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]

NCT06552169 / Not yet recruiting临床2期

The RETIRE Trial: A Randomized Phase 2 Trial of Adoptive Therapy With Treg Adoptive Cell Transfer (TRACT) To Prevent Rejection in Living Donor Kidney Transplant Recipients

The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients.
Enrolled subjects will be randomized to one of 2 study arms:
Arm 1 subjects will receive standard of care immunosuppression
Arm 2 subjects will receive initial standard of care (SOC) immunosuppression and a single infusion of TRK-001. Three months after the transplant, Arm 2 subjects may be able to begin reducing their immunosuppression medication to a 1-drug regimen.
The primary outcome measures of trial are to evaluate several components indicating immunologic problems with the transplanted organ at 1-year post-transplant and to evaluate the ability for the study subjects given TRK-001 to wean to a 1-drug immunosuppression regimen.
All enrolled subjects will be followed for 5 years post-transplant.

开始日期2024-12-01

申办/合作机构

TRACT Therapeutics, Inc.

[+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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8,819

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.

2025-01-01·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.

2025-01-01·CLINICA CHIMICA ACTA

Transplant patient classification based on everolimus blood concentrations: Is there a risk of “misclassifications” using immunoassays?

Letter

作者: Bargnoux, Anne-Sophie ; Le Quintrec, Moglie ; Badiou, Stéphanie ; Sutra, Thibault ; Szwarc, Ilan ; Pageaux, Georges-Philippe ; Dupuy, Anne-Marie ; Grillet, Pierre-Edouard ; Cristol, Jean-Paul

478

项与依维莫司相关的新闻（医药）

2024-11-01

·微信

PI3K抑制剂：HR阳性晚期乳腺癌一线治疗新联合用药方案

点击上方蓝字关注我们过去20年来，激素受体阳性HER2阴性晚期乳腺癌的治疗方法已经发生巨大变化。过去，通常的治疗方法是先用选择性雌激素受体调节剂他莫昔芬、雌激素合成酶（芳香化酶）抑制剂或雌激素受体拮抗剂氟维司群进行内分泌治疗，直至内分泌耐药，随后转向化疗。耐药可原发于乳腺癌诊断时，或继发于乳腺癌诊断后长期内分泌治疗引起的适者生存。细胞信号传导通路以及体细胞基因突变可将乳腺癌对内分泌敏感转变为耐药，例如细胞周期蛋白依赖性激酶CDK4/6、磷脂酰肌醇3激酶PI3K。PI3K由分子量分别为85千道尔顿的抑制亚基p85和110千道尔顿的催化亚基p110组成，p110又有p110α、p110β、p110γ、p110δ四种异构体，分别由PIK3CA、PIK3CB、PIK3CG、PIK3CD四种基因编码，其中PIK3CA激活突变发生于高达35%至40%的激素受体阳性乳腺癌，属于核心突变，存在于癌症起始细胞，主要引起原发耐药，而其他致癌突变主要引起继发耐药，例如雌激素受体α编码基因ESR1的突变。不过，前几代p110α抑制剂不良反应发生率较高，而且大多用于内分泌耐药二线治疗，联合CDK4/6抑制剂和内分泌治疗均告失败。新一代高效选择性p110α抑制剂伊那利塞（又译：伊纳沃利昔布）既可抑制p110α，又可促进PIK3CA突变基因编码的p110α降解。临床前研究已经证实伊那利塞联合CDK4/6抑制剂哌柏西利以及氟维司群具有协同作用，早期临床研究也发现该联合方案抗肿瘤活性良好。那么，对于PIK3CA突变的内分泌耐药晚期乳腺癌，将该联合方案前移至一线治疗，有效性和安全性效果如何？ 2024年10月31日，国际四大医学期刊之一、创刊于1812年的美国麻省医学会《新英格兰医学杂志》在线发表英国罗氏、伦敦大学癌症研究院、皇家马斯登医院、伦敦大学玛丽王后学院巴茨癌症研究所、韩国首尔大学医学院附属医院癌症研究所、西班牙巴塞罗那大学希伯伦河谷医院肿瘤研究所、美国基因泰克、哈佛大学医学院麻省总医院癌症中心、埃默里大学温希普癌症研究院、纽约纪念医院斯隆凯特林癌症中心、康奈尔大学威尔医学院、德国乳腺癌研究协作组、法兰克福大学贝塔尼血液学和肿瘤学中心、澳大利亚墨尔本大学彼得麦卡伦癌症中心、泰国宋卡王子大学、意大利帕尔马大学罗马涅肿瘤研究院、中国北京大学肿瘤医院李惠平、哈尔滨医科大学附属肿瘤医院张清媛、香港大学李嘉诚医学院、波兰居里夫人肿瘤研究院的INAVO 120研究报告，首次比较了哌柏西利＋氟维司群＋伊那利塞或安慰剂一线治疗PIK3CA突变且激素受体阳性HER2阴性乳腺癌局部晚期或远处转移患者的有效性和安全性。 INAVO120 (NCT04191499): A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer OFFICIAL TITLE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer 该国际多中心安慰剂双盲随机对照三期临床试验于2020年1月29日至2023年9月14日从全球28个国家入组PIK3CA突变且激素受体阳性HER2阴性乳腺癌术后内分泌治疗期间或术后内分泌治疗之后12个月内出现局部复发或远处转移尚未用过CDK4/6抑制剂患者325例，按1∶1随机分为两组进行一线治疗，伊那利塞组161例患者每天口服伊那利塞9毫克＋哌柏西利＋氟维司群，安慰剂组164例患者每天口服安慰剂＋哌柏西利＋氟维司群。主要终点为研究者评定的无进展生存。由于死亡事件数较少，总生存预设P值小于0.0098有统计学显著性。结果，伊那利塞与安慰剂相比：随访时间：中位21.3个月比21.5个月 18个月无进展生存率：46.2%比21.1% 无进展生存时间：中位15.0个月比7.3个月（95%置信区间：11.3～20.5、5.6～9.3）进展或死亡风险：降低57%（风险比：0.43；95%置信区间：0.32～0.59；P<0.001） 18个月总生存率：73.7%比67.5% 总死亡风险：降低36%（风险比：0.64；95%置信区间：0.43～0.97；P=0.03，未小于预设0.0098）客观缓解率：58.4%比25.0% 伊那利塞与安慰剂相比，不良反应发生率： 3或4级中性粒细胞减少：80.2%比78.4% 3或4级高血糖：5.6%比0% 3或4级口腔炎或黏膜炎：5.6%比0% 3或4级腹泻：3.7%比0% 3或4级皮疹：0比0 由于不良事件停用任何试验药物：6.8%比0.6% 因此，该研究结果表明，对于PIK3CA突变且激素受体阳性HER2阴性乳腺癌局部晚期或远处转移患者，伊那利塞与安慰剂相比，联合哌柏西利＋氟维司群一线治疗，中位无进展生存延长超过一倍、18个月无进展生存率和客观缓解率提高超过一倍，虽然毒性反应发生率较高，但是由于不良事件停用任何试验药物的患者比例6.8%远远低于其他类似药物，例如阿吡利塞的25%、依维莫司的19%、卡匹色替的13%。对此，美国国家综合癌症网络（NCCN）临床实践指南乳腺癌专家委员会主席、芝加哥西北大学费恩伯格医学院教授、罗伯特卢里综合癌症中心肿瘤内科主任威廉·格拉迪沙亲自撰写同期评论：改善激素受体阳性乳腺癌耐药患者结局。相关链接高选择性PI3K抑制剂获中国突破性治疗认定，开启激素受体阳性乳腺癌精准治疗新时代！重磅！罗氏伊纳沃利昔布获中国优先审评用于治疗PIK3CA突变激素受体阳性HER2阴性乳腺癌 N Engl J Med. 2024 Oct 31;391(17):1584-1596. IF: 96.2 Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Royal Marsden Hospital, Institute of Cancer Research, Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London; Roche, Welwyn Garden City, United Kingdom; Seoul National University Hospital, Seoul National University College of Medicine, Cancer Research Institute, Seoul National University, Seoul, Korea; Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Mass General Cancer Center, Harvard Medical School, Boston; Winship Cancer Institute at Emory University, Atlanta; Genentech, San Francisco; Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York; German Breast Group, Neu-Isenburg; Center for Hematology and Oncology Bethanien, Goethe University, Frankfurt, Germany; Peter MacCallum Cancer Centre, Melbourne, VIC; University of Melbourne, Parkville, VIC, Australia; Prince of Songkla University, Songkhla, Thailand; University of Parma, Parma; IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori," Meldola, Italy; Peking University Cancer Hospital and Institute, Beijing; Harbin Medical University, Harbin; Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China; Maria Sklodowska-Curie Institute of Oncology, Warsaw, Poland. BACKGROUND: Inavolisib is a highly potent and selective inhibitor of the alpha isoform of the p110 catalytic subunit of the phosphatidylinositol 3-kinase complex (encoded by PIK3CA) that also promotes the degradation of mutated p110α. Inavolisib plus palbociclib-fulvestrant has shown synergistic activity in preclinical models and promising antitumor activity in early-phase trials. METHODS: In a phase 3, double-blind, randomized trial, we compared first-line inavolisib (at an oral dose of 9 mg once daily) plus palbociclib-fulvestrant (inavolisib group) with placebo plus palbociclib-fulvestrant (placebo group) in patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who had had relapse during or within 12 months after the completion of adjuvant endocrine therapy. The primary end point was progression-free survival as assessed by the investigator. RESULTS: A total of 161 patients were assigned to the inavolisib group and 164 to the placebo group; the median follow-up was 21.3 months and 21.5 months, respectively. The median progression-free survival was 15.0 months (95% confidence interval [CI], 11.3 to 20.5) in the inavolisib group and 7.3 months (95% CI, 5.6 to 9.3) in the placebo group (hazard ratio for disease progression or death, 0.43; 95% CI, 0.32 to 0.59; P<0.001). An objective response occurred in 58.4% of the patients in the inavolisib group and in 25.0% of those in the placebo group. The incidence of grade 3 or 4 neutropenia was 80.2% in the inavolisib group and 78.4% in the placebo group; grade 3 or 4 hyperglycemia, 5.6% and 0%, respectively; grade 3 or 4 stomatitis or mucosal inflammation, 5.6% and 0%; and grade 3 or 4 diarrhea, 3.7% and 0%. No grade 3 or 4 rash was observed. Discontinuation of any trial agent because of adverse events occurred in 6.8% of the patients in the inavolisib group and in 0.6% of those in the placebo group. CONCLUSIONS: In patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer, inavolisib plus palbociclib-fulvestrant led to significantly longer progression-free survival than placebo plus palbociclib-fulvestrant, with a greater incidence of toxic effects. The percentage of patients who discontinued any trial agent because of adverse events was low. Funded by F. Hoffmann-La Roche; INAVO120 ClinicalTrials.gov number, NCT04191499 PMID: 39476340 DOI: 10.1056/NEJMoa2404625 N Engl J Med. 2024 Oct 31;391(17):1644-1647. IF: 96.2 Improving the Outcome of Bad-Acting Hormone Receptor-Positive Breast Cancer. Gradishar WJ. Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago. PMID: 39476346 DOI: 10.1056/NEJMe2411229 （来源：SIBCS）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。

申请上市

2024-10-30

·GlobeNewswire-Health Care

Sandoz reports third-quarter and nine-month 2024 sales

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Strong third-quarter biosimilars growth of 37% in constant currencies from existing portfolio and recent launchesGenerics growth acceleration driven by EuropeThird-quarter net sales¹ of USD 2.6 billion, up 12% in constant currencies (up 11% in USD)Nine-month net sales of USD 7.6 billion, up 9% in constant currencies (up 8% in USD)Net sales growth guidance increased to high-single digit in constant currencies (from mid- to high-single digit) and core EBITDA margin² guidance of around 20% confirmed Basel, October 30, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced net sales for the third quarter and nine months ended September 30, 2024. For the third quarter, net sales were USD 2.6 billion, an increase of 12% in constant currencies compared to the same quarter of the prior year. For the first nine months of 2024, net sales were USD 7.6 billion, an increase of 9% in constant currencies compared to the prior year. Richard Saynor, Chief Executive Officer of Sandoz, said: “We remain focused on execution, meeting key milestones in our biosimilars business and progressing on our journey as a standalone company. In recent months, we received approval for Pyzchiva® and Enzeevu™ in the US, launched Pyzchiva® in Europe and see continued strong uptake of Hyrimoz® in the US. “Net sales growth was achieved across generics and biosimilars, with generics accelerating in the third quarter and strong double-digit biosimilars growth in both the third quarter and first nine months. Additionally, all three regions contributed to this strong performance. We expect momentum in our business to continue, driving margin expansion through favorable product mix and leveraging our cost base. We have further advanced on our path to simplifying our business, including progression on the transformation program we launched earlier this year.” THIRD-QUARTER AND NINE-MONTH SALES Net sales for the third quarter were USD 2.6 billion, up 12% in constant currencies, compared to the third quarter of 2023. Volume contributed 13 percentage points of growth. This was partially offset by price erosion of 1 percentage point. Biosimilars were the key driver of growth in the quarter, while generics experienced solid demand. Growth accelerated in both businesses. Net sales for the first nine months of 2024 were USD 7.6 billion, up 9% in constant currencies compared to prior year. Volume contributed 11 percentage points of growth. This was partially offset by price erosion of 2 percentage points. The growth was primarily driven by biosimilars, with strong demand for both the base business and new in-market organic and acquired products in the US. Net sales by business Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc* USDcc*Generics 1 8541 794 34 5 5585 512 12Biosimilars 741 543 3637 2 0841 592 3132Net sales to third parties 2 5952 337 1112 7 6427 104 89 *constant currencies Generics overviewNet sales for the third quarter were USD 1.9 billion, up 4% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 5.6 billion, up 2% in constant currencies versus prior year. Growth in the Europe region accelerated in the third quarter, mainly driven by recent launches. The momentum continued in the International region, aided by demand for the antifungal agent Mycamine® and favorable pricing dynamics, partly offset by the divestment of the Chinese business. North America declined due to timing of new launches in the US. Biosimilars overviewNet sales for the third quarter were USD 741 million, up 37% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 2.1 billion, up 32% in constant currencies versus prior year. The strong double-digit biosimilars growth reflects the uptake of Hyrimoz® (adalimumab) in the US, the acquisition of Cimerli® (ranibizumab), the continued strong demand for our first-ever biosimilar, Omnitrope® (somatropin), and the launches of Tyruko® (natalizumab) and Pyzchiva® (ustekinumab) in Europe. Net sales by region Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc USDccEurope 1 3621 204 1312 3 9963 751 76North America 598 510 1718 1 7421 514 1515International 635 623 28 1 9041 839 49Net sales to third parties 2 5952 337 1112 7 6427 104 89 Europe overviewNet sales for the third quarter were USD 1.4 billion, up 12% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 4.0 billion, up 6% in constant currencies versus prior year. Strong growth in biosimilars continues, led by demand for Omnitrope® and the contribution from the recent launches of Tyruko® and Pyzchiva®. Generics momentum accelerated in the third quarter, driven by recent launches and the lapping of the strong prior-year comparison in the first half. North America overviewNet sales for the third quarter were USD 598 million, up 18% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.7 billion, up 15% in constant currencies versus prior year. Growth was driven by the ongoing uptake of Hyrimoz® in the US, the acquisition of Cimerli®, share gain of Omnitrope® in the US and the launch of Wyost®/Jubbonti® in Canada. This was partly offset by a decline in generics sales due to the timing of new launches in the US. International overviewNet sales for the third quarter were USD 635 million, up 8% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.9 billion, up 9% in constant currencies versus prior year. This was primarily a result of strong volume growth across both generics and biosimilars, contribution from the acquisition of Mycamine® in the prior year, favorable price dynamics and recent launches, partly offset by the divestment of the Chinese business in the second quarter. GUIDANCE 2024 On the back of strong momentum in its biosimilars business and solid generics demand, the company is increasing its full-year 2024 net sales guidance to high-single digit growth in constant currencies versus prior year (from mid- to high-single digit) and is confirming its core EBITDA margin guidance of around 20%. THIRD-QUARTER STRATEGIC MILESTONES Sandoz continued to execute on its strategy and passed additional milestones in its biosimilars portfolio. On July 1, the company announced the US FDA approval of biosimilar Pyzchiva® for all indications of the reference medicine. The company intends to launch Pyzchiva® in the US among the first wave of ustekinumab biosimilars in February 2025. On July 25, Sandoz announced the launch of biosimilar Pyzchiva® across Europe to treat chronic inflammatory diseases. Pyzchiva® was the first biosimilar to launch in Europe with all reference medicine strengths, including an initiation dose for Crohn’s disease. On August 12, Sandoz received FDA approval for Enzeevu™ to treat neovascular age-related macular degeneration. This approval further enhances the company’s leading US ophthalmology portfolio and increases access for patients. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential litigation or any potential settlements. KEY LINKS Webcast – Live at 9am CET Analyst call presentationAnalyst consensus DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion. CONTACTS Global Media Relations contacts Investor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comSteffen Kurzawa+41 79 800 8501Laurent de Weck+41 79 795 7364Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 5217 SUPPORTING FINANCIAL INFORMATION Quarterly net sales 2024 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDccGenerics 1 86901 1 835-11 1 85434Biosimilars 6232121 7203537 7413637Net sales to third parties 2 49256 2 55579 2 5951112 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDcc Europe 1 32642 1 30823 1 3621312North America 52466 6202223 5981718International 642412 62759 63528Net sales to third parties 2 49256 2 55579 2 5951112 2023 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Generics 1 86826 1 85046 1 79454 1 92066Biosimilars 5161117 5331314 54374 6232926Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Europe 1 2701016 1 2771412 1 204113 1 272104North America 496-5-3 508-4-2 510-4-3 6152020International 618-14 598-38 623312 656414Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 ¹ Net sales in this document refer systematically to net sales to third parties. In the first nine months of 2023, third-party sales excluded sales to our former parent. Post spin-off, sales to our former parent are reported as third-party sales.² An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024 Attachment 241030_Q3 and 9M Sales 2024_ Media Release.pdf

上市批准生物类似药并购

2024-10-25

·ioncology

甘露教授：精准医疗新突破——探索HR+/HER2-晚期乳腺癌患者的未来之路

点击上方蓝字关注我们编者按：激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2-）乳腺癌是乳腺癌中最常见的亚型之一，约占总体乳腺癌的70%。这类患者晚期一线治疗通常依赖于内分泌治疗联合CDK4/6抑制剂，尽管这一方案显著延长了患者的无进展生存期（PFS），但大部分患者最终会出现耐药，导致疾病进展。因此，寻找新的有效治疗策略，以延长患者的生存期并提高生活质量，成为医学界亟待解决的问题。近年来，随着分子生物学研究的深入，PAM（PI3K/AKT/mTOR）信号通路在乳腺癌发生发展中的重要性逐渐凸显，为HR+/HER2-晚期乳腺癌的治疗提供了新的靶点。肿瘤瞭望特邀重庆医科大学附属第一医院甘露教授从HR+/HER2-晚期乳腺癌的治疗现状与挑战、PAM通路的重要性、后CDK4/6抑制剂时代患者治疗新选择等方面，深入探讨HR+/HER2-晚期乳腺癌患者的未来之路。一、HR+/HER2-晚期乳腺癌的治疗现状与挑战乳腺癌是全球女性最常见的恶性肿瘤，2020年中国乳腺癌新发病例41.6万例，死亡病例约11.7万例。在每年新发乳腺癌患者中，约3%～10%的患者在确诊时即有远处转移。早期患者中约有30%可发展为晚期乳腺癌，晚期乳腺癌患者5年生存率仅为20%，中位总生存时间为2～3年[1]。HR+/HER2-乳腺癌约占总体乳腺癌的70%，内分泌治疗是其重要治疗选择[2]。PALOMA、MONARCH、MONALIEESA、DAWAN等一系列研究显示[3-7]，CDK4/6抑制剂（哌柏西利、阿贝西利、瑞波西利和达尔西利）联合内分泌治疗，能显著提高乳腺癌患者的治疗敏感性，延长患者的生存时间。目前CDK4/6抑制剂联合内分泌治疗已成为HR+/HER2-晚期乳腺癌（不合并内脏危象）患者的一线治疗优选方案。 CDK4/6抑制剂联合芳香化酶抑制剂（aromatase inhibitor, AI）的临床研究结果显示（MONALEESA-2研究、PALOMA-2研究、MONARCH-3研究和DAWNA-2），一线使用 CDK4/6抑制剂联合AI后无进展生存期（PFS）约为2年左右（各研究结果存在差异），与AI单药相比，CDK4/6抑制剂联合AI方案均显著降低疾病进展风险近50%[2]。但CDK4/6抑制剂失败后的治疗选择是临床治疗难题，国内外指南无标准治疗方案推荐，且既往多项研究显示，与PAM通路正常的乳腺癌患者相比，存在通路基因改变者肿瘤进展风险更高，DFS及OS更差。二、PAM通路的重要性磷脂酰肌醇3-激酶（phosphoinositide 3-kinase，PI3K）/蛋白激酶B（protein kinase，AKT）/哺乳动物雷帕霉素靶蛋白（mammalian target of rapamycin，mTOR）信号转导通路（简称PAM通路）的过度活化广泛存在于各类癌种，包括乳腺癌、肺癌、头颈部肿瘤、子宫内膜癌、前列腺癌、结直肠癌等，调节肿瘤细胞存活、增殖、分化、凋亡等多种过程，从而对肿瘤的发生、发展起到关键性作用[8-9]。PAM信号通路过度激活是内分泌治疗、化疗、靶向治疗耐药的重要机制之一，不仅使乳腺癌细胞适应雌激素剥夺，通过多药耐药相关蛋白和抗凋亡作用促进化疗耐药，还通过激活PAM信号通路相关蛋白参与CDK4/6抑制剂和抗HER2治疗耐药的发生[10]。尽管HR+/HER2-乳腺癌细胞对CDK4/6抑制剂耐药的机制多种多样，但PAM信号通路表达上调是常见的，在HR+乳腺癌中，约30%～40%的患者存在PAM信号通路被激活的现象[11]，因此，PAM信号通路可能成为逆转耐药性的重要靶点[12]。一项针对中国乳腺癌患者的研究显示，PAM通路突变率高达62.6%，高于欧美人群，其中PIK3CA突变率为45%，这些突变的数量和位置对患者的预后有显著影响[13]。三、CDK4/6抑制剂后的新选择在CDK4/6抑制剂联合内分泌治疗成为HR+/HER2-晚期乳腺癌一线治疗优选方案后，对于治疗进展后出现耐药的患者，医学界一直在探索新的治疗方案。目前，化疗仍是治疗选择之一，但仅能带来中位4～5个月的PFS[14-15]，且接受化疗的患者会出现众多不良反应，严重影响患者生活质量。针对CDK4/6抑制剂跨线治疗的探索由来已久，但目前仅有有限数据支持CDK4/6抑制剂跨线治疗，且只有postMONARCH这一项III期研究显示了PFS获益（6.0个月 vs 5.3个月）[16]。 PAM通路抑制剂的出现，为CDK4/6抑制剂耐药后的患者提供了新的治疗选择。PI3K位于PAM信号通路上游，在该通路中扮演着重要角色[17]。PIK3CA突变可以异常激活PI3K通路，促进肿瘤的增殖、转移和侵袭，因此，PI3K通路为治疗靶点成为了PIK3CA突变乳腺癌患者的重要治疗手段，这为PIK3CA突变型HR+/HER2-晚期乳腺癌患者带来新的治疗希望。多项研究显示了PI3K抑制剂可为PIK3CA突变人群带来更长的PFS获益，2024版NCCN指南推荐对于PIK3CA突变的HR+/HER2-绝经后乳腺癌患者，二线治疗首选PI3K抑制剂联合内分泌治疗（Ⅰ级推荐）。 AKT位于PAM通路的核心位置，其异常激活在乳腺癌的发生与发展中起着重要作用。AKT信号通路的激活可以通过多种机制实现，包括PIK3CA的激活突变、PTEN的失活突变以及上游信号通路的异常激活等。AKT一旦被激活，可磷酸化细胞核和细胞质中的许多靶点并激活多个具有调控细胞增殖功能的下游底物，从而促进肿瘤细胞生长、增殖和血管生成。此外，AKT通过抑制促凋亡基因Bcl-2家族成员BAD和BAX、负向调节FOXO等叉头转录因子等机制促进肿瘤细胞存活并抑制其凋亡[11]。AKT抑制剂相关研究正在大量开展中。 mTOR是PAM信号通路的关键下游效应分子，通过其两个不同的复合体mTORC1和mTORC2，调控多种细胞内过程。mTOR信号通路的异常激活在约30%的癌症中被发现,对肿瘤的发生、发展和转移起着重要的促进作用。mTOR过度激活会增加促癌蛋白的翻译，直接影响细胞生长、迁移和血管新生等过程。mTOR通过影响细胞周期、生长、存活和代谢等多个方面来促进肿瘤进展，在乳腺癌中，mTOR通路的异常在约70%的病例中被发现[18]。我国一项多中心回顾性研究数据显示，在CDK4/6抑制剂哌柏西利治疗进展后的HR/HER2-晚期乳腺癌患者中，应用内分泌治疗联合mTOR抑制剂依维莫司的患者中位PFS获益达5.1个月[19]。四、未来展望随着分子生物学研究的不断深入和精准医疗理念的逐渐普及，针对PAM通路的精准治疗为HR+/HER2-晚期乳腺癌患者带来了新的希望。通过检测PAM通路的突变状态，并结合患者的临床特征，临床医生可以为患者制定更加个体化的治疗方案。这不仅有助于延长患者的生存期，还能提高患者的生活质量。同时，NCCN、CSCO等国内外权威指南也将PI3K抑制剂、AKT抑制剂和mTOR抑制剂依维莫司纳入到了HR+/HER2-晚期乳腺癌患者的治疗药物推荐之中，但基于药物可及性及或内获批相关原因，目前在CSCO指南中对HR+晚期乳腺癌TAM治疗失败、非甾体类AI治疗失败及甾体类AI治疗失败的患者均II级推荐依维莫司联合内分泌治疗，而对于CDK4/6抑制剂治疗失败的患者，目前暂无I级推荐，在III级推荐中提及AKT抑制剂+内分泌治疗。 △2024版CSCO BC指南HR+晚期乳腺癌的解救内分泌治疗相关推荐* *指南内容涉及AZ未获批产品/适应症，阿斯利康不推荐任何未获批药品/适应症的使用。未来，随着更多针对PAM信号通路抑制剂的研发和临床应用，HR+/HER2-晚期乳腺癌的治疗将更加精准和有效。同时，也期待更多的基础研究能够揭示PAM通路在乳腺癌发生与发展中的具体机制，为新药的研发提供理论依据，为HR+/HER2-晚期乳腺癌患者带来更多新的治疗希望。甘露教授重庆医科大学附属第一医院中国抗癌协会乳腺癌专业委员会常委中国抗癌协会肿瘤临床研究管理学专委会常委中国抗癌协会肿瘤科普防治专业委员会委员中国抗癌协会肿瘤临床化疗专业委员会委员重庆市抗癌协会肿瘤心理学专业委员会副主任委员重庆市医学会乳腺病分会常委重庆市肿瘤医疗质量控制中心乳腺癌诊疗专家组成员审批编号CN-145761 过期日期 2025-10-18 *本材料由阿斯利康提供，仅供医疗卫生专业人士参考参考文献上下滑动查看更多内容 [1]、国家肿瘤质控中心乳腺癌专家委员会, 中国抗癌协会乳腺癌专业委员会, 中国抗癌协会肿瘤药物临床研究专业委员会. 中国晚期乳腺癌规范诊疗指南(2022版)[J]. 中华肿瘤杂志, 2022, 44(12):1262-1287.DOI: 10.3760/cma.j.cn112152-20221007-00680. [2]、国家肿瘤质控中心乳腺癌专家委员会, 中国抗癌协会肿瘤药物临床研究专业委员会. CDK4/6抑制剂治疗激素受体阳性人表皮生长因子受体2阴性乳腺癌临床应用专家共识(2023版)[J]. 中华肿瘤杂志, 2023, 45(12):1003-1017.lDOI: 10.3760/cma.j.cn112152-20230428-00188. [3]、Cristofanilli, Massimo et al. “Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial.” The Lancet. Oncology vol. 17,4 (2016): 425-439. doi:10.1016/S1470-2045(15)00613-0 [4]、Goetz, Matthew P et al. “MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer.” Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 35,32 (2017): 3638-3646. doi:10.1200/JCO.2017.75.6155 [5]、Slamon, Dennis J et al. “Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3.” Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 36,24 (2018): 2465-2472. doi:10.1200/JCO.2018.78.9909 [6]、Tripathy, Debu et al. “Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial.” The Lancet. Oncology vol. 19,7 (2018): 904-915. doi:10.1016/S1470-2045(18)30292-4 [7]、Xu B, Zhang Q, Zhang P, et al. Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial. Nat Med. 2021;27(11):1904-1909. doi:10.1038/s41591-021-01562-9 [8]、Dey, Nandini et al. “PI3K-AKT-mTOR inhibitors in breast cancers: From tumor cell signaling to clinical trials.” Pharmacology & therapeutics vol. 175 (2017): 91-106. doi:10.1016/j.pharmthera.2017.02.037 [9]、Castaneda, Carlos A et al. “The phosphatidyl inositol 3-kinase/AKT signaling pathway in breast cancer.” Cancer metastasis reviews vol. 29,4 (2010): 751-9. doi:10.1007/s10555-010-9261-0 [10]、中国抗癌协会肿瘤药物临床研究专业委员会, 国家肿瘤质控中心乳腺癌专家委员会, 中国抗癌协会肿瘤病理专业委员会, 等. PI3K/AKT/mTOR信号通路抑制剂治疗乳腺癌临床应用专家共识[J]. 中华肿瘤杂志, 2022, 44(7):673-692.DOI: 10.3760/cma.j.cn112152-20220412-00251. [11]、姚荟斌，赵伟鹏，史业辉. CDK4/6抑制剂治疗晚期乳腺癌的研究进展. [J].《天津医科大学学报》2021，27（5）：549 [12]、O'Brien, Neil A et al. “Targeting activated PI3K/mTOR signaling overcomes acquired resistance to CDK4/6-based therapies in preclinical models of hormone receptor-positive breast cancer.” Breast cancer research : BCR vol. 22,1 89. 14 Aug. 2020, doi:10.1186/s13058-020-01320-8 [13]、Xiao, Weikai et al. “Mutational Landscape of PI3K-AKT-mTOR Pathway in Breast Cancer: Implications for Targeted Therapeutics.” Journal of Cancer vol. 12,14 4408-4417. 27 May. 2021, doi:10.7150/jca.52993 [14]、Kaufman, Peter A et al. “Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane.” Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 33,6 (2015): 594-601. doi:10.1200/JCO.2013.52.4892 [15]、Li, Yi et al. “A multicenter analysis of treatment patterns and clinical outcomes of subsequent therapies after progression on palbociclib in HR+/HER2- metastatic breast cancer.” Therapeutic advances in medical oncology vol. 13 17588359211022890. 11 Jun. 2021, doi:10.1177/17588359211022890 [16]、Kevin Kalinsky, et al. Abemaciclib plus fulvestrant vs fulvestrant alone for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy: Primary outcome of the phase 3 postMONARCH trial. 2024 ASCO abstract LBA1001. [17]、Vanhaesebroeck, Bart et al. “PI3K signalling: the path to discovery and understanding.” Nature reviews. Molecular cell biology vol. 13,3 195-203. 23 Feb. 2012, doi:10.1038/nrm3290 [18]、Marafie, Sulaiman K et al. “mTOR: Its Critical Role in Metabolic Diseases, Cancer, and the Aging Process.” International journal of molecular sciences vol. 25,11 6141. 2 Jun. 2024, doi:10.3390/ijms25116141 [19]、Mo H, et al. Real-World Outcomes of Everolimus and Exemestane for the Treatment of Metastatic Hormone Receptor-Positive Breast Cancer in Patients Previously Treated With CDK4/6 Inhibitors. Clin Breast Cancer. 2022 Feb;22(2):143-148. （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

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
肝移植排斥反应	美国	Novartis Pharmaceuticals Corp.	2013-02-15
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

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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临床结果

适应症

分期

评价

查看全部结果

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	觸襯窪廠簾鏇製製鹹衊(鏇構窪顧製蓋獵鏇憲壓) = 窪膚齋鹹鏇積網醖願積築鹽鬱選壓積鹽糧鹽蓋 (憲鏇願範齋憲鬱鬱選選, 鏇顧夢繭積鑰壓壓鹽淵 ~ 網憲夢膚構鏇觸膚艱積) 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	觸獵獵鹽簾顧積糧製餘(鑰鬱遞簾淵鏇壓製顧積) = 鹹構壓廠製膚顧觸範壓鹽憲糧糧艱醖糧鹹觸構 (蓋獵簾糧網鏇醖蓋淵願, 糧積艱繭夢鏇齋範淵艱 ~ 鏇壓鹹願繭蓋憲艱網夢) 更多	-	2024-09-25
ESMO2024	临床1期	晚期神经内分泌肿瘤	92	Everolimus 6.1 - 10mg	製齋憲壓網餘鬱窪襯夢(鹹繭襯餘襯網製範簾廠) = 糧壓糧鹹糧簾積窪鬱醖齋鏇獵製構壓餘襯齋簾 (繭構餘顧範構鏇廠鹹製, 3.7 ~ 32) 更多	积极	2024-09-16
				Everolimus 6mg or less	製齋憲壓網餘鬱窪襯夢(鹹繭襯餘襯網製範簾廠) = 襯艱鹹鑰範夢夢蓋窪築齋鏇獵製構壓餘襯齋簾 (繭構餘顧範構鏇廠鹹製, 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)	繭艱鑰膚夢衊淵顧觸構(衊窪網鏇齋鑰糧憲構衊) = 齋願遞廠獵鏇膚遞蓋餘繭膚製顧鑰遞壓膚範夢 (鬱窪齋選構鬱壓鹽糧膚 ) 更多	不佳	2024-09-16
				Endocrine therapy alone (ETa)	繭艱鑰膚夢衊淵顧觸構(衊窪網鏇齋鑰糧憲構衊) = 蓋鹹艱構鹽廠顧選獵鹽繭膚製顧鑰遞壓膚範夢 (鬱窪齋選構鬱壓鹽糧膚 ) 更多
NCT02338609 (EXIST-LT, CTgov)	临床4期	-	15	Everolimus	艱鬱遞壓簾糧築壓廠鏇(選構網蓋壓襯淵願鏇積) = 膚觸蓋糧壓選窪遞衊餘顧衊網齋夢獵獵築鹽築 (鹹鏇繭鏇選夢衊蓋蓋觸, 醖壓齋糧願鏇觸廠遞廠 ~ 獵簾製蓋餘鹽鑰衊製選) 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 (papillary RCC)	膚糧鑰範網醖餘壓選膚(廠觸襯膚顧鏇簾糧廠製) = 積構糧簾網鑰壓鹹鏇鹽淵艱鹹鹹餘壓簾製襯觸 (膚膚鹽鏇醖網壓繭壓鹽 ) 更多	不佳	2024-08-01
				Placebo (papillary RCC)	膚糧鑰範網醖餘壓選膚(廠觸襯膚顧鏇簾糧廠製) = 鹹鹽糧築積夢鹽觸網窪淵艱鹹鹹餘壓簾製襯觸 (膚膚鹽鏇醖網壓繭壓鹽 ) 更多
NCT03154281 (CTgov)	临床1期	卵巢癌 \| 乳腺癌	14	niraparib+Everolimus (Cohort 1)	繭鹹淵築選鏇淵願選觸(積簾顧艱繭夢簾艱願襯) = 醖鬱鹽網壓蓋繭艱糧鹽觸衊蓋獵艱願蓋鬱糧範 (鬱憲廠鹹襯獵範觸鬱製, 顧簾繭餘壓範窪構鹹憲 ~ 願窪獵廠鏇鹽範簾醖憲) 更多	-	2024-08-01
				niraparib+Everolimus (Cohort 2)	繭鹹淵築選鏇淵願選觸(積簾顧艱繭夢簾艱願襯) = 廠淵製夢壓顧齋鏇積鏇觸衊蓋獵艱願蓋鬱糧範 (鬱憲廠鹹襯獵範觸鬱製, 繭網淵壓鏇簾醖艱淵膚 ~ 鹽鑰壓憲憲窪獵鹽鏇構) 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)	鹽餘艱憲製壓淵鹽窪淵(願願糧窪選夢壓獵壓積) = 窪夢壓範糧鹽糧觸淵衊願製觸獵繭範網醖繭構 (廠製鏇鬱餘獵獵鹹鹹觸, 5.5 ~ 9.0)	积极	2024-06-21
				Placebo (PBO) + Exemestane (EXE)	鹽餘艱憲製壓淵鹽窪淵(願願糧窪選夢壓獵壓積) = 壓鬱廠積範齋淵網膚顧願製觸獵繭範網醖繭構 (廠製鏇鬱餘獵獵鹹鹹觸, 1.9 ~ 3.6)
NCT04802759 (ASCO2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Negative	15	Giredestrant (G) + Everolimus (EVERO)	鹹範襯選糧蓋製膚艱鑰(鹽積簾廠夢遞齋壓鬱餘) = 築衊選網觸鬱鏇顧醖繭願範糧簾鬱獵艱遞鹹襯 (積築觸淵夢鹹蓋顧艱壓 ) 更多	积极	2024-05-24
ASCO2024 人工标引	N/A	肾细胞癌一线	99	IO + targeted therapy doublets (e.g., lenvatinib plus pembrolizumab)	齋構壓憲蓋齋壓鹽網觸(繭範襯窪鏇網廠鏇鏇淵) = 獵齋鹽顧鏇艱網觸鏇鹽鏇積鹽製繭鬱鏇構糧餘 (選糧餘糧醖築構膚糧鏇, 17 ~ 56) 更多	积极	2024-05-24
				Pure IO monotherapy and doublets (e.g., ipilimumab plus nivolumab)	齋構壓憲蓋齋壓鹽網觸(繭範襯窪鏇網廠鏇鏇淵) = 鑰糧憲餘鑰齋憲夢製鑰鏇積鹽製繭鬱鏇構糧餘 (選糧餘糧醖築構膚糧鏇 ) 更多