A Prospective, Multicenter, Open-Label, Randomized, Comparative, Phase 4 Trial to Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea

The purpose of this study is to evaluate the efficacy and safety of lower dose calcineurin inhibitors (CNI) in combination with Everolimus in Korean heart transplant recipients.

开始日期2025-08-14

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

NCT06972758

/ Not yet recruiting临床2期IIT

A Phase II Study of EVEerolimus as Adjuvant Therapy After Surgical Resection for Hepatocellular cArcinoma at High Risk of RecurreNCE [SEVERANCE Trial]

"Hepatic resection is the primary curative treatment for patients with a single, liver-confined hepatocellular carcinoma (HCC) without cirrhosis and is also considered in patients with cirrhosis if residual liver function is sufficient. Despite curative resection, HCC has a high recurrence rate, with 5-year recurrence reported in approximately 50-70% of patients. Notably, in cases with microvascular invasion, the 2-year recurrence rate reaches 55-75%. As early recurrence strongly impacts overall survival, there is a critical need for effective adjuvant therapies; however, no adjuvant treatment has yet been established or officially recommended.
Everolimus is an mTOR inhibitor that has both immunosuppressive and antitumor effects. Approximately half of HCC cases exhibit activation of the mTOR pathway. In liver transplant recipients, everolimus is used as an immunosuppressive agent and has been associated with reduced recurrence and improved survival, particularly in patients with elevated tumor markers prior to transplantation. Preclinical studies at our institution have shown that mTOR inhibitors may be more effective in preventing tumor development than in treating established tumors, suggesting a potential benefit for everolimus in an adjuvant setting.
To date, no clinical trials have assessed the efficacy of everolimus as adjuvant therapy after curative hepatic resection, especially in high-risk HCC characterized by microvascular invasion or satellite nodules. This study aims to evaluate the efficacy and safety of everolimus (Certirobell®) as adjuvant therapy in high-risk HCC patients following curative resection.
This is a single-center, single-arm Phase II trial conducted at Severance Hospital. A total of 60 patients with pathologically confirmed HCC who underwent R0 resection and exhibit high-risk features for recurrence will be enrolled. Everolimus will be administered orally, twice daily for 92 weeks, starting 4 to 6 weeks postoperatively. Initial dosing will be 1.0 mg twice daily, adjusted to 0.75 mg for patients with a Child-Pugh score of 6. Dosage adjustments will be made based on everolimus trough levels, targeting 3-8 ng/mL. Treatment will be discontinued upon confirmation of HCC recurrence.
The primary endpoint is 2-year recurrence-free survival (RFS). Secondary endpoints include 1-year RFS, 2-year recurrence rate, overall survival (OS), time to recurrence, and safety outcomes.
An interim analysis will be conducted after the first 30 patients have been enrolled and followed for 2 years. Based on the interim assessment of efficacy or futility, the study will either be terminated early or proceed with enrollment of an additional 30 patients.

开始日期2025-07-01

申办/合作机构

Yonsei University

NCT06832189

/ Not yet recruiting临床1期IIT

Everolimus and Epoetin for Sustained Liver Transplant Tolerance (EVEREST)(ITN101ST)

This is an open label, single-arm, multicenter phase 1b study of stable adult liver transplant recipients on a tacrolimus (TAC)-based immunosuppression (IS) regimen who will transition from TAC to Everolimus (EVR), receive five doses of EPO and concurrently initiate phased withdrawal from EVR.
The primary objective is to test the safety of administering Everolimus (EVR) and epoetin alfa (EPO) to induce operational tolerance in stable adult liver transplant recipients

开始日期2025-06-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

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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8,619

项与依维莫司相关的文献（医药）

2025-12-01·IMMUNOLOGIC RESEARCH

RAD001-mediated mTOR targeting in human monocyte-derived dendritic cells shifts them toward an immunogenic phenotype

Article

作者: Masoumi, Javad ; Hatami-Sadr, Amirhossein ; Baradaran, Behzad ; Hemmat, Nima ; Alipour, Shiva ; Alizadeh, Nazila ; Vaysi, Edris ; Naseri, Bahar

Dendritic cells (DCs) are essential for promoting T lymphocyte responses since they are specialist antigen-presenting cells. In order to maintain tolerance or initiate immune responses, DCs must be activated in a balanced and regulated manner via diverse signaling pathways. By using a variety of pharmacological components, we can interfere with their different signaling pathways such as the mammalian target of rapamycin (mTOR) to appropriately modulate DC activity. In the current study, we administered RAD001 to DCs to examine the impact of mTOR inhibition on both the maturation stage and the expression of inflammatory and anti-inflammatory molecules in DCs. Pure monocytes were cultivated and stimulated with GM-CSF and IL-4 to generate immature DCs, which were then treated with RAD001. The phenotype of the DCs was determined by labeling surface markers and analyzing them using flow cytometry. Afterward, real-time PCR was carried out to evaluate the expression of inflammatory and anti-inflammatory genes. The administration of RAD001 to DCs led to a significant upregulation in the gene expression of inflammatory molecules such as IL-12, IL-1β, tumor necrosis factor (TNF)-α, and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-KB). Conversely, RAD001 treatment resulted in a decrease in the gene expression of anti-inflammatory factors IL-10 and indoleamine 2,3-dioxygenase (IDO). However, the expression of differentiation and antigen presentation-related markers CD11c and human leukocyte antigens (HLA)-DR in RAD001-treated DCs was lower and higher compared to the control group that did not receive the treatment, respectively. Taken together, our findings indicated that RAD001 treatment of DCs can be a promising therapeutic approach for the generation of immunogenic DCs in order to barricade tumor growth. However, there is a need for further investigation to evaluate the impacts of mTOR inhibition by RAD001 in DCs on cellular immune responses in vitro and in vivo.

2025-08-01·CELLULAR SIGNALLING

MTDH∆7-mediated mTOR activation drives doxorubicin resistance in triple-negative breast cancer: Relevance of mTORC1 inhibition on chemosensitization

Article

作者: Kotamraju, Srigiridhar ; Neeli, Praveen Kumar ; Pulipaka, Sriravali ; Kumari, Sunita ; Chandra, Yogesh ; Sahoo, Shashikanta ; Annamaneni, Sandhya ; Kuncha, Madhusudana

Cancer chemoresistance poses a major hurdle in the management of several cancers, including breast cancer. Herein, we identified MTDH∆7, a splice variant of an oncogene, metadherin (MTDH), promotes doxorubicin (Dox)-induced chemoresistance in triple-negative breast cancer (TNBC) cells. Increased MTDH∆7 levels were positively correlated with the elevated levels of ABC transporters like ABCB1, ABCC1, and ABCG2, which in turn caused reduced intracellular Dox accumulation. Interestingly, everolimus, an mTORC1 inhibitor, potentiated Dox-induced cytotoxicity by inhibiting MTDH∆7-mediated increase in the aforementioned ABC transporters. Moreover, MTDH∆7 overexpression increased mTORC1 levels, possibly due to MTDH∆7-induced accentuation of mitochondrial respiration, ATP production, and AMPK inactivation. Mechanistically, enhanced phosphorylation of mTORC1 caused NF-κB-dependent activation of cAMP-regulatory element-binding protein (CREB). Further, activated CREB led to an increase in the levels of ABCB1, ABCC1, and ABCG2. Inhibition of either mTORC1 by everolimus or NF-κB by BAY-11-7082 or CREB by H89 reversed these effects and mitigated MTDH∆7-mediated Dox efflux. Accordingly, while Dox administration alone marginally caused tumor regression in SCID mice bearing LV.MTDH∆7-MDA-MB-231 cells, administration of everolimus greatly sensitized these mice to Dox-induced tumor regression. In agreement, intriguingly, a positive correlation was observed between elevated MTDH∆7, mTORC1 activation, and ABC transporters level in human breast cancer patient cohort tumor samples. Collectively, MTDH∆7, by promoting mTOR signaling causes breast cancer chemoresistance, and that targeting MTDH∆7-mTOR signaling axis effectively enhances chemosensitization.

2025-07-01·PEDIATRIC BLOOD & CANCER

A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric and Young Adult Solid Tumors

Article

作者: Kim, AeRang ; Krystal, Julie I. ; Macy, Margaret E. ; Glade Bender, Julia L. ; Balis, Frank M. ; Aluri, Jagadeesh ; Vo, Kieuhoa T. ; He, Cixin S. ; Okpara, Chinyere E. ; Friedman, Gregory K. ; Dela Cruz, Filemon S. ; DuBois, Steven G. ; Laetsch, Theodore W. ; Mody, Rajen ; Croop, James M. ; Watt, Tanya ; Morgenstern, Daniel A. ; O'Hara, Karen ; Fox, Elizabeth ; Weigel, Brenda J. ; Pressey, Joseph G.

ABSTRACT:

Introduction:

Developing targeted therapies with manageable toxicities remains a high priority for pediatric cancer. We sought to determine the recommended Phase 2 dose (RP2D) and evaluate the antitumor activity of lenvatinib+everolimus in children/young adults with select recurrent/refractory solid tumors.

Methods:

Patients 2–21 years old were eligible. Phase 1 used a rolling‐six design. Phase 2 was limited to patients with Ewing sarcoma (EWS), rhabdomyosarcoma (RMS), or high‐grade glioma (HGG), and ≤2 prior VEGF/VEGFR‐targeted therapies. Primary endpoints included the determination of maximum tolerated dose (MTD), RP2D, safety/toxicity (Phase 1), and objective response rate (ORR) per RECIST version 1.1 (RANO for HGG) at Week 16 (Phase 2).

Results:

In Phase 1, 23 patients received lenvatinib 11 mg/m2 (dose level [DL] 1, n = 18) or 8 mg/m2 (DL −1, n = 5) combined with everolimus 3 mg/m2 orally once daily. DL1 was declared the MTD/RP2D given dose‐limiting toxicities (proteinuria [n = 1]; hypertriglyceridemia and hypercholesterolemia [n = 1]) observed in two of 12 patients treated at DL1. In Phase 2, 41 patients (EWS, n = 10; RMS, n = 20; HGG, n = 11) were treated with the RP2D. Two patients with RMS experienced partial response by Week 16. No other objective responses were observed. Two patients with EWS experienced prolonged disease control (≥23 weeks). No new safety signals were identified. The safety profile was similar to those of treated adults with renal cell carcinoma.

Conclusion:

Lenvatinib+everolimus has a manageable safety profile in this pediatric population. Despite unmet efficacy endpoints, the antitumor activity observed in RMS and EWS may warrant further study in select pediatric solid tumors.

ClinicalTrials.gov number:

NCT03245151

646

项与依维莫司相关的新闻（医药）

2025-05-23

·PRNewswire

Eisai to Present E7386, Co-created by PRISM BioLab and Eisai, at the ASCO (American Society of Clinical Oncology) Annual Meeting

Abstract Released for E7386, Co-Developed Through Collaborative Research Between Eisai and PRISM TOKYO, May 22, 2025 /PRNewswire/ -- PRISM BioLab, Co. Ltd. ("PRISM"), a leading discovery and development biotechnology company designing small molecule inhibitors of protein-protein interaction (PPI) targets, today announced that the analysis of a combination study of E7386(*1), created through collaboration research with Eisai Co., Ltd. ("Eisai"), and Lenvatinib mesylate ("lenvatinib") (*2) will be presented by Eisai at the American Society of Clinical Oncology (ASCO) Congress 2025, held in Chicago, USA from May 30 to June 3, 2025. The abstract of the study has been released today. To determine the optimal dose of E7386 in combination with Lenvatinib in the open-label Phase Ib study (NCT04008797(*3)), expansion cohort of advanced endometrial cancer patients progressed following platinum-based chemotherapy and anti-PD-(L)1 immunotherapy have been implemented by Eisai and the enrollment of 30 patients was completed. By data cutoff (Oct 22, 2024), with 9 patients remaining on treatment, 30% (9 patients) showed the confirmed response (decrease of tumor size > 30%) for an overall response rate of 30.0%. Furthermore, among patients without prior Lenvatinib treatment, the overall response rate was 42.9%. Completing the enrollment of dose expansion cohort (n=30), the results confirmed promising preliminary antitumor activity of E7386 + Lenvatinib with a manageable safety profile. For the subsequent dose-optimization part for E7386 + LEN in advanced endometrial cancer, enrollment of patients had been initiated (NCT04008797). (*1) E7386 E7386 is an orally available small molecule CBP/ β-catenin inhibitor that inhibits protein-protein interactions between the transcription factor CBP and β-catenin, and regulates the Wnt signaling. E7386 achieved clinical POC (Proof of concept) in October 2021 and following clinical studies are ongoing including phase I for solid tumors as monotherapy, Phase Ib for solid tumors in combination with tyrosine kinase inhibitor Lenvatinib, Phase Ib/II for solid tumors in combination with pembrolizumab, the anti-PD-1 antibody from Merck & Co., Inc., Rahway, NJ, USA. (*2) Lenvatinib Lenvatinib is a multi-kinase inhibitor, discovered by Eisai and being co-developed and co-commercialized under a collaboration agreement with Merck & Co., Inc., Rahway, NJ, USA, which inhibits vascular endothelial growth factor receptors (VEGFRs),VEGFR1, VEGR2, VEGFR3 and fibroblast growth factor receptors (FGFRs), FGFR1, FGFR2, FGFR3, FGFR4, and other receptor tyrosine kinases, PDGFR-alpha, KIT, RET. Lenvatinib have been approved for thyroid cancer, hepatocellular carcinoma, thymic caner and renal cell carcinoma (in combination with Everolimus or pembrolizumab, the anti-PD-1 antibody from Merck & Co., Inc., Rahway, NJ, USA.). Lenvatinib is also approved for endometrium cancer in combination with pembrolizumab (*3) NCT04008797 NCT04008797 is an open-label Phase Ib study of E7386 in combination with other anticancer drug, Lenvatinib for the patients with solid tumors. The study has been implemented by Eisai in Japan, Korea, Taiwan region, US, and France determine the safety and the recommended phase 2 dose (RP2D) and also to see the pharmacokinetics and efficacy of E7386 + Lenvatinib. Enrolment of each cohort of hepatic, colon, endometrial cancers are ongoing. About PRISM BioLab PRISM BioLab is a discovery and development biotechnology company utilizing proprietary PepMetics® technology to discover orally available small molecule inhibitors of protein-protein interaction (PPI) targets and transform lives of patients suffering from cancer, autoimmune, fibrosis and other diseases. PepMetics® are a unique class of small molecules that mimic three-dimensional structures of alpha-helix and beta-turn, the peptide structures commonly found in intracellular PPI interphases and receptor-ligand interactions. By combining proprietary chemistry, know-how around PPI targets and AI-supported design, PepMetics® technology can deliver inhibitors of challenging PPI targets. The technology holds promise to expand the field of drug discovery by turning previously undruggable PPIs into targets readily druggable with small molecules and by generating oral small molecule alternatives for injectable biologics. PRISM BioLab is collaborating on new PPI targets with global and Japanese pharmaceutical companies. PepMetics® targeting CBP/beta-catenin PPIs licensed to Eisai Co., Ltd. and Ohara Pharmaceuticals Co., Ltd. are in clinical development for cancer and liver disease, respectively. SOURCE PRISM BioLab Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床结果ASCO会议上市批准免疫疗法

2025-05-22

·EINPresswire

Menarini Group Presents Updated Data Underscoring the Combinability of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2025 Annual Meeting

Preliminary efficacy analysis from the elacestrant plus everolimus and ribociclib cohorts of the ELEVATE study, along with updated safety data from additional cohorts of elacestrant plus targeted therapy combination arms, will be presented. These data highlight elacestrant’s potential role as an endocrine therapy backbone in combination with various targeted agents for patients with ER+/HER2- mBC. The robust elacestrant clinical development program across wide-ranging studies further solidifies its potential in monotherapy and combination settings, in mBC and in early breast cancer. FLORENCE, Italy and NEW YORK, May 22, 2025 (GLOBE NEWSWIRE) -- The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, will present updated preliminary efficacy and safety results from the Phase 1b/2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). The ELEVATE study was designed to evaluate the safety and efficacy of oral-oral combination treatment options to overcome different resistance mechanisms observed in ER+/HER2- mBC and improve patient outcomes. Additionally, various other trial-in-progress updates will be presented, investigating elacestrant’s potential to become an endocrine therapy (ET) backbone across the spectrum of breast cancer. These data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The ELEVATE study is comprised of six treatment regimens evaluating elacestrant in combination with CDK4/6 inhibitors (palbociclib, abemaciclib and ribociclib) and with inhibitors of the PI3K/AKT/mTOR pathway (everolimus, alpelisib and capivasertib). ELEVATE results reported at ASCO 2025 (abstract 1070/49) include updated efficacy data which demonstrate favorable preliminary progression-free survival (PFS) from the elacestrant plus ribociclib and the elacestrant plus everolimus cohorts. A recommended phase 2 dose (RP2D) was determined to be elacestrant 345 mg plus ribociclib 400 mg. The RP2D of elacestrant 345 mg plus everolimus 7.5 mg was previously reported. “It is encouraging to see the positive preliminary efficacy and safety results when everolimus and ribocilib, respectively, are combined with elacestrant. These findings are consistent with the promising elacestrant plus abemaciclib cohort data from the same study that was presented last December, which also demonstrated favorable preliminary efficacy and safety in this setting,” said Hope S. Rugo, MD, Director, Women's Cancers Program and Division Chief, Breast Medical Oncology, City of Hope Comprehensive Cancer Center. “As the progression-free survival data and safety data continue to mature across the various cohorts of the ELEVATE study, we are encouraged by elacestrant’s potential to become an endocrine therapy backbone in combination regimens for the treatment of metastatic breast cancer.” Additional data reported separately (abstract 1079/58) provided updated Phase 1b/2 safety results from four cohorts of the ELEVATE study, including elacestrant plus ribociclib, everolimus, alpelisib, and capivasertib. These updated preliminary results show that the combinations are consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy. “These data continue to underscore the potential value of elacestrant as a combination partner in the ER+/HER2- metastatic breast cancer treatment landscape,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are also exploring the potential of elacestrant in other patient populations, including our currently enrolling ELEGANT study, which is designed to assess its potential benefit in early breast cancer patients with high risk of recurrence.” In addition, the company will be presenting other data at the ASCO Annual Meeting. See below for a complete list of Menarini Stemline abstracts. Menarini Stemline Abstracts: Presentation Title: Elacestrant (Ela) combinations with ribociclib (Ribo) and everolimus (Eve) in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. Abstract Number: 1070 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 49 Presenting Author: Hope S. Rugo Presentation Title: Elacestrant combinations in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Safety update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. Abstract Number: 1079 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 58 Presenting Author: Nancy Chan Presentation Title: ADELA: a double-blind, placebo-controlled, randomized phase 3 trial of Elacestrant (ELA) + everolimus (EVE) versus ELA + placebo (PBO) in ER+/HER2- advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) + CDK4/6i. Abstract Number: TPS1129 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 103b Presenting Author: Antonio Llombart-Cussac Presentation Title: ELCIN: Elacestrant in women and men with CDK4/6 Inhibitor (CDK4/6i)-naïve estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC): an open-label multicenter phase 2 study. Abstract Number: TPS1127 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 102b Presenting Author: Virginia G. Kaklamani Presentation Title: ELEGANT: Elacestrant versus standard endocrine therapy (ET) in women and men with node-positive, estrogen Receptor-positive (ER+), HER2-negative (HER2-), early breast cancer (eBC) with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study. Abstract Number: TPS619 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 210a Presenting Author: Aditya Bardia Presentation Title: EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA) Abstract Number: TPS620 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 210b Presenting Author: Michail Ignatiadis About The Elacestrant Clinical Development Program Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. ELEVATE ( NCT05563220 ) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA ( NCT05386108 ) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN ( NCT05596409 ) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. ADELA ( NCT06382948 ) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease. About ORSERDU (elacestrant) U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Full prescribing information for the U.S. can be found at www.orserdu.com . Important Safety Information Warning and Precautions Dyslipidemia : Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU. Embryo-Fetal Toxicity : Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the final dose. Adverse Reactions Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each). The most common adverse reactions ( > 10%) , including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite(15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%). Drug interactions Concomitant use with CYP3A4 Inducers and/or inhibitors : Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU. Use in specific populations Lactation : Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose. Hepatic Impairment : Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B). The safety and effectiveness of ORSERDU in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit www.menarini.com . About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers. Media Contacts The Menarini Group Valeria Speroni Cardi Email: pressoffice@menarini.com Stemline Therapeutics, Inc. Cheya Pope Email: media@menarinistemline.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果ASCO会议临床2期临床3期

2025-05-21

·正大天晴药业集团

关注全球女性健康正大天晴艾立布林完成首批出口美国发货

5月19日，正大天晴乳腺癌领域中美双批产品甲磺酸艾立布林注射液在海州厂区完成首批出口美国发货，为公司进一步拓展海外市场再添新利器。随着产品出口，将为当地乳腺癌患者的临床治疗带来更多选择。正大天晴副总裁夏春光在发货仪式上表示，正大天晴甲磺酸艾立布林成功突破原料药合成工艺中的多项技术瓶颈，在中国获批3个月后，就凭借高精尖合成工艺和高标准生产工艺获得国际认可，在美国获批，进一步强化公司肿瘤创新与出海的战略布局。甲磺酸艾立布林注射液适用于治疗既往接受过至少两种化疗方案（包括蒽环类和紫杉烷类药物）治疗的局部晚期或转移性乳腺癌患者。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、帕妥珠单抗注射液、哌柏西利胶囊等产品，覆盖HER2阳性、HER2低表达、HR阳性以及三阴性乳腺癌等全分子分型，以期为患者提供更加精准的治疗方案。国际化为正大天晴的核心战略之一，目前，公司已有10多个产品出口到60多个国家或地区。艾立布林美国获批后，生产系统各部门高效完成药品生产、入库及放行工作，较短时间内即完成出口发货。本次甲磺酸艾立布林注射液的发货，将为当地乳腺癌患者提供更多元的治疗选择。同时，这也是正大天晴推进医药新质生产力在高端化药领域的实践落地，是以“中国智造”造福全球患者。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。● 谢承润参与港区省级政协委员联谊会接待吉林省委书记黄强一行来访活动冀加深双方研发临床合作造福患者● 中国生物制药董事会主席谢其润出席中金峰会：大药企如何在医药创新浪潮中乘势而上● 强强联合！中国生物制药携手京东健康深化战略合作两款重磅新品首发● 传承、青春、创新|中国生物制药《正青春》第二季第一集今日上线

上市批准

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

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临床结果

适应症

分期

评价

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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


ESMO_ELCC2025	临床2期	胸腺上皮肿瘤二线	37	Everolimus	鹹願積願積鑰構醖鏇鬱(鏇網構膚淵製觸簾齋積) = occurring in 8 (21.6%) pts 觸願鑰窪顧醖窪齋鬱觸 (糧製網壓衊網膚鏇餘壓 ) 更多	积极	2025-03-26
NCT03032406 (CTgov)	临床2期	复发性乳腺癌	53	Hydroxychloroquine (HCQ Alone (Arm A))	壓製繭築築範蓋餘糧鬱 = 廠淵願膚獵積鑰廠鹽獵餘獵淵簾夢餘襯醖憲廠 (顧簾齋醖糧壓淵遞壓觸, 遞衊顧壓廠觸鑰衊鹽廠 ~ 選遞繭獵衊製選襯鏇蓋) 更多	-	2025-03-05
				Everolimus (EVE Alone (Arm B))	壓製繭築築範蓋餘糧鬱 = 衊網築廠範膚觸顧積糧餘獵淵簾夢餘襯醖憲廠 (顧簾齋醖糧壓淵遞壓觸, 繭淵選鹹鹽繭膚醖膚膚 ~ 簾糧鑰艱醖襯願簾壓鑰) 更多
NCT02991807 (CTgov)	临床1/2期	PTEN 错构瘤综合征	46	RAD001 (RAD001)	獵願廠淵廠願網憲壓網 = 積鹽廠網糧衊觸鏇淵築遞膚築簾壓積襯顧壓觸 (醖蓋蓋遞膚網築網襯鹹, 觸窪淵糧淵構艱壓製艱 ~ 築願構觸鏇願鑰觸願淵) 更多	-	2025-02-17
				Placebo (Placebo)	獵願廠淵廠願網憲壓網 = 範網獵範網鬱範觸範夢遞膚築簾壓積襯顧壓觸 (醖蓋蓋遞膚網築網襯鹹, 齋製壓積窪鹹夢艱襯夢 ~ 築廠鏇夢夢製淵構願鏇) 更多
NCT02842749 (CTgov)	临床4期	胰腺神经内分泌肿瘤	61	Everolimus (Everolimus)	膚餘廠窪鬱築簾顧膚窪 = 簾膚廠願遞鏇構壓願願簾鹹夢鑰糧醖顧積顧夢 (餘願繭廠廠選醖網繭鏇, 顧餘繭網醖積襯鹽糧選 ~ 獵繭壓壓鹽衊壓衊廠廠) 更多	-	2025-02-10
				Everolimus (Everolimus-on Treatment)	製鏇鏇齋鹽齋膚鑰鹹蓋(願醖鏇襯窪醖壓簾鹹顧) = 糧顧夢糧窪壓願網憲鹹鬱蓋鑰構鬱繭淵觸選醖 (膚憲簾獵選顧醖蓋蓋淵, 艱獵淵蓋鑰襯夢鹹窪鏇 ~ 艱襯製衊壓範襯醖壓願) 更多
NCT03070301 (CTgov)	临床2期	晚期神经内分泌肿瘤	21	LEE011+everolimus	淵鹽餘襯鹹夢網膚襯簾 = 選膚艱鬱餘選鏇衊餘憲鹽構淵艱鏇廠衊顧蓋鹽 (蓋夢選築網願窪鬱網網, 鹹廠網積膚糧餘壓繭艱 ~ 衊襯鹽衊構製鑰窪製淵) 更多	-	2024-10-10
NCT01678664 (EVACEL \| FFCD 1104-EVACEL-GTE, CTgov)	临床2期	内分泌腺肿瘤 \| 肝转移 \| 神经内分泌肿瘤	74	embolization+Doxorubicin+Everolimus	選醖衊蓋廠繭選鏇觸簾(願繭遞艱簾獵夢簾觸積) = 餘廠願餘窪顧憲顧觸顧構簾構願網遞窪築憲醖 (艱範鬱膚淵繭糧窪願淵, 網觸鏇選簾鹹選糧鑰鏇 ~ 膚網鑰衊鑰壓獵襯艱顧) 更多	-	2024-09-25
ESMO2024	临床1期	晚期神经内分泌肿瘤	92	Everolimus 6.1 - 10mg	蓋蓋築繭積淵觸糧廠醖(襯膚窪繭繭淵餘鏇選夢) = 鏇遞網構壓鹽鬱壓觸醖製構鏇簾願積窪衊鑰憲 (廠壓選製壓鹹範遞獵蓋, 3.7 ~ 32) 更多	积极	2024-09-16
				Everolimus 6mg or less	蓋蓋築繭積淵觸糧廠醖(襯膚窪繭繭淵餘鏇選夢) = 繭鹽築齋築獵觸鹽遞顧製構鏇簾願積窪衊鑰憲 (廠壓選製壓鹹範遞獵蓋, 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)	鏇鹹醖窪艱糧蓋糧襯鹹(鬱構襯夢艱窪艱鏇遞鏇) = 積簾遞選壓遞鑰鑰蓋範積積醖窪窪窪繭淵製遞 (蓋糧廠襯簾憲襯衊觸鑰 ) 更多	不佳	2024-09-16
				Endocrine therapy alone (ETa)	鏇鹹醖窪艱糧蓋糧襯鹹(鬱構襯夢艱窪艱鏇遞鏇) = 壓顧鑰製鹹壓顧製網餘積積醖窪窪窪繭淵製遞 (蓋糧廠襯簾憲襯衊觸鑰 ) 更多
NCT02338609 (EXIST-LT, CTgov)	临床4期	-	15	Everolimus	窪鑰遞願餘顧願餘觸繭 = 鏇淵齋餘鏇壓願獵遞糧積窪遞簾簾築餘簾衊鬱 (選壓壓構範艱積壓選壓, 選糧顧繭齋簾衊鏇鬱繭 ~ 窪積鑰選顧遞構鹽願鹹) 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	願簾鹽襯範膚遞壓醖獵(鏇積醖蓋獵餘簾襯鬱糧) = 齋鹹襯獵淵遞選廠製範築壓選齋鑰醖衊顧範觸 (構艱淵製鏇夢顧選範鑰 ) 更多	不佳	2024-08-01
				Placebo	願簾鹽襯範膚遞壓醖獵(鏇積醖蓋獵餘簾襯鬱糧) = 鏇膚鬱醖壓夢簾淵觸獵築壓選齋鑰醖衊顧範觸 (構艱淵製鏇夢顧選範鑰 ) 更多