This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.

开始日期2027-02-14

申办/合作机构

National Cancer Institute

NCT07423611

/ Not yet recruiting临床2期IIT

A Multicenter, Open-label, Randomized Controlled Clinical Study Comparing the Efficacy and Safety of ctDNA-guided Ribociclib Plus Endocrine Therapy Versus Chemotherapy Followed by Ribociclib Plus Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

开始日期2026-10-01

申办/合作机构

复旦大学

NCT07618390

/ Not yet recruiting临床2期IIT

A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.

This is a prospective, multicenter, open-label, single-arm phase II investigator-initiated study designed to evaluate the efficacy and safety of inavolisib in combination with ribociclib and fulvestrant as first-line treatment in Chinese patients with PIK3CA-mutant, hormone receptor-positive (HR+), HER2-negative (HER2-), endocrine-resistant metastatic breast cancer (mBC). Approximately 160 patients will be enrolled at around 16 centers in China.
The study consists of a screening period of up to 28 days, a treatment period, and a post-treatment follow-up period.
PIK3CA mutation status must be determined in blood or tumor tissue using polymerase chain reaction (PCR)-based assays or next-generation sequencing (NGS) performed in a local clinical laboratory. Patients with locally confirmed PIK3CA mutations who meet all eligibility criteria will be enrolled and receive study treatment with inavolisib, ribociclib, and fulvestrant. Details of the treatment regimen are provided in the Study Treatment section. Study treatment will continue until radiologically confirmed disease progression as determined by the investigator, unacceptable toxicity, withdrawal of informed consent, or study termination, whichever occurs first.
Patients must have measurable disease according to RECIST v1.1. Patients with bone-only metastases are not eligible, even if the lesions are considered measurable. Locally advanced disease must be unsuitable for surgical resection or other local treatment with curative intent.

开始日期2026-06-01

申办/合作机构

中山大学孙逸仙纪念医院

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100 项与琥珀酸瑞波西利相关的临床结果

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100 项与琥珀酸瑞波西利相关的转化医学

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100 项与琥珀酸瑞波西利相关的专利（医药）

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1,446

项与琥珀酸瑞波西利相关的文献（医药）

2026-12-31·Journal of Pharmaceutical Policy and Practice

Economic evaluation of cyclin-dependent kinases 4 and 6 inhibitors in advanced hormonal receptor-positive and human epidermal growth factor receptor 2 negative breast cancer: a nationwide budget impact analysis

Article

作者: Hamad, Anas ; Shafei, Laila ; Hisham Al-Ziftawi, Nour ; Mohamed Ibrahim, Mohamed Izham ; Bojassoum, Salha ; Elazzazy, Shereen

Background:

Several trials demonstrated improvements in clinical outcomes associated with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors in breast cancer patients. The challenge remains regarding their high costs. Ribociclib and Abemaciclib are cost-effective in Qatar. Yet, their affordability was not studied. This budget impact analysis (BIA) is to assess the affordability of adopting CDK4/6 inhibitors in Qatar over five years duration (2024-2028).

Methods:

We ran a BIA to evaluate two scenarios: (1) Increasing abemaciclib's market share from 20% to 60%, replacing both palbociclib and ribociclib. (2) Assuming equal market share for both ribociclib and abemaciclib up to 80%, reducing palbociclib's share. The analysis considered treatment costs, patient population, and disease prevalence. All data were retrieved from the National Center for Cancer Care and Research, and costs were presented in Qatari Riyals (QAR). Sensitivity analyses were run to ensure the robustness of the conclusion. All results were compared to Qatar's budget threshold, which is QAR 453,822.

Results:

Based on a total of 173 patients using CDK4/6 inhibitors, increasing abemaciclib's market share to 60% yielded cumulative savings of QAR 14 million over five years, which is around QAR 14,613 per patient per year. However, equally increasing ribociclib's and abemaciclib's market share to 80% resulted in a modest budget increase, remaining within acceptable thresholds. Sensitivity analyses confirmed the robustness of these findings, showing that cost reductions and higher uptake rates further enhanced savings.

Conclusion:

Abemaciclib is a budget-saving option for HR+/HER2- breast cancer in Qatar, should it replace the market share by up to 60% over five years. In addition, ribociclib and abemaciclib are affordable treatment options if they equally contributes to up to 80% of the market share for the eligible advanced breast cancer patients. The results supported the concept of allocating CDK4/6 inhibitors as they were found to be affordable to the Qatari healthcare system.

2026-09-01·Biomaterials advances

Ribociclib-loaded folic acid conjugated chitosan-polycaprolactone hybrid nanoparticles for the management of glioblastoma

Article

作者: Mehra, Neelesh K ; Rajana, Naveen ; Quadros, Mural ; Mehta, Dhwani ; Islam, Md Asrarul ; Sanhueza Chavez, Carlos A ; Mokashi, Meghana ; Kumar, Sunil ; Gupta, Vivek ; Alkyam, Mayssam ; Ravula, Sravani ; Perron, Jeanette C

The objective of the present research investigation is to assess the anti-glioblastoma potential of Ribociclib (Ribo) and Ribociclib-loaded folic acid conjugated chitosan-polycaprolactone nanoparticles (RFCPNPs). Folic acid was conjugated to glycol chitosan by carbodiimide chemistry, and the formation of the conjugation was confirmed by FT-IR and ¹H NMR. RFCPNPs were fabricated by the single emulsification method, and particle size, PDI, surface charge, %EE, and % DL were 127.8 ± 4.37 nm, 0.197 ± 0.012, 5.05 ± 0.1 mV, 70.82 ± 4.25%, and 3.37 ± 0.20%, respectively. The presence of pH-sensitive biological macromolecule, i.e., chitosan, in the carrier system provides pH-sensitivity to RFCPNPs and displays diffusion-controlled release of the Ribo up to 48 h. RFCPNPs exhibited a bi-phasic release pattern, releasing approximately 22.9 ± 3.8%, 23.2 ± 5.8%, and 7.3 ± 1.2% of Ribo within 1 h, and 98.3 ± 1.6%, 86.6 ± 1.5%, and 75.8 ± 5.1% of Ribo were released from RFCPNPs in 48 h in pH 5.5, 6.8, and 7.4 dissolution media, respectively. The half-maximal inhibitory concentration (IC₅₀) of RFCPNPs was found to be 2.7 ± 0.3 and 3.2 ± 0.10 μM in U87 MG and U138 MG cells, which is 8-10-fold-, and 2-3-fold less than the pure Ribo and unconjugated nanoparticles, respectively. The receptor blocking assay demonstrated the significant role of folic acid in the anti-glioblastoma efficacy of the RFCPNPs. RFCPNPs exhibited enhanced ROS generation, apoptosis, and reduced mitochondrial membrane potential of U87 MG cells compared to the pure Ribo. RFCPNPs exhibited approximately 40% apoptotic cells, more than 1.6 times greater than those of the plain drug counterpart. The Ribo and RFCPNPs exhibited 27.1 ± 2.2%, 66.2 ± 1.3% cellular migration inhibition, and 380 ± 46 and 10 ± 4 colonies, respectively. U87 MG spheroids treated with Ribo and RFCPNPs demonstrated 64.3 ± 5.2% and 34.7 ± 11.0% viable cells, respectively. These outcomes suggest that the optimized nanocarrier represents a promising approach for treating glioblastoma.

2026-07-01·JHEP Reports

Clinical features and management for CDK4/6 inhibitor-DILI

Article

作者: Martín, Miguel ; Torres-Sempere, Julio ; Vega-Cano, Kreina Sharela ; Pinazo-Bandera, José ; Rodríguez, César A ; Salcedo, Magdalena ; Forns, Xavier ; Martínez-Sáez, Olga ; Alonso López, Sonia ; Morchón-Araujo, Daniel ; Jara, Pablo ; Romanos Nanclares, Álvaro ; Cejuela, Mónica ; Buti, Maria ; Mateos, Beatriz ; Ruiz-Cobo, Juan Carlos ; García-Cortés, Miren ; Zamora, Esther ; Ribelles, Nuria ; Riveiro-Barciela, Mar ; Esteban, Paula ; García-Fructuoso, Isabel ; Lozano, Rebeca ; Bellet, Meritxell ; Miranda, Elena López ; Domínguez-Gómez, Raquel ; Villagrasa, Ares

BACKGROUND & AIMS:

Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i)-ribociclib, abemaciclib, palbociclib-are the standard of care for metastatic breast cancer. Although hepatotoxicity is a frequent adverse event, data on CDK4/6i drug-induced liver injury (DILI) remain scarce. We aimed to define the incidence, clinical presentation, severity, management, and relapse of CDK4/6i-related DILI in a large real-world cohort.

METHODS:

Retrospective multicentre study including all patients who developed ≥grade 2 DILI (alanine aminotransferase/aspartate aminotransferase >3 × upper limit of normal) while receiving CDK4/6i between January/2018 and December/2022. Severity was assessed according to Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) and DILI-International Expert Working Group criteria.

RESULTS:

Among 2,222 CDK4/6i-treated patients, 100 (4.5%, 95% CI 3.7-5.4%) developed DILI. Incidence was significantly higher for ribociclib (8.3%, 95% CI 6.3-10.7%) and abemaciclib (6.7%, 95% CI 4.6-9.3%) than for palbociclib (1.4%, 95% CI 0.8-2.2%) (Difference, p <0.001). Most cases were grade 2 or 3 (CTCAE) and mild (DILI-International Expert Working Group), although moderate DILI (bilirubin >2 × ULN, n = 12) occurred with all three CDK4/6i. The most frequent pattern was hepatocellular, whereas cholestatic was mainly observed with abemaciclib. Liver biopsy findings (n = 11) were heterogeneous and, together with biochemical results, did not support an immune-mediated mechanism as the primary driver. Corticosteroids (n = 20) did not impact time to grade 1 or alanine aminotransferase normalisation. DILI recurred in 28.2% of CDK4/6i rechallenges (n = 85). Among patients treated with ribociclib, rechallenge with an alternative CDK4/6i was associated with lower risk of recurrence (p = 0.010).

CONCLUSIONS:

DILI caused by ribociclib and abemaciclib are more common that with palbociclib. The absence of immune-mediated features and the limited benefit of corticosteroids question their routine use. After CDK4/6i reintroduction, DILI recurrence rate was 28%. Standardised management is needed, particularly following the approval of ribociclib and abemaciclib as adjuvant therapy.

IMPACT AND IMPLICATIONS:

Although hepatotoxicity is a frequent adverse event, real-world data on CDK4/6i DILI remain scarce. DILI associated with ribociclib and abemaciclib is more common than for palbociclib, although moderate DILI (bilirubin >2 × normality) was observed with the three drugs. The absence of immune-mediated features and the limited benefit of corticosteroids question their routine use in CDK4/6i DILI. Relapse of DILI after rechallenge with a CDK4/6i was 28%, with all cases presenting as mild. The increasing use of CDK4/6i (metastatic breast cancer and ribociclib and abemaciclib as adjuvant therapy) highlights the need of standardising the management of CDK4/6i DILI.

1,388

项与琥珀酸瑞波西利相关的新闻（医药）

2026-06-25

·IQVIA艾昆纬

《康复工具箱：HR+/HER2-早期乳腺癌患者管理手册》正式发布

导读 HR+/HER2-乳腺癌是乳腺癌中最常见的分子亚型，约占全部乳腺癌患者的70%。与其他亚型相比，这类乳腺癌整体进展相对缓慢，预后相对较好，治愈潜力较高。内分泌治疗是HR+/HER2-早期乳腺癌辅助治疗的基石，可显著降低患者术后复发风险，但仅接受内分泌治疗，仍有部分患者的疾病会复发，无法实现治愈。近年来，包括CDK4/6抑制剂在内的创新治疗手段不断应用于临床，为进一步降低复发风险、持续改善患者长期结局提供了重要支持。阿贝西利和瑞波西利等药物的应用，也为HR+/HER2-早期乳腺癌辅助强化治疗带来了新的可能。在中国，越来越多乳腺癌患者在疾病早期即被确诊，并将在较长时间内经历手术、辅助治疗、随访及生活方式调整等多个重要阶段。随着诊疗水平不断提升，HR+/HER2-早期乳腺癌已逐渐转变为一种可通过系统化治疗，实现长期控制甚至治愈，且需要进行慢病化管理的疾病。然而，在真实诊疗过程中，患者在疾病认知、复发风险理解、长期管理路径及不良反应应对等方面仍存在明显不足，亟需系统化、可操作的指导。如何帮助患者更科学地理解疾病与治疗，更有效地参与全程管理，已成为HR+/HER2-早期乳腺癌患者管理中的重要议题。基于此，由IQVIA艾昆纬牵头、在CSCO患者教育委员会指导下，《康复工具箱：HR+/HER2-早期乳腺癌患者管理手册》正式发布。完整报告请扫描下方二维码获取本手册从患者视角出发，围绕复发风险评估、辅助治疗方案认知和不良反应管理及长期随访与依从性管理等关键环节，设计了一系列可操作的管理工具，旨在帮助患者更好地与医疗团队沟通与协作，提升自身疾病管理效率，从而促进康复进程并逐步回归正常生活。总结与展望尽管HR+/HER2-早期乳腺癌整体预后相对较好，但从复发风险认知到辅助治疗管理，再到长期随访与依从性支持，患者在康复过程中仍面临诸多现实挑战。此次《康复工具箱：HR+/HER2-早期乳腺癌患者管理手册》的发布，围绕患者在真实诊疗与康复场景中的核心需求，提供了一套更科学、更实用、更具可操作性的管理支持工具，帮助患者更好地理解疾病与治疗、加强与医疗团队的沟通协作，从而更为从容地走过康复之路。IQVIA也期待通过本手册能够进一步推动HR+/HER2-早期乳腺癌患者教育与全程管理的优化，帮助更多患者逐步走出对复发的担忧，坚定完成规范治疗，重返健康生活。更多详情，敬请垂询：纪盈盈 IQVIA艾昆纬大中华区医学事务解决方案负责人 yingying.ji@iqvia.com 单里骋 IQVIA艾昆纬大中华区医学事务解决方案首席咨询顾问 licheng.shan2@iqvia.com 声明原创内容的最终解释权以及版权归IQVIA艾昆纬中国所有。如需转载文章，请发送邮件至iqviagcmarketing@iqvia.com。

CSCO会议

2026-06-23

·ioncology

HR+/HER2-早期乳腺癌风险再认识：ESMO BC poster提示N1不伴高危因素人群长期风险不可低估

点击蓝字关注我们编者按 HR+/HER2-早期乳腺癌的复发呈早期高峰与长期持续风险并存的特点。相较于三阴性及HER2阳性乳腺癌复发事件更多聚集于治疗后早期且风险随后逐步下降，HR+/HER2-患者虽在治疗后前2–3年同样存在复发高峰，但其复发风险仍可在5年后持续存在，体现出更为突出的晚期复发倾向。因此，临床风险评估不应局限于短期结局，而应纳入更长期随访视角，并重视对部分传统认知中“非高危”人群远期风险的再评估。尤其对N1（1–3枚淋巴结阳性）患者，临床过去更关注合并大肿瘤、G3或高Ki-67等高危因素的人群，而对N1不伴高危因素者警惕不足。近期ESMO Breast Cancer 2026公布的Jhaveri等poster再次提示：N1不伴高危因素并不意味着风险相对较低，其10年复发风险与N1伴高危因素人群相似。专家简介邱鹏飞教授山东第一医科大学附属肿瘤医院主任医师医学博士博士生/博士后导师乳腺外科一病区主任剑桥大学、英国癌症研究中心访问学者首届国家优秀青年医师山东省泰山学者青年专家齐鲁卫生与健康杰出青年人才中国抗癌协会乳腺癌专业委员会委员中国抗癌协会国际医疗交流分会常委中华医学会肿瘤学分会乳腺肿瘤青年学组委员山东省青年医务工作者协会乳腺肿瘤多学科诊疗分会主委 Cancer Biology & Medicine 青年编委主持国家自然科学基金4项，第一/通讯作者在Lancet Oncol、Nat Commun等学术期刊发表论文40余篇研究介绍研究背景尽管辅助内分泌治疗（ET）改善了HR+/HER2-早期乳腺癌（EBC）患者结局，但复发风险，尤其是远处复发，仍是临床关键问题。既往研究提示，N1患者远处复发风险会随时间持续累积，因此有必要基于大型真实世界数据，对不同风险特征N1人群的长期复发模式进行再评估。研究方法本研究基于美国Flatiron Panoramic Breast Cancer数据库，纳入II/III期、HR+/HER2-、N1（含N1mi）且接受术后辅助ET、未联合CDK4/6抑制剂的患者。按临床病理因素分为两组：。主要评估RFS、DRFS和DR，并通过危险率和时间变化风险比分析不同时点的瞬时风险。研究结果共纳入45,236例N1患者，其中15,971例属于队列A，29,265例属于队列B。在RFS方面，队列A的5年/10年RFS率分别为 79.2%/61.8%，队列B为88.6%/69.9%；队列A复发在早期累积更快，但到10年时，两组RFS均降至70%以下。在DRFS方面，队列A的5年/10年DRFS率为 80.7%/63.5%，队列B为89.6%/71.9%。在远处复发（DR）方面，队列A的5年/10年DR率为 14.4%/23.6%，队列B为5.6%/13.6%。更重要的是，危险率和时间变化风险比分析显示，大约在7年后，两组的瞬时复发风险逐渐趋同：队列A更偏向高早期复发风险，队列B更偏向高晚期复发风险。研究结论本研究表明，患者则更易表现为晚期复发风险累积。两类人群在长期维度上均不容忽视。结果提示，对于II/III期HR+/HER2-、N1患者，临床不应仅依赖单纯ET管理，而需同时关注短期和长期复发风险，并考虑更优化的辅助治疗策略。大咖解读邱鹏飞教授这项ESMO BC poster的重要价值，在于提示临床重新认识HR+/HER2-早期乳腺癌中N1不伴高危因素患者的长期复发风险。既往实践中，这部分患者常因缺乏大肿瘤、G3 等高危特征而被视为相对低风险，但真实世界数据表明，其远处复发风险并不会因“表型相对温和”而消失，而是可随时间持续累积，长期结局同样不容忽视。这一结果提示我们，HR+/HER2-早期乳腺癌的风险评估不能仅停留于短期结局，更应重视远期复发负担。对于N1不伴高危因素患者，若仅依据早期风险相对平稳而降低警惕，可能导致强化治疗不足。从这一点看，NATALEE研究的临床意义尤为明确。该研究纳入了广泛的IIA–III期人群，覆盖了包括N1不伴高危因素在内、具有长期复发风险的患者。随着随访延长，瑞波西利联合内分泌治疗持续带来iDFS获益，且绝对获益逐步扩大，为这部分患者强化辅助治疗提供了重要循证依据。因此，这项poster与NATALEE研究共同传递出一个清晰信号：对N1不伴高危因素患者，关键不在于是否“看起来风险不高”，而在于是否存在值得被提前干预的长期复发风险。一旦长期风险被识别，强化辅助治疗就不仅具有临床合理性，也具备了更坚实的证据支持。审批码KI10068857-137385，有效期为2026-06-23至2027-06-22，资料过期，视同作废参考文献：（上下滑动可查看） 1. Jhaveri K, et.al 235P Long-term risk of recurrence (RoR) among real-world patients (pts) with hormone receptor–positive (HR+)/HER2-negative (HER2–) early breast cancer (EBC) with N1 disease.ESMO Open, 11 2. Slamon, Dennis et al. “Ribociclib plus Endocrine Therapy in Early Breast Cancer.” The New England journal of medicine vol. 390,12 (2024): 1080-1091. doi:10.1056/NEJMoa2305488 3. Hortobagyi, G N et al. “A phase III trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: final invasive disease-free survival results from the NATALEE trial.” Annals of oncology : official journal of the European Society for Medical Oncology vol. 36,2 (2025): 149-157. doi:10.1016/j.annonc.2024.10.015 4. Fasching, Peter A et al. “Ribociclib Plus Endocrine Therapy in Hormone Receptor-Positive/ERBB2-Negative Early Breast Cancer: 4-Year Outcomes From the NATALEE Randomized Clinical Trial.” JAMA oncology vol. 11,11 (2025): 1364-1372. doi:10.1001/jamaoncol.2025.3700 5. Crown, J et al. “Adjuvant ribociclib plus nonsteroidal aromatase inhibitor therapy in patients with HR-positive/HER2-negative early breast cancer: 5-year follow-up of NATALEE efficacy outcomes and updated overall survival.” ESMO open vol. 10,11 (2025): 105858. doi:10.1016/j.esmoop.2025.105858 （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期

2026-06-23

·复宏汉霖

专家说 | 胡夕春教授：中国原创CDK4/6抑制剂伏维西利“强效与高耐受”的平衡艺术

在HR+/HER2-晚期乳腺癌的内分泌治疗领域，如何破解耐药、平衡强效治疗与患者长期耐受，一直是临床专家攻坚的焦点。在2026年美国临床肿瘤学会（ASCO）年会上，由复旦大学附属肿瘤医院胡夕春教授领衔的FCN-437c-Ⅲ202研究交出了一份惊艳的答卷。数据显示，我国完全自主研发的创新CDK4/6抑制剂伏维西利联合氟维司群，成功将内分泌治疗失败的HR+/HER2-晚期乳腺癌患者中位无进展生存期（PFS）由5.6个月大幅拉长至14.0个月，实现了生存获益翻倍的临床跨越。更难能可贵的是，凭借独特的分子结构微调，伏维西利在精准克制肿瘤的同时，精巧地避开了胃肠道与肝脏毒性靶点，为内分泌治疗失败、体能下滑的患者筑起了坚实的安全屏障。【肿瘤资讯】特邀胡夕春教授深入解读这一“高效与耐受”完美平衡的中国原创研究，探寻其结构优化背后的科学奥秘与临床慢病化管理的新曙光。据悉，该研究Ⅲ期成果已被顶尖期刊《信号转导与靶向治疗》（STTT）（IF=40.8）杂志接收，实现了国际最高水平学术舞台与权威期刊的双重认可。胡夕春教授主任医师复旦大学附属肿瘤医院肿瘤内科主任，博士研究生导师 ESMO乳腺癌Faculty MemberABC5 panelist中国抗癌协会多原发和不明原发肿瘤专委会主任委员中国抗癌协会临床化疗专委会副主任委员中华医学会肿瘤分会肿瘤内科专家委员会副主任委员中国研究型医院学会乳腺专委会副主任委员中国抗癌协会乳腺癌专委会委员国家食品药品监督管理局审评中心审评专家发表论著200多篇，包括Lancet Oncol和JCO杂志等主编《肿瘤内科方案的药物不良反应及对策》和《肿瘤科常见诊疗问题问答–胡夕春医生查房实录》等主持十三五“重大新药创制”科技重大专项等上海市领军人才、中国抗癌协会科技奖二等奖、全国妇幼健康科学技术奖一等奖和上海市医学科技进步奖一等奖等点击观看胡夕春教授访谈视频 Q1：能否请您介绍一下FCN-437c-Ⅲ202研究的整体设计与核心数据？同时，在内分泌治疗环境日益复杂的背景下，伏维西利是如何凭借其差异化的分子结构或作用机制，实现这种“生存获益翻倍”的临床跨越的？胡夕春教授：Ⅲ期临床研究FCN-437c-Ⅲ202主要聚焦于既往内分泌治疗失败、且未使用过CDK4/6抑制剂治疗的HR+/HER2-晚期乳腺癌患者。从最新数据来看，结果令人振奋。在随访22.6个月的更新分析中，伏维西利联合氟维司群组的中位无进展生存期（PFS）达到了14.0个月，而对照组单药氟维司群只有5.6个月。联合治疗将疾病进展或死亡风险降低了52%（HR=0.48，p<0.0001）。图1：伏维西利联合方案为内分泌治疗失败的患者带来了具有统计学显著性与临床意义的PFS获益（p < 0.0001）更难得的是，伏维西利联合方案展现出了全方位的疗效。无论患者是绝经前/围绝经期（HR=0.45），还是伴有内脏转移（HR=0.51）甚至骨转移（HR=0.21），伏维西利都能显著降低疾病进展风险，为不同亚组的患者都带来了实实在在的临床获益。图2：FCN-437c-Ⅲ202研究亚组患者分析结果需要指出的是，伏维西利的差异化优势，核心就在于分子结构上的精雕细琢。伏维西利的分子结构与瑞波西利较为相似。其在瑞波西利的基础上优化噻吩并嘧啶母核以及增加甲基哌嗪-哌啶侧链，从而实现了高水平的生物活性与靶点的选择性。具体而言，伏维西利精准强化了药物对核心靶点CDK4/6的靶向作用，同时精巧地避开了与胃肠道毒性密切相关的靶点CDK9，从而有效减少误靶带来的毒副作用。而独特的侧链设计则优化了药物的代谢途径。这种结构上的深度改良，让伏维西利在高效抗肿瘤的同时，展现出了非常优异的临床耐受性。 Q2：FCN-437c-Ⅲ202研究证实，伏维西利在实现生存突破的同时，展现了卓越的安全性。特别是在肝脏保护和胃肠道耐受性方面的差异化优势，对于体能状态可能下滑的后线患者而言，这种“高效且耐受”的平衡对优化临床决策及保障生活质量具有怎样的意义？胡夕春教授：对于体能状态可能因多线治疗而下滑的后线患者，伏维西利高效且耐受的平衡具有深远的临床意义。首先，它大幅优化了临床决策。晚期患者常伴随肝功能受损或肝转移，这是晚期乳腺癌预后差的痛点。伏维西利凭借其独特的侧链结构设计，将肝毒性控制在极低水平：其≥3级转氨酶升高（ALT 1.3%，AST 2.5%）的发生率极低，任意等级转氨酶升高发生率亦仅为20%左右（ALT 18.8%，AST 23.8%）。这使得医生能为伴有基础肝病或肝转移的高危患者提供更安全的方案。同时，晚期患者对毒性耐受力弱，伏维西利≥3级呕吐、恶心发生率为0%；≥3级腹泻发生率极低（发生率为1.3%）。这种患者可感知不良反应的显著降低，不仅减少了止泻药等对症辅助用药，更降低了并发症处理难度，保障了患者的治疗连续性。表1：FCN-437c-Ⅲ202研究常见TEAE分析其次，它切实保障了患者的生活质量，实现了尊严生存。极低的永久停药率意味着患者能足量、足疗程完成治疗，避免因副作用导致的频繁调药或停药。生活质量评估数据也证实，接受伏维西利治疗的患者在总健康、功能与症状曲线上持续上扬。每日一次、进食无碍的简便方案，配合卓越的安全性，消解了用药复杂度与感知痛苦，为中国乳腺癌患者提供了兼顾生存长度与生活质量的慢病化管理优选方案。 Q3：除了在今年ASCO大会上进行展示之外，这项研究后续还有哪些学术发表与交流计划？胡夕春教授：在今年的ASCO会议上，我们这项研究成功亮相，向全球肿瘤领域的国际同行分享了HR+/HER2-晚期乳腺癌领域最新的临床研究成果。而正式的Ⅲ期临床试验结果目前已被国际顶尖学术期刊《信号转导与靶向治疗》（STTT）正式接收，并即将于近期公开发表，这无疑是更令人振奋的喜讯。一项高质量临床研究的最终见刊，必须通过极其严苛的国际同行评议，这不仅标志着国际最权威的学术界对我们研究设计的科学性、数据的真实性给予了高度认可，更是对其临床价值与应用前景的有力背书。这双重的学术瞩目，是对我们团队多年来坚守临床一线、严谨科研的最好肯定。未来，我们也极其期待能以此为契机，与更多国际顶尖团队开展深度的学术交流与合作，共同推动该领域的临床规范化治疗进程。转自：良医汇-肿瘤医生APP

100 项与琥珀酸瑞波西利相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	琥珀酸瑞波西利	L01XE	DB11730

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	Novartis Pharmaceuticals Canada, Inc.	2018-03-02
转移性乳腺癌	加拿大	Novartis Pharmaceuticals Canada, Inc.	2018-03-02
HR阳性/HER2阴性乳腺癌	美国	Novartis Pharmaceuticals Corp.	2017-03-13

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
晚期 HER2 阳性乳腺癌	临床3期	美国	Novartis AG	2022-03-28
晚期 HER2 阳性乳腺癌	临床3期	葡萄牙	Novartis AG	2022-03-28
晚期 HER2 阳性乳腺癌	临床3期	西班牙	Novartis AG	2022-03-28
早期乳腺癌	临床3期	-	Novartis Pharmaceuticals Corp.	2018-03-31
HER2 阴性乳腺癌	临床3期	意大利	Novartis Pharmaceuticals Corp.	2018-02-02
6型髓鞘减少脑白质营养不良	临床3期	意大利	Novartis Pharmaceuticals Corp.	2018-02-02
局部晚期乳腺癌	临床3期	意大利	Novartis Pharmaceuticals Corp.	2018-02-02
乳腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2017-06-07
晚期癌症	临床3期	美国	Novartis Pharmaceuticals Corp.	2016-11-30
晚期癌症	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2016-11-30

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临床结果

适应症

分期

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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


ASCO2026	N/A	HR阳性/HER2阴性乳腺癌一线 HR+/HER2−	5,649	Ribociclib + An Aromatase Inhibitor	獵鹽廠醖鑰繭積願簾衊(選築廠選積鏇鹽願鹽窪) = 齋鏇鹹廠醖襯蓋糧膚衊鹹觸遞簾齋鹽醖夢膚遞 (糧積顧壓構願襯構鑰鬱 ) 更多	积极	2026-05-29
				Aromatase Inhibitor Alone	-
NCT06481956 (RibHER, ASCO2026)	临床2期	HER2阳性转移性乳腺癌 HER2-positive	12	T-DM1 + ribociclib	鏇積醖餘鬱顧顧簾築積(築鏇鬱鬱網餘襯糧遞膚) = 窪蓋顧艱廠積窪鏇壓鑰網製夢顧壓積壓壓鬱繭 (壓簾鹹選夢艱衊窪鑰獵 ) 更多	积极	2026-05-29
				T-DM1 + ribociclib (ER-positive)	鏇積醖餘鬱顧顧簾築積(築鏇鬱鬱網餘襯糧遞膚) = 襯艱醖齋顧餘顧壓繭簾網製夢顧壓積壓壓鬱繭 (壓簾鹹選夢艱衊窪鑰獵 ) 更多
NCT02555189 (RiboX, ASCO2026)	临床1/2期	去势抵抗性前列腺癌 RB expression	46	Enzalutamide	鹹製齋鹽膚顧鹽鹽餘選(窪築齋製鑰築顧選糧壓) = 獵製簾襯構淵鹹遞壓窪顧襯顧壓鏇簾築鏇顧網 (簾網餘膚齋願夢餘觸窪, 43 ~ 95) 更多	不佳	2026-05-29
				Enzalutamide + Ribociclib	鹹製齋鹽膚顧鹽鹽餘選(窪築齋製鑰築顧選糧壓) = 窪構積遞獵淵糧襯襯簾顧襯顧壓鏇簾築鏇顧網 (簾網餘膚齋願夢餘觸窪, 65 ~ 93) 更多
ASCO2026	N/A	HR阳性/HER2阴性乳腺癌 HR+ \| HER2-	5,472	Ribociclib	簾範鹽觸醖衊鑰淵膚遞(鹽淵艱築壓遞廠廠壓構): HR = 0.65 (95.0% CI, 0.552 ~ 0.758), P-Value = <0.0001 更多	积极	2026-05-29
				Palbociclib (HR+/HER2- metastatic breast cancer)
ASCO2026	N/A	乳腺癌	15,374	Ribociclib	蓋醖淵願齋糧壓壓選範(壓觸糧鏇艱鑰淵鑰餘選) = 窪簾鬱築蓋願襯獵醖鹹顧壓齋選蓋窪糧簾艱窪 (廠齋範壓鹽壓廠餘構淵 ) 更多	积极	2026-05-29
				Abemaciclib	蓋醖淵願齋糧壓壓選範(壓觸糧鏇艱鑰淵鑰餘選) = 壓襯鏇衊顧蓋鹹醖鬱簾顧壓齋選蓋窪糧簾艱窪 (廠齋範壓鹽壓廠餘構淵 ) 更多
ASCO2026	N/A	HR阳性/HER2阴性乳腺癌一线 HR+/HER2-	1,509	RIB + AI	壓齋淵鬱築製艱獵蓋顧(繭築鹹壓製鏇窪餘顧觸) = 窪範繭鬱襯積網築餘鹹壓簾夢鏇獵範醖遞蓋壓 (艱廠鑰憲鹽齋鹽構糧願 ) 更多	积极	2026-05-29
				AI monotherapy	壓齋淵鬱築製艱獵蓋顧(繭築鹹壓製鏇窪餘顧觸) = 廠醖襯窪積淵齋觸餘願壓簾夢鏇獵範醖遞蓋壓 (艱廠鑰憲鹽齋鹽構糧願 ) 更多
NCT06495164 (Pubmed \| Oncologist)	N/A	转移性乳腺癌一线 HR Positive \| HER2 Negative	11,557	Palbociclib + AI	衊網鏇憲窪膚夢製範蓋(繭網膚鹽製築顧衊積築) = 醖簾窪齋範膚遞衊構餘襯廠蓋繭選簾憲衊艱鬱 (壓製餘顧齋壓淵範淵鹽 ) 更多	积极	2026-05-07
				Ribociclib + AI	衊網鏇憲窪膚夢製範蓋(繭網膚鹽製築顧衊積築) = 廠繭壓壓艱糧憲糧築壓襯廠蓋繭選簾憲衊艱鬱 (壓製餘顧齋壓淵範淵鹽 ) 更多
NCT02555189 (RiboX, CTgov)	临床1/2期	转移性去势抵抗性前列腺癌	52	Multigated Acquisition Scan+Enzalutamide+Ribociclib (Phase I: 200 mg Ribociclib + Enzalutamide)	廠繭膚觸構鑰夢築鬱願 = 鬱鹹獵鏇鹹獵遞夢膚鑰窪鑰壓積製積鹹憲範鏇 (製廠醖獵鏇醖構選衊鬱, 齋願簾蓋獵範鏇製夢觸 ~ 鹽選餘範繭鏇夢襯餘蓋) 更多	-	2026-04-22
				Multigated Acquisition Scan+Enzalutamide+Ribociclib (Phase I: 400 mg Ribociclib + Enzalutamide)	廠繭膚觸構鑰夢築鬱願 = 襯築餘夢願繭壓築窪願窪鑰壓積製積鹹憲範鏇 (製廠醖獵鏇醖構選衊鬱, 憲窪鹽鏇糧衊憲鑰鹹顧 ~ 築膚繭願鑰淵餘蓋窪憲) 更多
NCT02985125 (CTgov)	临床1/2期	转移性胰腺腺癌	12	LEE011+everolimus (Phase I - Dose Level 1)	鬱鬱顧齋糧構窪構蓋醖(獵選願蓋繭簾範淵遞築) = 鏇襯觸鹹醖襯鏇選鹽獵淵構繭憲糧壓鑰繭糧鬱 (鏇蓋夢蓋糧築壓壓鬱夢, 選淵積鹹醖繭衊壓獵網 ~ 觸齋夢鹹襯鑰衊鏇艱選) 更多	-	2026-04-07
				LEE011+everolimus (Phase I - Dose Level 2)	鬱鬱顧齋糧構窪構蓋醖(獵選願蓋繭簾範淵遞築) = 艱糧壓鬱觸膚憲淵簾膚淵構繭憲糧壓鑰繭糧鬱 (鏇蓋夢蓋糧築壓壓鬱夢, 簾鏇網淵遞鑰遞選構膚 ~ 觸醖選壓積膚鏇淵鏇襯) 更多
NCT02712723 (FELINE, CTgov)	临床2期	ER阳性/HER2阴性乳腺癌	121	Placebo+Letrozole (Placebo + Letrozole)	鏇淵鏇願選顧鑰醖衊繭 = 簾簾齋簾艱簾製構構獵窪窪遞築憲鹽獵糧選窪 (範窪構廠艱選襯壓選鹽, 衊夢鬱簾顧壓築夢壓衊 ~ 鑰廠觸製構膚鹽繭夢淵) 更多	-	2026-03-11
				Letrozole+Ribociclib (Ribociclib 600 mg + Letrozole)	鏇淵鏇願選顧鑰醖衊繭 = 醖網餘鹽壓餘糧製夢製窪窪遞築憲鹽獵糧選窪 (範窪構廠艱選襯壓選鹽, 淵壓衊網憲窪積膚獵顧 ~ 醖製築鹹壓衊築醖廠壓) 更多