This phase I trial tests the safety, side effects, and best dose of abemaciclib in combination with 5-fluorouracil and how well it works in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that has not responded to treatment (refractory). Abemaciclib, a type of cyclin-dependent kinase inhibitor, blocks certain proteins, which may help keep tumor cells from growing. 5-fluorouracil, a type of antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Giving abemaciclib in combination with 5-fluorouracil may be safe, tolerable, and/or effective in treating patients with metastatic and refractory colorectal cancer.

开始日期2025-10-31

申办/合作机构

National Cancer Institute

NCT06498648

/ 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2025-10-14

申办/合作机构

National Cancer Institute

NCT06810492

/ Not yet recruitingN/AIIT

A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer

To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.

开始日期2025-04-01

申办/合作机构

湖北省肿瘤医院（湖北省肿瘤研究所）

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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1,441

项与阿贝西利相关的文献（医药）

2025-06-01·Clinical Genitourinary Cancer

CDK4/6 Inhibition With Abemaciclib in Patients With Previously Treated Advanced Renal Cell Carcinoma

Article

作者: Xu, Wenxin ; McGregor, Bradley A ; Kaelin, William G ; Choueiri, Toni K ; McDermott, David ; Xie, Wanling ; Berg, Stephanie A ; Signoretti, Sabina ; Viswanathan, Srinivas R

BACKGROUND:

Preclincal data provide a rationale for cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors alone and in combination with HIF-2α inhibitors in treatment of clear cell renal cell carcinoma (ccRCC), with randomized phase 2 clinical trials currently open exploring the combination of palbociclib with belzutifan vs belzutifan in treatment resistant ccRCC (NCT05468697). However, single agent activity for CDK4/6 inhibitors in ccRCC has not been reported. In this multi-center phase 1b clinical trial (NCT04627064), we investigated the safety and efficacy of monotherapy with abemaciclib, an oral CDK4/6 inhibitor in patients with advanced pretreated RCC.

METHODS:

Adult patients with advanced RCC with a clear cell component and ECOG status of ≤ 2 progressing after at least 1 prior regimen including immunotherapy and a VEGFR TKI received abemaciclib 200 mg twice daily in 4-week cycles until progression or unacceptable toxicity. The primary objective was to evaluate the objective response rate (ORR) of abemaciclib with a secondary endpoint of safety. First imaging was performed after 8 weeks or 2 cycles. Response was assessed per RECIST 1.1 and toxicity graded per CTCAE v5.0.

RESULTS:

Eleven patients were enrolled between December 31, 2020 and October 03, 2023. Median age was 62 years (range 54-68); 73% (n = 8) had IMDC intermediate risk disease and 1 patient had translocation RCC with a clear cell component. Median number of prior therapies was 4 (range 1-9). ORR was 0% (0/11; 8 progressive disease, 1 stable disease stopping for clinical progression, 2 not evaluable with clinical progression). About 27% (n = 3) experienced grade ≥3 treatment-related adverse events (diarrhea n = 1, nausea n = 1, neutropenia n = 1).

CONCLUSION:

In patients with heavily pretreated metastatic RCC, abemaciclib monotherapy had no clinically meaningful activity without new toxicity signals. This data will offer important insight into interpretation of results for ongoing trials exploring CDK4/6 inhibition in combination with HIF-2α inhibitors and immunotherapy.

2025-05-01·Breast Cancer

The impact of axillary lymph-node dissection omission on adjuvant abemaciclib eligibility in HR-positive, HER2-negative breast cancer with positive sentinel lymph nodes

Article

作者: Nishikawa, Aya ; Yamada, Akimitsu ; Adachi, Shoko ; Narui, Kazutaka ; Endo, Itaru ; Oshi, Masanori ; Kawashima, Kei ; Ishikawa, Takashi ; Sasamoto, Mahato

BACKGROUND:

The MonarchE trial demonstrated the additional benefit of abemaciclib as an adjuvant endocrine therapy for high-risk patients with hormone receptor (HR)-positive HER2-negative breast cancer. Meanwhile, the ACOSOG Z0011 trial established the omission of axillary lymph-node dissection (ALND) as a standard practice in certain patients with positive sentinel lymph-node biopsy (SNB). However, as the MonarchE eligibility criteria include the presence of four or more lymph-node metastases, omitting ALND may hinder the assessment of abemaciclib eligibility in some cases.

METHODS:

The study population consisted of patients with clinically node-negative, HR-positive, HER2-negative breast cancer who underwent SNB at our institution between January 2008 and December 2021. The proportion of patients meeting the MonarchE cohort1 criteria, and the potential impact of ALND omission on abemaciclib eligibility were assessed.

RESULTS:

Among the 1537 patients, 189 underwent SNB followed by ALND due to the presence of one or more positive sentinel nodes. Of these, 69 (36.5%) were eligible for abemaciclib. Eligibility was uncertain without ALND in 138 patients. Among the 138 patients, 124 were candidates for ALND omission, including 11 who were found to have four or more metastatic lymph nodes after completing ALND.

CONCLUSIONS:

A few cases were identified in which abemaciclib eligibility was not properly determined due to ALND omission. This suggests that omitting ALND following SNB, when two of fewer positive nodes are detected, may not significantly impact the determination of abemaciclib eligibility.

2025-05-01·Breast Cancer

A prospective cohort study of abemaciclib-induced interstitial lung disease in metastatic breast cancer after chemotherapy

Article

作者: Nakayama, Sayuka ; Iwamoto, Takayuki ; Sugimoto, Naoya ; Nakayama, Takahiro ; Aihara, Tomohiko ; Mukai, Hirofumi ; Nagase, Hiroyuki ; Narui, Kazutaka ; Araki, Kazuhiro ; Kikawa, Yuichiro ; Taira, Naruto

BACKGROUND:

The safety of combination therapy with abemaciclib and hormone therapy in patients with hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) who were previously treated with chemotherapy for MBC remains unclear. Caution is required as the Pharmaceuticals and Medical Devices Agency (PMDA) and the U.S. Food and Drug Administration (FDA) have issued warnings about abemaciclib-induced interstitial lung disease (ILD).

METHODS:

This study was a secondary analysis of a prospective observational study involving patients who had previously undergone chemotherapy for HR + MBC. A certificated respiratory specialist reviewed the clinical information of patients who were suspected of having ILD to adjudicate abemaciclib-induced ILD and definitively diagnosed abemaciclib-induced ILD. In this study, the incidence, risk factors, and clinical course of interstitial lung disease (ILD) are reported.

RESULTS:

All cases of patients who received abemaciclib had no radiological evidence of ILD prior to abemaciclib treatment. The incidence of abemaciclib-induced ILD was 7.4% (n = 9/122). CTCAE grade 1/2 occurred in 77.8% (n = 7), with no grade 4/5 cases. The timing of ILD onset varied and our study did not identify any significant risk factors for abemaciclib-induced ILD. All cases of ILD ultimately were confirmed to be in remission or cured.

CONCLUSION:

In this multicenter prospective cohort study with a follow-up period of 3.3 years and a definition of ILD by a certified pulmonologist, we accurately evaluated abemaciclib-associated ILD after chemotherapy. The favorable clinical course of ILD indicate that abemaciclib treatment is an acceptable option for these MBC patients. However, because abemaciclib-induced ILD is difficult to predict, careful monitoring is required during abemaciclib treatment.

715

项与阿贝西利相关的新闻（医药）

2025-04-15

·信达生物

全国肿瘤防治宣传周 | 礼来与信达生物、和黄医药加速赋能医药创新，助力“健康中国”建设

2025年4月15日，中国上海——第31届全国肿瘤防治宣传周首日，全球领先的制药企业礼来制药和中国创新药企信达生物、和黄医药齐聚上海，共话本土医药创新发展，探索加速惠及中国肿瘤患者的新模式。二十载深耕，礼来是中国肿瘤创新发展坚定的参与者与同行者。与信达生物、和黄医药等本土创新生物医药企业逾十载深度合作，不仅成就了多款具有影响力的突破性创新药物的问世，更为中国肿瘤患者带来了生命希望与福祉，为“健康中国”建设贡献力量。中国药科大学附属上海高博肿瘤医院院长李进教授，礼来中国总裁兼总经理德赫兰女士，礼来全球高级副总裁、礼来中国药物开发及医学事务中心负责人王莉博士，信达生物创始人、董事会主席、首席执行官俞德超博士，和黄医药首席执行官兼首席科学官苏慰国博士，礼来全球副总裁、礼来中国药物开发及医学事务中心首席医学官迟海东博士，礼来中国副总裁、抗肿瘤事业部负责人尹航先生等嘉宾出席活动。二十载深耕助力中国肿瘤事业高质量发展中国是癌症负担最沉重的国家之一，国家癌症中心最新数据显示，2022年我国新发癌症病例达482.47万例，新增死亡病例达 257.42万例。“健康中国”行动明确提出，到2030年我国总体癌症5年生存率不低于46.6% 。这一系列目标和数据彰显了国家对癌症防控的高度重视和对治疗方案创新的迫切需求。中国药科大学附属上海高博肿瘤医院院长李进教授指出：“近年来，中国在肿瘤领域的创新持续加速，涌现出越来越多具有国际影响力的成果。跨国企业与本土力量齐头并进的广泛投入，不仅加速了全球前沿多中心临床研究落地中国，也让创新疗法更快惠及患者。我们期待这种开放与合作持续深化，帮助中国患者第一时间受益于创新疗法，亦让世界看到中国创新力量的崛起。”肿瘤是礼来重要的战略治疗领域之一。20年来，礼来在肿瘤领域积极探索以创新驱动的多元化业务模式，聚焦靶向治疗、免疫治疗以及克服肿瘤耐药药物的研发，已在中国获批上市9款创新药物，涵盖乳腺癌、肺癌、消化道肿瘤、血液肿瘤等10大癌种，并与本土战略伙伴建立了一条覆盖临床研究、生产质量到商业运营的端到端合作价值链。礼来中国总裁兼总经理德赫兰女士表示：“在中国，肿瘤给无数患者和家庭带来了沉重的负担。我们深知，患者不仅需要新的治疗选择，也期待更好的生活质量。礼来始终致力于为中国患者提供高质量的创新药物，并努力让这些药物更快地惠及更多患者。礼来是长期主义的践行者，我们将继续坚定地参与本土创新生态的建设，希望与本土伙伴紧密合作，真正解决患者的未尽之需，为中国肿瘤防治事业及整个社会的发展创造价值。” 礼来全球高级副总裁、礼来中国药物开发及医学事务中心负责人王莉博士表示：“礼来在肿瘤治疗领域拥有深厚的研发积淀，我们深刻理解中国市场的独特性和肿瘤患者需求的多样性，致力于通过扎实、确凿的临床研究推动肿瘤治疗进步。目前，中国已被正式纳入礼来全球早期临床研究计划，实现与全球研发体系的无缝对接。礼来也在持续加快研发步伐，带来更多卓越的创新治疗方案，帮助广大患者延续生命、提高生活质量。”十余载砥砺共进赋能本土创新，惠泽患者礼来致力于成为中国医疗保健领域的重要战略伙伴，与信达生物、和黄医药等本土创新生物医药企业的战略合作已结出累累硕果，为中国患者带来了多款高质量、可负担的创新药物。达伯舒®（信迪利单抗注射液）是礼来和信达生物在中国共同开发的具有国际品质的创新PD-1抑制剂，双方以此为起点，已建立起一个由中国创新药企与全球制药巨头之间的全面战略合作，其范围涵盖新药研发、临床研究、生产质量和市场销售等。信达生物创始人、董事会主席、首席执行官俞德超博士表示：“信达生物致力于开发老百姓用得起的高质量生物药。十年来，我们与礼来不断深化互信，拓展合作领域和范围，以科学创新、造福患者为共同追求，将信达对于中国健康医疗产业的深刻理解与研发、生产以及商业化的综合能力，与礼来全球前沿的科学洞见和宝贵经验相结合，实现优势互补。未来我们将继续探索更加多元的合作模式，提升药物可及性与可负担性，力争让患者用得上、用得起更多比肩乃至超越国际水平的中国创新药。”爱优特®（呋喹替尼胶囊）是礼来中国肿瘤产品组合中首个获批的肿瘤靶向治疗药物。2013年10月礼来与和黄医药达成战略合作，共同开发呋喹替尼， 2018年呋喹替尼在中国获批上市，为晚期结直肠癌患者提供新的治疗选择。如今，呋喹替尼亦相继在包括美国、欧洲、日本等在内的全球主要市场获批上市。和黄医药首席执行官兼首席科学官苏慰国博士表示：“和黄医药自成立以来一直坚持‘自主创新’和‘全球同步’两大战略原则，以开放姿态拥抱并积极参与全球创新，是最早与礼来建立战略合作的本土药企之一。这段长期合作不仅孕育了我们引以为傲的创新成果，也验证了中国创新走向世界的可行性。和黄医药将致力于把本土创新带向国际舞台，实现更多‘中国新’到‘全球新’，为全球市场提供优质的‘中国方案’。”近年来，礼来加速推进肿瘤领域的战略布局，不断拓展创新版图。2023年，礼来成功收购Point Biopharma，获得全球领先的放射性配体疗法平台，2025年1月收购Scorpion Therapeutics获得其PI3Kα抑制剂相关项目。2024年10月，礼来在北京成立中国医学创新中心。2025年3月礼来中国首个创新加速平台 —— 礼来北京创新孵化器（Lilly Gateway Labs, LGL）正式投入运营，致力于识别并支持那些处于早期研发阶段的高潜力生物技术企业。凭借这一系列前瞻性举措，礼来正躬身入局，积极推动肿瘤精准诊疗新时代的加速到来。关于信达生物- 滑动查看更多介绍 -“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在NMPA审评中，5个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。关于礼来制药- 滑动查看更多介绍 -礼来制药是一家致力于通过科学创新改善人类健康水平，惠及全球患者的医药公司。作为医疗健康行业的领军者，礼来制药拥有近150年的历史。今天，我们的药物已帮助全球数千万人。运用生物技术、化学和基因医学的力量，我们的科学家正在积极推动新的医学进展，以应对严峻的全球健康挑战。重新定义糖尿病与肥胖疗法，减少肥胖对人体的长期影响；助力阿尔茨海默病的防治行动；为一系列威胁人类健康的免疫性疾病提供解决方案；以及将难以治愈的癌症转变为可控的疾病。礼来制药迈向健康世界的每一步，都源自于我们“致力于让数百万患者生活得更美好”的信念。这包括致力于解决全球多重挑战的创新临床试验，同时确保药物的可及性和可负担性。如果需要了解更多关于礼来制药的信息，请登录：www.lilly.com。关于商标和商品名- 滑动查看更多介绍 -本文中提及的所有商标或商品名称均为礼来制药公司所有，若提及其他公司的商标或商品名称，其所有权则归各自所有者所有。为便于阅读，本文中提及的商标和商品名未标注®和™符号，但这并不意味着礼来制药或（在适用情况下）其他各自所有者不会在适用法律允许的最大范围内主张对这些商标和商品名的权利。我们使用或展示其他公司的商标和商品名，并非暗示与这些公司存在任何关系或意味获得这些公司的背书或赞助。关于礼来制药和信达生物的战略合作 - 滑动查看更多介绍 -礼来制药与信达生物拥有长期的战略合作关系，双方已建立起一个由中国创新药企与全球制药巨头之间的全面战略合作，其范围涵盖新药研发，临床研究，生产质量和市场销售等，旨在加速并积极推进创新药物惠及更多全球患者。2015年3月，双方达成了一项生物技术药物开发合作，在中国共同开发和商业化包括达伯舒®（信迪利单抗注射液）在内的肿瘤药物，该合作亦是迄今为止中国生物制药企业与跨国药企之间最大的合作之一。2015年10月，双方宣布再次拓展已建立的药物开发合作，增加三个新型肿瘤治疗抗体。2019年8月，双方合作扩展至糖尿病及代谢领域，信达生物获授权在中国开发和商业化礼来的一个潜在全球领先新型临床阶段GCG/GLP-1药物。2020年8月，礼来制药与信达生物宣布扩大信迪利单抗的战略合作。2022年3月，礼来制药宣布深化与信达生物在肿瘤领域的合作，礼来授予信达生物希冉择®（雷莫西尤单抗注射液）和睿妥®（塞普替尼胶囊）在中国大陆获批后独家商业化权利，以及授予信达生物享有捷帕力®（匹妥布替尼片）未来在中国大陆商业化权利的优先谈判权。2024年12月，礼来制药与信达生物就捷帕力®（匹妥布替尼片）在中国大陆的商业化达成合作授权。关于礼来制药与和黄医药的战略合作- 滑动查看更多介绍 -礼来制药与和黄医药的合作渊源起始于2007年，双方缔结药品开发合作伙伴关系。2013年，礼来与和黄医药达成战略合作协议，共同致力于呋喹替尼在中国的开发和销售。2018年，爱优特®（呋喹替尼胶囊）获中国国家药监局批准用于治疗转移性结直肠癌。参考文献：1.Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. PMID: 39036382; PMCID: PMC11256708.2.《健康中国行动—癌症防治行动实施方案（2023—2030年）》3. 阿贝西利片说明书；信迪利单抗注射液说明书；呋喹替尼胶囊说明书；塞普替尼胶囊说明书；匹妥布替尼片说明书；雷莫西尤单抗注射液说明书；利妥昔单抗注射液说明书；注射用培美曲塞二钠说明书；注射用盐酸吉西他滨说明书

免疫疗法放射疗法

2025-04-15

·礼来Lilly

全国肿瘤防治宣传周 | 礼来携手信达生物、和黄医药加速赋能本土医药创新

2025年4月15日，中国上海——第31届全国肿瘤防治宣传周首日，礼来携手本土合作伙伴信达生物、和黄医药齐聚上海，共话本土医药创新发展，探索加速惠及中国肿瘤患者的新模式。二十载深耕，礼来是中国肿瘤创新发展坚定的参与者与同行者。与信达生物、和黄医药等本土创新生物医药企业逾十载深度合作，不仅成就了多款具有影响力的突破性创新药物的问世，更为中国肿瘤患者带来了生命希望与福祉，为“健康中国”建设贡献力量。中国药科大学附属上海高博肿瘤医院院长李进教授，礼来中国总裁兼总经理德赫兰女士，礼来全球高级副总裁、礼来中国药物开发及医学事务中心负责人王莉博士，信达生物创始人、董事长兼首席执行官俞德超博士，和黄医药首席执行官兼首席科学官苏慰国博士，礼来全球副总裁、礼来中国药物开发及医学事务中心首席医学官迟海东博士，礼来中国副总裁、抗肿瘤事业部负责人尹航先生等嘉宾出席活动。二十载深耕，助力中国肿瘤事业高质量发展中国是癌症负担最沉重的国家之一，国家癌症中心最新数据显示，2022年我国新发癌症病例达482.47万例，新增死亡病例达 257.42万例1。“健康中国”行动明确提出，到2030年我国总体癌症5年生存率不低于46.6%2。这一系列目标和数据彰显了国家对癌症防控的高度重视和对治疗方案创新的迫切需求。中国药科大学附属上海高博肿瘤医院院长李进“近年来，中国在肿瘤领域的创新持续加速，涌现出越来越多具有国际影响力的成果。跨国企业与本土力量齐头并进的广泛投入，不仅加速了全球前沿多中心临床研究落地中国，也让创新疗法更快惠及患者。我们期待这种开放与合作持续深化，帮助中国患者第一时间受益于创新疗法，亦让世界看到中国创新力量的崛起。”肿瘤是礼来重要的战略治疗领域之一。20年来，礼来在肿瘤领域积极探索以创新驱动的多元化业务模式，聚焦靶向治疗、免疫治疗以及克服肿瘤耐药药物的研发，已在中国获批上市9款创新药物，涵盖乳腺癌、肺癌、消化道肿瘤、血液肿瘤等10大癌种3，并与本土战略伙伴建立了一条覆盖临床研究、生产质量到商业运营的端到端合作价值链。礼来中国总裁兼总经理德赫兰“在中国，肿瘤给无数患者和家庭带来了沉重的负担。我们深知，患者不仅需要新的治疗选择，也期待更好的生活质量。礼来始终致力于为中国患者提供高质量的创新药物，并努力让这些药物更快地惠及更多患者。礼来是长期主义的践行者，我们将继续坚定地参与本土创新生态的建设，希望与本土伙伴紧密合作，真正解决患者的未尽之需，为中国肿瘤防治事业及整个社会的发展创造价值。”礼来全球高级副总裁礼来中国药物开发及医学事务中心负责人王莉“礼来在肿瘤治疗领域拥有深厚的研发积淀，我们深刻理解中国市场的独特性和肿瘤患者需求的多样性，致力于通过扎实、确凿的临床研究推动肿瘤治疗进步。目前，中国已被正式纳入礼来全球早期临床研究计划，实现与全球研发体系的无缝对接。礼来也在持续加快研发步伐，带来更多卓越的创新治疗方案，帮助广大患者延续生命、提高生活质量。”十余载砥砺共进，赋能本土创新，惠泽患者礼来致力于成为中国医疗保健领域的重要战略伙伴，与信达生物、和黄医药等本土创新生物医药企业的战略合作已结出累累硕果，为中国患者带来了多款高质量、可负担的创新药物。达伯舒®（信迪利单抗注射液）是礼来和信达生物在中国共同开发的具有国际品质的创新PD-1抑制剂，双方以此为起点，已建立起一个由中国创新药企与全球制药巨头之间的全面战略合作，其范围涵盖新药研发、临床研究、生产质量和市场销售等。信达生物创始人董事长兼首席执行官俞德超“信达生物致力于开发老百姓用得起的高质量生物药。十年来，我们与礼来不断深化互信，拓展合作领域和范围，以科学创新、造福患者为共同追求，将信达对于中国健康医疗产业的深刻理解与研发、生产以及商业化的综合能力，与礼来全球前沿的科学洞见和宝贵经验相结合，实现优势互补。未来我们将继续探索更加多元的合作模式，提升药物可及性与可负担性，力争让患者用得上、用得起更多比肩乃至超越国际水平的中国创新药。”爱优特®（呋喹替尼胶囊）是礼来中国肿瘤产品组合中首个获批的肿瘤靶向治疗药物。2013年10月礼来与和黄医药达成战略合作，共同开发呋喹替尼， 2018年呋喹替尼在中国获批上市，为晚期结直肠癌患者提供新的治疗选择。如今，呋喹替尼亦相继在包括美国、欧洲、日本等在内的全球主要市场获批上市。和黄医药首席执行官兼首席科学官苏慰国“和黄医药自成立以来一直坚持‘自主创新’和‘全球同步’两大战略原则，以开放姿态拥抱并积极参与全球创新，是最早与礼来建立战略合作的本土药企之一。这段长期合作不仅孕育了我们引以为傲的创新成果，也验证了中国创新走向世界的可行性。和黄医药将致力于把本土创新带向国际舞台，实现更多‘中国新’到‘全球新’，为全球市场提供优质的‘中国方案’。”近年来，礼来加速推进肿瘤领域的战略布局，不断拓展创新版图。2023年，礼来成功收购Point Biopharma，获得全球领先的放射性配体疗法平台，2025年1月收购Scorpion Therapeutics获得其PI3Kα抑制剂相关项目。2024年10月，礼来在北京成立中国医学创新中心。2025年3月礼来中国首个创新加速平台 —— 礼来北京创新孵化器（Lilly Gateway Labs, LGL）正式投入运营，致力于识别并支持那些处于早期研发阶段的高潜力生物技术企业。凭借这一系列前瞻性举措，礼来正躬身入局，积极推动肿瘤精准诊疗新时代的加速到来。Lilly关于礼来制药礼来制药是一家致力于通过科学创新改善人类健康水平，惠及全球患者的医药公司。作为医疗健康行业的领军者，礼来制药拥有近150年的历史。今天，我们的药物已帮助全球数千万人。运用生物技术、化学和基因医学的力量，我们的科学家正在积极推动新的医学进展，以应对严峻的全球健康挑战。重新定义糖尿病与肥胖疗法，减少肥胖对人体的长期影响；助力阿尔茨海默病的防治行动；为一系列威胁人类健康的免疫性疾病提供解决方案；以及将难以治愈的癌症转变为可控的疾病。礼来制药迈向健康世界的每一步，都源自于我们“致力于让数百万患者生活得更美好”的信念。这包括致力于解决全球多重挑战的创新临床试验，同时确保药物的可及性和可负担性。如果需要了解更多关于礼来制药的信息，请登录：www.lilly.com。Lilly关于商标和商品名本文中提及的所有商标或商品名称均为礼来制药公司所有，若提及其他公司的商标或商品名称，其所有权则归各自所有者所有。为便于阅读，本文中提及的商标和商品名未标注®和™符号，但这并不意味着礼来制药或（在适用情况下）其他各自所有者不会在适用法律允许的最大范围内主张对这些商标和商品名的权利。我们使用或展示其他公司的商标和商品名，并非暗示与这些公司存在任何关系或意味获得这些公司的背书或赞助。Lilly关于礼来制药和信达生物的战略合作礼来制药与信达生物拥有长期的战略合作关系，双方已建立起一个由中国创新药企与全球制药巨头之间的全面战略合作，其范围涵盖新药研发，临床研究，生产质量和市场销售等，旨在加速并积极推进创新药物惠及更多全球患者。2015年3月，双方达成了一项生物技术药物开发合作，在中国共同开发和商业化包括达伯舒®（信迪利单抗注射液）在内的肿瘤药物，该合作亦是迄今为止中国生物制药企业与跨国药企之间最大的合作之一。2015年10月，双方宣布再次拓展已建立的药物开发合作，增加三个新型肿瘤治疗抗体。2019年8月，双方合作扩展至糖尿病及代谢领域，信达生物获授权在中国开发和商业化礼来的一个潜在全球领先新型临床阶段GCG/GLP-1药物。2020年8月，礼来制药与信达生物宣布扩大信迪利单抗的战略合作。2022年3月，礼来制药宣布深化与信达生物在肿瘤领域的合作，礼来授予信达生物希冉择®（雷莫西尤单抗注射液）和睿妥®（塞普替尼胶囊）在中国大陆获批后独家商业化权利，以及授予信达生物享有捷帕力®（匹妥布替尼片）未来在中国大陆商业化权利的优先谈判权。2024年12月，礼来制药与信达生物就捷帕力®（匹妥布替尼片）在中国大陆的商业化达成合作授权。Lilly关于礼来制药与和黄医药的战略合作礼来制药与和黄医药的合作渊源起始于2007年，双方缔结药品开发合作伙伴关系。2013年，礼来与和黄医药达成战略合作协议，共同致力于呋喹替尼在中国的开发和销售。2018年，爱优特®（呋喹替尼胶囊）获中国国家药监局批准用于治疗转移性结直肠癌。参考文献Please scroll down for more.1 Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. PMID: 39036382; PMCID: PMC11256708.2 《健康中国行动—癌症防治行动实施方案（2023—2030年）》3 阿贝西利片说明书；信迪利单抗注射液说明书；呋喹替尼胶囊说明书；塞普替尼胶囊说明书；匹妥布替尼片说明书；雷莫西尤单抗注射液说明书；利妥昔单抗注射液说明书；注射用培美曲塞二钠说明书；注射用盐酸吉西他滨说明书PP-MG-CN-3905

免疫疗法突破性疗法放射疗法临床研究

2025-04-11

·sermonixpharma.com

Sermonix Pharmaceuticals’ Lasofoxifene Is Well Tolerated, Demonstrates Promising Ki67 Suppression in Phase 2 I-SPY 2 Arm Evaluating Therapy in Neoadjuvant Breast Cancer Setting

COLUMBUS, Ohio, and SAN FRANCISCO, Nov. 02, 2024 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), and Quantum Leap Healthcare Collaborative™ today broadly announced that in the Phase 2 clinical trial evaluating lasofoxifene as a neoadjuvant endocrine therapy in molecularly selected HR+/HER2-, locally advanced breast cancer, the investigational drug was well tolerated and demonstrated promising early activity in suppressing the Ki67 protein in both premenopausal and postmenopausal patients. Results from the study, an arm of the Endocrine Optimization Pilot Protocol (EOP), a sub-study of Quantum Leap’s ongoing I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2), were initially shared yesterday in a poster presentation at RISE UP for Breast Cancer. Twenty patients (10 pre- and nine postmenopausal women, and one male) were enrolled in the lasofoxifene arm of the study, during which early Ki67 suppression in premenopausal patients was seen in the absence of ovarian function suppression (OFS). Ki67 is a marker that measures how fast cancer cells are dividing. “Lasofoxifene continued to demonstrate a strong tolerability profile while showing promising Ki67 suppression in this Phase 2 study, supporting our plans to further explore its potential in the neoadjuvant setting,” said Dr. David Portman, Sermonix founder and chief executive officer. “We are currently studying lasofoxifene in the ELAINE-3 Phase 3 combination study with abemaciclib in the ESR1-mutated metastatic breast cancer setting. We are excited to see it continue to demonstrate broad potential while offering unique quality of life benefits for people confronted with breast cancer.” Patients were enrolled in the I-SPY 2 arm from March 2023 to May 2024. Median total days of treatment was 154 days. At the time of data analysis, three patients were still on treatment and two discontinued treatment due to physician or patient preference. Median Ki67 expression went from 10% at baseline (range 1.0-40%) to 4% (1.0-18.0%) at Week 3. At three weeks, Ki67 expression was suppressed to <10% in 14 out of 16 (88%) patients, and to <2.7% in 6 out of 16 (38%) patients. Adverse events (AEs) were all grade 1-2. Most common AEs include hot flushes (65%), constipation (40%), fatigue (40%) and nausea (25%). “The I-SPY 2 EOP provides a biomarker-rich platform to test novel endocrine agents in the neoadjuvant setting in a molecularly selected group of patients with tumors that are predicted to have little to no benefit from chemotherapy,” said Dr. Jo Chien, principal investigator of the sub-study. “Lasofoxifene has demonstrated significant activity based on early Ki67 suppression, not only in postmenopausal women, but also in 10 premenopausal women without concomitant ovarian function suppression, with baseline Ki67 of 12.5% (1.0-40.0%) going to 3.0% (1.0-15%) at Week 3. It is exciting to see that lasofoxifene is well-tolerated even in our youngest patients who are often most impacted by the debilitating side effects of current standard endocrine therapy options.” Quantum Leap partners with a consortium that includes the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors and clinicians from 41 major U.S. cancer research centers. About LasofoxifeneLasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with a CDK4/6 inhibitor in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc., has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy, could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer. About SermonixSermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking a Phase 3 clinical study of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn more at SermonixPharma.com. To learn more about the ELAINE studies, visit DiscoverElaine.com. About Quantum Leap Healthcare CollaborativeQuantum Leap Healthcare Collaborative (QLHC) is a 501c(3) nonprofit pioneer that designs, implements, and succeeds at building and iterating creative and nimble solutions that drive meaningful results for patients. Our mission is to better serve patients by accelerating and innovating health care through approaches that challenge the status quo of science and care. All our efforts focus on achieving our long-term vision to improve human health for all through personalized medicine by bridging the gap between research and care. QLHC provides operational, financial, and regulatory oversight to I-SPY. For more information, visit https://www.quantumleaphealth.org/. About the I-SPY TRIALsThe I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 30 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org. Quantum Leap Healthcare Collaborative Media Contact:Jacqueline MurrayDirector, Marketing and Communications(415) 839-8082j.murray@quantumleaphealth.org

临床2期临床3期临床结果

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
晚期乳腺癌	加拿大	Eli Lilly Canada, Inc.	2019-04-08
转移性乳腺癌	加拿大	Eli Lilly Canada, Inc.	2019-04-08
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
去势敏感前列腺癌	临床3期	美国	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	中国	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	日本	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	阿根廷	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	澳大利亚	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	比利时	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	巴西	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	加拿大	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	捷克	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	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


Phase 2 study of letrozole, abemaciclib and metformin (AACR2025)	临床2期	复发性子宫内膜癌 ER positive \| RB1 \| CCNE1 ... 更多	25	Letrozole/Abemaciclib/Metformin	選蓋網鬱繭築廠淵壓獵(夢鏇齋蓋願壓餘觸鹽網) = 獵膚醖衊淵鑰觸夢憲鏇齋壓鹽積製齋願壓範憲 (繭網積積遞積艱鑰廠繭, 14.9% ~ 53.5) 更多	积极	2025-04-29
NCT04975308 (EMBER-3, Pubmed \| N Engl J Med)	临床3期	晚期乳腺癌	874	Imlunestrant	鏇壓齋艱遞鹹壓鬱餘襯(積廠願糧遞鹹餘鬱鹽簾) = 獵蓋糧鹹襯蓋遞製築鏇構鑰壓選淵築襯餘網膚 (鬱廠蓋願艱鹽壓顧夢築 ) 更多	积极	2025-03-27
				Standard Therapy	鏇壓齋艱遞鹹壓鬱餘襯(積廠願糧遞鹹餘鬱鹽簾) = 襯製願糧鏇廠蓋膚範製構鑰壓選淵築襯餘網膚 (鬱廠蓋願艱鹽壓顧夢築 ) 更多
NCT05169567 (postMONARCH, CTgov)	临床3期	HR阳性/HER2阴性乳腺癌	368	Fulvestrant+Abemaciclib (Arm A: Abemaciclib Plus Fulvestrant)	鹹製窪廠壓艱齋製願簾(艱獵醖憲壓繭糧簾鑰鹽) = 願夢鏇網願願顧蓋鬱蓋襯觸膚觸築顧築膚窪鹽 (積觸壓膚齋構廠齋築獵, 鬱膚積齋鏇淵夢築觸鏇 ~ 網艱淵齋鹽餘築夢鏇獵) 更多	-	2025-03-25
				Placebo+Fulvestrant (Arm B: Placebo Plus Fulvestrant)	鹹製窪廠壓艱齋製願簾(艱獵醖憲壓繭糧簾鑰鹽) = 醖範築築憲遞構鹹壓憲襯觸膚觸築顧築膚窪鹽 (積觸壓膚齋構廠齋築獵, 淵憲淵窪壓製獵鏇鏇窪 ~ 製淵艱觸夢鏇鹽鏇願觸) 更多
NCT05169567 (postMONARCH, Pubmed \| J Clin Oncol)	临床3期	晚期乳腺癌 ESR1 \| PIK3CA mutations	368	Abemaciclib + Fulvestrant	衊壓廠鑰憲築鬱憲衊壓(獵窪積網製簾構廠窪齋) = 鏇構鹹製製醖廠範簾壓願艱蓋鹽範遞網蓋廠範 (構蓋製鬱廠遞齋築顧網, 5.6 ~ 8.6) 更多	积极	2025-03-20
				Placebo + Fulvestrant	衊壓廠鑰憲築鬱憲衊壓(獵窪積網製簾構廠窪齋) = 齋鑰構膚積觸齋蓋簾簾願艱蓋鹽範遞網蓋廠範 (構蓋製鬱廠遞齋築顧網, 3.7 ~ 5.6) 更多
NCT04298983 (RAD 1805, CTgov)	临床2期	前列腺癌 \| 前列腺腺癌	9	Androgen deprivation therapy (ADT)+Abemaciclib 150 MG by mouth twice daily	餘壓顧顧鏇範願鬱鏇衊 = 憲醖壓獵鏇憲憲範憲艱鬱壓衊鹽壓鹽蓋遞淵積 (遞淵醖鑰憲窪遞齋範夢, 鹹鹽獵築窪糧淵膚齋鑰 ~ 範製廠糧鹹鹽製餘網憲) 更多	-	2025-03-19
NCT03706365 (CYCLONE 2, CTgov)	临床2/3期	转移性去势抵抗性前列腺癌	393	Prednisone+Abiraterone acetate+Abemaciclib (Abemaciclib)	範簾蓋衊遞簾壓鑰顧廠(範衊廠窪鹽顧淵願壓鏇) = 齋簾鏇襯憲憲願構壓觸願觸鑰餘鹹觸鬱積憲膚 (選鏇顧襯觸築獵鹹淵繭, 網築鑰餘糧膚夢蓋糧鑰 ~ 糧淵鹽簾憲選鬱選醖廠) 更多	-	2025-03-06
				Placebo+Prednisone+Abiraterone acetate (Placebo)	範簾蓋衊遞簾壓鑰顧廠(範衊廠窪鹽顧淵願壓鏇) = 選憲選鏇艱簾獵鏇糧廠願觸鑰餘鹹觸鬱積憲膚 (選鏇顧襯觸築獵鹹淵繭, 製糧廠積築繭艱鏇餘鹽 ~ 艱齋醖願壓齋齋遞襯製) 更多
NCT04256941 (CTgov)	临床2期	转移性乳腺癌	4	Fulvestrant (Fulvestrant)	餘襯廠鹽鏇構糧壓觸艱(襯膚廠襯齋餘簾艱廠廠) = 襯衊壓鹽窪糧製壓襯範廠襯蓋壓鬱鹽觸鬱簾簾 (簾廠範廠網觸膚淵願觸, 衊繭網積醖鬱製願窪繭 ~ 鏇淵簾鏇鑰齋網廠製餘) 更多	-	2024-12-27
				fulvestrant+ribociclib (Kisqali)+abemaciclib (verzenio)+palbociclib (Ibrance) (Continuing AI After Randomization)	餘襯廠鹽鏇構糧壓觸艱(襯膚廠襯齋餘簾艱廠廠) = 糧糧觸鹽淵範顧襯齋顧廠襯蓋壓鬱鹽觸鬱簾簾 (簾廠範廠網觸膚淵願觸, 壓壓繭繭鹽鏇壓觸餘製 ~ 簾衊廠鏇窪顧築廠選簾) 更多
NCT04975308 (EMBER-3, Pubmed \| SABCS2024) 人工标引	临床3期	晚期乳腺癌	874	Imlunestrant	築選範鏇鏇顧鬱鬱糧範(鹽艱鏇鹹獵網淵壓構選) = 蓋襯醖壓壓衊網鑰壓構構蓋簾選淵窪糧憲構糧 (遞襯膚鹹顧築網顧衊網 ) 更多	积极	2024-12-11
				Standard therapy	築選範鏇鏇顧鬱鬱糧範(鹽艱鏇鹹獵網淵壓構選) = 製鑰壓網蓋鹽鑰構夢廠構蓋簾選淵窪糧憲構糧 (遞襯膚鹹顧築網顧衊網 ) 更多
NCT05548127 (TACTIVE-U, GlobeNewswire) 人工标引	临床1期	ER阳性/HER2阴性乳腺癌三线	16	Vepdegestrant + Abemaciclib	選廠製鏇齋遞鑰壓製築(壓選鏇醖遞衊淵願餘夢) = None 範齋齋蓋衊願艱夢齋壓 (衊夢壓築繭襯壓製選觸 ) 更多	积极	2024-12-10
				Vepdegestrant + Abemaciclib (mutant ESR1)
NCT05563220 \| NCT05386108 (ELEVATE, SABCS2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Negative	55	Elacestrant + Abemaciclib (all efficacy-evaluable)	鹹遞廠窪網網膚廠顧廠(選襯積淵餘艱製鑰醖鬱) = 衊艱繭獵夢壓蓋觸醖夢網築製鬱築繭鑰窪齋鏇 (壓構範艱鹽窪鏇憲遞憲 )	积极	2024-12-10
				Elacestrant + Abemaciclib (ESR1-mut population)	鹹遞廠窪網網膚廠顧廠(選襯積淵餘艱製鑰醖鬱) = 壓願夢窪選鹹鬱憲醖膚網築製鬱築繭鑰窪齋鏇 (壓構範艱鹽窪鏇憲遞憲 )