Tagraxofusp-ERZS

Preliminary efficacy analysis from the elacestrant plus everolimus and ribociclib cohorts of the ELEVATE study, along with updated safety data from additional cohorts of elacestrant plus targeted therapy combination arms, will be presented. These data highlight elacestrant’s potential role as an endocrine therapy backbone in combination with various targeted agents for patients with ER+/HER2- mBC. The robust elacestrant clinical development program across wide-ranging studies further solidifies its potential in monotherapy and combination settings, in mBC and in early breast cancer. FLORENCE, Italy and NEW YORK, May 22, 2025 (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, will present updated preliminary efficacy and safety results from the Phase 1b/2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). The ELEVATE study was designed to evaluate the safety and efficacy of oral-oral combination treatment options to overcome different resistance mechanisms observed in ER+/HER2- mBC and improve patient outcomes. Additionally, various other trial-in-progress updates will be presented, investigating elacestrant’s potential to become an endocrine therapy (ET) backbone across the spectrum of breast cancer. These data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The ELEVATE study is comprised of six treatment regimens evaluating elacestrant in combination with CDK4/6 inhibitors (palbociclib, abemaciclib and ribociclib) and with inhibitors of the PI3K/AKT/mTOR pathway (everolimus, alpelisib and capivasertib). ELEVATE results reported at ASCO 2025 (abstract 1070/49) include updated efficacy data which demonstrate favorable preliminary progression-free survival (PFS) from the elacestrant plus ribociclib and the elacestrant plus everolimus cohorts. A recommended phase 2 dose (RP2D) was determined to be elacestrant 345 mg plus ribociclib 400 mg. The RP2D of elacestrant 345 mg plus everolimus 7.5 mg was previously reported. “It is encouraging to see the positive preliminary efficacy and safety results when everolimus and ribocilib, respectively, are combined with elacestrant. These findings are consistent with the promising elacestrant plus abemaciclib cohort data from the same study that was presented last December, which also demonstrated favorable preliminary efficacy and safety in this setting,” said Hope S. Rugo, MD, Director, Women's Cancers Program and Division Chief, Breast Medical Oncology, City of Hope Comprehensive Cancer Center. “As the progression-free survival data and safety data continue to mature across the various cohorts of the ELEVATE study, we are encouraged by elacestrant’s potential to become an endocrine therapy backbone in combination regimens for the treatment of metastatic breast cancer.” Additional data reported separately (abstract 1079/58) provided updated Phase 1b/2 safety results from four cohorts of the ELEVATE study, including elacestrant plus ribociclib, everolimus, alpelisib, and capivasertib. These updated preliminary results show that the combinations are consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy. “These data continue to underscore the potential value of elacestrant as a combination partner in the ER+/HER2- metastatic breast cancer treatment landscape,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are also exploring the potential of elacestrant in other patient populations, including our currently enrolling ELEGANT study, which is designed to assess its potential benefit in early breast cancer patients with high risk of recurrence.” In addition, the company will be presenting other data at the ASCO Annual Meeting. See below for a complete list of Menarini Stemline abstracts. Menarini Stemline Abstracts: Presentation Title: Elacestrant (Ela) combinations with ribociclib (Ribo) and everolimus (Eve) in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. Abstract Number: 1070 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 49 Presenting Author: Hope S. Rugo Presentation Title: Elacestrant combinations in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Safety update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. Abstract Number: 1079 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 58 Presenting Author: Nancy Chan Presentation Title: ADELA: a double-blind, placebo-controlled, randomized phase 3 trial of Elacestrant (ELA) + everolimus (EVE) versus ELA + placebo (PBO) in ER+/HER2- advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) + CDK4/6i. Abstract Number: TPS1129 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 103b Presenting Author: Antonio Llombart-Cussac Presentation Title: ELCIN: Elacestrant in women and men with CDK4/6 Inhibitor (CDK4/6i)-naïve estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC): an open-label multicenter phase 2 study. Abstract Number: TPS1127 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 102b Presenting Author: Virginia G. Kaklamani Presentation Title: ELEGANT: Elacestrant versus standard endocrine therapy (ET) in women and men with node-positive, estrogen Receptor-positive (ER+), HER2-negative (HER2-), early breast cancer (eBC) with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study. Abstract Number: TPS619 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 210a Presenting Author: Aditya Bardia Presentation Title: EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA) Abstract Number: TPS620 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 210b Presenting Author: Michail Ignatiadis About The Elacestrant Clinical Development Program Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. ELEVATE ( NCT05563220 ) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA ( NCT05386108 ) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN ( NCT05596409 ) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. ADELA ( NCT06382948 ) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease. About ORSERDU (elacestrant) U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is 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. Full prescribing information for the U.S. can be found at www.orserdu.com . Important Safety Information Warning and Precautions Dyslipidemia : Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU. Embryo-Fetal Toxicity : Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the final dose. Adverse Reactions Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each). The most common adverse reactions ( > 10%) , including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite(15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%). Drug interactions Concomitant use with CYP3A4 Inducers and/or inhibitors : Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU. Use in specific populations Lactation : Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose. Hepatic Impairment : Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B). The safety and effectiveness of ORSERDU in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 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 Contacts The Menarini Group Valeria Speroni Cardi Email: pressoffice@menarini.com Stemline Therapeutics, Inc. Cheya Pope Email: media@menarinistemline.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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BPDCN是一种侵袭性血液恶性肿瘤，预后较差 VisualDx是全球2,300多家医院、诊所和医学院使用的临床决策支持系统 VisualDx的系统旨在利用BPDCN皮肤病变的实际图像和集成到VisualDx平台中的人工智能/机器学习（ AI/ML ）技术，增强对可能患有BPDCN的人的识别 意大利佛罗伦萨和纽约 2025年3月21日 /美通社/ -- 美纳里尼集团（ “美纳里尼” ）是一家领先的国际制药和诊断公司， Stemline Therapeutics, Inc. （ “Stemline” ）是美纳里尼集团的全资子公司，专注于为癌症患者提供转化性肿瘤治疗。他们今天宣布，他们正在与VisualDx合作，以加强对可能患有BPDCN的人的识别。 这是一个创新的公司合作引入人工智能/机器学习（ AI/ML ）工具以帮助识别BPDCN作为可能的早期鉴别诊断的例子。 该项目包括利用整合到VisualDx平台中的BPDCN皮肤病变的实际图像和AI/ML技术。 AI模型现已在VisualDx中上线。 VisualDx是一家以医生为主导的公司，致力于改善医疗决策、医学教育和研究。 VisualDx工具是全球2,300多家医院、诊所和医学院使用的临床决策支持系统。 该软件包括一个全面的临床图像数据库，通过与学习机构和其他机构合作提交，并经临床医生审查，以帮助医疗保健专业人员识别所有皮肤类型的皮肤问题。 通过人工智能图像搜索，临床医生可以更好地了解不同的皮肤状况，以支持患者在整个护理过程中获得更准确的诊断。 BPDCN是一种侵袭性孤儿血液恶性肿瘤，预后不良（诊断后约8.7至14个月 [1] ） ，通常表现为皮肤病变，也可能累及骨髓、血液、中枢神经系统、淋巴结和内脏。 皮肤科医生可能是第一个识别BPDCN和活检可疑病变迹象的人。 然后，病理学家可以通过测试在BPDCN细胞上高度表达的某些生物标志物来测试BPDCN。 Tagraxofusp-erzs是美国、欧洲和全球其他地区唯一获批的BPDCN患者治疗药物，也是首个也是唯一获批的CD123靶向治疗药物。 “BPDCN是一种罕见的临床侵袭性血液恶性肿瘤，通常表现为皮肤病变。 由于其侵袭性和未成熟的细胞参与，如果不及时治疗，预后可能会很差。”爱因斯坦血液癌症研究所分子药理学教授、白血病项目主任兼联合主任Marina Konopleva博士说。 “早期诊断在改善患者预后方面发挥着关键作用，新兴的AI/ML技术可能为BPDCN的鉴别诊断和早期识别提供有价值的支持。” “BPDCN通常首先表现为皮肤病变，通常预后不良。 美纳里尼集团首席执行官Elcin Barker Ergun表示： “迫切需要早期诊断，以便患者可以获得适当的治疗选择。 “我们很高兴与VisualDx合作，为医疗团队提供使用最新人工智能/机器学习（ AI/ML ）技术的工具，以帮助解释具有挑战性的皮肤病变。” VisualDx不会存储临床医生拍摄患者皮肤检查照片上传的任何图像。 这有助于保护患者的隐私。 关于BPDCN BPDCN ，以前称为芽肿性NK细胞淋巴瘤，是一种侵袭性孤儿血液恶性肿瘤，通常具有皮肤表现，预后历史上较差。 BPDCN通常表现为皮肤病变，也可能涉及骨髓、血液、中枢神经系统、淋巴结和内脏。 BPDCN起源细胞是浆细胞样树突状细胞（ pDC ）前体。 BPDCN的诊断基于CD123、CD4和CD56的免疫表型诊断三联体以及其他标志物。 世界卫生组织（ WHO ）在2008年将这种疾病称为“BPDCN” ；以前的名称包括芽肿性NK细胞淋巴瘤和CD4 +/CD56 +血液皮肤肿瘤。 关于ELZONRIS ® (Tagraxofusp-erzs) 美国适应症： ELZONRIS是一种用于治疗2岁及以上成人和儿童患者的母细胞性浆细胞样树突细胞肿瘤(BPDCN)的处方药。 有关美国的完整处方信息，请访问 www.elzonris.com 重要的安全信息， ELZONRIS ® 盒装警告：毛细血管泄漏综合征 可能危及生命或致命的毛细血管泄漏综合征(CLS)可能发生在接受ELZONRIS的患者身上。 监测CLS的体征和症状，并采取建议的措施。 警告和注意事项 毛细血管泄漏综合征 在接受ELZONRIS治疗的患者中已有毛细血管泄漏综合征（ CLS ）的报道，包括危及生命和致命的病例。 在临床试验中接受ELZONRIS的患者中， CLS的总发病率为53% （ 65/122 ） ，其中43% （ 52/122 ）的患者为1级或2级， 7% （ 8/122 ）的患者为3级， 1% （ 1/122 ）的患者为4级， 4例死亡（ 3% ）。 发病的中位时间为4天（范围- 1至46天） ，除5名患者外，所有患者在第1周期都经历了一次事件。 在开始使用ELZONRIS治疗之前，请确保患者具有足够的心脏功能，并且血清白蛋白大于或等于3.2 g/dL。 在ELZONRIS治疗期间，在开始每次ELZONRIS给药前和给药后根据临床指征监测血清白蛋白水平，并评估患者是否存在CLS的其他体征或症状，包括体重增加、新发水肿或水肿恶化，包括肺水肿、低血压或血流动力学不稳定。 超敏反应 ELZONRIS可引起严重的超敏反应。 在临床试验中接受ELZONRIS的患者中， 43% (53/122)接受ELZONRIS治疗的患者报告了超敏反应， 7% (9/122)中≥ 3级。 在≥ 5%的患者中报告的超敏反应表现包括皮疹、瘙痒和口腔炎。 监测患者在使用ELZONRIS治疗期间的超敏反应。 如果发生超敏反应，请中断ELZONRIS输注，并根据需要提供支持性护理。 肝毒性 ELZONRIS治疗与肝酶升高相关。 在临床试验中接受ELZONRIS的患者中， ALT升高发生在79% （ 96/122 ） ，应用安全测试升高发生在76% （ 93/122 ）。 26% （ 32/122 ）的患者报告了3级ALT升高。 30% （ 36/122 ）的患者报告了3级应用安全测试升高， 3% （ 4/122 ）的患者报告了4级应用安全测试升高。 在第1周期中，大多数患者的肝酶升高，并且在剂量中断后是可逆的。 在每次输注ELZONRIS之前监测丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶(AST)应用安全测试。 如果转氨酶升高到超过正常上限的5倍，则暂停ELZONRIS ，并在正常化或解决后恢复治疗。 不良反应 最常见的不良反应（发生率≥ 30% ）是毛细血管泄漏综合征、恶心、疲劳、发热、外设水肿和体重增加。 最常见的实验室异常（发生率≥ 50% ）是白蛋白、血小板、血红蛋白、钙和钠的降低，以及葡萄糖、ALT和应用安全测试（ AST ）的增加。 请参阅完整 处方信息 ，包括盒装警告。 如需报告疑似不良反应，请通过 1-877-332-7961 联系Stemline Therapeutics, Inc. ，或通过 1-800-FDA-1088 或 www.fda.gov/medwatch 联系FDA。 关于美纳里尼集团 美纳里尼集团是一家领先的国际制药及诊断公司，营业额超过47亿美元，员工超过17,000人。 美纳里尼专注于心脏病、癌症、肺病、胃肠病、传染病、糖尿病、炎症和镇痛方面等产品需求缺口巨大的治疗领域。 美纳里尼拥有18个生产基地和9个研发中心，产品遍布全球140个国家\/地区。 如需了解更多信息，请访问 menarini.com 。 关于Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline")是美纳里尼集团旗下的一家全资子公司，是一家专注于为患者提供转化性肿瘤治疗的商业化生物制药公司。 Stemline实现elacestrant的商业化，这种口服内分泌治疗药物适用于治疗美国、欧洲和全球其他地区患雌激素受体(ER)阳性、人表皮生长因子受体2 (HER2)阴性、 ESR1 突变晚期或转移性乳腺癌且接受过至少一种内分泌疗法后疾病进展的绝经后女性或成年男性。 Stemline还在美国、欧洲和全球其他地区实现针对CD123的新型靶向治疗药物tagraxofusp-erzs的商业化，用于治疗一种侵袭性血液癌--母细胞性浆细胞样树突细胞肿瘤(BPDCN)。 此外， Stemline还在欧洲实现selinexor的商业化，这是一种用于多发性骨髓瘤的XPO1抑制剂。 该公司还在乳腺癌和血液癌适应症中分别使用elacestrant和tagraxofusp进行多项标签扩展研究，并且拥有众多处于不同开发阶段且针对多种实体和血液癌的其他候选药物的临床试验项目。 关于VisualDx VisualDx是一家致力于通过增强思维和及时可视化来改善医疗决策的公司。 它致力于缩小医学差距，并相信技术可以弥合知识差距，以实现更公平的护理。 VisualDx已成为全球2,300多家医院、诊所和医学院的专业标准资源，它将面向问题的临床搜索与世界上最好的精心策划的医学图像库相结合，再加上专家的医学知识和复杂的机器学习算法，以帮助进行鉴别诊断、变异、治疗和患者沟通。 如需了解更多信息，请访问 www.visualdx.com [1] Pagano L, et al Haematological. 2013; 98 (2): 239-246和Pemmaraju N Curr Hematol Malig Rep. 2017; 12 (6): 510-512