Selinexor

ADELA, an international phase III study being conducted across multiple countries, combines elacestrant with everolimus to treat advanced ER+/HER2- breast cancer with ESR1 mutations, aiming to delay disease progression. The study was presented by the Menarini Group and MEDSIR at the San Antonio Breast Cancer Symposium 2024 (SABCS 2024), one of the world's most prestigious events in oncology. MEDSIR's participation at SABCS 2024 solidifies its position as a global leader in oncology research and underscores its commitment to innovation and the development of more personalized and effective therapies. FLORENCE, Italy and BARCELONA, Spain, Dec. 12, 2024 /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, along with MEDSIR, a leading global independent clinical research company in oncology and part of Oncoclínicas & Co., the largest specialized oncology treatment group in Latin America, presented research on the pioneering clinical trial ADELA. This important research addresses therapeutic resistance in advanced ER+/HER2- breast cancer. Presented at the San Antonio Breast Cancer Symposium 2024 (SABCS), the study represents a key milestone in the quest for more effective and personalized treatment options for patients with disease progression. The standard first-line treatment for advanced ER+/HER2- breast cancer combines endocrine therapy with CDK4/6 inhibitors. ESR1 mutations develop as a result of prior exposure to endocrine therapy during metastatic treatment, and up to 50% of ER+, HER2- advanced or metastatic breast cancers will develop these mutations. ESR1 mutations cause the tumors to become resistant to endocrine therapy, in turn causing the cancer to progress; therefore, it is important to test for ESR1 whenever mBC progresses. Longer exposure to endocrine therapy during first-line treatment increases the chance of a patient's tumor developing an ESR1 mutation. With the goal of addressing this unmet medical need, the ADELA phase III clinical trial investigates a new therapeutic option combining elacestrant, a next generation, oral selective estrogen receptor degrader, with everolimus, an mTORC1 inhibitor. This combination is being evaluated in patients with advanced ER+/HER2- breast cancer that harbors ESR1 mutations, and who have experienced progression after standard first-line treatment. Results from the phase III EMERALD study were the basis for elacestrant's approval. Meanwhile, everolimus has shown efficacy in inhibiting other resistance mechanisms in this type of cancer. The elacestrant and everolimus combination has demonstrated preliminary efficacy with a manageable safety profile in the phase 1b/2 ELEVATE study (NCT05563220). "We at Menarini Stemline are delighted to announce the collaboration with MEDSIR to continue advancing the clinical research to explore the combination therapy with elacestrant," said Nassir Habboubi, MD, Chief Medical Officer of Stemline Therapeutics. "We are committed to driving innovation in cancer treatment by delivering transformational therapies aiming to extend the lives of people living with cancer." The primary objective of this international, randomized, double-blind trial is to evaluate whether the combination of elacestrant and everolimus offers greater efficacy in delaying disease progression compared to elacestrant monotherapy. Additionally, it investigates other crucial aspects, such as overall survival, toxicity profile, and the impact on patients' quality of life. The ADELA study represents a critical step in understanding how to overcome tumor resistance challenges in patients with ESR1 mutations, with the goal of advancing towards more effective and safer treatments. "At MEDSIR, we understand innovation not only as achieving clinical results but as the ability to transform patients' lives on a global scale. With ADELA, we take a decisive step toward accomplishing less invasive and more accessible treatments, aiming to offer new hope to those facing the most complex forms of the disease. This advancement reinforces our commitment to increasingly personalized and patient-centered medicine, a fundamental pillar in shaping the future of oncology," said Dr. Antonio Llombart-Cussac, Senior Scientific Leader at MEDSIR. The phase III study not only has significant clinical objectives, but also holds the potential to pave the way for regulatory approval of this therapeutic combination, enabling its use in a broader population of patients with advanced breast cancer. Moreover, the international scope of the study, which includes participation from multiple countries, including Spain, Italy, France, Austria, the Czech Republic, Greece, Germany, and the United Kingdom, underscores the study's global importance and relevance in the scientific community. The presentation of the ADELA study at an event as prominent as SABCS 2024 reinforces MEDSIR's leadership in excellence-driven oncology research and highlights its focus on addressing unmet needs in breast cancer treatment. The ADELA study is active and already recruiting patients. 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 . 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 . 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 . About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline") a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes ORSERDU® (elacestrant) in the U.S. and Europe, 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. Stemline also commercializes ELZONRIS® (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the U.S. and E.U. to date. Stemline also commercializes NEXPOVIO® (selinexor) in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers. About MEDSIR   Established in 2012, MEDSIR prides itself on working closely with its strategic partners to drive innovation in oncology research. Operating in Spain and the United States, the company provides end-to-end clinical trial management, from study design to publication, with an extensive global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that enables research partners to benefit from the best of both worlds: industry clinical research and investigator-driven trials.   With the aim of promoting independent research worldwide, MEDSIR has formed a strategic alliance with Oncoclínicas, the leading oncology group in Brazil, which offers outstanding research potential in South America.  For further information:     About Oncoclínicas & CO   Oncoclínicas&Co is the largest group dedicated to cancer treatment in Latin America, with a specialized and innovative model focused on the entire oncology care journey, combining operational efficiency, humanized care, and high specialization through a medical team composed of over 2,700 specialist physicians with an emphasis on oncology. With its mission to democratize cancer treatment, it offers a comprehensive system that integrates outpatient clinics with high-complexity cancer centers. The company operates 145 units across 39 Brazilian cities, allowing high-quality access in all regions it serves, aligned with world-class standards. Focusing on technology, precision medicine, and genomics, Oncoclínicas performed approximately 635,000 treatments in 2023. It is the exclusive partner in Brazil of the Dana Farber Cancer Institute, affiliated with Harvard Medical School, one of the world's leading cancer research and treatments centers. The company also owns Boston Lighthouse Innovation, a bioinformatics firm based in Cambridge, United States, and holds shares in Medsir, a company dedicated to the development and management of clinical trials for independent cancer research, based in Barcelona, Spain. Recently, Oncoclínicas expanded its operations to Saudi Arabia through a joint venture with the Al Faisaliah Group, bringing its mission to beat cancer to a new continent and providing advanced oncology care on a global scale by combining oncological hyperspecialization with innovative treatment approaches. The company is part of the IDIVERSA index, launched by B3, highlighting companies committed to gender and racial diversity. For more information, visit: .    Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

近日，凭借在血液及实体肿瘤领域卓越的创新研发实力和发展潜力，德琪医药斩获2项行业大奖。 “年度创新力奖” 12月5日，由格隆汇主办的“第九届·全球投资嘉年华·2025”于深圳盛大召开。本次活动中，格隆汇“金格奖”大中华区卓越上市公司评选结果隆重揭晓，德琪医药荣获“年度创新力奖”。该奖项旨在表彰致力于探索前沿科技、引领行业前行、最具突破性和创新性的企业，此次获奖标志着业界和资本市场对公司综合实力的认可。 格隆汇“金格奖”评选以“全球视野，下注中国”为初衷，参评对象覆盖香港证券交易所、上海证券交易所、深圳证券交易所、及在美国挂牌上市的所有中国公司，通过定量数据分析和专家评审团等方式得出最终结果。 “最具价值医药及医疗公司” 12月11日，全球领先的港美股资讯平台智通财经主办的“第九届智通财经资本市场年会”上颁布了一系列优质奖项，德琪医药荣获“最具价值医药及医疗公司”奖项。该奖项旨在表彰公司治理结构健康、行业地位显著、主营业务良好的医药及医疗类港美股上市公司，凸显了业界和投资者对于公司创新成果和未来发展的认可和期望。 本次评选通过企业自荐参评、综合评分、公众投票、专家评审等多个环节，由投资机构、分析师、行业协会及媒体组成的专家评审委员会，根据企业过往一年的业绩成长、行业排名、公司治理、社会影响力、资本市场回报、ESG成绩等因子进行评分，遴选出最终获奖名单。 德琪医药在肿瘤研发领域，以创新为导向，不断探索新的机制、新的临床研究和治疗方案。Claudin 18.2抗体偶联药物ATG-022以其有效靶向作用于Claudin 18.2极低表达的肿瘤，不断推进差异化的临床研究；口服型CD73小分子抑制剂ATG-037显示了逆转抗PD-1耐药的能力；肿瘤领域的同类首款药物ATG-031，是全球最快进入临床的作用于CD24的实体瘤的巨噬细胞激活剂；PD-L1/4-1BB双特异性抗体ATG-101，相比同类产品，除有效性外，在克服肝脏毒性方面差异明显。此外，商业化产品希维奥®（塞利尼索片）目前已在9个亚太市场获批上市并陆续实现医保收录。公司预计其将于2025年在更多亚太市场获批上市并纳入医保。 未来，德琪医药将继续专注血液及实体肿瘤治疗领域的创新研发，秉持“医者无疆，创新永续”的初心，聚焦亚太乃至全球患者尚未满足的临床需求，加速在研管线的全球临床开发，惠及更多患者及其家庭。 关于德琪医药    德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：6996.HK）是一家以研发为驱动，并已进入商业化阶段的生物制药领先企业，以“医者无疆，创新永续”为愿景，德琪医药专注于血液及实体肿瘤领域的同类首款和同类最优疗法的早期研发、临床研究、药物生产及商业化，致力于通过提供突破性疗法，改善全球患者生活质量。 自2017年以来，德琪医药现已建立起一条拥有9款从临床延展至商业化阶段的肿瘤药物资产研发管线，其中，6款产品具有全球权益，3款产品具有亚太权益。公司已在美国及多个亚太市场获得31个临床批件（IND），并递交了10个新药上市申请（NDA）。目前，希维奥®（塞利尼索片）已获得中国大陆、中国台湾、中国香港、中国澳门、韩国、新加坡、马来西亚、泰国和澳大利亚的新药上市批准。 前瞻性陈述    本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内有关任何董事或本公司意向的陈述或提述乃于本文刊发日期作出。任何该等意向均可能因未来发展而出现变动。有关这些因素和其他可能导致未来业绩与任何前瞻性声明存在重大差异的因素的进一步讨论，请参阅我们截至2023年12月31日的公司年报中描述的其他风险和不确定性，以及之后向香港证券交易所提交的文件。