Over the past decades, healthcare systems face significant challenges to meet the needs of an aging population due to progressive debility, functional decline and chronic diseases development. While there is a growing appreciation of the potential impact of mTOR inhibitors on slowing aging processes, preventing chronic disease and prolonging healthy lifespan, a major challenge in developing clinical trials to establish the clinical efficacy of mTOR inhibitors is the absence of pharmacokinetics (PK) and pharmacodynamics (PD) data in older adults. The proposed study will provide the foundation for future clinical trials assessing the role of mTOR inhibitors on aging related indications

开始日期2025-05-01

申办/合作机构

The University of Texas Southwestern Medical Center

[+2]

NCT04199026 / Not yet recruiting早期临床1期IIT

Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas

This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

开始日期2025-01-31

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT06658093 / Not yet recruiting早期临床1期IIT

RESTOR [Rapamycin and Everolimus Study Towards Older Rejuvenation]: An Exploratory PK/PD Study of mTOR Inhibition in Older Human Subjects

As people get older, there are changes in their cells and tissues that may affect their ability to function. This can lead to increased death and age-associated disorders, like heart disease, cancer, and Alzheimer's disease. Studies in animal models have been able to identify drugs that slow the aging process, leading to a longer, healthier life. This study is focused on one such family of drugs, called mTOR inhibitors, and the investigators' goal is to test two of these drugs, Rapamycin (Sirolimus) and Everolimus (Afinitor), in healthy older adults to find a dose and dose timing that can be used to safely inhibit mTOR to the levels seen in young healthy persons. The investigators expect that the dose that works well in women may differ from the one that is best in men, so it is important to include both sexes in this research.

开始日期2025-01-01

申办/合作机构

University of Texas Health Science Center At San Antonio

[+1]

100 项与依维莫司相关的临床结果

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100 项与依维莫司相关的转化医学

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100 项与依维莫司相关的专利（医药）

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8,555

项与依维莫司相关的文献（医药）

2025-02-01·CURRENT CANCER DRUG TARGETS

Screening miRNAs to Hinder the Tumorigenesis of Renal Clear Cell Carcinoma Associated with KDR Expression

Article

作者: Suseela, Rangaraj ; Miji, Thandaserry Vasudevan ; Bharathi, Muruganantham ; Muthusami, Sridhar ; Almoallim, Hesham S. ; Kaviyaprabha, Rangaraj ; Thangaleela, Subramanian ; Sivakumar, Priyadarshini

Introduction::

This study delved into the role of Kinase Insert Domain Receptor (KDR) and its associated miRNAs in renal cell carcinoma through an extensive computational analysis. The potential of our findings to guide future research in this area is significant.

Methods::

Our methods, which included the use of UALCAN and GEPIA2 databases, as well as miRDB, MirDIP, miRNet v2.0, miRTargetLink, MiEAA v2.1, TarBase v8.0, INTERNET, and miRTarBass, were instrumental in identifying the regulation of miRNA associated with KDR expression. The predicted miRNA was validated with the TCGA-KIRC patients’ samples by implementing CancerMIRNome. The TargetScanHuman v8.0 was implemented to identify the associations between human miRNAs and KDR. A Patch Dock server analyzed the interactions between hsa-miR-200b-3p-KDR and hsa-miR-200b-3p with KDR.

Results::

The KDR expression rate was investigated in the Kidney Renal Cell Carcinoma (KIRC) samples, and adjacent normal tissues revealed that the expression rate was significantly higher than the normal samples, which was evident from the strong statistical significance (P = 1.63e-12). Likely, the KDR ex-pression rate was estimated as high at tumor grade 1 and gradually decreased till the metastasis grade, reducing the survival rate of the KIRC patients. To identify these signals early, we predicted a miRNA that could trigger the expression of KDR. Furthermore, we uncovered the potential associations between miR-200c-3p expressions by regulating KDR towards the progression of KIRC.

Discussion::

Upon examining the outcome, it became evident that miR-200c-3p was significantly down-regulated in KIRC compared to the normal samples. Moreover, the negative correlation was obtained for hsa-miR-200c-3p (R = - 0.276) along with the KDR expression describing that the increased rate of hsa-miR-200c-3p might reduce the KDR expression rate, which may suppress the KIRC initiation or progres-sion.

Conclusion::

The in-silico analysis indicated that the significant increase in KDR expression during the initiation of KIRC could serve as an early diagnostic marker. Moreover, KDR could be utilized to identify advancements in KIRC stages. Additionally, hsa-miR-200c-3p was identified as a potential regulator capable of downregulating and upregulating KDR expression among the 24 miRNAs screened. This find-ing holds promise for future research endeavors. Concurrent administration of the FDA-approved 5-fluor-ouracil with KIRC drugs, such as sorafenib, zidovudine, and everolimus, may have the potential to en-hance the therapeutic efficacy in downregulating hsa-miR-200c-3p. However, further in vitro studies are imperative to validate these findings and gain a comprehensive understanding of the intricate regulatory interplay involving hsa-miR-200c-3p, KDR, 5-fluorouracil, and other FDA-approved drugs for the treat-ment of KIRC. This will facilitate the identification of KIRC stage progression and its underlying pre-ventative mechanisms.

2025-02-01·Clinical Genitourinary Cancer

Cost-Effectiveness Analysis of Lenvatinib plus Pembrolizumab or Everolimus as First-Line Treatment for Advanced Renal Cell Carcinoma

Article

作者: Zheng, Huanrui ; Zhang, Jinhua ; Tong, Yao ; Zhou, Jin

BACKGROUND:

Recently, due to its promising efficacy against advanced renal cell carcinoma (RCC), the combination therapy with lenvatinib and pembrolizumab or everolimus has been approved as a first-line treatment for patients with advanced RCC in China and the United States. However, the high costs of combination therapies, especially of those new drugs, may limit their viability as clinical treatment options. Thus, our study aimed to evaluate the cost-effectiveness of using lenvatinib plus pembrolizumab or everolimus as a first-line treatment for patients with advanced RCC from the perspective of the Chinese healthcare system and US third-party payers.

METHODS:

We established a Markov model using TreeAge Pro 2022 software to estimate and compare the cost and effectiveness of the therapy with lenvatinib plus pembrolizumab or everolimus with those of sunitinib therapy for treating advanced RCC based on the clinical data derived from a phase III randomized controlled trial (CLEAR, ClinicalTrials.gov number NCT02811861). Transition probabilities and other data were calculated and obtained by using parametric survival modeling. The direct medical costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were used as economic indicators in this analysis. The robustness of the model was assessed by performing one-way and probability sensitivity analyses (PSA).

RESULTS:

Among the 3 treatment strategies, the sunitinib 1 was the least expensive option. All ICERs were far higher than the thresholds of $38,024 and $100,000 selected for China and the United States, respectively. The ICERs of the therapy with lenvatinib plus pembrolizumab versus sunitinib therapy were 106,749.06 US$/QALY and $414,672.19 US$/QALY in China and the United States, respectively. Thus, among these 2, the former strategy was less cost-effective than the latter. In addition, the ICERs of the lenvatinib plus everolimus treatment vs. sunitinib treatment were $44,353.18 US$/QALY and $292,653.10 US$/QALY in China and the United States, respectively. Thus, among these 2 strategies, the former was less cost-effective than the latter. The total cost of the lenvatinib plus everolimus treatment strategy was lower than that of lenvatinib plus pembrolizumab; however, the former treatment was less effective than the latter.

CONCLUSION:

The treatment with lenvatinib plus pembrolizumab or everolimus is less cost-effective than the sunitinib treatment for patients with advanced RCC in China and the United States.

2025-01-01·NEUROPHARMACOLOGY

Abnormal increased mTOR signaling regulates seizure threshold in Dravet syndrome

Article

作者: Ho, Shih-Yin ; Chang, Kai-Chieh ; Tsai, Che-Wen ; Chen, I Chun ; Chen, Hou-Jen ; Liou, Horng-Huei ; Tsai, Feng-Chiao

Excessive activation of mTOR has been observed in the brains of mouse models for Dravet syndrome. We aim to confirm whether that the overactivation of mTOR contributes to the neuropathological changes leading to epileptogenesis and neurobehavior deficits to support a novel pharmacological therapeutic approach for Dravet syndrome. The mTOR inhibitor everolimus, as a clinical antiseizure medication, was utilized to investigate whether mTOR is involved in hyperthermia-induced seizures, anxiety-like, and autism-like behaviors, as well as to explore potential pathogenic mechanisms in Scn1a^E1099X/+ mice, a model of Dravet syndrome. First, we found that mTOR signaling was upregulated in hippocampus tissues and neural cultures derived from Scn1a^E1099X/+ mice prior to seizure onset. Behaviorally, everolimus increased the seizure threshold and improved anxiety-like and autism-like behaviors in Scn1a^E1099X/+ mice. Electrophysiologically, everolimus reduced the frequency of spontaneous excitatory postsynaptic currents in dentate granule neurons from Scn1a^E1099X/+ mice. Biochemically, everolimus prevented hyperthermia-induced phosphorylation of hippocampal S6 ribosome in hippocampus, and it delayed hyperthermia-induced increase of cytosolic Ca²⁺ level in primary neuronal cultures derived from Scn1a^E1099X/+ mice. Our results provide the evidence that overactivated mTOR as an important neuropathological change which regulates seizure threshold, impairments of neurobehavior, neuronal glutamatergic transmission and intracellular Ca²⁺ levels in Scn1a^E1099X/+ mice. Inhibition of mTOR is a potential pharmacological therapeutic approach.

516

项与依维莫司相关的新闻（医药）

2024-12-17

·ioncology

SABCS中国之声丨张剑教授：多款中国创新药物亮相世界舞台，或可进一步改善乳腺癌人群临床获益

编者按：2024年12月10~13日，第47届圣安东尼奥国际乳腺癌论坛（SABCS）在美国圣安东尼奥隆重举行。作为乳腺癌研究领域中规模最大、最具盛名的科学聚会之一，SABCS大会集结了近一年来乳腺癌领域的最新研究成果、临床实践经验、治疗进展和技术创新等内容；其中，包括了来自复旦大学附属肿瘤医院张剑教授团队主导及参与的多项研究，会后《肿瘤瞭望》特邀张剑教授现场分享相关成果。《肿瘤瞭望》：复旦肿瘤团队在本届SABCS上展示了多项研究，这些研究有哪些创新点或突破性发现，能否简要为我们介绍一下? 张剑教授：圣安东尼奥国际乳腺癌论坛是一年一度的全球乳腺癌盛会，吸引了众多国内外专家与学者。今年，据我所知，包括徐兵河院士、邵志敏教授和李俊杰教授在内的多位国内专家受邀进行了口头报告，吴炅教授、胡夕春教授、王晓稼教授、刘真真教授、姚和瑞教授、孟晋教授、张克兢教授等都有焦点壁报（Poster Spotlight）的呈现和讨论；当然，我们团队在本次会议中有2篇Poster Spotlight研究入选，并且在壁报环节有6篇研究入选。主要研究结果如下。首先，复旦肿瘤团队研究了一种新型口服SERD类药物SIM0270，大会公布了相关的Ia期单药扩展队列Cohort S1和Ib期联合依维莫司Cohort B1的研究结果[1,2]。研究发现，SIM0270单药不仅在整体有效率上能够达到预期，更重要的是，SIM0270在疾病控制率方面也取得了良好结果；同时，无论是在ESR1突变还是非突变的患者中，SIM0270都具有一定的疗效。此外，SIM0270联合依维莫司的Ib期研究探索，研究入组了40例患者，观察到有效率的进一步提升，无进展生存期（PFS）达到了8.2个月。这些数据为3期临床研究奠定了基础，目前3期临床试验正在进行中，拟在CDK4/6抑制剂经治人群中比较SIM0270联合依维莫司对比医生选择的内分泌治疗（依西美坦+依维莫司或氟维司群单药）的疗效。其次，复旦肿瘤团队还报道了一项PM8002的研究[3]，该药是一种针对VEGF和PD-L1靶点的双功能抗体。在针对三阴性乳腺癌一线治疗的Ib/II期研究中，我们发现确认的客观缓解率超过70%，并且在非选择性的整体人群中位PFS达到了13.5个月（95% CI：9.4个月~19.3个月）。更重要的是，本次会议上更新了总生存数据，近18个月的总生存率为70%。这表明抗血管生成联合免疫治疗在一线治疗中具有一定价值，且疗效不依赖于PD-L1的表达。此外，复旦肿瘤团队还展示了其他相关研究结果，如BL-B01D1药物的研究[4]；该研究报道了近160例HR+/HER2-、HER2+以及三阴性乳腺癌患者使用BL-B01D1的临床结局。结果显示，BL-B01D1的整体有效率与既往的HER3靶向药物疗效相近甚至更高，且安全性总体可控。这部分数据的更新为我们后续的新药研究提供了坚实的基础。当然，在本次入选研究中，还包括复旦肿瘤团队开展的CDK4选择性抑制剂的相关探索[5]、以及团队开展的伊尼妥单抗真实世界分析研究[6]、三阴性乳腺癌患者使用白蛋白紫杉醇联合特瑞普利单抗和PARP抑制剂治疗的相关探索[7]、其他新型口服SERD的相关研究[8]、ARX788 在III期ACE-Breast-02研究中的患者特征分析和安全性管理内容[9]。总体而言，在本次圣安东尼奥国际乳腺癌论坛上，复旦肿瘤团队分享了最新的研究成果。需要特别指出的是，本次2024 SABCS年终盘点（Year in Review）中，有两项中国的研究被收录，都来自于复旦肿瘤，一项是邵志敏教授团队的新辅助研究纳入Early Breast Cancer Updates，一项是吴炅/张剑教授团队的晚期研究纳入Advanced Breast Cancer Updates。期待会后有机会和同道们进一步深入交流。参考文献上下滑动查看更多内容 [1]. Zhang QY, …, Wu J, Zhang J, et al. PS14-03: Updated analyses from a Phase I study of the brain-penetrant oral SERD- SIM0270 in patients with ER-positive, HER2-negative advanced breast cancer. SABCS 2024. [2]. Zhang J, et al. PS14-04: SIM0270, a brain-penetrant oral SERD, in combination with everolimus in patients with ER+/HER2- advanced breast cancer: the phase Ib study. SABCS 2024. [3]. Wu J, Zhang J, et al. PS3-08: Interim Overall Survival of Patients with Locally Advanced or Metastatic Triple-Negative Breast Cancer treated with First Line PM8002/BNT327 in Combination with Nab-Paclitaxel in Phase Ib/II Study. SABCS 2024. [4]. Wu J, Zhang J, et al. P5-07-27: BL-B01D1, a first-in-class EGFRxHER3 bispecific antibody-drug conjugate, in patients with Locally Advanced or Metastatic Breast Cancer and other Solid Tumor: Updated results from a phase 1 study. SABCS 2024. [5]. Zhang J, Shao ZM, et al. P4-08-26: Trial in progress: First-in-human phase 1a/1b, dose escalation/expansion study of BGB-43395 (CDK4 selective inhibitor) as monotherapy or combination therapy in Chinese patients with metastatic HR+/HER2- breast cancer & other advanced solid tumors. SABCS 2024. [6]. Mu YX, Zhang J, et al. P5-03-14: Efficacy and safety of inetetamab-containing regimens in patients with HER2-positive metastatic breast cancer in first-line/second line setting. SABCS 2024. [7]. Zhang J, et al. P4-04-31: A phase Ib/II study of PARPi Mefuparib Hydrochloride (CVL218) in combination with PD-1 inhibitor plus chemotherapy in metastatic or recurrent triple-negative breast cancer (TNBC). SABCS 2024. [8]. Zhang J, et al. P4-04-17: TFX06 shows remarkable safety and extracranial and intracranial efficacy in patients with ER+/HER2- breast cancer in a phase 1 study. SABCS 2024. [9]. Hu XC, Zhang J, et al. P5-05-22: ARX788 for patients with HER2-positive advanced breast cancer: characterization, time course, and monitoring and management of adverse event from the phase III ACE-Breast-02 study. SABCS 2024. 张剑教授复旦大学附属肿瘤医院肿瘤内科主任医师、博导负责复旦大学附属肿瘤医院Ⅰ期临床研究担任复旦大学附属肿瘤医院福建医院临床研究中心主任/肿瘤内科常务副主任中国医药教育协会肿瘤药物临床研究专业委员会主任委员中国老年保健协会肿瘤防治与临床研究专业委员会主任委员长江学术带乳腺联盟主任委员上海市抗癌协会肿瘤药物临床研究专业委员会候任主任委员中国抗癌协会乳腺癌专业委员会常委中国抗癌协会乳腺癌专业委员会青委会副召集人中国临床肿瘤学会乳腺癌专家委员会委员中国抗癌协会肿瘤临床研究管理学专业委员会委员上海“医苑新星”杰青人才获得者，曾担任国家药品监督管理局药品审评中心临床兼职审评员。获2023十大医学先锋专家、2023“人民好医生”杰出贡献奖。以第一作者、共同第一作者或通信作者在Lancet Oncol、Ann Oncol、Nat Commun、Clin Cancer Res、J Hematol Oncol、STTT等SCI收录期刊上发表论文80篇。（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3期

2024-12-16

·复宏汉霖

2024 ESMO IO | 复宏汉霖H药汉斯状®新辅助治疗食管鳞癌研究数据发布

2024年欧洲肿瘤内科学会免疫肿瘤大会（ESMO IO）于当地时间12月11日至13日在瑞士日内瓦及线上同步举行。会上，由复宏汉霖自主研发的创新型单抗H药汉斯状®（斯鲁利单抗）联合化疗新辅助治疗可切除局晚期食管鳞癌的单臂II期试验数据以壁报形式发布。该研究由浙江大学医学院附属第二医院吴明、沈虹教授团队开展。 H药汉斯状®（通用名：斯鲁利单抗注射液）为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国和多个东南亚国家获批，惠及患者约9万人。截至目前，H药已在中国获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞状细胞癌（ESCC）和非鳞状非小细胞肺癌（nsNSCLC）等5项适应症，此外，H药一线治疗ES-SCLC的上市申请也已获得欧盟EMA受理，有望于2025年获批上市。聚焦肺癌和消化道肿瘤等瘤种，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，在全球同步开展10余项肿瘤免疫联合疗法临床试验，于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超4600人。其中，H药联合化疗治疗不可切除局部晚期/复发或转移性食管鳞癌(ESCC)的一线治疗方案已于2023年9月获得中国国家药监局（NMPA）批准上市，为我国食管鳞癌患者带来了免疫治疗新选择。以下为此次发布的详细信息：左右滑动查看更多图片论文题目：斯鲁利单抗联合化疗新辅助治疗可切除局晚期食管鳞癌的一项单臂II期试验报告时间：2024年12月12日（日内瓦时间）研究设计：关键入组标准： -病理学和影像学确诊的可手术切除的食管鳞癌初治受试者； -分期为II-IVA 期（AJCC 第八版食管鳞癌临床分期）； -治疗前评估可R0手术切除的患者； -ECOG评分0~1。治疗方案：新辅助治疗：斯鲁利单抗4.5mg/kg，i.v，d1+白蛋白紫杉醇260 mg/m2，d1+卡铂AUC=5，i.v，d1，每21天重复一次，治疗三周期。末次给药后4~6周行食管癌根治切除手术。主要研究终点：病理完全缓解率(Pathological complete response，pCR率)。结果： 45例患者最终接受手术，并全部（100%）达到了R0切除，其中3例完全缓解，30例部分缓解，ORR（Objective Response Rate，客观缓解率）达到68.8%，DCR（Disease control rates，疾病控制率）为100%。在病理学上，有14例患者达到原发肿瘤和淋巴结的完全缓解，pCR为31.1%。只有2例患者出现了≥3级AE。结论：这项单臂的II期研究证实了斯鲁利单抗联合化疗新辅助治疗局部进展期食管鳞癌显示出值得期待的疗效和可耐受的安全性。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，3款产品在国际获批上市，25项适应症获批，4个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌、食管鳞状细胞癌和非鳞状非小细胞肺癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Latest Results of Serplulimab in The Neoadjuvant Treatment of ESCC Released In 2024 ESMO IO From 11 to 13 December 2024, the 2024 European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress took place in Geneva, Switzerland, and online. At this congress, the results of a phase 2 clinical trial of serplulimab in combination with chemotherapy in the neoadjuvant treatment of oesophagexal squamous cell carcinoma have been published in poster presentation. This study was led by Professor Ming Wu and and Professor Hong Shen from the Second Affiliated Hospital Zhejiang University School of Medicine. HANSIZHUANG (serplulimab), Henlius’ first self-developed innovative Anti-PD-1 mAb, is the world’s first anti-PD-1 mAb for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Up to date, it has been approved in China and several Southeast Asian countries, benefiting about 90,000 patients. In China, it has been approved by the NMPA for the treatment of 5 indications including squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Furthermore，the marketing applications of the first-line treatment for ES-SCLC is under review by the European Medicines Agency (EMA), which is expected to be approved in 2025. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,600 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. From which, HANSIZHUANG in combination with chemotherapy for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC has been approved by the China National Medical Products Administration (NMPA) in September 2023, providing a new treatment option for patients with ESCC. The detailed results of the study released at 2024 ESMO-IO are as follows: Title: Serplulimab Combined with Chemotherapy in The Neoadjuvant Treatment of Resectable Oesophagexal Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial Time: December 12, 2024(CET) Study Design: Key Inclusion Criteria: -Histologically or cytologically diagnosed with ESCC; -Clinical stage II-IVA, based on the American Joint Committee on Cancer (AJCC) 8th edition; -Pre-treatment evaluation indicates potential for R0 resection; -Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. Treatment: Three cycles of neoadjuvant therapy (21 days per cycle):Serplulimab (4.5mg/kg intravenously on day 1), Carboplatin (AUC=5 intravenously on day 1),Albumin paclitaxel (260 mg/m2 intravenously on day 1).Surgery (4-6 weeks after the last neoadjuvant treatment cycle). Primary Outcome: Pathological complete response (PCR). Results: Three patients opted out of surgical treatment and withdrew from the study. A total of 45 patients underwent minimally invasive oesophagectomy following serplulimab-based neoadjuvant therapy, and all achieved R0 resection. Complete pCR in both primary tumor and lymph nodes was achieved in 14 patients (31.1%). Only two patients experienced grade 3 AEs. Conclusion: In this single-arm phase 2 study, serplulimab in combination with chemotherapy in the neoadjuvant setting for locally advanced ESCC has shown promising antitumor activity and an acceptable safety profile. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 25 indications are approved worldwide, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (nsNSCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

上市批准临床2期临床3期临床结果申请上市

2024-12-16

·正大天晴药业集团

2024 SABCS|正大天晴公布安罗替尼治疗乳腺癌最新数据

2024年第47届圣安东尼奥乳腺癌研讨会（SABCS）于12月10日至13日在美国举行，是乳腺癌研究领域规模最大、最负盛名的学术盛会之一。本次大会，正大天晴聚焦HR+/HER2-以及三阴性乳腺癌，公布多项以安罗替尼为基础的临床研究数据。安罗替尼联合治疗“最毒乳腺癌”之称的三阴性乳腺癌研究的客观缓解率（ORR）高达75.0%；在治疗乳腺癌CDK4/6抑制剂耐药HR+乳腺癌患者中疾病控制率（DCR）达94.9%。安罗替尼联合派安普利单抗和白蛋白结合型紫杉醇一线治疗晚期三阴性乳腺癌的疗效和安全性：一项前瞻性、II期临床研究研究纳入43例体力状况评分（ECOG PS）0-1、不可手术切除的局部晚期或复发/转移性三阴性乳腺癌（TNBC）患者，符合条件的患者接受安罗替尼+派安普利单抗+白蛋白结合型紫杉醇治疗，中位随访时间为8.67个月。40例疗效可评估患者的主要终点客观缓解率（ORR）为75.0%，次要终点疾病控制率（DCR）为97.5%，中位无进展生存期（PFS）为10.64个月，中位总生存期（OS）尚未达到。其中，1例患者达完全缓解（CR），29例患者达部分缓解（PR），9例疾病稳定（SD），1例疾病进展（PD）。[1] 安罗替尼联合白蛋白结合型紫杉醇为基础的化疗新辅助治疗HER2阴性乳腺癌：一项前瞻性、单臂、单中心、II期临床研究研究纳入31例体力状况评分（ECOG PS）0-2、既往未接受过系统治疗的HR阳性、HER2阴性乳腺癌患者，符合条件的患者接受5周期安罗替尼+6周期化疗（白蛋白结合型紫杉醇+蒽环类药物+环磷酰胺）后接受手术治疗。截至2024年6月30日，28例患者接受至少一次治疗，27例患者接受了手术治疗。主要终点总病理完全缓解（tpCR）率为14.8%，乳腺病理完全缓解（bpCR）率和腋窝病理完全缓解（apCR）率均为18.5%，客观缓解率（ORR）为92.9%。其中，4例患者达到完全缓解（CR），22例患者达到部分缓解（PR）。[2] 后CDK4/6抑制剂时代的新选择：以安罗替尼为基础的联合方案治疗CDK4/6抑制剂耐药的HR阳性转移性乳腺癌的多中心真实世界研究该研究回顾性分析53例疾病进展前均接受至少一线CDK4/6抑制剂治疗确诊HR阳性、HER2阴性转移性乳腺癌患者，患者接受安罗替尼治疗，联合用药包括艾立布林、白蛋白结合型紫杉醇、依托泊苷、卡培他滨、帕博利珠单抗、信迪利单抗或氟维司群等，中位随访时间为9.2个月。39例疗效可评估患者的中位无进展生存期（PFS）为7.1个月，客观缓解率（ORR）为30.8%，疾病控制率（DCR）为94.9%。其中，12例患者达部分缓解（PR），25例患者达到疾病稳定（SD）。[3] 聚焦乳腺癌领域，正大天晴已上市氟维司群注射液、多西他赛注射液、依维莫司片、注射用曲妥珠单抗、哌柏西利胶囊、艾立布林注射液等创新产品。其中，艾立布林注射液是今年12月获批上市的新品种。此外，企业还布局了帕妥珠单抗注射液、CDK2/4/6抑制剂库莫西利胶囊、HER2双抗ADC药物TQB2102等多种创新药和生物类似药。参考文献： [1]TaoSun,et al.A prospective phase 2 study on efficacy and safety of AK105, anlotinib combined with nab-paclitaxel (nab-P) as a first-line therapy in patients(pts) with advanced triple-negative breast cancer (TNBC).2024 SABCS. [2]HuiminMeng,et al.Neoadjuvant anlotinib plus nab-paclitaxel based chemotherapy in patients with HER2-negative breast cancer: A prospective, single-arm, single-center, phase II clinical study.2024 SABCS. [3]BinliangLiu.et al.A New Option for post-CDK4/6is Resistance Era:Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4/6 Inhibitors.2024 SABCS. 声明： 1. 本新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2. 本公司不对任何药品和/或适应症作推荐。 3. 本新闻稿中涉及的信息仅供参考，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。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ● 南京市委书记周红波调研正大天晴：紧密产学研合作为企业提供优质便捷的技术支撑和人才保障 ● 格索雷塞全国首批发货，肺癌患者有了新“医”靠！ ● 正大天晴攻克化药“珠峰”，甲磺酸艾立布林注射液获批上市 ● 优势互补共创“产学研”新格局正大天晴与香港中文大学医学院签署合作框架协议

临床2期临床结果临床终止

100 项与依维莫司相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02714	依维莫司	L04AA18 L01XE10	DB01590

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
癫痫	美国	Novartis Pharmaceuticals Corp.	2021-12-30
癫痫部分性发作	美国	Novartis Pharmaceuticals Corp.	2018-04-10
结节性硬化症相关的肾血管平滑肌脂肪瘤	中国	Novartis Pharma AG	2016-12-12
复发性乳腺癌	日本	Novartis Pharma AG	2014-03-17
胰神经内分泌瘤	中国	Novartis Pharma AG	2014-02-01
室管膜下巨细胞星形细胞瘤	中国	Novartis Pharma AG	2014-02-01
HR阳性/HER2阴性乳腺癌	美国	Novartis Pharmaceuticals Corp.	2012-07-20
胃肠胰神经内分泌肿瘤	日本	Novartis Pharma AG	2011-12-22
结节性硬化症	欧盟	Novartis Europharm Ltd.	2011-09-02
结节性硬化症	冰岛	Novartis Europharm Ltd.	2011-09-02
结节性硬化症	列支敦士登	Novartis Europharm Ltd.	2011-09-02
结节性硬化症	挪威	Novartis Europharm Ltd.	2011-09-02
星形细胞瘤	美国	Novartis Pharmaceuticals Corp.	2010-10-29
血管平滑肌脂肪瘤	加拿大	Novartis Pharmaceuticals Canada, Inc.	2010-03-15
HR阳性乳腺癌	欧盟	Novartis Europharm Ltd.	2009-08-02
HR阳性乳腺癌	冰岛	Novartis Europharm Ltd.	2009-08-02
HR阳性乳腺癌	列支敦士登	Novartis Europharm Ltd.	2009-08-02
HR阳性乳腺癌	挪威	Novartis Europharm Ltd.	2009-08-02
神经内分泌肿瘤	欧盟	Novartis Europharm Ltd.	2009-08-02
神经内分泌肿瘤	冰岛	Novartis Europharm Ltd.	2009-08-02

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
癫痫发作	临床3期	美国	Novartis Pharmaceuticals Corp.	2017-06-08
癫痫发作	临床3期	日本	Novartis Pharmaceuticals Corp.	2017-06-08
癫痫发作	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2017-06-08
癫痫发作	临床3期	比利时	Novartis Pharmaceuticals Corp.	2017-06-08
癫痫发作	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2017-06-08
癫痫发作	临床3期	哥伦比亚	Novartis Pharmaceuticals Corp.	2017-06-08
癫痫发作	临床3期	法国	Novartis Pharmaceuticals Corp.	2017-06-08
癫痫发作	临床3期	匈牙利	Novartis Pharmaceuticals Corp.	2017-06-08
癫痫发作	临床3期	意大利	Novartis Pharmaceuticals Corp.	2017-06-08
癫痫发作	临床3期	墨西哥	Novartis Pharmaceuticals Corp.	2017-06-08

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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


NCT03070301 (CTgov)	临床2期	晚期神经内分泌肿瘤	21	LEE011+everolimus	淵鏇鑰蓋鑰糧簾齋淵鬱(廠憲製夢淵繭鬱壓網顧) = 繭製餘衊築窪鬱鑰觸襯觸艱顧膚獵築衊糧願築 (願廠膚鹽築築糧簾齋繭, 製顧觸遞壓醖齋遞夢廠 ~ 憲鬱蓋獵蓋觸遞餘齋遞) 更多	-	2024-10-10
NCT01678664 (EVACEL \| FFCD 1104-EVACEL-GTE, CTgov)	临床2期	肝转移 \| 内分泌腺肿瘤 \| 神经内分泌肿瘤	74	embolization+Doxorubicin+Everolimus	壓餘鏇願製積鬱顧願鑰(窪襯鹹構衊願獵鬱願網) = 遞衊願壓蓋獵膚築鹹齋窪襯構遞襯顧鹽醖餘範 (膚鹽繭夢廠憲選顧衊製, 顧選襯夢遞願襯網鏇遞 ~ 築觸齋艱蓋網壓齋築襯) 更多	-	2024-09-25
ESMO2024	临床1期	晚期神经内分泌肿瘤	92	Everolimus 6.1 - 10mg	鏇襯鏇糧築顧鹽顧艱壓(簾鹹餘壓鬱範構齋蓋鏇) = 淵遞艱顧繭顧蓋選觸餘構積繭夢壓遞積齋憲鑰 (製獵簾願繭獵構蓋鏇廠, 3.7 ~ 32) 更多	积极	2024-09-16
				Everolimus 6mg or less	鏇襯鏇糧築顧鹽顧艱壓(簾鹹餘壓鬱範構齋蓋鏇) = 網鏇願廠鏇構衊廠觸膚構積繭夢壓遞積齋憲鑰 (製獵簾願繭獵構蓋鏇廠, 3.9 ~ 27) 更多
EVERGREEN (ESMO2024)	N/A	ER阳性/HER2阴性乳腺癌 PIK3CA-AKT1-PTEN pathway alterations	207	Everolimus-based endocrine therapy (EVE)	網積鬱築鬱遞選廠選糧(鏇遞艱艱網網壓簾醖糧) = 艱壓獵獵鏇積鹽艱廠鑰範築積鬱範餘構齋製膚 (夢鏇餘鹹淵廠膚膚醖鹽 ) 更多	不佳	2024-09-16
				Endocrine therapy alone (ETa)	網積鬱築鬱遞選廠選糧(鏇遞艱艱網網壓簾醖糧) = 鏇鹹顧膚齋構鹹淵獵製範築積鬱範餘構齋製膚 (夢鏇餘鹹淵廠膚膚醖鹽 ) 更多
NCT02338609 (EXIST-LT, CTgov)	临床4期	-	15	Everolimus	鑰淵壓鹹壓糧壓鹹蓋憲(夢鑰獵艱鏇衊鹹艱觸鑰) = 選鏇衊膚餘製顧廠網鏇鬱簾網鏇窪鏇鬱艱餘餘 (鬱顧襯觸鏇壓願襯製範, 窪憲艱夢淵襯獵顧壓網 ~ 蓋憲膚願壓遞餘廠製壓) 更多	-	2024-08-09
NCT01120249 (EVEREST, Pubmed \| JAMA Netw Open) 人工标引	临床3期	肾细胞癌 \| 乳状状肾细胞癌辅助	110	Everolimus	繭製遞獵淵餘壓鏇鏇簾(鏇窪積鹽獵顧淵廠鹽窪) = 觸鹹選壓獵積壓夢製餘窪齋範憲窪廠範獵觸築 (選遞餘選襯夢夢範範鏇 ) 更多	不佳	2024-08-01
				Placebo	繭製遞獵淵餘壓鏇鏇簾(鏇窪積鹽獵顧淵廠鹽窪) = 繭願網襯鏇襯積獵餘鏇窪齋範憲窪廠範獵觸築 (選遞餘選襯夢夢範範鏇 ) 更多
NCT03154281 (CTgov)	临床1期	卵巢癌 \| 乳腺癌	14	niraparib+Everolimus (Cohort 1)	簾簾廠衊鬱齋醖鑰夢齋(鹽網窪選糧壓淵鏇繭鬱) = 鑰觸蓋遞鹹網鏇網夢積築蓋夢齋艱憲鹹網鹹憲 (觸鹹糧鏇壓築構艱鏇獵, 遞觸獵鹹壓憲鏇淵醖製 ~ 鏇壓獵積簾蓋壓鹽襯築) 更多	-	2024-08-01
				niraparib+Everolimus (Cohort 2)	簾簾廠衊鬱齋醖鑰夢齋(鹽網窪選糧壓淵鏇繭鬱) = 壓築願淵衊廠鑰顧鏇築築蓋夢齋艱憲鹹網鹹憲 (觸鹹糧鏇壓築構艱鏇獵, 願鑰憲築選餘繭膚糧窪 ~ 範選範廠窪鬱選獵窪願) 更多
NCT03312738 (BOLERO-5, Pubmed) 人工标引	临床2期	ER阳性/HER2阴性乳腺癌 HER2 Negative \| ER Positive	159	Everolimus (EVE) + Exemestane (EXE)	襯鹽範鹹鹽窪醖網顧鹽(醖願獵築網鹹顧選蓋餘) = 蓋鑰築築壓鹹鹹遞膚齋糧繭鹹醖蓋衊築願膚蓋 (衊淵範窪襯顧觸觸衊獵, 5.5 ~ 9.0)	积极	2024-06-21
				Placebo (PBO) + Exemestane (EXE)	襯鹽範鹹鹽窪醖網顧鹽(醖願獵築網鹹顧選蓋餘) = 積鏇顧觸襯醖餘壓夢窪糧繭鹹醖蓋衊築願膚蓋 (衊淵範窪襯顧觸觸衊獵, 1.9 ~ 3.6)
AHNS2024	N/A	头颈部鳞状细胞癌	-	Everolimus	艱構觸壓簾艱鬱糧齋餘(鹹衊鑰鑰衊壓夢願壓窪) = 蓋淵願憲選顧鏇衊願獵鑰築蓋蓋遞構襯鬱鹽築 (襯窪選鏇鏇築襯鹹製醖 )	-	2024-05-15
				anti-PD-1	艱構觸壓簾艱鬱糧齋餘(鹹衊鑰鑰衊壓夢願壓窪) = 築餘鬱膚鏇憲鬱構構積鑰築蓋蓋遞構襯鬱鹽築 (襯窪選鏇鏇築襯鹹製醖 )
ID 427 (ESMO_BC2024)	N/A	HR阳性乳腺癌 CDK 4/6 inhibitors	69	Everolimus + Exemestane	餘觸淵鏇簾獵簾願築選(鑰蓋構獵蓋鑰網蓋繭廠) = 遞構築憲夢廠網製夢窪淵願顧遞鹹鑰淵製鬱鑰 (窪鏇鑰製憲顧顧範衊選 )	不佳	2024-05-14