A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm

To learn if olutasidenib, when combined with a drug called a hypomethylating agent (HMA) can help to control MDS, CMML, and/or MPN. The safety of the drug combination will also be studied.

开始日期2025-03-11

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT06566742 / Not yet recruiting临床2期IIT

A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.

To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.

开始日期2025-02-28

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT06668584 / Not yet recruiting临床1/2期IIT

A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients with IDH1-mutated Myeloid Malignancies

The goal of this clinical research study is to learn about the safety and tolerability of giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance therapy after they receive a stem cell transplant.

开始日期2024-12-31

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与 Olutasidenib 相关的临床结果

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100 项与 Olutasidenib 相关的转化医学

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100 项与 Olutasidenib 相关的专利（医药）

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项与 Olutasidenib 相关的文献（医药）

2024-10-01·JAMA Oncology

Contemporary Management of Acute Myeloid Leukemia

Review

作者: Sekeres, Mikkael A. ; Venugopal, Sangeetha

Importance:

Acute myeloid leukemia (AML) is a clonal hematopoietic cancer that disrupts normal hematopoiesis, ultimately leading to bone marrow failure and death. The annual incidence rate of AML is 4.1 per 100 000 people in the US and is higher in patients older than 65 years. Acute myeloid leukemia includes numerous subgroups with heterogeneous molecular profiles, treatment response, and prognosis. This review discusses the evidence supporting frontline therapies in AML, the major principles that guide therapy, and progress with molecularly targeted therapy.

Observations:

Acute myeloid leukemia is a genetically complex, dynamic disease. The most commonly altered genes include FLT3, NPM1, DNMT3A, IDH1, IDH2, TET2, RUNX1, NRAS, and TP53. The incidence of these alterations varies by patient age, history of antecedent hematologic cancer, and previous exposure to chemotherapy and/or radiotherapy for any cancer. Since 2010, molecular data have been incorporated into AML prognostication, gradually leading to incorporation of targeted therapies into the initial treatment approach of induction chemotherapy and subsequent management. The first molecularly targeted inhibitor, midostaurin, was approved to treat patients with AML with FLT3 variants in 2017. Since then, the understanding of the molecular pathogenesis of AML has expanded, allowing the identification of additional potential targets for drug therapy, treatment incorporation of molecularly targeted therapies (midostaurin, gilteritinib, and quizartinib targeting FLT3 variants; ivosidenib and olutasidenib targeting IDH1 variants, and enasidenib targeting IDH2), and identification of rational combination regimens. The approval of hypomethylating agents combined with venetoclax has revolutionized the therapy of AML in older adults, extending survival over monotherapy. Additionally, patients are now referred for hematopoietic cell transplant on a more rational basis.

Conclusions and Relevance:

In the era of genomic medicine, AML treatment is customized to the patient’s comorbidities and AML genomic profile.

2024-09-19·Blood Cancer Journal

Current status and research directions in acute myeloid leukemia.

Review

作者: Yilmaz, Musa ; Daver, Naval ; Kadia, Tapan ; Kantarjian, Hagop ; Sasaki, Koji ; Ravandi, Farhad ; Short, Nicholas J ; Borthakur, Gautam ; Issa, Ghayas ; Jabbour, Elias ; DiNardo, Courtney D

The understanding of the molecular pathobiology of acute myeloid leukemia (AML) has spurred the identification of therapeutic targets and the development of corresponding novel targeted therapies. Since 2017, twelve agents have been approved for the treatment of AML subsets: the BCL2 inhibitor venetoclax; the CD33 antibody drug conjugate gemtuzumab ozogamicin; three FLT3 inhibitors (midostaurin, gilteritinib, quizartinib); three IDH inhibitors (ivosidenib and olutasidenib targeting IDH1 mutations; enasidenib targeting IDH2 mutations); two oral hypomethylating agents (oral poorly absorbable azacitidine; fully absorbable decitabine-cedazuridine [latter approved as an alternative to parenteral hypomethylating agents in myelodysplastic syndrome and chronic myelomonocytic leukemia but commonly used in AML]); and CPX-351 (encapsulated liposomal 5:1 molar ratio of cytarabine and daunorubicin), and glasdegib (hedgehog inhibitor). Other targeted therapies (menin inhibitors, CD123 antibody-drug conjugates) are showing promising results. To achieve optimal results in such a rare and heterogeneous entity as AML requires expertise, familiarity with this rare cancer, and the access to, and delivery of disparate therapies under rigorous supportive care conditions. In this review, we update the standard-of-care and investigational therapies and outline promising current and future research directions.

2024-07-11·BLOOD

Complete remission with partial hematological recovery as a palliative endpoint for treatment of acute myeloid leukemia

Article

作者: Shen, Yuan Li ; De Claro, R. Angelo ; Norsworthy, Kelly ; Chen, Haiyan ; Przepiorka, Donna ; Pulte, E. Dianne ; Theoret, Marc R. ; Le, Robert Q.

Abstract:

Complete remission with partial hematological recovery (CRh) has been used as an efficacy endpoint in clinical trials of nonmyelosuppressive drugs for acute myeloid leukemia (AML). We conducted a pooled analysis to characterize the clinical outcomes for patients with AML who achieved CRh after treatment with ivosidenib, olutasidenib, enasidenib, or gilteritinib monotherapy in clinical trials used to support marketing applications. The study cohort included 841 adult patients treated at the recommended drug dosage; 64.6% were red blood cell or platelet transfusion dependent at study baseline. Correlations between disease response and outcomes were assessed by logistic regression modeling for categorical variables and by Cox proportional hazards modeling for time-to-event variables. Patients with CRh had a higher proportion with transfusion independence (TI) for at least 56 days (TI-56; 92.3% vs 22.3%; P < .0001) or TI for at least 112 days (TI-112; 63.5% vs 8.7%; P < .0001), a reduced risk over time for severe infection (hazard ratio [HR], 0.43; P = .0007) or severe bleeding (HR, 0.17; P = .01), and a longer overall survival (OS; HR, 0.31; P < .0001) than patients with no response. The effects were consistent across drugs. In comparison with patients with CR, the effect sizes for CRh were similar for TI-56 and for risk over time of infection or bleeding but less for TI-112 and OS. CRh is associated with clinical benefits consistent with clinically meaningful palliative effects for the treatment of AML with nonmyelosuppressive drugs, although less robustly than for CR.

项与 Olutasidenib 相关的新闻（医药）

2024-10-25

·精准药物

胶质瘤NCCN指南更新及分子标志物相关靶免药物总结

导语在过去20多年，胶质瘤治疗领域的突破性进展寥寥无几。然而，今年似乎按了加速器，先后有3款药物：Tovorafenib、伯瑞替尼、Vorasidenib，获得突破性成功，成为对应靶点在胶质瘤中的首款获批药物。这些新药的获批共同开启了脑胶质瘤精准诊疗的新篇章。Vorasidenib也于9月30日纳入NCCN指南。本期就指南更新内容进行介绍，同时对胶质瘤分子标志物相关的靶免药物进行汇总分享，以便读者全面了解。一、NCCN指南更新 2024年8月6日，FDA批准Vorasidenib用于治疗手术后（包括活检、次全切或全切）携带IDH1/2突变的2级星形细胞瘤或少突胶质细胞瘤的12岁及以上患者。2024年9月30日，中枢神经系统癌症NCCN指南从2024V2版更新升级为2024V3版，纳入Vorasidenib并扩大其适应症范围，具体更新内容如下：在GLIO-A 2/9和GLIO-A 4/9页面中的以下4个临床场景中添加靶向IDH1或IDH2突变的Vorasidenib作为治疗选择： 01 作为手术/活检后的辅助治疗方案，用于RT和化疗不是首选、WHO2级、KPS≥60的患者： ►少突胶质细胞瘤（1类），首选 ►IDH突变的星形细胞瘤（1类），首选 ►注脚修改：Vorasidenib是IDH1和IDH2突变的双重抑制剂。在一项Vorasidenib对比安慰剂的3期研究中（Mellinghoff IK, et al.N Engl J Med 2023;389:589-601），在病灶残留或复发的2级IDH突变胶质瘤患者（手术后且未接受治疗）中，与安慰剂相比，Vorasidenib改善了中位PFS（27.7个月vs 11.1个月）。虽然Vorasidenib的FDA批准程序仍在进行中，但符合条件的新诊断的WHO2级疾病患者可以通过扩大准入计划（NCT05592743）获得Vorasidenib。同样适用于GLIO-2A、GLIO-4A页面的脚注k。 02 作为辅助治疗方案，用于KPS <60、WHO2级的患者 ►少突胶质细胞瘤（2A类），在某些情况下适用 ►IDH突变星形细胞瘤（2A类），在某些情况下适用 03 作为RT+化疗后复发或进展性疾病的治疗方案，用于WHO2级、KPS≥60的患者 ►少突胶质细胞瘤（2A类），首选 ►IDH突变星形细胞瘤（2A类），首选 04 作为复发或进展性疾病的治疗方案，用于KPS ≥60的患者 ►少突胶质细胞瘤，WHO3级（2B类），首选 ►IDH突变型星形细胞瘤，WHO3级或4级（2B类），首选 ▼IDH突变、1p19q共缺失的少突胶质细胞瘤：系统治疗方案选择 ▼IDH突变的星形细胞瘤：系统治疗方案选择二、胶质瘤分子标志物相关的靶免药物汇总 2.1 获批或指南推荐检测的分子标志物及其药物 1 靶向药物分子标志物：IDH1/2 异柠檬酸脱氢酶（IDH）是三羧酸循环中的一种关键性限速酶，包括IDH1、IDH2和IDH3这3种异构酶，其功能是催化异柠檬酸生成α-酮戊二酸（α-KG）。IDH的特定突变会导致α-KG的代谢异常，D-2-羟戊二酸（D-2-HG）高浓度积累，引起基因的表观修饰异常和氧化还原失衡。超过90%的IDH基因突变为IDH1 R132 突变（常见R132H突变），其余为IDH2 R172突变。 ▼胶质瘤中IDH突变频率、突变类型及其占比 Vorasidenib Vorasidenib（AG-881）是首个获批应用于胶质瘤中的IDH抑制剂。其获批基于INDIGO临床试验（NCT04164901），该试验是一项3期、多中心、随机、双盲、安慰剂对照研究，比较了Vorasidenib与安慰剂在仅接受过手术治疗的IDH1或IDH2突变的2级胶质瘤（少突胶质瘤、星形细胞瘤）残余或复发性患者中的疗效。试验数据显示，Vorasidenib的客观缓解率（ORR）为18%，包括1例部分缓解（PR）和3例轻微缓解（MR）。使用该药物观察到的无强化低级别胶质瘤患者的中位无瘤生存期为36.8个月（95%CI：11.2-40.8个月），强化胶质瘤患者的中位无瘤生存期为3.6个月（95%CI：1.8-6.5个月）。此外，在多名患者中观察到持续的肿瘤缩小。研究结论指出：在2级IDH突变胶质瘤患者中，Vorasidenib显著提高了无进展生存期，并延迟了下一次干预的时间。艾伏尼布艾伏尼布是首个获指南推荐应用于胶质瘤的IDH1抑制剂。该推荐基于以下研究结果：在66例晚期胶质瘤患者中，艾伏尼布耐受性良好，无剂量限制性毒性报道。未达到最大耐受剂量；扩大队列选择500毫克，每天一次。≥ 3 级不良事件发生率为19.7%；3% （n= 2）被认为与治疗有关。非增强型胶质瘤患者（n = 35），客观缓解率为2.9%，部分缓解1例。35例非增强型胶质瘤患者中有30例（85.7%）病情稳定，而31例增强型胶质瘤患者中有14例（45.2%）病情稳定。非增强型和增强型胶质瘤组的中位无进展生存期分别为13.6个月（95% Cl：9.2-33.2个月）和1.4个月（95% Cl：1.0-1.9个月）。在探索性分析中，艾伏尼布降低了非增强性肿瘤的体积和生长速度。结论：在mIDH1晚期胶质瘤患者中，艾伏尼布 500 mg /天1次具有良好的安全性、延长疾病控制时间和减少非增强性肿瘤的生长。目前，还有多款在研的IDH抑制剂，如Olutasidenib、DS-1001（AB-218）的初步研究已表明其在胶质瘤中具有较好的临床应用前景。 2 靶向药物分子标志物：BRAF突变/融合、NF1突变 BRAF基因变异会导致下游MEK/ERK信号通路持续激活，促进肿瘤的生长增殖和侵袭转移。在不同的脑胶质瘤中，BRAF变异的形式不同，主要包括BRAF融合和BRAF V600E。在毛细胞星形细胞瘤（PA，WHO 1级）中高发KIAA1549-BRAF融合（约60%-70%），被认为是PA的诊断标志物。在各个级别的胶质瘤中均检测到BRAF V600E突变，在多形性黄色星形细胞瘤（PXA，WHO 2/3级）中约为70%，在上皮样胶质母细胞瘤中约为50%，在胚胎发育不良性神经上皮瘤（DNET）中约为30%，在节细胞胶质瘤（WHO 1级）中约50%，在PA中约为10%。BRAF基因变异是儿童低级别胶质瘤（LGG）中最常见的致癌驱动因素。神经纤维瘤病1型（NF1）是最常见的常染色体显性肿瘤易感性综合征，由NF1基因胚系突变导致。高达30%的NF1患者会在20岁前患脑肿瘤，其中大部分是低级别胶质瘤，最常见于视觉通路，最常见的病理学亚型是PA。 ▼各类型胶质瘤中 BRAF基因变异频率 ▼常见BRAF融合的断点频率针对BRAF基因变异，NCCN指南推荐用于胶质瘤的靶向药物有：达拉非尼+曲美替尼、维莫非尼±考比替尼、司美替尼，已获药监局批准的药物有Tovorafenib、达拉非尼+曲美替尼。针对NF1基因突变，NCCN指南推荐药物有司美替尼。 Tovorafenib 2024年4月23日，FDA加速批准Tovorafenib（RAF抑制剂）用于BRAF基因融合/重排或BRAF V600突变的6个月及以上复发或难治性儿童低级别胶质瘤患者。这是首个获批用于BRAF融合/重排脑胶质瘤适应症的RAF抑制剂，其获批是基于一项多中心、开放标签、单臂临床试验FIREFLY-1（NCT04775485，II期）的研究结果。FIREFLY-1旨在评估Tovorafenib作为每周一次的单药疗法治疗6个月至25岁患有复发或进展性pLGG患者的疗效与安全性，研究共纳入137名患者（第1组：77名患者携带已知的BRAF激活突变，第2组：60名患者携带已知的RAF变异）。研究结果显示，在第1组RAPNO-LGG标准可评估的76例患者中，最佳ORR为51%，其中包括28例PR（37%）和11例MR（14%），中位持续响应时间（DoR）为13.8个月（95%CI：11.3-NE[不可估计]）。目前正在开展全球III期试验LOGGIC/FIREFLY-2（NCT05566795），旨在评估新诊断的LGG患者每周一次的Tovorafenib单药疗法，入组患者均具有已知的激活RAF改变。司美替尼 NCCN指南推荐用于BRAF变异包括BRAF V600E突变或BRAF融合和NF1突变的复发或进展性局限性胶质瘤成人患者。该推荐基于一项多中心 II 期试验（NCT01089101）的第1组和第3组研究结果：司美替尼对复发性、难治性或进展性伴有常见BRAF变异的PA和NF1相关pLGG具有活性。第1组包括患有WHO 1级毛细胞星形细胞瘤（PA）的儿童，25例符合条件且可评估的肿瘤中有18例（72%）具有 KIAA1549-BRAF融合，有7例（28%）具有BRAF V600E 突变。9例（36%）患者达到PR，9例（36%）疾病稳定（SD）和7例（28%）疾病进展（PD）。2年PFS为70%（95%CI：47%−85%）。在具有 KIAA1549-BRAF 融合的肿瘤中7例（38.9%）PR，而在BRAF V600E肿瘤中2例（28.6%）PR 。第3组包括25例患有任何NF1相关pLGG（WHO 1级和2级）的儿童接受治疗。10例（40%）患者达到 PR，15例（60%） SD和1例（4%）PD。2年PFS为96%（95% CI：74%-99.4%）。 3 靶向分子标志物：MET融合脑胶质瘤中MET异常形式主要有MET融合、MET ex14跳突、MET扩增及MET蛋白过表达；约12%脑胶质瘤被发现存在MET融合，其中PTPRZ1-MET（简称ZM）融合通常与MET ex14跳突同时出现在既往有低级别病史的胶质母细胞瘤中，发生率约为14%，并与更差的预后相关。 ▼MET融合断点（A）及其在5个癌种中的情况（B）和伴侣基因染色体分布（C）注：BC：脑癌，LC：肺癌，IC：小肠癌，GC：胃癌，BDC：胆管癌伯瑞替尼伯瑞替尼（Vebreltinib，PLB-1001）是一种高选择性MET抑制剂，于2024年4月23日获得NMPA批准用于既往治疗失败的具有PTPRZ1-MET融合基因的IDH突变型星形细胞瘤（WHO 4级）或有低级别病史的胶质母细胞瘤成人患者。这使其成为我国首个获批治疗脑胶质瘤MET异常患者的靶向药。获批主要是基于一项随机、对照、开放、多中心的II/III期临床研究（FUGEN，NCT06105619），该研究旨在对比伯瑞替尼与TMZ剂量密度方案或依托泊苷+顺铂方案的安全性和有效性。截至2023年12月，该研究共纳入了84例患者。结果显示，相较于TMZ剂量密度方案或顺铂联合依托泊苷方案，伯瑞替尼单药方案mOS为6.31个月，对照组为3.38个月，降低48%的死亡风险，可显著改善ZM融合脑胶质瘤患者生存。整体安全耐受，常见不良反应多为1-2级，可通过临床管理恢复。 4 靶向药物分子标志物：NTRK融合编码TRK融合蛋白（TRKA、TRKB、TRKC）的基因包括NTRK1、NTRK2或NTRK3的基因，这些基因融合蛋白增加了激酶功能，并与许多实体瘤发生有关。大约0.55-2%的胶质瘤/神经上皮肿瘤含有NTRK融合，但在儿童高级别胶质瘤（HGG）中NTRK融合发生率可能高达5.3%，弥漫性内生性脑桥胶质瘤（DIPG）达4%，3岁以下非脑干HGG达40%。 ▼中枢神经系统肿瘤中NTRK融合的发生率及高频的融合基因类型小分子TRK抑制剂拉罗替尼（Larorectinib，FDA/NMPA）、恩曲替尼（Entrectinib，FDA/NMPA）、瑞普替尼（Repotrectinib，FDA）已在成人和儿童各种癌症的多项试验中显示出抗肿瘤活性，并已获得国内外药监局批准用于NTRK融合的实体瘤患者。目前，针对NTRK融合的成人复发或进展性胶质母细胞瘤以及儿童HGG患者，NCCN指南推荐首选拉罗替尼和恩曲替尼；针对成人患者，2024.V2版NCCN指南新增推荐了瑞普替尼。瑞普替尼瑞普替尼获批基于多中心、单臂、开放标签的I/II期临床试验TRIDENT-1（NCT03093116），该研究纳入了3例TKI经治的胶质母细胞瘤患者，ORR为33.3%，DoR为23.5个月。文献研究报道一名2岁的女性婴儿半球型脑胶质瘤，伴有ZBTB43-NTRK2融合和CDKN2A/2B半合子缺失，在左额颞肿瘤首次手术切除后，接受了诱导化疗，自体外周血干细胞移植（aPBSCT）联合卡铂和塞替派，以及质子治疗（55.8 Gy）。第二次手术切除残留肿瘤后，参加了口服瑞普替尼的临床试验，在3年随访期间未发生疾病复发。 ▼瑞普替尼在TKI经治的NTRK融合胶质母细胞瘤患者中的疗效 ▼NTRK融合的婴儿半球型脑胶质瘤的治疗过程 5 免疫药物分子标志物：超突变遗传性癌症易感性综合征CMMRD（结构性错配修复缺陷综合征，由MMR基因[MLH1、PMS2、MSH2、MSH6]的双等位基因突变导致）经常导致儿童弥漫性高级别胶质瘤的发展，其特点是比偶发脑肿瘤或其他实体肿瘤具有更高的突变负荷。由此产生的超突变肿瘤可能对免疫检查点抑制敏感。针对超突变的复发或进展性的儿童中枢神经系统肿瘤患者，NCCN指南推荐首选纳武利尤单抗、帕博利珠单抗。然而，其有效性的证据目前仅限于病例报告和单一机构的经验。 ▼CMMRD和林奇综合征的遗传模式图（林奇综合征为MMR基因杂合突变，CMMD为MMR基因双等位基因突变）一项研究报告了两个患有复发性多灶性GBM的bMMRD（biallelic MMR deficiency syndrome，同CMMRD）的姐弟，存在POLE突变和高肿瘤突变负荷（预测具有较高的新生抗原），接受了抗程序性死亡-1（PD-1）抑制剂纳武利尤单抗的治疗，在几个月的治疗后，这两个孩子的临床和放射学反应都很明显。另一项案例研究报道，一例5岁女孩存在纯合MSH6 c.1883G>A 突变而患有GBM和CMMRD，接受免疫检查点抑制剂（ICI）纳武利尤单抗治疗，肿瘤缩小了60%，临床症状得到改善，响应持续10个月。研究表明，将CMMRD的基因组和/或分子检测纳入常规儿科肿瘤学临床护理可以确定可能从ICI中受益的患者亚群。一项在丹娜-法伯/波士顿儿童医院对11例复发性或难治性中枢神经系统肿瘤儿童患者进行的回顾性研究显示，免疫检查点抑制剂在儿童患者中具有相当好的耐受性，值得进一步的临床试验研究。 2.2 临床试验/案例报道的其他分子标志物及药物 1 靶向药物分子标志物：ALK融合婴儿半球胶质瘤携带 ALK、ROS1、NTRK1/2/3 或MET受体酪氨酸激酶重排，与其他儿科高级别胶质瘤相比，更适合治疗，生存结果更好。一名3岁的婴儿半球胶质瘤患者肿瘤细胞显示ALK 具有弥漫性免疫反应，RNA 测序显示SPECC1L-ALK融合，于是采用ALK抑制剂洛拉替尼治疗，至8个月，仅残余较小的肿瘤，实行探查性手术后未发现肿瘤，停止治疗6 个月后疾病进展，恢复洛拉替尼治疗，治疗一个月实现几乎完全缓解。另一项案例研究报道，一名3岁婴儿型半球胶质瘤，DNA测序检出QKI-ALK融合，经常规放化疗治疗进展后，采用阿来替尼治疗2个月左右，治疗期间发生肺部转移，更换为洛拉替尼治疗，实现脑部和肺部病灶的完全缓解。 2 靶向药物分子标志物：FGFR变异约有8%的胶质瘤患者会发生FGFR基因组改变，尤其是FGFR1和FGFR3，并且在约3%-5%的GBM患者中存在FGFR3-TACC3（F3T3）融合突变。研究表明F3T3融合是染色体4p16上70kb区域串联复制的结果，通常伴有低水平的局灶扩增，存在该基因融合的肿瘤细胞大量表达嵌合蛋白。FGFR1-TACC1（F1T1）融合在特定的低级别胶质瘤(如室外神经细胞瘤)中可达60%。文献报道1例胶质母细胞瘤患者，携带FGFR3扩增和FGFR3-TACC3融合，经安罗替尼和替莫唑胺治疗2个月后实现部分缓解。原发性脊髓胶质母细胞瘤（PSC GBM）检出FGFR3 p.S249C，接受10个周期的安罗替尼联合伊立替康化疗，随访约10个月期间，患者症状明显减轻，疗效得以维持。有文章报道，两例携带有FGFR3-TACC3融合突变的GBM患者，在接受安罗替尼治疗后疾病得到持续缓解。一项在复发性胶质瘤患者（携带FGFR改变）中进行的多中心II期临床研究（NCT01975701）数据显示，26名接受FGFR抑制剂Infigratinib治疗的患者的6个月PFS率为16.0%，中位PFS为1.7个月，客观缓解率为3.8%。但是4名携带FGFR1（K656E，n = 2) 或FGFR3（ K650E; n = 1）点突变或FGFR3-TACC3融合突变的肿瘤患者疾病控制持续时间超过1年。另外一项临床研究（NCT04083976）报道了FGFR抑制剂厄达替尼在具有FGFR改变的14种实体瘤体治疗中的有效性，其中30名高级别胶质瘤患者的ORR为20%。一项佩米替尼的II期临床研究纳入9例为F3T3融合的胶质瘤（共纳入13例FGFR变异），1例完全缓解，1例部分缓解，2例疾病稳定。目前一项旨在评估佩米替尼在先前治疗过的胶质母细胞瘤或其他原发性中枢神经系统肿瘤患者（携带FGFR1-3改变，包括融合/重排，激活突变或框内缺失）中的疗效和安全性的研究（NCT05267106，II期）正在进行招募中。一项关于Zoligratinib（Debio-1347）的单中心研究纳入5例FGFR变异的儿童胶质瘤患者，1例F3T3融合，1例F1T1融合，在融合的患者中1例PR，1例SD。参考资料【1】 Shen D , Zhang J , Yuan K ,et al.Landscape of IDH1/2 mutations in Chinese patients with solid tumors: A pan-cancer analysis[J].Molecular Genetics & Genomic Medicine, 2021.DOI:10.1002/mgg3.1697. 【2】Watts JM, Baer MR, Yang J, et al. 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Genomic context of NTRK1/2/3 fusion-positive tumours from a large real-world population [published correction appears in NPJ Precis Oncol. 2021 Sep 17;5(1):86]. NPJ Precis Oncol. 2021;5(1):69. Published 2021 Jul 20. doi:10.1038/s41698-021-00206-y 【27】Fangusaro J, Onar-Thomas A, Young Poussaint T, et al. Selumetinib in paediatric patients with BRAF-aberrant or neurofibromatosis type 1-associated recurrent, refractory, or progressive low-grade glioma: a multicentre, phase 2 trial. Lancet Oncol. 2019;20(7):1011-1022. doi:10.1016/S1470-2045(19)30277-3 【28】Brown NF, Carter T, Kitchen N, Mulholland P. Dabrafenib and trametinib in BRAFV600E mutated glioma. CNS Oncol. 2017;6(4):291-296. doi:10.2217/cns-2017-0006 【29】Marks AM, Bindra RS, DiLuna ML, et al. Response to the BRAF/MEK inhibitors dabrafenib/trametinib in an adolescent with a BRAF V600E mutated anaplastic ganglioglioma intolerant to vemurafenib. Pediatr Blood Cancer. 2018;65(5):e26969. doi:10.1002/pbc.26969 【30】Mellinghoff IK, Ellingson BM, Touat M, et al. Ivosidenib in Isocitrate Dehydrogenase 1-Mutated Advanced Glioma. J Clin Oncol. 2020;38(29):3398-3406. doi:10.1200/JCO.19.03327 【31】Hou Z, Wu H, Luo N, et al. Almonertinib Combined with Anlotinib and Temozolomide in a Patient with Recurrent Glioblastoma with EGFR L858R Mutation. Oncologist. 2023;28(5):449-452. doi:10.1093/oncolo/oyac280 【32】Neyns B, Sadones J, Joosens E, et al. Stratified phase II trial of cetuximab in patients with recurrent high-grade glioma. Ann Oncol. 2009;20(9):1596-1603. doi:10.1093/annonc/mdp032 【33】Bagchi A, Orr BA, Campagne O, et al. Lorlatinib in a Child with ALK-Fusion-Positive High-Grade Glioma. N Engl J Med. 2021;385(8):761-763. doi:10.1056/NEJMc2101264 【34】Lai M, Li S, Li H, et al. Lorlatinib for ALK-fused, infant-type hemispheric glioma with lung metastasis: a case report. Ann Clin Transl Neurol. 2023;10(5):836-841. doi:10.1002/acn3.51766 【35】Wen PY, Stein A, van den Bent M, et al. Dabrafenib plus trametinib in patients with BRAFV600E-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial. Lancet Oncol. 2022;23(1):53-64. doi:10.1016/S1470-2045(21)00578-7 【36】Mellinghoff IK, Ellingson BM, Touat M, et al. Ivosidenib in Isocitrate Dehydrogenase 1-Mutated Advanced Glioma. J Clin Oncol. 2020;38(29):3398-3406. doi:10.1200/JCO.19.03327 【37】Ivosidenib off-label use for IDH mutant gliomas: The MD Anderson Cancer Center real life experience.Meeting Abstract | 2023 ASCO Annual Meeting I.DOI: 10.1200/JCO.2023.41.16_suppl.e14022 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) e14022-e14022. 【38】Miller JJ, Gonzalez Castro LN, McBrayer S, et al. Isocitrate dehydrogenase (IDH) mutant gliomas: A Society for Neuro-Oncology (SNO) consensus review on diagnosis, management, and future directions. Neuro Oncol. 2023;25(1):4-25. doi:10.1093/neuonc/noac207 【39】https://fore.bio/fore-biotherapeutics-to-present-promising-new-data-from-phase-1-2a-trial-evaluating-plixorafenib-fore8394-in-patients-with-braf-altered-advanced-solid-and-central-nervous-system-tumors-at-asco-2023/ 【40】https://fore.bio/fore-biotherapeutics-announces-oral-presentation-at-sno-2023-reporting-updated-phase-1-2a-results-for-plixorafenib-in-braf-v600-advanced-solid-tumors-including-novel-data-for-patients-with-braf-v600/ 声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

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2024-10-16

·GlobeNewswire-Health Care

Optime Care Expands Partnership with Rigel Pharmaceuticals to Include Commercial Distribution for TAVALISSE®

ST. LOUIS, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Optime Care, a nationally recognized specialty pharmacy and an AscellaHealth Company, today announces an expanded arrangement with Rigel Pharmaceuticals, Inc, effective October 14, 2024, to include commercial distribution of TAVALISSE® (fostamatinib). TAVALISSE is an oral medicine that can help patients manage chronic immune thrombocytopenia (ITP) by protecting their platelets from destruction. “Under this expanded agreement, Optime Care will now manage commercial distribution for three Rigel products: TAVALISSE, GAVRETO® (pralsetinib) and Rezlidhia® (olutasidenib),” says Stephanie Wasilewski, PharmD, general manager, Optime Care. “This new phase of our collaboration reflects Rigel Pharmaceuticals’ ongoing confidence in Optime Care’s ability to support highly specialized patient populations while optimizing patient outcomes. Our patient access and HUB services, including patient assistance programs (PAP), co-pay assistance and reimbursement support, are critical to delivering a high standard of care." Optime Care is recognized for its comprehensive patient support programs that integrate pre-commercialization expertise, distribution and national medication fulfillment. The company’s high-touch patient care model ensures seamless treatment transitions through high-touch patient support and HUB services designed to enhance patient outcomes. This collaboration marks another milestone in Optime Care’s ongoing mission to support patients with rare and complex diseases. “Optime Care continues to prove itself as a valuable partner in delivering our therapies to patients who need them most,” says Scott Yohe, VP, market access, Rigel Pharmaceuticals. “Their comprehensive approach to patient care and deep understanding of complex disease states make Optime Care a great choice to help us bring TAVALISSE, along with our other therapies, to patients nationwide. We look forward to continuing our successful collaboration.” Wasilewski notes that Rigel Pharmaceuticals selected Optime Care as a partner for the distribution of TAVALISSE based on our proven expertise in managing rare and chronic conditions, alongside a demonstrated ability to deliver superior patient support services. “Our services include patient intake, prescription fulfillment, prior authorization support and financial assistance programs,” she continues. “This collaboration underscores our ability to scale our support while maintaining the highest level of care for all patients.” Optime Care specialists excel in communication, optimizing the patient journey through personalized clinical guidance and ongoing support for patients and their families. Their deep understanding of complex, chronic diseases enhances patient access to essential therapies, streamlines care coordination and ensures that financial assistance is available for those who need it. About Optime CareOptime Care, Inc., an AscellaHealth Company, is a nationally recognized specialty pharmacy, distribution and patient management organization offering a suite of comprehensive services tailored to maximize therapeutic opportunities for the treatment of orphan and rare disorders. The executive team has partnered in the launch and management of over 40 orphan products and programs while consistently implementing the best brand services for the community. Optime Care has dual-accreditation from the Utilization Review Accreditation Commission (URAC) for compliance with specialty pharmacy and the Accreditation Commission for Health Care (ACHC) for specialty pharmacy services that demonstrate a commitment to providing quality care and services to consumers. Visit www.ascellahealth.com About RigelRigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com. About TAVALISSE® TAVALISSE is a prescription medication used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when a prior treatment for ITP has not worked well enough. It is not known if TAVALISSE is safe and effective in children. What is the most important information I should know about TAVALISSE? TAVALISSE can cause serious side effects including: High blood pressure (hypertension). New or worsening high blood pressure is common in people treated with TAVALISSE and can be severe. Your healthcare provider will check your blood pressure regularly during treatment with TAVALISSE. If needed, your healthcare provider may start you on blood pressure medicine or change your current medicine to treat your blood pressure. Tell your healthcare provider if you get headaches, confusion, dizziness, chest pain, or shortness of breath.Liver problems. Changes in liver function blood tests are common with TAVALISSE. Liver problems may occur and can be severe. Your healthcare provider will regularly do blood tests to check how well your liver is working during treatment with TAVALISSE.Diarrhea. Diarrhea is common in people treated with TAVALISSE and can be severe. Tell your healthcare provider if you get diarrhea during treatment with TAVALISSE. Your healthcare provider may recommend changes in your diet, drinking more water, or medicine to limit these symptoms.Decreases in white blood cell count (neutropenia). Decreases in your white blood cell count are common with TAVALISSE and can be severe. This may increase your risk for infection, including serious infections. Your healthcare provider will regularly do blood tests to check your white blood cell counts. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TAVALISSE if you have side effects. What do I need to discuss with my healthcare provider before taking TAVALISSE? Before you take TAVALISSE, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressurehave liver problemsare pregnant or plan to become pregnant. TAVALISSE can harm your unborn baby. Your healthcare provider will check if you are pregnant before starting treatment with TAVALISSE.Females who can become pregnant should use effective birth control during treatment with TAVALISSE and for at least 1 month after the last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TAVALISSE with certain other medicines may affect how the other medicines work or how TAVALISSE works. What are the possible side effects of TAVALISSE? The most common side effects of TAVALISSE include: Nausea, rash, dizziness, tiredness, respiratory infection, chest pain, and stomach (abdomen) pain. These are not all the side effects of TAVALISSE. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA, at 1-800-FDA-1088. This press release was published by a CLEAR® Verified individual.

2024-09-06

·drugs

First Patient Enrolled in Phase 1b/2 Triplet Therapy Trial of REZLIDHIA in mIDH1 AML

SOUTH SAN FRANCISCO, Calif., Sept. 5, 2024. Rigel Pharmaceuticals, a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the first patient has been enrolled in a Phase 1b/2 triplet therapy trial of decitabine and venetoclax in combination with REZLIDHIA (olutasidenib) in patients with mutated isocitrate dehydrogenase- 1 (mIDH1) acute myeloid leukemia (AML). REZLIDHIA is a potent, selective, oral, small-molecule inhibitor of mIDH11, designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells, that is approved for the treatment of relapsed or refractory (R/R) mIDH1 AML. The clinical trial is sponsored and is being conducted by The University of Texas MD Anderson Cancer Center (MD Anderson) and opened for enrollment in August (NCT06445959). The trial is led by principal investigator Courtney DiNardo, M.D., MSCE, Professor of Leukemia at MD Anderson. It is a multi-center, open-label, non-randomized clinical trial, with the Phase 1b part of the trial seeking to determine the safety and tolerability and recommended Phase 2 dose of oral or intravenous (IV) decitabine and venetoclax in combination with olutasidenib in mIDH1 R/R patients. The Phase 2 part of the trial will include 60 patients and its primary objective is to determine the complete remission rate in both newly diagnosed (n=30) and R/R mIDH1 AML patients (n=30). This is the first trial in Rigel's multi-year strategic development alliance with MD Anderson. "We believe REZLIDHIA has strong potential in a wide range of cancers where mIDH1 plays an important role. Studying REZLIDHIA in combination with two widely used agents in AML could provide a new all-oral front-line option to patients who are in urgent need of innovative treatments," said Raul Rodriguez, Rigel's president and CEO. "MD Anderson is the ideal partner on this journey to evaluate REZLIDHIA's impact on AML and other hematological cancers. We are excited to have the first patient enrolled in this initial trial in mIDH1 AML." As part of the strategic alliance with MD Anderson related to IDH1 mutated hematologic neoplasms, Rigel and MD Anderson will evaluate the potential of olutasidenib in combination with other agents to treat newly diagnosed and R/R patients with AML, higher-risk myelodysplastic syndromes (MDS) and advanced myeloproliferative neoplasms (MPN). The alliance will also support the evaluation of olutasidenib as monotherapy in clonal cytopenia of undetermined significance (CCUS), lower-risk MDS and as maintenance therapy in post-hematopoietic stem cell transplant patients. About AML Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 20,800 new cases in the United States, most in adults, in 2024. 2 Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow. 3 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment. 4 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need. About Rigel Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. References Forward-Looking Statements This press release contains forward-looking statements relating to, among other things, the potential of REZLIDHIA (olutasidenib), both as a monotherapy and in combination with other agents, as a therapeutic for R/R AML and the potential of REZLIDHIA as a therapy for a broad range of mIDH1 cancers including higher-risk myelodysplastic syndromes (MDS), advanced myeloproliferative neoplasms (MPN), clonal cytopenia of undetermined significance (CCUS), lower-risk MDS and as maintenance therapy in post-hematopoietic stem cell transplant patients, and the benefits of Rigel's collaboration with MD Anderson Cancer Center. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "potential", "may", "will" and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks and uncertainties and are subject to changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, the risks and uncertainties of clinical trials and drug development; risks and uncertainties of commercialization and marketing of olutasidenib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that olutasidenib may have unintended side effects, adverse reactions or incidents of misuse; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law. SOURCE Rigel Pharmaceuticals, Inc. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床2期临床1期

100 项与 Olutasidenib 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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适应症	国家/地区	公司	日期
IDH1突变急性髓性白血病	美国	Rigel Pharmaceuticals, Inc.	2022-12-01

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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
难治性急性髓细胞白血病	临床3期	美国	Rigel Pharmaceuticals, Inc.	2022-01-30
难治性急性髓细胞白血病	临床3期	美国	Forma Therapeutics Holdings, Inc.	2022-01-30
高危骨髓增生异常综合征	临床2期	美国	Rigel Pharmaceuticals, Inc.	2025-03-11
IDH1突变胶质瘤	临床2期	美国	Rigel Pharmaceuticals, Inc.	2025-03-11
骨髓增生性疾病	临床2期	美国	Rigel Pharmaceuticals, Inc.	2025-03-11
意义不明的克隆性血细胞减少症	临床2期	美国	Rigel Pharmaceuticals, Inc.	2025-02-28
慢性粒单核细胞白血病	临床2期	美国	Rigel Pharmaceuticals, Inc.	2025-02-28
髓系肿瘤	临床2期	美国	The University of Texas MD Anderson Cancer Center	2024-12-31
星形细胞瘤	临床2期	美国	Rigel Pharmaceuticals, Inc.	2024-06-01
星形细胞瘤	临床2期	澳大利亚	Rigel Pharmaceuticals, Inc.	2024-06-01

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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


NCT03684811 (ESMO2024) 人工标引	临床1/2期	软骨肉瘤 IDH1 Mutation	23	Olutasidenib 150mg BID	鬱醖顧窪廠積夢構齋鑰(齋壓襯製鹽窪鹽夢積範) = 繭願鏇廠窪憲獵衊積膚顧膚顧淵願膚繭鬱淵積 (簾廠鹽顧願壓網鬱衊築, 1.71 ~ 4.88) 更多	积极	2024-09-13
				Olutasidenib 150mg BID (conventional chondrosarcomas)	鬱醖顧窪廠積夢構齋鑰(齋壓襯製鹽窪鹽夢積範) = 獵衊齋鏇願窪鏇夢觸齋顧膚顧淵願膚繭鬱淵積 (簾廠鹽顧願壓網鬱衊築, 1.74 ~ 5.10) 更多
NCT02719574 (ASCO2024) 人工标引	临床2期	IDH1突变急性髓性白血病 IDH1 Mutation	16	Olutasidenib	廠壓窪壓衊築積獵淵鏇(顧製淵構鬱廠鏇鹽鹽鹹) = 鏇積積鹽獵築觸膚艱繭壓齋製積艱醖鏇艱鹹網 (艱網鏇獵淵獵壓鏇窪壓 ) 更多	积极	2024-05-24
NCT02719574 (ASCO2024) 人工标引	临床2期	IDH1突变急性髓性白血病 IDH1 Mutation	153	Olutasidenib	淵繭獵憲網鑰襯糧鑰糧(蓋製夢壓襯築簾鏇構憲) = 窪艱壓遞積糧選膚觸鹹鬱製繭獵願願願壓餘襯 (繭膚鹽夢願蓋選網膚壓, 24.5-40.2) 更多	积极	2024-05-24
				Olutasidenib (prior venetoclax)	淵繭獵憲網鑰襯糧鑰糧(蓋製夢壓襯築簾鏇構憲) = 艱選製鹹顧顧鏇鏇顧膚鬱製繭獵願願願壓餘襯 (繭膚鹽夢願蓋選網膚壓 ) 更多
NCT02719574 (ASCO2024) 人工标引	临床2期	IDH1突变急性髓性白血病	45	Olutasidenib (Age ≥75 years)	範鬱築鏇艱齋願壓願簾(鑰鬱襯廠構觸範選願壓) = 製壓觸衊顧窪夢醖膚網廠夢繭範鹹鬱鑰築糧構 (鹽遞簾淵繭範築淵夢艱 ) 更多	积极	2024-05-24
NCT02719574 (EHA2024) 人工标引	临床2期	IDH1突变急性髓性白血病 IDH1 Mutation	16	Olutasidenib ±azacitidine	餘壓簾壓窪膚觸廠醖壓(顧窪壓夢簾範憲繭構顧) = 廠襯積遞夢鏇衊壓鹹艱觸衊築淵鹹鬱鬱糧餘獵 (製願積簾鹹窪鬱衊鹹淵 ) 更多	积极	2024-05-14
				Olutasidenib	餘壓簾壓窪膚觸廠醖壓(顧窪壓夢簾範憲繭構顧) = 積簾鏇醖願範築選醖遞觸衊築淵鹹鬱鬱糧餘獵 (製願積簾鹹窪鬱衊鹹淵 ) 更多
Phase 2 registrational study (EHA2024)	临床2期	急性髓性白血病 mIDH1	18	Olutasidenib 150mg BID alone	鑰鹹鹹範遞製鏇壓衊製(膚獵鏇觸簾網築鑰觸衊) = 積鹹醖鏇窪願網窪製選積鹽鬱餘餘鹹膚範膚憲 (構膚鹽範蓋網觸顧鹹製 ) 更多	积极	2024-05-14
				Olutasidenib 150mg BID + azacitidine	鑰鹹鹹範遞製鏇壓衊製(膚獵鏇觸簾網築鑰觸衊) = 構膚鹹窪衊廠築鬱範衊積鹽鬱餘餘鹹膚範膚憲 (構膚鹽範蓋網觸顧鹹製 ) 更多
NCT02719574 (ASH2023)	临床1/2期	骨髓增生异常综合征	22	Olutasidenib	觸蓋壓鹹衊壓鑰積鏇糧(顧壓製鬱壓蓋衊夢獵獵) = 淵遞繭襯願願壓餘鹹淵繭範範醖窪獵淵遞蓋積 (繭醖齋積積繭艱選窪壓 ) 更多	-	2023-12-09
EHA2023	临床2期	IDH1突变急性髓性白血病	17	Olutasidenib 150 mg twice daily in combination with azacitadine (AZA)	簾廠鑰願壓窪遞製鹽餘(膚齋鹹築壓齋構廠憲醖) = 壓鏇廠淵淵構窪鏇獵鏇範選獵膚襯壓選構憲襯 (繭糧鬱鹹窪膚淵淵築壓 )	-	2023-06-08
NCT02719574 (ASCO2023) 人工标引	临床2期	急性髓性白血病 IDH1 Mutation	17	Olutasidenib 150 mg ± azacitadine	窪願廠憲夢齋選鹽築繭(鏇鹹醖範製積夢夢衊襯) = 蓋願鏇廠築蓋選衊獵餘鹹鏇獵壓艱夢鬱觸廠餘 (願衊餘簾構衊醖醖鬱餘 ) 更多	积极	2023-05-31
				Olutasidenib 150 mg ± azacitadine (patients who previously received the combination of VEN-AZA)	襯願鏇獵鹹鑰遞憲膚網(齋積願艱範窪獵廠構齋) = 製餘鹹網鹹鹽襯淵獵廠鹹齋齋壓壓獵夢醖範蓋 (鑰窪網願糧艱齋構網齋 )
NCT02719574 (Pubmed)	临床1/2期	IDH1突变急性髓性白血病	153	Olutasidenib 150 mg	遞獵壓窪鑰醖鑰憲製蓋(觸遞糧醖窪襯淵醖鏇齋) = 範網鑰鏇築壓鑰範鏇鬱鏇餘選壓鏇願窪壓網鏇 (襯壓網遞範顧範糧襯齋, 27.0 ~ 43.0) 更多	积极	2023-02-01