阿贝西利(Abemaciclib) - 药物靶点：CDK4 x CDK6_在研适应症：HR阳性HER2阴性淋巴结阳性乳腺癌，HR阳性/HER2阴性乳腺癌，去势抵抗性前列腺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Abemaciclib (JAN/USAN)、Abemaciclib mesylate、Bemaciclib

+ [7]

靶点

CDK4 x CDK6

作用机制

CDK4抑制剂(细胞周期蛋白依赖性激酶4抑制剂)、CDK6抑制剂(细胞周期蛋白依赖性激酶6抑制剂)

治疗领域

癌症皮肤和肌肉骨骼疾病呼吸系统疾病+ [7]

在研适应症

HR阳性HER2阴性淋巴结阳性乳腺癌HR阳性/HER2阴性乳腺癌去势抵抗性前列腺癌+ [54]

非在研适应症

晚期胆管癌晚期癌症脑转移瘤+ [14]

原研机构

Eli Lilly & Co.

在研机构

Eli Lilly & Co.

美国礼来亚洲公司上海代表处Eli Lilly Nederland BV

+ [3]

非在研机构

Lilly del Caribe, Inc.

礼来苏州制药有限公司

最高研发阶段批准上市

首次获批日期

美国 (2017-09-28),

HR阳性/HER2阴性乳腺癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、优先审评 (中国)、特殊审批 (中国)

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结构

分子式C27H32F2N8

InChIKeyUZWDCWONPYILKI-UHFFFAOYSA-N

CAS号1231929-97-7

关联

240

项与阿贝西利相关的临床试验

NCT06025747 / Recruiting临床1期IIT

A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for High-Risk Adipocytic Retroperitoneal Sarcomas

This phase I trial tests the safety, side effects, and best dose of abemaciclib and how well it works with radiation therapy before surgery in treating patients with high-risk adipocytic retroperitoneal sarcoma. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving abemaciclib together with radiation therapy before surgery may shrink tumors in patients with high-risk adipocytic retroperitoneal sarcoma.

开始日期2024-10-15

申办/合作机构

University of Washington

[+1]

NCT06498648 / Not yet recruiting临床1/2期IIT

Phase I/II Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas

This phase 1/2 trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.

开始日期2024-09-30

申办/合作机构

National Cancer Institute

NCT06413706 / Not yet recruiting临床2期

A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Temozolomide Compared to Temozolomide Monotherapy in Children and Young Adults With Newly Diagnosed High-Grade Glioma Following Radiotherapy

The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy.
Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.

开始日期2024-09-01

申办/合作机构

Eli Lilly & Co.

100 项与阿贝西利相关的临床结果

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100 项与阿贝西利相关的转化医学

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100 项与阿贝西利相关的专利（医药）

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840

项与阿贝西利相关的文献（医药）

2024-12-31·Future Science OA

Real-world effectiveness of palbociclib in HR+/HER2- metastatic breast cancer: a literature review

Review

作者: Kümler, Iben ; Christiansen, Emilie Adrian

Approximately 70% of newly diagnosed breast cancers are of the HR+/HER2- subtype. For the treatment of patients with HR+/HER2- metastatic breast cancer, current guidelines recommend the use of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in combination with endocrine therapy. In this review we assess existing literature concerning real-world effectiveness of palbociclib. Survival outcomes in terms of progression-free survival and overall survival are discussed and compared among the included real-world studies and in relation to the phase III PALOMA trials.

2024-11-01·CANCER TREATMENT REVIEWS

Abemaciclib increases the risk of venous thromboembolism in breast cancer: Integrate meta-analysis, pharmacovigilance database analysis, and in vitro validation

Review

作者: Zhang, Zhiqi ; Cui, Yimin ; Chong, Shan ; Liu, Qianxin ; Xiong, Fei ; Xu, Ling ; Gu, Zhichun ; Hua, Manqi ; Xiang, Qian ; Hou, Jingyi ; Cui, Xiangli ; Zhang, Zhuo

BACKGROUND:

Recently, cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) have emerged as a novel treatment strategy for breast cancer. However, increasing reports of CDK4/6i-associated venous thromboembolism (VTE) have garnered attention. This study assessed CDK4/6i-associated VTE in breast cancer, and examined the effect of CDK4/6i on platelet/coagulation function for the first time in vitro.

METHODS:

PubMed and Embase databases were searched for studies published from the establishment of the database to December 31, 2022 for randomized controlled trials (RCTs) and real-world studies of CDK4/6i in patients with breast cancer, and the data obtained from the included studies were used for meta-analysis. A disproportionality analysis by extracting adverse drug reaction signals of CDK4/6i-associated VTE from the FDA Adverse Event Reporting System (FAERS) database was also conducted. Additionally, the in vitro effect of CDK4/6i on platelet function was assessed based on platelet aggregation tests and flow cytometry, and coagulation function was assessed based on the blood clotting function test.

FINDINGS:

A total of 16,903 patients in 13 RCTs and 6,490 patients in 9 real-world studies were included in the meta-analysis. In RCTs, VTE occurred in 193 (2.1 %) and 55 (0.7 %) patients in the CDK4/6i and control groups, respectively. In real-world studies, the aggregate incidence rate of VTE was 4.2 % (95 % CI: 2.1, 6.3). The meta-analysis of RCTs revealed that abemaciclib (Odds ratio [OR]: 4.40 [95 % CI: 2.74,7.05], p < 0.001) and palbociclib (OR: 2.35 [95 % CI: 1.34, 4.12], p < 0.01) significantly increased the risk of VTE in patients with breast cancer compared to placebo. FAERS database analysis revealed that abemaciclib (reporting odds ratio [ROR]: 1.63 [95 % CI: 1.36, 1.97]; IC₀₂₅: 0.67) and ribociclib (ROR: 1.17 [95 % CI: 1.0, 1.39]; IC₀₂₅: 0.18) demonstrated a significantly increased signal of VTE. Similarly, findings from in vitro experiments demonstrated that abemaciclib enhanced agonist-induced platelet activation, especially when collagen was used as the inducer, and this effect became more prominent with increasing its concentration.

INTERPRETATION:

Use of abemaciclib may increase the risk of VTE in patients with breast cancer, which may be partially attributed to the effect of abemaciclib on platelet function. Close monitoring of VTE occurrence is highly recommended while using abemaciclib, especially in patients at a high risk of VTE.

2024-11-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Biochemical and biophysical characterization of Leishmania donovani citrate synthase

Article

作者: Ranjan, Preeti ; Dubey, Vikash Kumar ; Sarma, Manash

Citrate synthase is a crucial enzyme in the TCA cycle and represents a potential therapeutic target. However, knowledge about this enzyme in Leishmania parasites remains limited. In this study, we have successfully cloned, expressed, and purified citrate synthase from Leishmania donovani (LdCS) using a bacterial system, and characterized it through various biophysical and biochemical methods. Circular dichroism analysis at physiological pH indicates that LdCS is properly folded. Further investigation into its tertiary structure using a quencher reveals that most tryptophan residues are located within the protein's hydrophobic core. Biochemical assays show that the recombinant enzyme is catalytically active, with optimal activity at pH 7.0. Kinetic studies provided parameters such as Km and Vmax. Enzyme inhibition assays revealed that LdCS activity is competitively inhibited by FDA-approved compounds-Abemaciclib, Bazedoxifene, Vorapaxar, and Imatinib-with Ki values ranging from 2 to 3 μM, demonstrating significant binding affinity. This research paves the way for exploring LdCS as a potential drug target for treating leishmaniasis.

572

项与阿贝西利相关的新闻（医药）

2024-09-19

·艾美达医药咨询

礼来市值今年能否突破万亿美元？

礼来近年来在全球制药行业中展现出了卓越的领导力，其市值已攀升至制药行业的顶端，成为当前市值最高的制药公司。这一地位的获得，源于礼来在多个关键治疗领域的创新突破，特别是在糖尿病、肥胖症、阿尔茨海默病和肿瘤治疗等重大疾病领域，其研发管线和新药上市带来的巨大市场影响力尤为显著。礼来的卓越表现不仅让其市值稳步增长，也使其市值迅速逼近1万亿美元大关，成为全球资本市场上备受关注的焦点。在制药行业中，市值突破1万亿美元是一个标志性的成就，代表着企业在研发、市场拓展和财务表现方面的综合实力。礼来公司凭借其深厚的研发基础和不断扩展的全球市场布局，已经在迈向这一里程碑的路上取得了令人瞩目的进展。随着礼来在多领域的新药接连取得重大突破，投资者和市场分析师普遍看好其未来的增长潜力。截止目前，礼来、诺和诺德、强生、默沙东、艾伯维等企业跻身千亿美元市值俱乐部，礼来居首位。 01 强者之争近年来，GLP-1受体激动剂市场成为糖尿病和肥胖症治疗领域的焦点。作为这一领域的领导者，诺和诺德凭借其创新产品Ozempic和Wegovy，一直占据着市场主导地位。然而，全球制药巨头礼来正通过其王牌GLP-1药物Zepbound和Mounjaro与Wegovy和Ozempic厮杀。这种棋逢对手的局面不仅反映了两家公司在技术与市场策略上的较量，也折射出GLP-1类药物在全球医药市场中的巨大潜力。诺和诺德与礼来日渐胶着的竞争局面也反映在这两大制药巨头第二季度的财报中。礼来凭借2024年第二季度113亿美元的销售收入位列制药巨头第十名。不过Ozempic依靠Q2 41.7亿美元的收入在重磅炸弹中位列第二，仅次于默沙东的Keytruda，后者收入了72.7亿美元，礼来的Mounjaro以30.9亿美元排名第六。在市值前25名的制药巨头中，礼来2024年第二季度销售额同比增长率以36%的成绩傲视群雄，而且自 2023 年第二季度以来，礼来的收入每季度同比增长至少高达 28%。诺和诺德以27%的同比增长率排名第二。从目前的情况来看，如果将semaglutide灌装的Wegovy和Ozempic与tirzepatide对应的Zepbound和Mounjaro捆绑对比的话，礼来的追赶势头表现得非常迅猛。2023年第一季度（彼时Zepbound尚未获得FDA批准）tirzepatide的销售额只是semaglutide的16%，而2024年第二季度，tizepatide的销售额已经是semaglutide的74%（图1）。图1. 诺和诺德semaglutide产品（Wegovy+Ozempic）与礼来tirzepatide产品（Zepbound+Moujaro）季度销售额走势对比图。（图片来源：Maven Bio）相比之下，诺和诺德的semaglutide产品Ozempic和Wegovy在第二季度因供应问题而未能达到分析师预期。诺和诺德称，Wegovy的季度销售额增长了53%，达到17亿美元，低于分析师预测的近20亿美元。随着礼来和诺和诺德在药物研发、市场推广以及价格竞争等方面的不断博弈，GLP-1类药物市场的主导权之争将更加白热化。此外，随着临床试验结果的发布和市场动态的不断变化，诺和诺德和礼来之间的竞争势头将持续升温。 02 礼来何时能够跻身“万亿俱乐部”？人们最关注的一个问题是，礼来何时能够跻身“万亿俱乐部”？帮助礼来扶摇而上并逼近一万亿美元市值壮举的，主要来自于Mounjaro 和 Zepbound 的推动力。这两款tirzepatide灌装药品分别针对Ⅱ型糖尿病和肥胖症，它们的巨大成功为其带来了源源不断的财富。 Mounjaro在今年第二季度的销售额增长了两倍多，达到约 31 亿美元，超过了 24 亿美元的普遍预期。减肥药 Zepbound 的销售额达到 12 亿美元，超过了分析师预测的 8.19 亿美元。Mounjaro 和 Zepbound 的收入目前占礼来公司总销售额的近 40%。受到第二季度销售额业绩的鼓舞，礼来其年度销售预测上调了 30 亿美元，这是礼来在第一季度销售额业绩出炉后上调全年销售额预测20亿美元之后的又一次上调。礼来公司的股价今年飙升了 65%，其市值目前接近 8644 亿美元。对于礼来股票走向最为乐观的当属美国银行的分析师。在最新的收益报告发布后，美国银行团队将礼来股票目标价从 1000 美元上调至 1150 美元。这是华尔街的最高价预测，如果能实现的话，将使礼来的市值超过1 万亿美元。美国银行分析师还上调了他们对 Mounjaro/Zepbound 2024 年、2025 年和 2026 年的收入预测，理由是“对近期供应动态的信心增强”。在一片乐观的情绪中当然也潜伏着风险，最主要的顾虑在于礼来股票的价格，其市盈率（即股票价格相对于公司收益的比率）非常高，达到了60，而相比之下，标准普尔500指数的市盈率只有23倍。尽管如此，礼来最近的财务表现的确并没有辜负投资者的高期待。除了tirzepatide产品之外，Verzenio也是礼来的另一个重磅产品。今年上半年，这款乳腺癌药物的销售额同比飙升 42%，达到约 24 亿美元。礼来产品线中的其他三种产品也继续实现两位数的百分比销售增长，如速效胰岛素 Humalog、2 型糖尿病和慢性心力衰竭药物 Jardiance 以及自身免疫性疾病药物 Taltz。在阿尔茨海默病领域，礼来也具有跑马圈地的实力。其Donanemab-azbt（Kisunla）今年7月2日获得了FDA的批准。华尔街的共识是，该药物的年销售额峰值将达到 50 亿美元左右。礼来的管线中，还有备受期待的3G减肥药（Glucagon/GLP-1/GIP 三重受体共激动剂）retatrutide和小分子GLP-1减肥药Orfoglipron，它们的关键III期数据有望在2026年和2025年公布。除此之外，礼来管线中还有四款处于I、II期的减肥资产。总结从长期来看，礼来的市值突破万亿美元似乎只是时间问题。这一里程碑不仅标志着礼来在制药行业的领先地位，也将进一步巩固其在全球资本市场上的影响力。对于投资者而言，尽管礼来的股价已经不低，但在公司持续创新、拓展市场的背景下，仍然具有较大的增长潜力。 Ref. Dunleavy, K. With 36% increase, Eli Lilly leads industrywide sales boom in Q2. Fierce Pharma. 22. 08. 2024. Manalac, T. Lilly’s Mounjaro Helps Patients Lose More Weight Than Novo’s Ozempic: Study. Biospace. 09. 07. 2024. Lilly and Novo: How do GLP-1 Sales Compare? (Q2 '24) Maven Bio. 14. 08. 2024. Slabodkin, G. With Lilly’s Zepbound Price Cut and Novo’s Impending Senate Hearing, Wegovy Is in the Hot Seat. Biospace. 30. 08. 2024. Mishra, T. Eli Lilly gets Overweight rating from Morgan Stanley with no revision in target. Investing.com. 27. 08. 2024. Is Eli Lilly Stock a No-Brainer Buy After the Company's Brilliant Zepbound Move? Motley Fool. 29. 08. 2024. La Monica, P. R. Eli Lilly Could Become the First $1 Trillion Pharma Stock. How Weight-Loss Drugs Can Get It There. Barron’s. 30. 08. 2024. 本文转载自贝壳社/布布免责声明本文系转载，仅做分享之用，不代表平台观点。图片、文章、字体等版权均属于原作者所有，如有侵权请告知，我们会及时处理。 ------------------------------ 「长按」二维码添加小达「进群」与更多行业伙伴共探市场前沿资讯艾美达医药咨询艾美达（北京）医药信息咨询有限公司，成立于2014年4月，是一家专业的医药行业咨询服务提供商。公司致力于将产业政策研究与真实世界的数据挖掘深度结合，洞悉行业政策对市场的影响，通过专业的研究提供前瞻性的市场分析，为企业产品上市后的市场准入提供整体解决方案。

财报医药出海

2024-09-18

·drugs

FDA Expands Use of Breast Cancer Drug Kisqali

WEDNESDAY, Sept. 18, 2024 -- Women with early stage breast cancer may now take Kisquali, a medication already approved for advanced disease, following the U.S. Food and Drug Administration's expanded approval of the treatment, drug maker Novartis announced Tuesday. “The FDA approval of Kisqali for this early breast cancer population, including those with NO [hasn't spread to nearby lymph nodes] disease, is a pivotal moment in improving our approach to care,” said Dr. Dennis Slamon , director of clinical/translational research at UCLA's Jonsson Comprehensive Cancer Center and lead investigator on the company's trial of the drug. “Today’s approval allows us to offer treatment with a CDK4/6 inhibitor [Kisquali] to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning,” he added in a company news release . What prompted the expanded approval? In a phase 3 clinical trial involving women with earlier stage cancers, Kisqali reduced the risk of a breast cancer coming back by 25% after three years when given along with standard treatments, which can include chemotherapy, surgery and radiation followed by hormone therapy. After four years, Kisqali reduced the risk by 28.5%, according to an updated analysis presented Monday at the European Society for Medical Oncology annual meeting in Barcelona. “We want to do everything that we can to incrementally decrease the chances of this cancer coming back,” Dr. Vandana Abramson , co-leader of the Breast Cancer Research Program at the Vanderbilt-Ingram Cancer Center in Nashville, Tenn., told NBC News. “So if a patient was already at a potentially 10% risk of the cancer coming back, this would decrease it further, down to 7%.” While Verzenio , a drug in the same class, has been approved to lower the risk of early breast cancer returning, it's only for people with a very high risk of recurrence. Kisqali will be available to a much broader group of patients, whose disease may not be as aggressive at the time of diagnosis, Novartis said. The expanded approval is for patients with HR-positive, HER2-negative breast cancer, the most common form of the disease. It's for stage 2 and 3 cases, meaning the cancer hasn’t spread beyond the breast or nearby lymph nodes. While the drug’s effects were studied for three years, research has shown that breast cancer can recur decades after diagnosis. “It would be nice to still see additional longer follow-up data to see if we are impacting just rates of early recurrences, or will we also have an impact on late recurrences?” Dr. Komal Jhaveri , a breast medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told NBC News . Still, the drug will not come cheap. “The cost, out-of-pocket, if you’re taking it for the entire three years, would be close to $300,000-$400,000,” Abramson noted. With the expanded approval, it’s more likely that insurance plans will offer coverage for the treatment, but that can still tax the health care system as a whole. “Some of the criticisms of the study have been: well, it was only a 3% benefit,” Dr. Eleonora Teplinsky , head of breast and gynecologic medical oncology at Valley Health System in New Jersey, told NBC News. “Three percent more patients benefit. What does that mean? But I think that’s then up to the patient to decide what they want to do. It’s important for them to have the option.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

上市批准临床3期临床结果加速审批

2024-09-18

·药研网

早期乳腺癌患者复发风险降低25%！诺华CDK4/6抑制剂 Kisqali 再获 FDA 批准！

9月17日，诺华宣布，FDA已批准其 CDK4/6 抑制剂Kisqali（ribociclib）与芳香化酶抑制剂（AI）联合用于高复发风险的激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2-）II 期和 III 期早期乳腺癌（EBC）患者的辅助治疗，包括淋巴结阴性（N0）疾病患者。乳腺癌是女性健康领域的头号杀手，IARC 2024发布的全球癌症数据显示，乳腺癌稳居女性发病率榜首（23.8%）。 Kisqali （ribociclib）是一种选择性细胞周期蛋白依赖性激酶抑制剂，一类通过抑制称为细胞周期蛋白依赖性激酶 4 和 6 （CDK4/6）的两种蛋白质来帮助减缓癌症进展的药物。Kisqali 最早于2017年3月在美国获批上市，用于HR+/HER2-晚期或转移性乳腺癌治疗，并于2023年在中国上市。此次Kisqali获批基于一项全球 III 期多中心、随机、开放标签的NATALEE 试验结果，旨在评估 Kisqali （ribociclib）联合内分泌治疗（ET）作为研究性辅助治疗与单独使用 ET 在 II 期和 III 期 HR+/HER2-EBC 患者中的疗效和安全性。在接受Kisqali联合内分泌治疗（ET）辅助治疗的HR+/HER2-早期乳腺癌患者（包括高危 N0 疾病患者）中，与单独接受ET的患者相比，复发风险显著且具有临床意义地降低了25.1%（HR=0.749；95% CI：0.628，0.892；P=0.0006）在所有患者亚组中一致观察到侵袭性无病生存期（iDFS）获益。最近在 2024 年欧洲肿瘤内科学会（ESMO）大会上提交的 NATALEE 试验的最新分析再次巩固了 FDA 的审查数据。结果显示，三年治疗期后获益加深，与单独使用 ET 相比，Kisqali组合疗法组患者复发风险降低 28.5% （HR=0.715;CI 95% 0.609–0.840;P<0.0001）。诺华将继续评估 NATALEE 患者的长期结果，包括总生存期。小结诺华 Kisqali上半年销量13.44亿美元，同比增长52%，此前诺华曾预测Kisqali 在晚期乳腺癌适应症方面，销售高峰可达到40亿美元。如今，Kisqali在早期乳腺癌获批，市场表现值得期待。去年3月，礼来的 CDK4/6 抑制剂 Verzenio已获FDA批准扩大乳腺癌治疗人群，用于激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）、淋巴结阳性、复发风险高的早期乳腺癌成年患者的辅助治疗。礼来Verzenio上半年销售额 23.82亿美元，同比增长42%！随着 FDA 对 Kisqali 的批准，诺华与礼来在早期乳腺癌领域的竞争将愈发激烈! End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信 wfj_GM 商务合作稿件征集点击了解详情往期回顾 1 5月| 20家药企裁员（附名单） 2 18亿美元，ADC又出海! 宜联生物宣布新授权 3 2024 ASCO| 默沙东/科伦TROP2 ADC、信达、礼新CLDN18.2 ADC数据公布

上市批准临床结果临床2期临床3期

100 项与阿贝西利相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10688	阿贝西利	L01XE50	DB12001

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HR阳性HER2阴性淋巴结阳性乳腺癌	欧盟	Eli Lilly Nederland BV	2018-09-26
HR阳性HER2阴性淋巴结阳性乳腺癌	冰岛	Eli Lilly Nederland BV	2018-09-26
HR阳性HER2阴性淋巴结阳性乳腺癌	列支敦士登	Eli Lilly Nederland BV	2018-09-26
HR阳性HER2阴性淋巴结阳性乳腺癌	挪威	Eli Lilly Nederland BV	2018-09-26
HR阳性/HER2阴性乳腺癌	美国	Eli Lilly & Co.	2017-09-28

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
去势抵抗性前列腺癌	临床3期	美国	Eli Lilly & Co.	2022-04-14
去势抵抗性前列腺癌	临床3期	中国	Eli Lilly & Co.	2022-04-14
去势抵抗性前列腺癌	临床3期	日本	Eli Lilly & Co.	2022-04-14
去势抵抗性前列腺癌	临床3期	阿根廷	Eli Lilly & Co.	2022-04-14
去势抵抗性前列腺癌	临床3期	澳大利亚	Eli Lilly & Co.	2022-04-14
去势抵抗性前列腺癌	临床3期	比利时	Eli Lilly & Co.	2022-04-14
去势抵抗性前列腺癌	临床3期	巴西	Eli Lilly & Co.	2022-04-14
去势抵抗性前列腺癌	临床3期	加拿大	Eli Lilly & Co.	2022-04-14
去势抵抗性前列腺癌	临床3期	捷克	Eli Lilly & Co.	2022-04-14
去势抵抗性前列腺癌	临床3期	法国	Eli Lilly & Co.	2022-04-14

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04552769 (CTgov)	临床2期	甲状腺未分化癌 \| 甲状腺癌	9	abemaciclib	網壓壓窪鹹遞遞繭構網(範餘積糧廠願鬱鏇選壓) = 醖艱築繭願糧糧範鹽獵築蓋獵襯鑰製構糧願艱 (膚糧鑰鏇顧憲顧膚憲築, 壓鑰襯鹹積鏇繭構襯選 ~ 觸積襯繭壓願鹹範鹽壓) 更多	-	2024-09-19
NCT05169567 (postMONARCH, ESMO2024)	临床3期	ESR1 mutation \| PI3K pathway alteration	368	Abemaciclib + Fulvestrant	壓襯齋鏇窪積糧鏇網願(顧襯壓顧艱顧餘遞襯餘) = 簾遞鹽壓醖淵餘醖獵選鏇鹽餘獵觸壓繭膚衊遞 (襯範蓋獵積窪鹹顧糧網, 5.6 ~ 8.6)	积极	2024-09-16
				Placebo + Fulvestrant	壓襯齋鏇窪積糧鏇網願(顧襯壓顧艱顧餘遞襯餘) = 築鹽淵製觸積鏇糧鹹膚鏇鹽餘獵觸壓繭膚衊遞 (襯範蓋獵積窪鹹顧糧網, 3.7 ~ 5.6)
NCT04534283 (CTgov)	临床2期	癌症	16	LY3214996+abemaciclib	鬱淵鑰網齋鹽鹽齋網範(壓齋鏇蓋鑰願艱憲範憲) = 壓鑰艱憲醖鹽積鑰鹹製遞顧鬱遞壓獵鏇範醖積 (繭鬱願鹹糧觸選願糧積, 選遞艱願憲選淵醖遞餘 ~ 鏇網廠鑰艱齋鬱膚夢淵) 更多	-	2024-08-07
NCT03155997 (monarchE, Pubmed)	临床3期	HR阳性HER2阴性淋巴结阳性乳腺癌	-	Abemaciclib plus endocrine therapy	廠艱鹹衊鹹艱顧願憲蓋(觸鹽衊積鏇餘築獵築齋) = Participants who received abemaciclib plus endocrine therapy had more side effects than those who received endocrine therapy alone, but most of these effects were mild to moderate and reversible upon the end of therapy. The most common side effects in the abemaciclib group were diarrhea, infections, low number of white blood cells, and tiredness. 選選蓋壓齋鹹觸衊製鑰 (鹹選繭壓築壓觸簾鹹鑰 ) 更多	积极	2024-07-18
				Standard of care endocrine therapy
NCT05169567 (postMONARCH, ASCO2024) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌二线 HR+ \| HER2-	368	Abemaciclib + Fulvestrant	膚餘鬱簾獵淵蓋網簾憲(鹽蓋繭窪積鏇鹹範簾餘): HR = 0.73 (95% CI, 0.57 ~ 0.95) 更多	积极	2024-06-02
				Placebo + Fulvestrant
NCT04188548 (EMBER, ASCO2024) 人工标引	临床1期	子宫内膜癌 ER+	72	Imlunestrant	製衊構糧觸顧築夢製鹹(淵鑰襯觸醖憲鹽觸鹹廠) = 醖齋壓鏇蓋窪壓願鏇艱顧遞蓋範鏇窪膚範範廠 (構壓獵襯夢壓鬱鬱繭壓 ) 更多	积极	2024-05-24
				Imlunestrant + Abemaciclib	製衊構糧觸顧築夢製鹹(淵鑰襯觸醖憲鹽觸鹹廠) = 鹹獵遞構夢鏇餘觸選憲顧遞蓋範鏇窪膚範範廠 (構壓獵襯夢壓鬱鬱繭壓 ) 更多
NCT05386108 (ELECTRA, ASCO2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌二线 ER Positive \| HER2 Negative \| ESR1 Mutation	26	Elacestrant + Abemaciclib	齋廠繭衊選衊夢願製選(淵鑰顧願夢觸憲範積願) = 醖壓餘遞顧鹹窪鹽鹹憲鏇構憲繭積膚艱選遞簾 (夢簾鑰襯網遞淵餘壓鏇 ) 更多	积极	2024-05-24
NCT02523014 (Alliance A071401, ASCO2024) 人工标引	临床2期	脑膜瘤 NF2 mutations \| CDK pathway alterations	36	Abemaciclib	構鑰範衊襯顧餘製獵獵(簾齋餘鏇艱齋網範齋蓋) = 廠齋壓蓋簾鬱簾齋膚艱鑰餘觸艱範鹹範壓衊構 (繭觸鹹網餘齋範範鏇顧, 33 ~ 75) 达到更多	积极	2024-05-24
NCT03706365 (CYCLONE 2, ASCO2024) 人工标引	临床3期	转移性去势抵抗性前列腺癌	393	ABEMA + ABI group	鏇願夢齋鬱夢範蓋廠築(艱選膚範壓鹹積壓壓膚): HR = 0.829 (95% CI, 0.619 ~ 1.111), P-Value = 0.2123 未达到更多	不佳	2024-05-24
				PBO + ABI group
ASCO2024 人工标引	N/A	HR阳性/HER2阴性乳腺癌 HER2 Negative \| Hormone Receptor Positive	14,010	Abemaciclib+Fulvestrant	窪醖窪餘獵顧壓觸鏇膚(範製淵齋齋醖簾襯衊鏇) = 47% reduction in risk 襯壓蓋艱艱築築獵構壓 (鏇廠簾願蓋壓鑰顧艱積 ) 更多	积极	2024-05-24
				Abemaciclib+Fulvestrant+NSAI