Menarini reports Phase 3 SENTRY trial data on selinexor plus ruxolitinib in myelofibrosis at EHA 2026

FLORENCE, Italy and NEW YORK, June 14, 2026 /PRNewswire/ -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, announced that new data related to the pivotal Phase 3 SENTRY trial will be presented as a late-breaking oral[i] at The European Hematology Association (EHA) 2026 Congress.

SENTRY (NCT04562389), a pivotal Phase 3 trial, is a randomized, double-blind, placebo-controlled trial of 60 mg selinexor in combination with ruxolitinib in frontline myelofibrosis (MF) (n=353), versus ruxolitinib monotherapy. Conducted by Karyopharm Therapeutics, Inc., in collaboration with the Menarini Group, SENTRY was designed to evaluate two co-primary endpoints: spleen volume reduction of 35% or more (SVR35) and absolute total symptom score (Abs-TSS).

The trial met the first co-primary endpoint, demonstrating that patients who were treated with the combination of selinexor plus ruxolitinib achieved a clear and statistically significant improvement in SVR35, compared to patients who received ruxolitinib alone. These results highlight that the combination arm enabled rapid, deep and sustained spleen volume reductions.

"Achievement of spleen reduction is the essential goal of myelofibrosis treatment. Importantly, the spleen reduction results seen in SENTRY were rapid, deep and durable, and associated with potential overall survival benefit for the patients receiving the combination," said Dr. Claire Harrison, Professor of Myeloproliferative Neoplasms and Deputy Chief Medical Officer at Guy's and St. Thomas' NHS Foundation Trust. "We are encouraged that these results represent a potential new therapeutic advance for our patients who are in dire need of better options."

Other key highlights include:

• Absolute Total Symptom Score (Abs-TSS): The combination arm demonstrated a comparable benefit to ruxolitinib alone, with a 9.9 point improvement in Abs-TSS at week 24, in patients who received the combination, compared to a 10.9 point improvement in patients who received ruxolitinib alone. The difference across the two arms was not statistically significant, and the combination arm did not meet this second co-primary endpoint.
• Overall Survival (OS): While these data were immature at the time of analysis, a promising early OS signal, a pre-specified secondary endpoint, was observed with the selinexor combination compared to ruxolitinib alone. The study showed a greater than 50% reduction in the risk of death for patients receiving the selinexor combination (HR 0.43).
• Spleen Volume Reduction: Consistent SVR35 benefit was observed across prespecified subgroups. Notably, at week 24, superior spleen volume reduction was achieved by the selinexor combination, regardless of the ruxolitinib dose, including by patients receiving less than 15 mg of ruxolitinib per day.
• Variant Allele Frequency (VAF) Reduction: This pre-specified exploratory endpoint, which is associated with SVR35, was observed in 32% of patients in the selinexor plus ruxolitinib arm at week 24 versus 23.9% of patients treated with ruxolitinib alone, indicating the combination's potential for disease modification.
• Safety and Tolerability: The combination demonstrated a manageable safety and tolerability profile consistent with the known profile of selinexor and ruxolitinib individually. No new safety signals were observed.

"The strength of the spleen response and the encouraging early overall survival data observed in the SENTRY study creates hope for a potential new treatment option for patients suffering from this devastating disease with dismal outcomes," said Elcin Barker Ergun, CEO of the Menarini Group. "Our dedication and commitment to bring transformational treatments to patients facing cancer is stronger than ever."

All of the relevant information can be found at https://stemline.com/contact/

Please see Summary of Product Characteristics (SmPC) and European Public Assessment Report at www.ec.europa.eu.

For further information, please visit www.menarini.com.