Elacestrant hydrochloride

The combination of selinexor plus ruxolitinib met the first co-primary endpoint demonstrating a statistically significant improvement of spleen volume reduction (SVR35) of 49.8% for the combination arm vs 28% for the control arm at week 24.Post-hoc analysis from the phase 3 SENTRY trial suggests SVR35 may predict overall survival (OS); new data from the phase 1 SENTRY trial demonstrates a similar finding. Data selected by EHA’s Scientific Program Committee for late-breaking oral presentation.Data stems from the pivotal study conducted in collaboration with Karyopharm Therapeutics, Inc. FLORENCE, Italy and NEW YORK, June 14, 2026 (GLOBE NEWSWIRE) -- 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 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 (NEXPOVIO®) 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 at week 24: 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. selinexor plus ruxolitinib (n=235)placebo + ruxolitinib (n=118)SVR35 at week 1249.4% (n=116)20.3% (n=24)SVR35 at week 2449.8% (n=117)28.0% (n=33)SVR35 at week 36*46.9% (n=97)23.0% (n=23) * Analysis conducted in those patients who completed a spleen assessment or discontinued the study prior to week 36 “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.” About Myelofibrosis (MF)Myelofibrosis (MF) is a type of blood cancer that belongs to a group of diseases called Myeloproliferative Neoplasms (MPNs). These diseases are caused by the overgrowth of abnormal blood-forming cells in the bone marrow, which leads 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 about one or two people diagnosed each year for every 100,000 individuals, and the median survival after diagnosis is six years. Additionally, for people living with MF, their quality of life can be compromised by symptoms including fatigue, an enlarged spleen, and low blood counts, all of which are caused by the disease. 1,2,3 About NEXPOVIO® (selinexor) NEXPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor. The Menarini Group holds licensing rights for selinexor (NEXPOVIO® in ex-U.S. markets) and currently markets it in numerous European countries and global territories. In the U.S., Karyopharm Therapeutics markets selinexor as XPOVIO and the full prescribing information is available here. Please see NEXPOVIO® Summary of Product Characteristics (SmPC) and European Public Assessment Report at www.ec.europa.eu. Please refer to local prescribing information where NEXPOVIO is approved for full information. IMPORTANT SAFETY INFORMATION for NEXPOVIOContraindications: Hypersensitivity to selinexor or to any of the excipients listed in the SmPC. Special warnings and precautions for use: Recommended concomitant treatmentsPatients should be advised to maintain adequate fluid and caloric intake throughout treatment. Intravenous hydration should be considered for patients at risk of dehydration.Prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents should be provided prior to and during treatment with NEXPOVIO®. Haematology:Patients should have their complete blood counts (CBC) assessed at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Thrombocytopenia:Thrombocytopenic events (thrombocytopenia and platelet count decreased) were frequently reported in adult patients receiving selinexor, which can be severe (Grade 3/4).Grade 3/4 thrombocytopenia can sometimes lead to clinically significant bleeding and in rare cases may lead to potentially fatal haemorrhage. Thrombocytopenia can be managed with dose interruptions, modifications, platelet transfusions, and/or other treatments as clinically indicated.Patients should be monitored for signs and symptoms of bleeding and evaluated promptly. Neutropenia:Severe neutropenia (Grade 3/4) has been reported with selinexor. In a few cases concurrent infections occurred in patients with Grade 3/4 neutropenia. Patients with neutropenia should be monitored for signs of infection and evaluated promptly. Gastrointestinal toxicity:Nausea, vomiting, diarrhoea, which sometimes can be severe and may require the use of anti-emetic and anti-diarrhoeal medicinal products. Prophylaxis with 5HT3 antagonists and/or other anti-nausea agents should be provided prior to and during treatment with selinexor. Fluids with electrolytes should be administered to prevent dehydration in patients at risk. Nausea/vomiting can be managed by dose interruptions, modifications, and/or initiation of other antiemetics medicinal products as clinically indicated. Diarrhoea can be managed with dose interruptions, modifications and/or administration of anti-diarrhoea medicinal products. Weight loss and anorexia:Patients should have their body weight, nutritional status and volume checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment. Patients experiencing new or worsening decreased appetite and weight may require dose modification, appetite stimulants, and nutritional consultations. Confusional state and dizziness:Patients should be instructed to avoid situations where dizziness or confusional state may be a problem and to not take other medicinal products that may cause dizziness or confusional state without adequate medical advice. Patients should be advised not to drive or operate heavy machinery until symptoms resolve. Hyponatraemia:Patients should have their sodium levels checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment. Hyponatraemia should be treated as per medical guidelines (intravenous sodium chloride solution and/or salt tablets), including dietary review. Cataract:Selinexor can cause new onset or exacerbation of cataract. Ophthalmologic evaluation may be performed as clinically indicated. Cataract should be treated as per medical guidelines, including surgery if warranted. Tumour lysis syndrome (TLS):TLS has been reported in patients receiving therapy with selinexor. Patients at a high risk for TLS should be monitored closely. Treat TLS promptly in accordance with institutional guidelines. Fertility, pregnancy and lactation:Women of childbearing potential should be advised to avoid becoming pregnant or abstain from sexual intercourse while being treated with selinexor and for at least 1 week following the last dose of selinexor. Women of childbearing potential/contraception in males and females:Women of childbearing potential and male adult patients of reproductive potential should be advised to use effective contraceptive measures or abstain from sexual intercourse while being treated with selinexor and for at least 1 week following the last dose of selinexor.Pregnancy:There are no data from the use of selinexor in pregnant women. Selinexor is not recommended during pregnancy and in women of childbearing potential not using contraception.If the patient becomes pregnant while taking selinexor, selinexor should be immediately discontinued, and the patient should be apprised of the potential hazard to the foetus. Breast-feeding:It is unknown whether selinexor or its metabolites are excreted in human milk. A risk to breast-fed children cannot be excluded. Breast-feeding should be discontinued during treatment with selinexor and for 1 week after the last dose.Undesirable effectsSummary of the safety profile:The most frequent adverse reactions (≥30%) of selinexor in combination with bortezomib and dexamethasone were nausea, thrombocytopenia, fatigue, anaemia, decreased weight, diarrhea, and peripheral neuropathy.The most commonly reported serious adverse reactions (≥3%) were pneumonia, cataract, sepsis, diarrhoea, vomiting and anaemia. The most frequent adverse reactions (≥30%) of selinexor in combination with dexamethasone were nausea, thrombocytopenia, fatigue, anaemia, decreased appetite, decreased weight, diarrhoea, vomiting, hyponatraemia, neutropenia and leukopenia.The most commonly reported serious adverse reactions were pneumonia, sepsis thrombocytopenia, acute kidney injury, and anaemia. Description of selected adverse reactions:Infections: Infection was the most common non-haematological toxicity.In patients who received selinexor in combination with bortezomib and dexamethasone, upper respiratory tract infection and pneumonia were the most commonly reported infections in 21% and 15% of patients, respectively. In patients who received selinexor in combination with dexamethasone, upper respiratory tract infection and pneumonia were the most commonly reported infections (in 15% and 13% of patients, respectively) with 25% of reported infections being serious and fatal infections occurring in 3% of treated patients. Elderly population:Patients 75 years and older had a higher incidence of discontinuation due to an adverse reaction, higher incidence of serious adverse reactions, and higher incidence of fatal adverse reactions. Reporting of suspected adverse reactions:Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. About The Menarini GroupThe Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $5.5 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further 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 focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated 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, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers. Media ContactsThe Menarini GroupValeria Speroni CardiEmail: pressoffice@menarini.com Stemline Therapeutics, Inc.Cheya PopeEmail: media@menarinistemline.com References Myelofibrosis. NORD (National Organization for Rare Disorders). https://rarediseases.org/mondo-disease/myelofibrosis/Myelofibrosis. The Leukemia & Lymphoma Society (LLS). https://bloodcancerunited.org/blood-cancer/myeloproliferative-neoplasms-mpns/myelofibrosis-mfMyelofibrosis. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/myelofibrosis/symptoms-causes/syc-20355057

Roche (SIX: RO, ROP; OTCQX: RHHBY) has submitted a New Drug Application (NDA) to the US FDA for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), as adjuvant treatment for adults with estrogen receptor (ER)-positive, HER2-negative stage I, II, and III breast cancer. The FDA has accepted the filing under Priority Review, marking a significant regulatory milestone for an oral SERD in the adjuvant breast cancer setting. The NDA, submitted under Priority Review, seeks approval for giredestrant as an adjuvant endocrine therapy in patients with ER-positive, HER2-negative early-stage breast cancer across stage I through III. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of 30 November 2026, the company said. Separately, Roche noted that the FDA has also accepted an NDA for giredestrant in combination with everolimus for ESR1-mutated ER-positive advanced breast cancer, with a decision expected in December 2026. The filing is supported by data from the lidERA Breast Cancer study (NCT04961996), a Phase III, randomized, open-label, multicenter trial evaluating adjuvant giredestrant versus standard-of-care endocrine therapy in patients with medium- or high-risk stage I–III ER-positive, HER2-negative breast cancer. The trial enrolled more than 4,100 patients, with invasive disease-free survival (iDFS) as the primary endpoint. Results demonstrated that giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy (hazard ratio 0.70; 95% confidence interval 0.57–0.87; p\=0.0014). At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease, compared with 89.6% in the standard-of-care arm. The iDFS benefit was reported as consistent across clinically relevant subgroups. Overall survival data were immature at the time of analysis, though a positive directional trend was observed. The treatment discontinuation rate was 5.3% with giredestrant versus 8.2% with standard-of-care endocrine therapy, suggesting a tolerability profile that may support adherence. Giredestrant is an oral, potent next-generation SERD and full estrogen receptor antagonist designed to block estrogen binding and trigger receptor degradation, thereby inhibiting tumor cell proliferation. The adjuvant ER-positive breast cancer treatment landscape has long been anchored by tamoxifen and aromatase inhibitors, with no new endocrine therapy class introduced in over two decades. The only approved oral SERD currently on the market is Menarini/Radius Health’s elacestrant (Orserdu), which holds an indication in the metastatic setting for ESR1-mutated disease rather than the early-stage curative context. Fulvestrant, an injectable SERD, is used in advanced disease but lacks an adjuvant indication. Giredestrant’s Phase III data in the adjuvant setting therefore positions it in largely uncontested regulatory territory among oral SERDs, though the broader selective estrogen receptor degrader breast cancer field continues to attract development activity. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.