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- The mixture of selinexor plus ruxolitinib met the primary co-primary endpoint demonstrating a statistically vital enchancment of spleen quantity discount (SVR35) of 49.8% for the mix arm vs 28% for the management arm at week 24.
- Put up-hoc evaluation from the section 3 SENTRY trial suggests SVR35 might predict total survival (OS); new knowledge from the section 1 SENTRY trial demonstrates an analogous discovering.
- Knowledge chosen by EHA’s Scientific Program Committee for late-breaking oral presentation.
- Knowledge stems from the pivotal examine performed in collaboration with Karyopharm Therapeutics, Inc.
FOR MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY
FLORENCE, Italy and NEW YORK, June 14, 2026 /PRNewswire/ — The Menarini Group (“Menarini”), a number one worldwide pharmaceutical and diagnostics firm, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group centered on bringing transformational oncology remedies to most cancers sufferers, introduced that new knowledge associated to the pivotal Section 3 SENTRY trial will probably be introduced as a late-breaking oral[i] at The European Hematology Affiliation (EHA) 2026 Congress.
SENTRY (NCT04562389), a pivotal Section 3 trial, is a randomized, double-blind, placebo-controlled trial of 60 mg selinexor together with ruxolitinib in frontline myelofibrosis (MF) (n=353), versus ruxolitinib monotherapy. Performed by Karyopharm Therapeutics, Inc., in collaboration with the Menarini Group, SENTRY was designed to judge two co-primary endpoints: spleen quantity discount of 35% or extra (SVR35) and absolute complete symptom rating (Abs-TSS).
The trial met the primary co-primary endpoint, demonstrating that sufferers who have been handled with the mix of selinexor plus ruxolitinib achieved a transparent and statistically vital enchancment in SVR35, in comparison with sufferers who acquired ruxolitinib alone. These outcomes spotlight that the mix arm enabled speedy, deep and sustained spleen quantity reductions.
selinexor plus ruxolitinib (n=235) | placebo + ruxolitinib (n=118) | |
SVR35 at week 12 | 49.4% (n=116) | 20.3% (n=24) |
SVR35 at week 24 | 49.8% (n=117) | 28.0% (n=33) |
SVR35 at week 36* | 46.9% (n=97) | 23.0% (n=23) |
*Evaluation performed in these sufferers who accomplished a spleen evaluation or discontinued the examine previous to week 36 | ||
“Achievement of spleen discount is the important purpose of myelofibrosis therapy. Importantly, the spleen discount outcomes seen in SENTRY have been speedy, deep and sturdy, and related to potential total survival profit for the sufferers receiving the mix,” stated Dr. Claire Harrison, Professor of Myeloproliferative Neoplasms and Deputy Chief Medical Officer at Man’s and St. Thomas’ NHS Basis Belief. “We’re inspired that these outcomes characterize a possible new therapeutic advance for our sufferers who’re in dire want of higher choices.”
Different key highlights embrace:
- Absolute Complete Symptom Rating (Abs-TSS): The mixture arm demonstrated a comparable profit to ruxolitinib alone, with a 9.9 level enchancment in Abs-TSS at week 24, in sufferers who acquired the mix, in comparison with a ten.9 level enchancment in sufferers who acquired ruxolitinib alone. The distinction throughout the 2 arms was not statistically vital, and the mix arm didn’t meet this second co-primary endpoint.
- Total Survival (OS): Whereas these knowledge have been immature on the time of study, a promising early OS sign, a pre-specified secondary endpoint, was noticed with the selinexor mixture in comparison with ruxolitinib alone. The examine confirmed a larger than 50% discount within the danger of demise for sufferers receiving the selinexor mixture (HR 0.43).
- Spleen Quantity Discount: Constant SVR35 profit was noticed throughout prespecified subgroups. Notably, at week 24, superior spleen quantity discount was achieved by the selinexor mixture, whatever the ruxolitinib dose, together with by sufferers receiving lower than 15 mg of ruxolitinib per day.
- Variant Allele Frequency (VAF) Discount: This pre-specified exploratory endpoint, which is related to SVR35, was noticed in 32% of sufferers within the selinexor plus ruxolitinib arm at week 24 versus 23.9% of sufferers handled with ruxolitinib alone, indicating the mix’s potential for illness modification.
- Security and Tolerability: The mixture demonstrated a manageable security and tolerability profile in keeping with the recognized profile of selinexor and ruxolitinib individually. No new security indicators have been noticed.
“The energy of the spleen response and the encouraging early total survival knowledge noticed within the SENTRY examine creates hope for a possible new therapy choice for sufferers affected by this devastating illness with dismal outcomes,” stated Elcin Barker Ergun, CEO of the Menarini Group. “Our dedication and dedication to carry transformational remedies to sufferers dealing with most cancers is stronger than ever.”
About Myelofibrosis (MF)
Myelofibrosis (MF) is a sort of blood most cancers that belongs to a bunch of ailments known as Myeloproliferative Neoplasms (MPNs). These ailments are brought on by the overgrowth of irregular blood-forming cells within the bone marrow, which results in the formation of scar tissue. This scarring makes it tough for the physique to supply wholesome blood cells. The incidence of MF is uncommon, with solely about one or two folks identified annually for each 100,000 people, and the median survival after prognosis is six years. Moreover, for folks residing with MF, their high quality of life could be compromised by signs together with fatigue, an enlarged spleen, and low blood counts, all of that are brought on by the illness. 1,2,3
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at adverseevents@menarinistemline.com. All the related info could be discovered at https://stemline.com/contact/
Please see Abstract of Product Traits (SmPC) and European Public Evaluation Report at www.ec.europa.eu.
Please seek advice from native prescribing info the place selinexor is authorised for full info. Menarini Group holds licensing rights for selinexor and at the moment markets it in quite a few European nations and world territories. Within the U.S., Karyopharm Therapeutics markets selinexor and the complete prescribing info is on the market right here.
About The Menarini Group
The Menarini Group is a number one worldwide pharmaceutical and diagnostics firm, with a turnover of $5.5 billion and over 17,000 workers. Menarini is concentrated on therapeutic areas with excessive unmet wants with merchandise for cardiology, oncology, pneumology, gastroenterology, infectious ailments, diabetology, irritation, and analgesia. With 18 manufacturing websites and 9 Analysis and Growth facilities, Menarini’s merchandise can be found in 140 nations worldwide. For additional info, please go to www.menarini.com.
About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical firm centered on bringing transformational oncology remedies to sufferers. Stemline commercializes elacestrant, an oral endocrine remedy indicated for the therapy of postmenopausal girls or grownup males with estrogen receptor (ER)-positive, human epidermal progress issue receptor 2 (HER2)-negative, ESR1-mutated superior or metastatic breast most cancers with illness development following at the least one line of endocrine remedy, within the U.S., Europe, and different world areas. Stemline additionally commercializes tagraxofusp-erzs, a novel focused remedy directed to CD123, for sufferers with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic most cancers, in the US, Europe, and different world areas. As well as, Stemline commercializes selinexor, an XPO1 inhibitor for a number of myeloma, in Europe. The corporate can also be conducting a number of label-expansion research with elacestrant and tagraxofusp in breast and hematologic most cancers indications, respectively, and has an intensive scientific pipeline of extra drug candidates in numerous phases of improvement for a number of strong and hematologic cancers.
References
1. Myelofibrosis. NORD (Nationwide Group for Uncommon Issues). https://rarediseases.org/mondo-disease/myelofibrosis/
2. Myelofibrosis. The 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 security and efficacy of the investigational mixtures and unapproved indications mentioned on this press launch haven’t been established by the FDA, EMA, or another regulatory authority.
