A Randomized, Placebo-Controlled Phase 2 Study of IDH1 Inhibition Using Ivosidenib As Maintenance Therapy for IDH1-mutant Acute Myeloid Leukemia Following Allogeneic Stem Cell Transplantation

This is a Phase 2 study of the study drug, ivosidenib (a mutant IDH1 inhibitor), compared to placebo, given to patients with IDH1-mutant acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HCT).

开始日期2025-05-01

申办/合作机构

The General Hospital Corp.

[+1]

NCT06717958

/ Not yet recruiting临床2期

A Prospective, Single-arm, Open-label, Multicenter Phase II Trial Evaluating the Efficacy and Safety of Ivosidenib Maintenance Therapy After Allogeneic Stem Cell Transplantation (alloSCT) in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Neoplasia (MD) Carrying an IDH1 Mutation

maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days

开始日期2025-02-01

申办/合作机构

Dresden University of Technology

ChiCTR2400094961

/ Recruiting临床2期IIT

A single-arm, open-label Phase II clinical study on the efficacy and safety of Ivosidenib combined with Nab-paclitaxel sequentially followed by radiotherapy in the treatment of advanced solid tumors

开始日期2025-01-01

申办/合作机构-

100 项与艾伏尼布相关的临床结果

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100 项与艾伏尼布相关的转化医学

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100 项与艾伏尼布相关的专利（医药）

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385

项与艾伏尼布相关的文献（医药）

2025-04-09·Future Oncology

IDHIRA: a prospective, observational study on ivosidenib in patients with IDH1 R132-mutated advanced cholangiocarcinoma

Article

作者: Looß, Marion ; Ringwald, Kai ; Grebhardt, Sina ; Hagemeyer, Nora ; Potthoff, Karin ; Michl, Marlies

CLINICAL TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is NCT06607302.

2025-04-03·Expert Opinion On Drug Safety

Safety profile of isocitrate dehydrogenase inhibitors in cancer therapy: a pharmacovigilance study of the FDA Adverse Event Reporting System

Article

作者: Li, Ruizhen ; Lv, Ruxue ; Fu, Yiming ; Guo, Zhaoze ; Li, Wenjie

BACKGROUND:

Isocitrate dehydrogenase (IDH) inhibitors hold promise for IDH-mutated cancer patients and demonstrated favorable clinical efficacy. Nonetheless, a comprehensive understanding of the associated toxicities of IDH inhibitors remains notably lacking.

RESEARCH DESIGN AND METHODS:

This pharmacovigilance analysis utilized the FDA Adverse Event Reporting System (FAERS) database to assess notable adverse events (AEs) attributed to IDH inhibitors (enasidenib and ivosidenib) from January 2018 to December 2023.

RESULTS:

In the FAERS database, 2,905 enasidenib-associated and 1,289 ivosidenib-related AEs records were identified, respectively. The toxicity profiles of IDH1 and IDH2 inhibitors exhibited notable similarities. The most commonly significant system-organ classes induced by IDH inhibitors encompassed general disorders and administration site conditions, investigations, gastrointestinal disorders, and infections and infestations. The most common AEs included nausea, fatigue, diarrhea, decreased appetite, decreased platelet count, fever, pneumonia, weakness, sepsis, constipation, vomiting, rash, and reduced hemoglobin levels. Notably, temporal analysis of AEs shows enasidenib and ivosidenib have median onset times of 137 and 75 days, with distinct initial peak frequencies.

CONCLUSION:

The reversible nature of the toxicities associated with IDH inhibitors underscores their promise as a therapeutic agent with a favorable safety profile.

2025-04-01·INTERNATIONAL JOURNAL OF SURGICAL PATHOLOGY

Spectrum of Findings Seen in Patients With IDH1/2-Mutant Cholangiocarcinoma

Article

作者: Afghan, Maaz Khan ; Rocca, Juan ; Currie, Brian Michael ; Javaid, Sana ; Hissong, Erika ; Golden, Encouse ; Kasi, Pashtoon Murtaza ; Samstein, Benjamin ; Popa, Elizabeta ; Khan, Sahrish ; Lutfi, Areeb ; Kierans, Andrea Siobhan

Background:

Cholangiocarcinoma—with a growing incidence rate and poor prognosis—is not an uncommon cancer. Molecular profiling can reveal actionable aberrations in at least a third of the tumors. This is especially so in the case of intrahepatic cholangiocarcinoma (ICC), where mutations in the isocitrate dehydrogenase 1 and 2 genes ( IDH1/2 ) make up 15%–20% of these tumors. IDH1/2 mutant ICC is a rare disease that has not been adequately reported. To expand the spectrum of findings seen in these patients, we present a single institution case series.

Methods and results:

We descriptively characterize the clinical, radiological, and histopathological findings of 12 such patients. IDH1/2 mutant ICC was found in elderly women, with two-thirds of patients having additional co-mutations. Anecdotally, patients who did receive systemic and/or locoregional therapies had long-term durable outcomes.

Conclusion:

Our findings indicate an increasing need to personalize an approach for these patients with specific molecular alterations. With the advent of the IDH1 inhibitor ivosidenib and other inhibitors in this space, IDH1/2 mutation have both prognostic and predictive value. Our series builds upon the patterns and findings seen in these patients.

285

项与艾伏尼布相关的新闻（医药）

2025-04-12

·药智网

施维雅的「肿瘤大业」

近日，施维雅豪横出手以7.8亿美元从Black Diamond Therapeutics引进一款针对实体瘤RAS突变和RAF改变的尚处于1期临床的小分子药物BDTX-4933。如今，施维雅的竞争地位因慢性疾病药物市场的挑战而受到威胁，其正主动寻找新的前进道路，最新目标便是涉足肿瘤领域。近年来，施维雅通过收购和引进不断加强其肿瘤管线，已成为肿瘤治疗领域一匹不可小看的“黑马”。1IDH抑制剂领跑者异柠檬酸脱氢酶（IDH)是三羧酸循环中的一种关键性限速酶，IDHs存在三种同工酶，分别为IDH1、IDH2和IDH3。其中IDH1和IDH2的突变所造成的功能缺失，会直接影响产物构成——α-酮戊二酸转化为致癌代谢物2-羟基戊二酸，促进癌症的发生。IDH1突变多见于实体肿瘤，IDH2突变常见于血液系统肿瘤，但IDH3突变并不常见。在如今靶点内卷的时代，IDH抑制剂领域犹如一片蓝海。在这片蓝海赛道中，施维雅可谓遥遥领先，不仅拥有IDH1/2抑制剂Voranigo（vorasidenib），还有已上市的IDH1抑制剂Tibsovo（ivosidenib）和IDH2抑制剂Idhifa（enasidenib）。这三款产品均由施维雅于2020年以18亿美元收购Agios制药公司的肿瘤业务所得。2024年8月，施维雅围绕IDH布局肿瘤业务迎来了里程碑事件：FDA批准Voranigo（vorasidenib）上市，用于治疗携带IDH突变的低级别弥漫性脑胶质瘤。这款可穿透血脑屏障、同时针对IDH1和IDH2突变的双重抑制剂，是FDA批准的首款可用于这类患者的全身疗法。具体数据看，vorasidenib的主要终点中位无进展生存期（PFS）达到27.7个月，而安慰剂组为11.1个月。关键次要终点至下一次干预时间（TTNI）具备统计学显著性，vorasidenib组的中位TTNI尚未达到，而安慰剂组为17.8个月，两者具有统计学显著性差异。其他数据，vorasidenib组每6个月的肿瘤体积平均减少2.5%，而安慰剂组每6个月的肿瘤体积平均增加13.9%。同时，施维雅还在进一步挖掘vorasidenib的潜力。目前已启动一线治疗4级星形细胞瘤的2期临床、联合PD-1抑制剂pembrolizumab的1期临床以及联合替莫唑胺治疗IDH1或IDH2突变脑胶质瘤的1b/2期临床研究。对vorasidenib的临床布局，可以看出施维雅对产品朝一线拓展以及联合用药方面的规划。施维雅的IDH1抑制剂ivosidenib上市已多年，已斩获四项适应证，从IDH1突变的血液肿瘤与实体瘤均有覆盖。对于ivosidenib的适应症拓展，施维雅在IDH1突变的胆管癌一线及二线、软骨肉瘤一线及二线、急性髓系白血病（AML）一线以及骨髓增生异常综合征（MDS）的一线治疗中，均有临床研究在进行中。相比之下，IDH赛道中其他产品，除了已上市的Rezlidhia（olutasidenib），和黄医药的IDH1/2抑制剂HMPL-306进展最快，处在3期临床阶段。其他已进入临床阶段的同类在研药物还有贝达药业的BPI-221351、礼来的LY3410738、Nerviano Medical Sciences的NMS-173。可见未来施维雅在IDH赛道中，不论是双靶点还是双靶点，还将领跑相当长一段路程。另外，随着vorasidenib和ivosidenib适应症不断向一线推进，相关产品想要跟上施维雅的步伐还存在不小的难度。2雄心勃勃施维雅进军肿瘤领域始于2018年收购Shire肿瘤业务，获得包括Oncospar（培门冬酶）（一种用于治疗急性淋巴细胞性白血病的药物）和Onivyde（伊立替康脂质体注射液）。2022年3月，Onivyde在中国获批，打破了国内继1999年吉西他滨获批胰腺癌适应症后，近20年没有针对胰腺癌的治疗方案获批的状况，为胰腺癌患者带来了创新的解决方案，也是施维雅中国上市的首个肿瘤产品。而后又通过收购Agios Pharmaceuticals成为IDH抑制剂的顶级玩家，并购丹麦Symphogen公司补强肿瘤抗体研发实力。另外，施维雅还不断通过外部合作模式拓展其早期临床管线，包括与GNS合作开发多发性骨髓瘤药物，与Oncodesign合作探索胰腺癌治疗新靶点、与Gustave Roussy签署肿瘤学合作框架协议。胃肠道肿瘤一直是施维雅深耕的重点领域。2015年花费1.3亿美元从TAIHO引进的Lonsurf（trifluridine+tipiracil，曲氟尿苷替匹嘧啶）已成为结直肠癌的三线标准治疗方案。此外，施维雅还在Lonsurf的联合疗法上“下功夫”：与贝伐珠单抗的联合方案相比单药可显著改善mCRC成人患者PFS和OS，已获FDA批准适应症，与EGFR单抗S95026（futuximab/modotuximab）的联合方案在疗效和安全性进行临床确证。目前，施维雅管线中的其他肿瘤在研产品覆盖到MET、TIM3、CD73、NKG2A、MAT2A等多个靶点，药物类型既有小分子又有抗体药物，适应症拓展至非小细胞肺癌等实体瘤。此外，在MNC竞相拥抱AI的当下，施维雅也不例外，分别与人工智能公司Aqemia、Owkin合作开发创新靶点的小分子药物，今年初又与谷歌云达成一项为期5年的合作，聚焦人工智能与生成式AI技术，助力新药研发效率。此外，施维雅还建立了自己的高通量AI平台Patrimony，并利用平台取得了多项重大成果。目前肿瘤领域已成为施维雅战略增长的新支柱。财报显示，2024财年施维雅合并收入达到59.02亿欧元，同比增长10.8%；其中肿瘤学领域的销售收入为14.30亿欧元，占集团合并收入的24.2%，较2023财年的20.2%有所提升。施维雅曾在2022年发布2030集团发展目标，预期2025年实现10亿欧的肿瘤领域的收入，到2030年的收入至少要30亿欧。结合已上市肿瘤产品的销售业绩，施维雅在肿瘤领域形成了早期创新发现、临床拓展以及持续商业化的完整布局，相信随着vorasidenib的获批，以及围绕IDH展开的肿瘤业务，同时并借力AI技术不断开发创新肿瘤产品，施维雅在肿瘤领域的持续规划将助其实现目标。参考来源[1]施维雅公司官网[2]Exclusive:Servier Establishes First U.S.Toehold in Boston with Immediate Focus on Oncology[3]实体瘤，血液瘤领域“双开花”，一起来看IDH1的最新进展；凯莱英药闻权威榜单定义行业标杆，赋能企业品牌价值！识别二维码，解锁年度惊喜！声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

并购临床2期临床1期上市批准

2025-04-09

·癌度

一文细说肺癌EGFR基因的罕见突变，哪些靶向药的效果好？

癌度医学临床招募资讯微信群（点击）肺癌目前仍然是全球最为常见的癌症死亡原因，非小细胞肺癌是肺癌的主要亚型，大概80%至85%的肺癌属于非小细胞肺癌，非小细胞肺癌包括肺腺癌、肺鳞癌和大细胞肺癌，其中EGFR基因突变占亚裔肺腺癌的50%左右，西方肺腺癌则是20%为EGFR基因突变。对于非小细胞肺癌有多种靶向药，比如吉非替尼、厄洛替尼、埃克替尼属于第一代靶向药，达克替尼和阿法替尼属于第二代靶向药，奥希替尼、阿美替尼和伏美替尼属于第三代靶向药。对于不同的EGFR基因突变类型，可能这三类靶向药的疗效是存在差异的，今天癌度给大家编译的一篇研究就是围绕这些做的分析。本文参考文献图示1、EGFR基因的突变类别我们今天讨论的是EGFR基因，EGFR基因的突变位置可能有多种，不同位置发生的突变使用的药物效果是存在差异的。19号外显子非移码缺失突变和L858R突变是常见突变类型，占到EGFR基因突变的85%左右，20号外显子插入突变则是EGFR的另外一类突变（有研究说占到了10%左右），此外还有一些患者在EGFR基因存在不只一种突变，这种情况则属于“复合突变”。EGFR基因的突变类型美国MD安德森癌症中心则是将EGFR基因突变分为四类，经典EGFR突变、T790M样、P环和alpha螺旋压缩突变（代号PACC）和外显子20突变。如上面的图示，很多罕见突变都是属于PACC突变，一般来说罕见的EGFR基因突变在临床试验中都是被排除在外的，所以这些罕见突变使用哪些靶向药疗效好？目前还没有一个答案。2、第二代靶向药解决EGFR罕见突变最终纳入了38项研究，包括1836名患者，这些患者大多数是使用第一代、第二代靶向药治疗，也有患者使用第三代靶向药进行治疗，我们一起看看这些靶向药的治疗效果。不同的药物治疗应答率根据研究，对于EGFR基因的G719X、S768I、E709X、L747X 和 E709- T710delinsD突变，第二代靶向药的治疗应答率为47.8%至72.3%，这个治疗应答率比第一代和第三代靶向药效果要好。L861Q突变使用第三代靶向药的治疗应答率为75%，对于G719X、E709X 或S768I复合突变使用第二代和第三代靶向药的治疗应答率都高于50%，不过对于这些突变使用第三代靶向药的疗效数据偏少。对于EGFR基因的经典突变，第一代、第二代和第三代靶向药的治疗应答率分别为35.4%、51.9%和67.9%；对于PACC突变来说，第一代、第二代和第三代靶向药的治疗应答率分别为37.2%、59.6%和46.3% 。3、看情况下菜这个文章的结论是：第二代口服靶向药阿法替尼治疗 G719X、S768I、E709X 和 L747X 突变以及复合罕见突变，二代药物相比使用第三代靶向药的疗效会好一些。对于其他的罕见基因，比如L861的EGFR突变则是直接使用第三代靶向药会更好（如奥希替尼）。相信通过上面的图示，大家可以参考自己的基因检测报告来分析所谓位置，以及使用那一代靶向药更有可能获益。欢迎大家关注癌度，我们可为大家解读和分析基因检测报告，也欢迎大家联系癌度加入相似病友社群，或联系癌度申请相应的药物临床试验！参考文献：Borgeaud M, et al., Unveiling the Landscape of uncommon EGFR Mutations in Non-Small Cell Lung Cancer - A Systematic Review, Journal of Thoracic Oncology (2024). 往期推荐让人惊叹，高TMB晚期小细胞肺癌两次治疗失败后单用PD-1肿瘤病灶全消失18个月之久！吞噬癌细胞，抗CD24人源化单克隆抗体KH801治疗实体瘤，可申请免费用！新概念抗癌药之一，靶向CD46免疫调节抗体偶联药FOR46首次人体临床试验，疗效令人鼓舞！开眼界，IDH1基因突变会发生在肺癌，使用艾伏尼布实现了神奇的逆转！

临床结果临床研究临床终止基因疗法

2025-04-08

·PRNewswire

TIBSOVO's Continued Success Solidifies Its Position as a Leader in IDH1 Mutant Space | DelveInsight

With its ability to specifically inhibit the mutant IDH1 enzyme, TIBSOVO addresses an unmet need in personalized cancer treatment, offering new hope for patients with limited options. As clinical evidence continues to support its efficacy and safety, TIBSOVO is positioned for strong growth in the oncology market, especially with expanding indications and global market penetration. LAS VEGAS, April 8, 2025 /PRNewswire/ -- DelveInsight's " TIBSOVO Market Size, Forecast, and Market Insight Report" highlights the details around TIBSOVO, the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TIBSOVO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Servier's TIBSOVO (ivosidenib) Overview TIBSOVO (ivosidenib) is a small molecule developed by Servier, acts as an isocitrate dehydrogenase-1 (IDH1) inhibitor. It is indicated for patients with a susceptible IDH1 mutation, which is identified through an FDA-approved test. Currently, TIBSOVO is approved for the treatment of newly diagnosed acute myeloid leukemia (AML), relapsed or refractory AML, relapsed or refractory myelodysplastic syndromes (MDS), and locally advanced or metastatic cholangiocarcinoma. According to Servier's pipeline, TIBSOVO is also being actively investigated for a range of additional indications, with key areas of exploration including solid tumors and hematological malignancies. Learn more about TIBSOVO projected market size for AML, cholangiocarcinoma, and MDS @ TIBSOVO Market Potential The oncology market has experienced significant growth in recent years, driven by advances in cancer research, the development of targeted therapies, and the increasing global prevalence of cancer. As the second-leading cause of death worldwide, cancer continues to pose a major public health challenge, creating a substantial demand for innovative treatments. The market is marked by a shift toward personalized medicine, where therapies are tailored to an individual's genetic profile, allowing for more effective and less toxic treatments. Immunotherapies, such as checkpoint inhibitors, CAR-T cell therapies, and oncolytic virus therapies, are at the forefront of these advancements, offering new hope to patients with previously untreatable cancers. Moreover, the oncology market is expanding due to the growing adoption of precision oncology and molecular diagnostics, which enable earlier and more accurate detection of cancer. This has led to increased investments in research and development, especially in areas like liquid biopsies, companion diagnostics, and next-generation sequencing. The demand for more effective and accessible cancer treatments is fueling innovation in both the pharmaceutical and biotechnology sectors, with numerous new drugs and therapies entering clinical trials and moving toward commercialization. As a result, the oncology market is poised to continue growing, with significant opportunities for breakthrough therapies in immuno-oncology, targeted treatments, and gene therapies. DelveInsight has expertise in the oncology market with an experienced team handling the oncology domain proficiently. DelveInsight has released a series of epidemiology-based market reports on Acute Myeloid Leukemia, Cholangiocarcinoma, and Myelodysplastic Syndrome. These reports include a comprehensive understanding of current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Gain deeper insights into these diseases with a customized report tailored to your needs. Connect with us today—our experts are ready to assist you! Emerging Competitors of TIBSOVO TIBSOVO faces significant competition in the newly diagnosed AML market from several alternative treatments. Oral therapies like VENCLEXTA (venetoclax), which inhibits BCL-2, and DAURISMO (glasdegib), which targets the hedgehog pathway, present strong contenders. Additionally, emerging therapies such as Lisaftoclax (Ascentage Pharma), another BCL-2 inhibitor, and gilteritinib (Astellas), a kinase inhibitor, are expected to further challenge TIBSOVO in the newly diagnosed AML space. In the R/R AML market, TIBSOVO competes with several therapies, including XOSPATA (gilteritinib), IDHIFA (enasidenib), and others. Emerging therapies such as Ziftomenib (Kura Oncology) and RVU-120 (Ryvu Therapeutics) are also expected to compete with TIBSOVO upon their approval. Ziftomenib, a small molecule developed by Kura Oncology, is currently in Phase I/II trials. In the relapsed/refractory (R/R) MDS market, TIBSOVO faces competition from therapies such as RYTELO (Imetelstat), an IV injection that inhibits oligonucleotide telomerase, and REBLOZYL (Luspatercept), a subcutaneous injection, among other treatment options. In the metastatic cholangiocarcinoma market, TIBSOVO faces relatively less competition, as there are few approved therapies. One such competitor is PEMAZYRE (pemigatinib), a kinase inhibitor that was approved in the US in 2020 and in Europe in 2021. Whereas, Tyra Biosciences' TYRA-200, an FGFR1/2/3 inhibitor, is in phase I stage of development that might be a threat to TIBSOVO one approved. To know more about the number of competing drugs in development, visit @ TIBSOVO Market Positioning Compared to Other Drugs Key Developmental Activities of TIBSOVO In October 2023, Servier announced that the FDA has approved TIBSOVO (ivosidenib tablets) for the treatment of IDH1-mutated R/R MDS. In May 2023, Servier announced that the European Commission has approved TIBSOVO as a targeted therapy in two indications: in combination with azacitidine for the treatment of adult patients with newly diagnosed AML with an isocitrate dehydrogenase-1 R132 mutation who are not eligible to receive standard induction chemotherapy; as well as in monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy. In May 2022, Servier announced FDA approval of TIBSOVO (ivosidenib tablets) in combination with azacitidine for patients with newly diagnosed IDH1-mutated acute myeloid leukemia. In August 2021, Servier announced FDA approval for TIBSOVO (ivosidenib tablets) for the treatment of adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test. TIBSOVO is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma. In May 2019, Agios announced FDA approval of TIBSOVO (ivosidenib tablets) as monotherapy for newly diagnosed adult patients with IDH1 mutant acute myeloid leukemia not eligible for intensive chemotherapy. In July 2018, the FDA approved TIBSOVO (ivosidenib) for relapsed or refractory acute myeloid leukemia with an idh1 mutation. In February 2018, the FDA accepted a new drug application and granted priority review for ivosidenib in relapsed or refractory AML with an IDH1 mutation. In December 2017, Agios submitted an NDA to the FDA for ivosidenib for the treatment of patients with relapsed/refractory aml and an IDH1 mutation. TIBSOVO Patent Details TIBSOVO is a drug owned by Servier Pharmaceuticals. Currently, it is protected by 10 Orange book-listed patents filed from 2018 to 2023, out of which none have expired yet. It is also protected by ODE exclusivity for various indications. Discover how TIBSOVO is shaping the blood cancer treatment landscape @ TIBSOVO Side Effects TIBSOVO Market Dynamics In recent years, the therapeutic landscape has undergone significant changes, with promising approaches including immunotherapy, chemotherapy combined with targeted treatments, and the regulation of immune checkpoint-mediated signaling pathways. One such treatment, Ivosidenib, works by inducing the bone marrow to develop normal blood cells, helping to reduce the frequency of blood transfusions. Investment in the research and development of drugs has surged, contributing to a rich pipeline and forecasting promising opportunities in the treatment markets for AML and cholangiocarcinomas. Therapies like TIBSOVO have the potential to capture market attention due to their efficacy and innovation. As healthcare spending continues to rise globally, the pharmaceutical market is expected to expand, providing greater opportunities for market penetration by manufacturers and facilitating the development and distribution of new treatments. Despite progress in cancer treatment, significant gaps remain in understanding the full process that governs carcinogenesis and resistance to treatments, particularly in cancers like acute myeloid leukemia (AML). This highlights the need for more advanced research to address these challenges. Additionally, the limited biomarker testing for patients with the IDH1 mutation restricts the targeted patient pool, posing a challenge for therapies like TIBSOVO to achieve their expected market share. The increasing competition from emerging therapies, such as KEYTRUDA (pembrolizumab), IMFINZI (durvalumab), and the combination of Azacitidine + Venetoclax, further intensifies the pressure on TIBSOVO. Moreover, the difficulty in obtaining sufficient patient pools and diagnostic samples during disease recurrence presents significant hurdles to the effective development of translational research, potentially slowing progress in optimizing treatments. Dive deeper to get more insight into TIBSOVO's strengths & weaknesses relative to competitors @ TIBSOVO Market Drug Report Table of Contents Related Reports Acute Myeloid Leukemia Market Acute Myeloid Leukemia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key AML companies including Agios Pharmaceuticals, Abbvie, Jazz Pharmaceuticals, Astellas Pharma, Pfizer, Novartis Oncology, Daiichi Sankyo, AstraZeneca, Astex Pharmaceuticals, Inc., Chimerix, Takeda, Rafael Pharmaceuticals Inc., Delta-Fly Pharma, GlycoMimetics Incorporated, BerGenBio ASA, MacroGenics, Syndax Pharmaceuticals, Arog Pharmaceuticals, Forma Therapeutics, Sellas Life Sciences Group, Actinium Pharmaceuticals, Clear Creek Bio Inc., CellCentric Ltd., Biosight Ltd., Astex Pharmaceuticals, Inc., Curis, Inc., NexImmune Inc., Immunomedics, Inc., Sumitomo Dainippon Pharma Co., Ltd., Incyte Corporation, Aprea Therapeutics, Immunicum, DCPrime BV, GT Biopharma, Inc., Hanmi Pharmaceutical Company Limited, Cardiff Oncology, Bio-Path Holdings, Actinium Pharmaceuticals, Aptevo Therapeutics, Synimmune GmbH, GEMoaB Monoclonals, ImmunoGen, Inc., AGC Biologics S.p.A., Precigen, Inc., Novartis Pharmaceuticals, Xencor, Inc., Novartis, Celgene, Bristol Myers Squibb, among others. Relapsed/Refractory Acute Myeloid Leukemia Market Relapsed/Refractory Acute Myeloid Leukemia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key R/R AML companies including Agios Pharmaceuticals, Abbvie, Jazz Pharmaceuticals, Astellas Pharma, Pfizer, Novartis Oncology, Daiichi Sankyo, AstraZeneca, Astex Pharmaceuticals, Inc., Chimerix, Takeda, Rafael Pharmaceuticals Inc., Delta-Fly Pharma, GlycoMimetics Incorporated, BerGenBio ASA, MacroGenics, Syndax Pharmaceuticals, Arog Pharmaceuticals, Forma Therapeutics, Sellas Life Sciences Group, Actinium Pharmaceuticals, Clear Creek Bio Inc., CellCentric Ltd., Biosight Ltd., Astex Pharmaceuticals, Inc., Curis, Inc., NexImmune Inc., Immunomedics, Inc., Sumitomo Dainippon Pharma Co., Ltd., Incyte Corporation, Aprea Therapeutics, Immunicum, DCPrime BV, GT Biopharma, Inc., Hanmi Pharmaceutical Company Limited, Cardiff Oncology, Bio-Path Holdings, Actinium Pharmaceuticals, Aptevo Therapeutics, Synimmune GmbH, GEMoaB Monoclonals, ImmunoGen, Inc., AGC Biologics S.p.A., Precigen, Inc., Novartis Pharmaceuticals, Xencor, Inc., Novartis, Celgene, Bristol Myers Squibb, among others. Myelodysplastic Syndrome Market Myelodysplastic Syndrome Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key MDS companies such as Bristol-Myers Squibb, Astex Pharmaceutical, Taiho Oncology, Fibrogen, AbbVie, Gilead Sciences, Novartis, Syros Pharmaceuticals, Takeda, Pfizer, Geron Corporation, Karyopharm Therapeutics, Antengene Corporation, BerGenBio ASA, Jazz Pharmaceuticals, Aprea Therapeutics, Sanofi, Medac, among others. Cholangiocarcinoma Market Cholangiocarcinoma Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key cholangiocarcinoma companies such as AstraZeneca, Decalth Systems, Basilea Pharmaceutica, Taiho Oncology, Eisai Pharmaceuticals, TransThera Sciences, Incyte Corporation, Roche, Agios Pharmaceuticals, Servier Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准免疫疗法临床1期优先审批

100 项与艾伏尼布相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11090	艾伏尼布	L01XX62	DB14568

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
骨髓增生异常综合征	美国	Servier Pharmaceuticals LLC初创企业	2023-10-24
IDH1突变的胆管癌	澳大利亚	SERVIER LABORATORIES (AUST.) PTY. LTD.	2023-04-06
IDH1突变急性髓性白血病	中国	基石药业（苏州）有限公司	2022-01-30
IDH1突变急性髓性白血病	中国	Servier Pharmaceuticals LLC初创企业	2022-01-30
胆管癌	美国	Servier Pharmaceuticals LLC初创企业	2021-08-25
急性髓性白血病	美国	Servier Pharmaceuticals LLC初创企业	2018-07-20

未上市

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适应症	最高研发状态	国家/地区	公司	日期
软骨肉瘤	临床3期	美国	Institut de Recherches Intern Servier	2024-07-09
软骨肉瘤	临床3期	美国	Servier Bio-Innovation LLC	2024-07-09
软骨肉瘤	临床3期	中国	Institut de Recherches Intern Servier	2024-07-09
软骨肉瘤	临床3期	日本	Institut de Recherches Intern Servier	2024-07-09
软骨肉瘤	临床3期	日本	Servier Bio-Innovation LLC	2024-07-09
软骨肉瘤	临床3期	澳大利亚	Institut de Recherches Intern Servier	2024-07-09
软骨肉瘤	临床3期	澳大利亚	Servier Bio-Innovation LLC	2024-07-09
软骨肉瘤	临床3期	巴西	Institut de Recherches Intern Servier	2024-07-09
软骨肉瘤	临床3期	巴西	Servier Bio-Innovation LLC	2024-07-09
软骨肉瘤	临床3期	加拿大	Institut de Recherches Intern Servier	2024-07-09

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05209074 (ASCO_GI2025)	临床1期	胰腺腺癌新辅助 IDH1 mutant	16	Ivosidenib 500mg	夢艱憲鑰顧網憲範醖壓(蓋廠衊齋艱獵製繭淵膚) = 廠鹹醖襯願遞鏇壓齋鬱醖蓋顧獵醖膚窪襯鬱醖 (築遞艱遞壓鏇衊鏇窪築 )	-	2025-01-23
NCT04493164 (ASH2024) 人工标引	临床2期	IDH1突变急性髓性白血病 \| 高危骨髓增生异常综合征 IDH1 Mutation	11	CPX-351 + Ivosidenib	願夢窪繭獵繭窪觸鏇鹹(鏇蓋壓衊築網願淵獵餘) = 鹹憲齋糧襯製醖廠願遞壓選鏇膚網壓製獵艱憲 (積願鹹鬱觸鹹齋構壓餘 ) 更多	积极	2024-12-09
				CPX-351 + Ivosidenib (Adult patients 18 years or older with R/R AML or high-risk MDS harboring an IDH1 mutation)	願夢窪繭獵繭窪觸鏇鹹(鏇蓋壓衊築網願淵獵餘) = 鬱齋餘繭遞壓鏇願鹹夢壓選鏇膚網壓製獵艱憲 (積願鹹鬱觸鹹齋構壓餘 ) 更多
NCT03173248 (AGILE, ASH2024)	临床3期	急性髓性白血病 IDH1m	-	Ivosidenib + Azacitidine	淵觸醖鹹醖鹹窪範廠餘(遞選網網獵選獵夢製夢): HR = 0.39 (95% CI, 0.24 ~ 0.64) 更多	积极	2024-12-09
				Azacitidine
NCT05010772 (4277, ASH2024)	临床1期	急性髓性白血病 complex cytogenetics \| antecedent MDS/MPN \| therapy-related AML ... 更多	31	ASTX727 alone	艱餘壓衊網鏇齋膚鹹淵(顧憲夢鑰繭繭構鏇鏇齋) = 廠襯鹹願夢衊鹹製簾艱壓蓋蓋積蓋鏇壓願顧壓 (築醖憲夢網簾艱積衊獵 ) 更多	积极	2024-12-09
				ASTX727 plus venetoclax	艱餘壓衊網鏇齋膚鹹淵(顧憲夢鑰繭繭構鏇鏇齋) = 製願窪鬱網遞構築構獵壓蓋蓋積蓋鏇壓願顧壓 (築醖憲夢網簾艱積衊獵 ) 更多
ASH2024	N/A	骨髓增生异常综合征	-	Ivosidenib 500 mg	鏇蓋鬱淵廠襯糧蓋廠鏇(齋壓鹽襯艱觸壓顧遞積) = 製膚襯製齋醖構憲願製膚願網廠積膚鬱簾鏇壓 (鬱獵獵蓋鏇願網襯範餘 ) 更多	-	2024-12-08
ASH2024	N/A	IDH1突变急性髓性白血病	-	Ivosidenib (IVO) and venetoclax (VEN)	鹹積夢壓膚窪積網製遞(襯繭選餘築簾鹹顧淵網) = 築餘艱鑰膚遞鹹糧鏇鏇糧鏇顧窪遞簾艱遞繭構 (壓鑰築築衊艱襯鹹鏇鹽 )	-	2024-12-08
				Ivosidenib (IVO), venetoclax (VEN), and azacitidine (AZA)	鹹積夢壓膚窪積網製遞(襯繭選餘築簾鹹顧淵網) = 構範窪築選鏇遞廠壓醖糧鏇顧窪遞簾艱遞繭構 (壓鑰築築衊艱襯鹹鏇鹽 )
NCT03471260 (ASH2024) 人工标引	临床1/2期	急性髓性白血病 \| 骨髓增生性疾病 \| 骨髓增生异常综合征 IDH1-Mutated	56	Ivosidenib + Venetoclax ± Azacitidine	構齋顧醖艱壓顧築繭鹹(鑰餘鑰選餘糧鑰範壓選) = 齋積廠醖築膚衊願網獵鬱鏇願艱鏇選鬱齋鹽選 (膚鹽觸憲鑰鬱壓鏇窪獵 ) 更多	积极	2024-12-07
				Ivosidenib + Venetoclax ± Azacitidine (received SCT)	膚蓋製願餘積醖築憲願(廠齋獵構遞網壓製範鏇) = 憲鬱廠顧醖衊糧顧鹹鹹簾鏇鏇窪齋獵繭遞簾餘 (積選蓋廠觸膚夢積顧鹹, 85.2 ~ 100)
DDDR-24 (SNO2024)	N/A	IDH1突变胶质瘤一线 IDH1 inhibitor	77	Ivosidenib	窪蓋窪膚觸積製鏇襯衊(壓觸繭製壓顧鑰憲積鑰) = 鬱齋糧選窪夢壓遞範淵壓網憲顧醖夢壓鹹夢製 (襯艱鏇餘獵簾襯範衊餘 ) 更多	积极	2024-11-11
INNV-31 (SNO2024)	N/A	IDH1突变胶质瘤	21	Ivosidenib	艱窪衊壓積選鑰衊網顧(鑰鏇顧範鬱顧廠觸選醖) = N=4 鹹築蓋鏇繭獵鏇鹹襯壓 (壓齋築憲繭糧夢鹽構糧 ) 更多	-	2024-11-11
SNO2024	N/A	IDH1突变胶质瘤 canonical IDH1 mutation (p.Arg132His)	14	Ivosidenib + Bevacizumab	顧衊壓壓鏇淵襯鏇製醖(構顧獵遞範構鏇衊製夢) = diarrhea (n=2), creatine phosphokinase elevations (n=1), QTc prolongation (n=1), and thrombocytopenia (n=1) 鹽襯繭淵鹽願遞鏇鬱夢 (艱選鑰餘鏇願顧廠蓋壓 ) 更多	-	2024-11-11