Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells.
This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance.
The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".

开始日期2025-09-01

申办/合作机构

Kura Oncology, Inc.

NCT06769490

/ Not yet recruiting临床1期

Phase 1 Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

The goal of this all-oral combination is to deliver safe and effective therapy for the largest portion of AML subtypes (NPM1mt, KMT2Ar, NUP98r
40-45%).

开始日期2025-06-30

申办/合作机构-

NCT06930352

/ Not yet recruiting临床2期IIT

Frontline Ziftomenib in NPM1-Mutated or KMT2A-Rearranged Acute Myeloid Leukemia in Patients Not Eligible for Intensive Induction or Other Therapy

This phase II trial tests how well ziftomenib works in treating patients with NPM1 mutated or KMT2A rearranged acute myeloid leukemia (AML) and are not eligible to receive standard therapy. AML is often due to genetic changes in the cancer cells, including mutations in the NPM1 gene and rearrangements involving the KMT2A gene. These mutations result in activation of the menin pathway. Menin is a type of protein in the body that helps to regulate some of the naturally occurring processes in the body, but can also be involved in some types of cancers. Ziftomenib blocks this menin pathway and may prevent the cancer cells from continuing to grow. Giving ziftomenib may kill more cancer cells in patients with NPM1 mutated or KMT2A rearranged AML that are not eligible to receive standard therapy.

开始日期2025-06-01

申办/合作机构

Ohio State University Comprehensive Cancer Center

[+1]

100 项与 Ziftomenib 相关的临床结果

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100 项与 Ziftomenib 相关的转化医学

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100 项与 Ziftomenib 相关的专利（医药）

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项与 Ziftomenib 相关的文献（医药）

2025-09-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Menin inhibitors in KMT2A-rearranged and NPM1-mutated acute leukemia: A scoping review of safety and efficacy

Review

作者: Kalfah, Anas ; Dali, Sara Al ; Mohamed, Shehab F ; Al-Mashdali, Abdulrahman F

BACKGROUND:

Menin inhibitors represent a novel therapeutic approach targeting the Menin-KMT2A interaction in acute leukemias with KMT2A rearrangements or NPM1 mutations. This scoping review synthesizes current clinical evidence for emerging Menin inhibitors in development.

METHODS:

We systematically analyzed clinical trials, conference proceedings, and regulatory documents regarding Menin inhibitors in clinical development through December 2024. Primary outcomes included response rates, minimal residual disease (MRD) status, and safety profiles.

RESULTS:

Thirteen clinical trials investigating six Menin inhibitors (Revumenib, Ziftomenib, Bleximenib, BMF-219, DS-1594, and Enzomenib) were identified. Revumenib demonstrated consistent efficacy across five pivotal trials, achieving MRD-negative rates of 70-90% in both KMT2A-rearranged and NPM1-mutated leukemias, leading to FDA approval in November 2024. Ziftomenib showed particular efficacy in NPM1-mutated cases but exhibited a higher incidence of differentiation syndrome (30%) in KMT2A-rearranged patients. Bleximenib reported a 93% overall response rate, pending MRD validation. Early resistance emergence, primarily through MEN1 mutations, was observed across trials, emerging as early as two treatment cycles.

CONCLUSIONS:

Menin inhibitors demonstrate promising clinical activity in molecularly defined leukemias, with Revumenib establishing proof-of-concept for this therapeutic approach. However, challenges remain, including resistance development, optimal timing of therapy initiation, and determination of effective combination strategies. Larger randomized trials with extended follow-up are needed to establish long-term efficacy and safety profiles. The rapid clinical development of multiple agents in this class suggests an expanding role for Menin inhibitors in leukemia treatment paradigms.

2025-02-01·CTS-Clinical and Translational Science

Pharmacokinetics and ADME Characterization After Oral and Intravenous Administration of [¹⁴C]‐Ziftomenib in Healthy Male Participants

Article

作者: Mitra, Amitava ; El‐Shahat, Taha ; Leoni, Mollie ; Dale, Stephen ; Tabachri, Marilyn ; Ahsan, Julie Mackey

ABSTRACT:

Ziftomenib, a potent, selective inhibitor that binds menin at the lysine methyltransferase 2 interaction site, has demonstrated promising clinical activity with manageable toxicity in heavily pretreated patients with acute myeloid leukemia (AML) and nucleophosmin 1 mutations. This phase 1, open‐label study characterized the absorption, metabolism, excretion, and bioavailability of ziftomenib in healthy men and comprised two parts. In part A, a single oral dose of ziftomenib 400 mg (containing 250 μCi [14C]‐ziftomenib) was given to evaluate routes and rates of elimination, total radioactivity, and other pharmacokinetic parameters. In part B, a single oral dose of ziftomenib 400 mg followed by an intravenous dose of ziftomenib < 100 μg (containing 1 μCi [14C]‐ziftomenib) was administered to evaluate absolute bioavailability (both n = 8 patients). A median tmax of 3.5 h and an elimination t1/2 of 61.5 h demonstrated rapid ziftomenib absorption and enabled once‐daily dosing. Total radioactivity recovery was 89.7% in feces and 0.5% in urine over 480 h. Absolute bioavailability of 12.9% was observed. Ziftomenib was primarily metabolized by oxidation, N‐demethylation, and N‐dealkylation, with 19 metabolites recovered in plasma. All metabolites were considered minor (< 10% of total drug‐related exposure). Ziftomenib was the most abundant plasma component (> 10% of total drug‐related exposure). In conclusion, ziftomenib underwent limited metabolism following absorption and was primarily excreted as unchanged parent drug in feces. Ziftomenib was well tolerated with no new safety concerns in healthy men. Considering the pharmacokinetic profile and manageable safety outcomes, these findings support further clinical investigation of ziftomenib as treatment for AML.

2024-10-01·LANCET ONCOLOGY

Ziftomenib in relapsed or refractory acute myeloid leukaemia (KOMET-001): a multicentre, open-label, multi-cohort, phase 1 trial

Article

作者: Nie, Kun ; Patnaik, Mrinal M ; Pettit, Kristen ; Peterlin, Pierre ; Issa, Ghayas C ; Savona, Michael R ; Erba, Harry P ; Salamero, Olga ; Baer, Maria R ; Soifer, Harris S ; Shah, Mithun Vinod ; Walter, Roland B ; Kremyanskaya, Marina ; Rodríguez-Arbolí, Eduardo ; Berthon, Celine ; Adès, Lionel ; Grembecka, Jolanta ; Tabachri, Marilyn ; DeBotton, Stephane ; Leoni, Mollie ; Linhares, Brian M ; Cierpicki, Tomasz ; Altman, Jessica K ; Ray, Joshua ; Wang, Eunice S ; Mitra, Amitava ; Montesinos, Pau ; Foran, James M ; Heiblig, Mael ; Corum, Daniel ; Clegg, Bradley ; Fathi, Amir T ; Schiller, Gary ; Dale, Stephen ; Ahsan, Julie Mackey ; Papayannidis, Cristina

BACKGROUND:

Ziftomenib (KO-539) is an oral selective menin inhibitor with known preclinical activity in menin-dependent acute myeloid leukaemia models. The primary objective of this study was to determine the recommended phase 2 dose in patients with relapsed or refractory acute myeloid leukaemia based on safety, pharmacokinetics, pharmacodynamics, and preliminary activity.

METHODS:

KOMET-001 is a multicentre, open-label, multi-cohort, phase 1/2 clinical trial of ziftomenib in adults with relapsed or refractory acute myeloid leukaemia. Results of the phase 1 study, conducted at 22 hospitals in France, Italy, Spain, and the USA, are presented here and comprise the dose-escalation (phase 1a) and dose-validation and expansion (phase 1b) phases. Eligible patients were aged 18 years or older, had relapsed or refractory acute myeloid leukaemia, and had an Eastern Cooperative Oncology Group performance status of 2 or less. For phase 1a, patients (all molecular subtypes) received ziftomenib (50-1000 mg) orally once daily in 28-day cycles. For phase 1b, patients with NPM1 mutations or with KMT2A rearrangements were randomly assigned (1:1) using third-party interactive response technology to two parallel dose cohorts (200 mg and 600 mg ziftomenib). Primary endpoints were maximum tolerated dose or recommended phase 2 dose in phase 1a, and safety, remission rates, and pharmacokinetics supporting recommended phase 2 dose determination in phase 1b. Analyses were performed in all patients who received at least one dose of ziftomenib (modified intention-to-treat population). Phase 1a/1b is complete. This trial is registered with ClinicalTrials.gov, NCT04067336, and the EU Clinical Trials register, EudraCT 2019-001545-41.

FINDINGS:

From Sept 12, 2019, to Aug 19, 2022, 83 patients received 50-1000 mg ziftomenib (39 [47%] were male and 44 [53%] were female). Median follow-up was 22·3 months (IQR 15·4-30·2). Of 83 patients, the most common grade 3 or worse treatment-emergent adverse events were anaemia (20 [24%]), febrile neutropenia (18 [22%]), pneumonia (16 [19%]), differentiation syndrome (12 [15%]), thrombocytopenia (11 [13%]), and sepsis (ten [12%]). Overall, 68 of 83 patients had serious adverse events, with two reported treatment-related deaths (one differentiation syndrome and one cardiac arrest). Differentiation syndrome rate and severity influenced the decision to halt enrolment of patients with KMT2A rearrangements. In Phase 1b, no responses were reported in patients treated at the 200 mg dose level. At the recommended phase 2 dose of 600 mg, nine (25%) of 36 patients with KMT2A rearrangement or NPM1 mutation had complete remission or complete remission with partial haematologic recovery. Seven (35%) of 20 patients with NPM1 mutation treated at the recommended phase 2 dose had a complete remission.

INTERPRETATION:

Ziftomenib showed promising clinical activity with manageable toxicity in heavily pretreated patients with relapsed or refractory acute myeloid leukaemia. Phase 2 assessment of ziftomenib combination therapy in the upfront and relapsed or refractory setting is ongoing.

FUNDING:

Kura Oncology.

178

项与 Ziftomenib 相关的新闻（医药）

2025-06-03

·药明康德

疗效长达8小时！FDA受理老花眼眼药水上市申请；“癌症之王”总生存率达65%！癌症疫苗最新进展公布……

疗效长达8小时！FDA受理老花眼眼药水上市申请Tenpoint Therapeutics今日宣布，美国FDA已受理其为Brimochol PF滴眼液所提交的新药申请（NDA），用于治疗老花眼。该申请的PDUFA日期为2026年1月28日。该NDA的提交得到了关键性3期临床试验BRIO-I和BRIO-II研究中积极数据的支持。之前公布的BRIO-II数据显示，相较于对照组，Brimochol PF在所有时间点（最长至8小时）显著改善患者的近视力（p<0.008）。Brimochol PF还在所有时间点显示出具有临床意义和统计学显著的瞳孔缩小效果。瞳孔缩小是缩瞳药物类别疗法的关键作用机制，通过形成针孔效应，矫正近视力丧失并增加景深。Brimochol PF结合了卡巴胆碱和溴莫尼定两种获批药物。缩瞳剂卡巴胆碱在缩小瞳孔的同时，可能刺激控制晶状体形状的睫状体肌肉的收缩，改变晶状体的形状，导致它的屈光特征发生变化和引起远视力下降。经常接受治疗的患者还会出现头痛、近视移位、眼睛发红等副作用。溴莫尼定是一种α2受体激动剂，它可以起到抑制睫状体肌肉收缩和减少红眼的作用，还可以提高卡巴胆碱的半衰期，让它的效果可以持续8-12个小时，这意味着早上滴一次眼药水效果可能持续一整天。疾病进展或死亡风险降低近半！罗氏组合疗法3期试验结果积极罗氏（Roche）日前公布3期IMforte研究的积极结果，该试验旨在评估PD-L1抑制剂Tecentriq（atezolizumab）联合小分子疗法Zepzelca（lurbinectedin）作为广泛期小细胞肺癌（ES-SCLC）一线诱导治疗后维持疗法的作用。分析显示，与Tecentriq单药维持治疗相比，该联合方案使疾病进展或死亡风险降低46%，死亡风险降低27%。根据新闻稿，这是在ES-SCLC一线维持治疗中，在无进展生存期（PFS）与总生存期（OS）上均显示出具有临床意义改善的首项3期研究。在IMforte研究中，患者在接受约三个月、四个周期的Tecentriq联合化疗（卡铂和依托泊苷）后被随机分配进入维持治疗阶段。分析显示，Tecentriq与Zepzelca联合治疗组患者自随机化后的中位总生存期为13.2个月，而Tecentriq单药组为10.6个月（HR=0.73；95% CI：0.57–0.95；p=0.0174）；独立评估下的中位无进展生存期分别为5.4个月与2.1个月（HR=0.54；95% CI：0.43–0.67；p<0.0001）。安全性方面未观察到新的不良信号，结果与两款药物既有安全性概况一致。“癌症之王”总生存率达65%！癌症疫苗最新进展公布日前，OSE Immunotherapeutics公布其癌症疫苗Tedopi的最新临床进展。在2期TEDOPaM研究中，Tedopi联合FOLFIRI化疗作为维持治疗在晚期或转移性胰腺导管腺癌（PDAC）患者中展现出积极疗效。该研究纳入了107名HLA-A2阳性的患者，所有患者在接受八个周期的FOLFIRINOX诱导化疗后无疾病进展，随后被随机分入接受FOLFIRI单药（A组）或Tedopi联合FOLFIRI（B组）治疗。研究主要终点为B组患者的一年总生存率。结果显示，Tedopi联合FOLFIRI治疗组12个月的总生存率为65%，达到了预设的统计学显著性目标。此外，该方案耐受性良好，未观察到新的安全性信号，且有两例患者出现完全缓解（CR），进一步支持了Tedopi作为“现货型”新表位癌症疫苗用于PDAC治疗的潜力。突破性小分子获FDA授予优先审评资格Kura Oncology与Kyowa Kirin近日宣布，美国FDA已接受其在研疗法ziftomenib用于治疗复发/难治性（R/R）NPM1突变（NPM1-m）急性髓系白血病（AML）成人患者的NDA，并授予优先审评资格。该申请的PDUFA日期为2025年11月30日。根据新闻稿，若获批准，ziftomenib将成为首个用于NPM1突变R/R AML治疗的menin抑制剂。此次NDA主要基于2期注册性KOMET-001研究的结果。该研究达到主要终点，即完全缓解与部分血液学恢复的完全缓解（CRh）总率，且达到统计学显著性。Ziftomenib在治疗过程中耐受性良好，骨髓抑制作用有限，因药物相关原因停药的比例仅为3%。Ziftomenib是一种针对menin与KMT2A/MLL蛋白复合体之间相互作用的候选药物。该疗法已获得FDA授予的孤儿药资格和突破性疗法认定，用于治疗AML。参考资料：[1] Tenpoint Therapeutics Ltd. Announces FDA Acceptance of New Drug Application for BRIMOCHOL™ PF for the Treatment of Presbyopia. Retrieved June 3, 2025 form https://cdn.prod.website-files.com/64b01a75c3f993c7c15191dd/683e898a70e25f0e10cf6159_PR%20NDA%20Acceptance%203June%20FINAL.pdf[2] Roche’s Tecentriq combined with lurbinectedin shows significant survival benefit in extensive-stage small cell lung cancer. Retrieved June 3, 2025 from https://www.roche.com/media/releases/med-cor-2025-06-03[3] OSE Immunotherapeutics Provides Clinical Updates on Neo-Epitope Based Cancer Vaccine Tedopi® in Pancreatic Cancer and Non-Small Cell Lung Cancer. Retrieved June 3, 2025 from https://www.globenewswire.com/news-release/2025/06/02/3092136/0/en/OSE-Immunotherapeutics-Provides-Clinical-Updates-on-Neo-Epitope-Based-Cancer-Vaccine-Tedopi-in-Pancreatic-Cancer-and-Non-Small-Cell-Lung-Cancer.html[4] Kura Oncology and Kyowa Kirin Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib in Adults with Relapsed or Refractory NPM1-Mutant AML. Retrieved June 3, 2025 from https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-announce-fda-acceptance-and免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期临床结果疫苗免疫疗法加速审批

2025-06-03

·BioSpace

Kura Posts New Data, Secures NDA Acceptance in Acute Myeloid Leukemia Race With Syndax

iStock, Deagreez Kura Oncology won FDA priority review for its drug the day before announcing new data at ASCO 2025 showing remission in about one-quarter of patients. But Syndax’s Revuforj also has priority review in this indication, with a PDUFA date two months earlier. Kura Oncology showed off new Phase II data for its acute myeloid leukemia drug and, at about the same time, got its New Drug Application accepted at the FDA with a PDUFA date set for late this year. That puts Kura in a head-to-head race with Syndax, which submitted an NDA to the agency in April in the same AML subtype for its drug Revuforj, which last fall earned approval for a different type of leukemia. On Sunday, the San Diego–based Kura and its development partner Kyowa Kirin announced that their NDA for ziftomenib, for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with specific mutations, had been accepted by the FDA with priority review. The PDUFA date is set for Nov. 30—just over two months after Syndax’s Sept. 26 PDUFA. Revuforj has also been granted priority review. Whichever drug gets approved first would be the first for patients with AML with this specific mutational background. Kura’s stock jumped about 17% early Monday after the news of the NDA acceptance. Later that day at ASCO 2025, the company showcased the data behind that acceptance. In 92 patients who had been pretreated for R/R NPM1-mutant AML, 21 achieved full remission or remission with some blood cell recovery, good for a complete remission or complete remission with partial hematologic recovery rate of 23%. “Overall, results were in line with expectations,” Mizuho analysts wrote in a note to investors early Tuesday, adding that the presented results lined up with previously released info in the conference’s abstract. Both ziftomenib and Syndax’s Revuforj are oral menin inhibitors, a new class of anti-cancer drugs. Revuforj’s approval for leukemia last November represented the first FDA nod for the class. A week after Revuforj’s FDA approval, Kura signed a co-development and commercialization deal for ziftomenib with Kyowa Kirin, wherein the latter paid Kura $330 million upfront and pledged up to $1.16 billion total in milestone payments. That deal gave Kyowa Kirin commercialization rights for the drug outside the U.S., with potential royalties due to Kura.

优先审批引进/卖出上市批准申请上市临床2期

2025-06-02

·FierceBiotech

ASCO: Kura, Kyowa reveal 23% remission rate behind oral leukemia drug\'s phase 2 win

“Beyond ziftomenib’s clinical activity, we are highly encouraged by its consistent safety and tolerability profile,” Kura Oncology Chief Medical Officer Mollie Leoni, M.D., said in a release.\n Kura Oncology and Kyowa Kirin have shared details of the phase 2 win for their oral leukemia treatment ziftomenib as the FDA mulls whether to greenlight the selective menin inhibitor.The trial of ziftomenib enrolled 92 heavily pretreated patients with relapsed or refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). Kura and Kyowa announced back in February that the midstage study had hit its primary endpoint of demonstrating a statistically significant improvement in complete response (CR) rate as well as partial hematological recovery (CRh) but held back the data until today.In a session at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, the companies revealed that 21 patients had either achieved full remission or a remission with some blood cell recovery, equivalent to a CR/CRh rate of 23%.The trial was powered to detect a CR/CRh rate of 20% to 30%, and today’s data seem to fall just within the ballpark expectation of TD Cowen analysts, who predicted at the start of the year that the trial would generate a CR/CRh rate “in the mid-20%s.”A total of 13 patients had a CR, and the remaining eight had a CRh, Kura and Kyowa explained in an accompanying June 2 release. The median duration of these responses was 3.7 months, with 12 of the patients free of any residual cancer cells.A median OS rate of six months was seen across all patients in the study, rising to 16.4 months among those who responded to treatment.The companies submitted an approval request to the FDA in April for ziftomenib in R/R NPM1-mutant AML and have plans to launch two phase 3 trials later this year in AML patients with NPM1 or KMT2A gene mutations and in NPM1 patients who cannot receive intensive chemotherapy. “Beyond ziftomenib’s clinical activity, we are highly encouraged by its consistent safety and tolerability profile,” Kura Chief Medical Officer Mollie Leoni, M.D., said in the release.“Notably, the low rate of myelosuppression, 3% discontinuation rate due to ziftomenib [treatment-related adverse events], lack of clinically significant QTc prolongation, absence of drug-drug interactions and effective management of differentiation syndrome through protocol-specified mitigation strategies underscore ziftomenib’s favorable benefit-risk profile for patients with relapsed or refractory NPM1-mutated AML,” Leoni added.Japan-based Kyowa fronted $330 million last year and pledged up to $1.1 billion in milestones to get in on the ziftomenib action. The two companies are sharing responsibility for launching various trials in AML and other blood cancers “over the next several years,” with Kura funding the development of ex-U.S. trials until the end of 2028, after which point the biopharmas will split the costs.

$ASCO: Kura, Kyowa reveal 23% remission rate behind oral leukemia drug\'s phase 2 win$

临床2期ASCO会议临床结果加速审批临床3期

100 项与 Ziftomenib 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
NPM1突变急性髓系白血病	申请上市	美国	Kura Oncology, Inc.	2025-04-08
急性髓性白血病	临床3期	-	Kura Oncology, Inc.	2025-09-01
混合表型急性白血病	临床2期	美国	Kura Oncology, Inc.	2019-09-12
混合表型急性白血病	临床2期	比利时	Kura Oncology, Inc.	2019-09-12
混合表型急性白血病	临床2期	加拿大	Kura Oncology, Inc.	2019-09-12
混合表型急性白血病	临床2期	法国	Kura Oncology, Inc.	2019-09-12
混合表型急性白血病	临床2期	德国	Kura Oncology, Inc.	2019-09-12
混合表型急性白血病	临床2期	意大利	Kura Oncology, Inc.	2019-09-12
混合表型急性白血病	临床2期	西班牙	Kura Oncology, Inc.	2019-09-12
混合表型急性白血病	临床2期	英国	Kura Oncology, Inc.	2019-09-12

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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


NCT04067336 (KOMET-001, ASCO2025)	临床1/2期	复发性急性髓细胞白血病 NPM1-mutant	112	Ziftomenib 600 mg QD	鑰鬱壓壓願鑰獵製選醖(願積鹹遞顧鹹膚願鹹衊) = ≤5% anemia 觸積顧簾觸窪鹽網窪觸 (鑰製範餘鏇遞廠鏇簾廠 ) 更多	积极	2025-05-30
NCT04067336 (KOMET-001, Company_Website) 人工标引	临床1/2期	急性髓性白血病 NPM1 Mutation	-	Ziftomenib	範簾蓋獵遞廠網簾簾鹽(齋襯觸鹽蓋簾膚糧簾廠) = The KOMET-001 trial achieved its primary endpoint of CR plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant. 選遞廠顧簾築遞壓積鬱 (鏇獵構遞製願衊襯蓋顧 ) 达到更多	积极	2025-02-07
KOMET-007 (GlobeNewswire) 人工标引	临床1期	NPM1突变急性髓系白血病 \| KMT2A易位的急性白血病一线 NPM1 Mutation \| KMT2A Rearrangement	54	ziftomenib +venetoclax/azacitidine	繭獵壓選餘鬱遞築夢鑰(簾膚壓積築網網鏇廠獵) = 襯網鹹簾獵齋淵窪夢蓋糧鹽製襯壓餘鏇選淵選 (獵憲糧獵範壓窪膚艱獵 ) 更多	积极	2024-12-09
KOMET-007 (GlobeNewswire) 人工标引	临床1期		54	Ziftomenib+cytarabinecytarabine/daunorubicindaunorubicin	繭獵壓選餘鬱遞築夢鑰(簾膚壓積築網網鏇廠獵) = 蓋積夢膚窪膚艱簾淵觸糧鹽製襯壓餘鏇選淵選 (獵憲糧獵範壓窪膚艱獵 ) 更多	积极	2024-12-09
ASH2024	N/A	-	-	Ziftomenib 200 mg	獵窪獵鏇憲淵選鹽範製(觸範蓋繭獵繭齋顧範鏇) = 窪簾蓋鑰壓艱廠廠窪衊繭衊蓋簾餘築鑰襯範顧 (鹹憲觸憲選廠選鑰簾鬱 ) 更多	-	2024-12-08
ASH2024	N/A	-	-	Ziftomenib 400 mg	獵窪獵鏇憲淵選鹽範製(觸範蓋繭獵繭齋顧範鏇) = 壓襯範鑰顧積膚鬱選築繭衊蓋簾餘築鑰襯範顧 (鹹憲觸憲選廠選鑰簾鬱 ) 更多	-	2024-12-08
ASH2024	N/A	-	-	Ziftomenib 200 mg	願醖夢製選顧鹽淵製製(窪淵鏇蓋網糧構構膚衊) = 鬱蓋淵構襯廠鬱襯衊積膚蓋膚夢簾憲淵顧糧觸 (構廠築蓋願網網觸獵顧 )	-	2024-12-07
ASH2024	N/A	-	-	Ziftomenib 400 mg	願醖夢製選顧鹽淵製製(窪淵鏇蓋網糧構構膚衊) = 範鬱夢夢糧網觸鹹齋鏇膚蓋膚夢簾憲淵顧糧觸 (構廠築蓋願網網觸獵顧 )	-	2024-12-07
NCT04067336 (KOMET-001, Pubmed \| Lancet Oncol) 人工标引	临床1/2期	急性髓性白血病 NPM1 Mutation \| KMT2A Rearrangement	83	Ziftomenib 50-1000 mg	窪鏇鏇壓鹹蓋網築製繭(觸遞網構築築淵齋齋夢) = the most common grade 3 or worse treatment-emergent adverse events were anaemia (20 [24%]), febrile neutropenia (18 [22%]), pneumonia (16 [19%]), differentiation syndrome (12 [15%]), thrombocytopenia (11 [13%]), and sepsis (ten [12%]). 膚鹽膚憲遞襯構構簾衊 (膚獵鬱窪壓繭餘廠壓糧 ) 更多	积极	2024-10-01
NCT04067336 (KOMET-001, SOHO2023)	临床1/2期	NPM1突变急性髓系白血病 FLT3 \| IDH1/2 \| NPM1	29	Ziftomenib 600mg	鹽齋獵願範淵餘艱鏇鏇(艱顧遞製築獵鬱鏇鹹製) = developed in 1 of 29 patients, detected at C4D28; the patient maintained stable disease through cycle 7 鹹獵餘憲壓選蓋夢齋艱 (淵窪獵繭鹹糧網遞膚窪 ) 更多	积极	2023-09-01
NCT04067336 (KOMET-001, EHA2023)	临床1/2期	谱系不明的急性白血病 \| 复发性急性髓细胞白血病 \| 混合表型急性白血病 ... 更多	-	Ziftomenib	範鹽憲鹹夢憲壓網鬱鬱(淵範願艱鬱獵遞蓋鑰醖) = 衊鹽顧衊繭淵糧夢夢衊簾襯網淵顧積醖淵餘選 (簾齋齋選餘構製蓋餘夢 ) 更多	-	2023-06-08
NCT04067336 (KOMET-001, ASH 12022 \| ASH 22022) 人工标引	临床1/2期	复发性急性髓细胞白血病	-	Ziftomenib 200 mg	膚範選觸餘廠鏇夢淵觸(簾構餘窪觸選觸壓餘築) = 鹹壓鹽廠鹽鹽簾繭獵餘膚衊鹽憲構憲範鬱廠壓 (網衊淵遞鏇簾憲襯壓壓, 0 ~ 26.5) 更多	积极	2022-11-15
NCT04067336 (KOMET-001, ASH 12022 \| ASH 22022) 人工标引	临床1/2期	复发性急性髓细胞白血病	-	Ziftomenib 600 mg	膚範選觸餘廠鏇夢淵觸(簾構餘窪觸選觸壓餘築) = 淵憲憲鹽憲築憲製齋衊膚衊鹽憲構憲範鬱廠壓 (網衊淵遞鏇簾憲襯壓壓, 5.5 ~ 57.2) 更多	积极	2022-11-15