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- Selinexor in combination with ruxolitinib met the first co-primary endpoint, demonstrating a statistically significant improvement in spleen volume reduction (SVR35) at Week 24, with 49.8% in the combination arm versus 28% in the control arm.
- A post-hoc analysis of the Phase 3 SENTRY trial suggests that SVR35 may predict overall survival (OS); new data from the Phase 1 SENTRY trial show similar findings.
- The EHA Scientific Program Committee selected the data for a late-breaking oral presentation.
- Data derived from a pivotal study conducted in collaboration with Karyopharm Therapeutics, Inc.
For medical and pharmaceutical industry media only
Florence, Italy and New YorkJune 15, 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 delivering transformative oncology treatments for 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.
The trial met the first co-primary endpoint, demonstrating a clear and statistically significant improvement in SVR35 for patients receiving selinexor in combination with ruxolitinib compared to those receiving ruxolitinib alone. These results highlight that the combination therapy achieved rapid, deep, and durable spleen volume reductions.
“Achieving spleen restoration is a fundamental goal in myelofibrosis treatment. Importantly, the spleen reduction results seen in SENTRY were rapid, deep, and durable, and were associated with a potential overall survival benefit in 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 offer a potential new treatment advance for patients who urgently need better options.”
Other key highlights include:
- Absolute Total Symptom Score (Abs-TSS): The combination arm showed a comparable benefit to ruxolitinib alone in patients receiving the combination, with a 9.9-point improvement in Abs-TSS at Week 24 versus a 10.9-point improvement in patients receiving ruxolitinib alone. The difference between the two arms was not statistically significant, and the combination arm did not meet the second co-primary endpoint.
- Overall Survival (OS): Although these data were immature at the time of analysis, a promising early OS signal was observed with selinexor combination therapy compared to ruxolitinib alone (a pre-specified secondary endpoint). The study showed a greater than 50% reduction in the risk of death (HR 0.43) for patients receiving the selinexor combination.
- Spleen Volume Reduction: Consistent SVR35 benefits were observed across pre-specified subgroups. Notably, at Week 24, superior spleen volume reduction was achieved with the selinexor combination regardless of ruxolitinib dose, including in patients receiving less than 15 mg of ruxolitinib daily.
- Variant Allele Frequency (VAF) Reduction: This pre-specified exploratory endpoint, correlated with SVR35, was observed in 32% of patients in the selinexor plus ruxolitinib arm at Week 24, compared to 23.9% in patients treated with ruxolitinib alone, suggesting the disease-modifying potential of the combination.
- Safety and Tolerability: The combination demonstrated a manageable safety and tolerability profile, consistent with the known profiles 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 offer a potential new treatment option for patients with this devastating disease, where outcomes have been disappointing,” said Elcin Barker Ergun, CEO of the Menarini Group. “Our dedication and commitment to bringing transformative treatments to cancer patients is stronger than ever.”
About Myelofibrosis (MF)
Myelofibrosis (MF) is a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs). These diseases are caused by the overgrowth of abnormal blood-forming cells in the bone marrow, leading to the formation of scar tissue. This scarring makes it difficult for the body to produce healthy blood cells. The incidence of MF is rare, with only one to two people per 100,000 diagnosed each year, and the median survival after diagnosis is six years. Additionally, for patients with MF, their quality of life can be affected by symptoms such as fatigue, enlarged spleen, and low blood cell counts, all caused by the disease. 1,2,3
Please refer to the Summary of Product Characteristics (SmPC) and the European Public Assessment Report at www.ec.europa.eu.
Please refer to the locally approved prescribing information for selinexor for full details. The Menarini Group holds the licensing rights for selinexor and currently markets it in numerous European countries and globally. In the United States, Karyopharm Therapeutics markets selinexor, and full prescribing information is available here.
About the Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company with a turnover of $5.5 billion and over 17,000 employees. Menarini focuses on therapeutic areas with significant unmet needs, with products covering cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. Menarini has 18 production sites and 9 R&D centers, with products marketed in 140 countries worldwide. For more information, please visit www.menarini.com.
About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company committed to delivering transformative oncology treatments for patients. In the United States, Europe, and other regions globally, Stemline commercializes elacestrant, an oral endocrine therapy for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline also commercializes tagraxofusp-erzs, a targeted therapy directed at CD123, for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive blood cancer, in the United States, Europe, and other regions globally. Additionally, Stemline commercializes the XPO1 inhibitor selinexor in Europe for the treatment of multiple myeloma. The company is also conducting several label expansion studies for elacestrant and tagraxofusp in breast cancer and hematologic cancer indications, respectively, and has numerous clinical trial programs for other drug candidates at various stages of development targeting a range of solid and hematologic cancers.
References
1. Myelofibrosis. NORD (National Organization for Rare Disorders). https://rarediseases.org/mondo-disease/myelofibrosis/
2. Myelofibrosis. Leukemia & Lymphoma Society (LLS). https://bloodcancerunited.org/blood-cancer/myeloproliferative-neoplasms-mpns/myelofibrosis-mf
3. Myelofibrosis. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/myelofibrosis/symptoms-causes/syc-20355057
[i] The safety and efficacy of the study combination and unapproved indications discussed in this press release have not been established by the FDA, EMA, or any other regulatory authority.