms, stated, "The reduction in spleen volume is critical in managing myelofibrosis, and the observed results were not only significant but prompt and durable, potentially corresponding to enhanced overall survival in treated patients."

Highlights of the SENTRY Trial Data

The SENTRY trial (NCT04562389) was a randomized, double-blind study involving 353 patients. Alongside the primary endpoint of spleen size reduction, secondary endpoints being assessed included symptom total absolute score (Abs-TSS) and overall survival.

• - Spleen Volume Reduction: The primary objective was met with a statistically significant improvement in RVS35 - the combined treatment group experienced a remarkable decrease in spleen size.
• - Symptom Management: While the combined treatment group's Abs-TSS improvement of 9.9 points was comparable to the 10.9-point improvement seen in ruxolitinib monotherapy, this difference was not statistically significant.
• - Overall Survival: Preliminary results showed a promising early signal for overall survival with the combination treatment. Interestingly, it suggested more than a 50% reduction in death risk (HR 0.43) compared to ruxolitinib alone.
• - Safety Profile: The combined approach demonstrated a tolerable safety and side effect profile, consistent with established data on both selinexor and ruxolitinib.

The Importance of These Findings

With myelofibrosis affecting only a small fraction of the population—with an incidence of about 1-2 cases per 100,000 individuals—innovative treatment options are desperately needed. The median survival rate post-diagnosis hovers around six years, and quality of life can be significantly compromised due to symptoms like fatigue and spleen enlargement.

Elcin Barker Ergun, CEO of Menarini Group, highlighted, "The clear response from spleen volume reductions and the initial encouraging data on overall survival signify a promising new treatment avenue for patients enduring this challenging disease." He reiterated Menarini’s commitment to advancing transformative treatments for cancer patients globally.

Future Implications

The presented data from the SENTRY trial could pave the way for regulatory discussions around the combination's potential licensure. As the medical community eagerly awaits further post-hoc analyses and longitudinal data concerning overall survival, both Menarini and Stemline are dedicated to enhancing therapeutic strategies that can significantly improve patient outcomes in myelofibrosis.

As research progresses, there is cautious optimism that new therapeutic options may emerge to better empower patients in their fight against this malignancy, which has long been difficult to manage.

For further updates regarding the SENTRY trial and myelofibrosis treatments, individuals are encouraged to follow developments from Menarini Group and allied organizations. This pivotal trial represents hope for many individuals facing the challenges of myelofibrosis.