更新于：2024-11-21

Decitabine

地西他滨

更新于：2024-11-21

概要

概要

基本信息

药物类型

小分子化药

别名

2'-deoxy-5-azacytidine、4-Amino-1-(2-deoxy-beta-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one、4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-s-triazin-2(1H)-one

+ [19]

靶点

DNMT1

作用机制

DNMT1抑制剂(DNA（胞嘧啶-5）-甲基转移酶-1抑制剂)

治疗领域

肿瘤血液及淋巴系统疾病其他疾病+ [2]

在研适应症

难治性贫血难治性贫血伴原始细胞过多慢性粒单核细胞白血病+ [19]

非在研适应症

急性红细胞白血病急性巨核细胞白血病急性单核细胞白血病+ [24]

原研机构

Eisai Co., Ltd.

在研机构

Merck Sharp & Dohme Corp.

Astex Pharmaceuticals, Inc.

Eisai, Inc.

+ [8]

非在研机构

Janssen-Cilag GmbH

Teva Pharmaceutical Industries Ltd.Janssen Research & Development LLC

+ [9]

最高研发阶段批准上市

首次获批日期

美国 (2006-05-02),

难治性贫血伴原始细胞过多难治性贫血慢性粒单核细胞白血病+ [2]

最高研发阶段(中国)无进展

特殊审评孤儿药 (欧盟)

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结构

分子式C8H12N4O4

InChIKeyXAUDJQYHKZQPEU-KVQBGUIXSA-N

CAS号2353-33-5

关联

435

项与地西他滨相关的临床试验

NCT06129734 / Not yet recruiting临床1/2期IIT

Phase 1B/2A Study of Weekly Decitabine and Venetoclax Treatment as Maintenance Therapy in High-Risk Myeloid Malignancy Patients Post Allograft Stem Cell Transplant

The goal of this interventional clinical trial is to determine if low doses of gentle chemotherapy after bone marrow transplant may prevent relapse and promote an increase in survival and decrease in side effects in participants with acute myeloid leukemia and myelodysplastic syndromes. The main question it aims to answer is whether or not providing a new, gentler way of administering chemotherapy will help control leftover cancer with minimal side effects. This treatment involves decitabine and venetoclax. Participants will receive standard post-transplant care. Participants will be administered decitabine once per week with normal transplant follow up visits, and then will take a venetoclax pill about 6 to 8 hours later. Participants will meet their study team at the beginning, midway, and at the end of the trial to receive bone marrow testing. Participants will receive treatment until either one year of therapy, relapse, or recurrent dose limiting toxicity (DLT) despite dose reduction.

开始日期2025-04-01

申办/合作机构

The Case Comprehensive Cancer Center

NCT06597734 / Not yet recruiting临床2期IIT

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]

NCT06561074 / Not yet recruiting临床2期IIT

A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)

To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination 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

100 项与地西他滨相关的临床结果

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100 项与地西他滨相关的转化医学

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100 项与地西他滨相关的专利（医药）

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8,151

项与地西他滨相关的文献（医药）

2024-12-31·Hematology

Sweet syndrome induced by FLT3 inhibitors: case report and literature review

Review

作者: Zhang, Ran ; Ma, Hongbing ; Yang, Linhui

BACKGROUNDAcute febrile neutrophilic dermatosis, also commonly referred to as Sweet syndrome, is often associated with tumors, infections, immune disorders and medications. FLT3 inhibitor-induced Sweet syndrome is a rare complication.METHODS AND RESULTSWe report a patient with relapsed and refractory acute monocytic leukemia harboring high-frequency FLT3-ITD and DNMT3a mutations. The FLT3 inhibitor gilteritinib was administered for reinduction therapy after failure of chemotherapy with a combination of venetoclax, decitabine, aclarubicin, cytarabine and granulocyte colony-stimulating factor. The leukemia patient achieved remission after 1 month of treatment. However, Sweet syndrome induced by gilteritinib, which was confirmed by skin biopsy, developed during induction therapy. Similar cases of Sweet syndrome following FLT3 inhibitor therapy for acute myeloid leukemia were reviewed.CONCLUSIONAttention should be given to this rare complication when FLT3 inhibitors are used for acute myeloid leukemia therapy, and appropriate treatments need to be administered in a timely manner.

2024-12-31·Epigenetics

Upregulation of GPR133 expression impaired the phagocytosis of macrophages in recurrent spontaneous miscarriage

Article

作者: Lu, Zhouping ; Sun, Jia-Xue ; Su, Xin ; Li, Wen-Xuan ; Jin, Liping ; Liu, Chenfei ; Yao, Yongli ; Xu, Xiang-Hong ; Yang, Haoyu

Decidual macrophages are the second-largest immune cell group at the maternal-foetal interface. They participate in apoptotic cell removal, and protect the foetus from microorganisms or pathogens. Dysfunction of decidual macrophages gives rise to pregnancy complications such as preeclampsia and recurrent spontaneous miscarriage (RSM). However, the mechanisms by which decidual macrophages are involved in the occurrence of adverse pregnancy outcomes have not been elucidated. Here we integrated DNA methylation and gene expression data from decidua macrophages to identify potential risk factors related to RSM. GPR133 was significantly hypomethylated and upregulated in decidual macrophages from RSM patients. Further demethylation analysis demonstrated that GPR133 expression in decidual macrophages was significantly increased by 5-Aza-dC treatment. In addition, the influence of GPR133 on the phagocytic ability of macrophages was explored. Phagocytosis was impaired in the decidual macrophages of RSM patients with increased GPR133 expression. Increased GPR133 expression induced by demethylation treatment in the decidual macrophages of healthy control patients led to a significant decrease in phagocytic function. Importantly, knockdown of GPR133 resulted in a significant improvement in the phagocytic function of THP-1 macrophages. In conclusion, the existing studies have shown the influence of GPR133 on the phagocytic function of decidual macrophages and pregnancy outcomes, providing new data and ideas for future research on the role of decidual macrophages in RSM.

2024-12-31·Hematology

Acute myeloid leukemia with ETV6::CHIC2 fusion gene: ‘Pitfalls’ in diagnosis

Article

作者: Wang, Weiguo ; Yue, Yun ; Wu, Zhongfeng ; Ma, Li ; Zhang, Xia ; Wang, Wei

OBJECTIVESAcute myeloid leukemia (AML) with ETV6::CHIC2 and basophilia is rare in hematologic malignancies with poor prognosis. Due to the small number of clinical cases, it is misdiagnosed and missed frequently, and it is necessary to explore laboratory detection for accurate diagnosis.METHODSWe report a case of AML with ETV6::CHIC2 and basophilia by morphological screening, immunotyping with precise gating, interpretation of FISH results, and RNA transcriptome sequencing, thus laying the accurate diagnosis for clinical treatment.RESULTSWe confirmed a rare case of AML with ETV6::CHIC2 rather than FIP1L1::PDGFRA by morphological analysis, correct immunophenotyping via precise gating, rejecting one-sided view of FISH positive result and targeted RNA sequencing. Precise analysis and more advanced means avoid misdiagnosis and missed frequently. After accurate diagnosis, venetoclax and decitabine therapy were given instead of imatinib; eventually, the patient achieved a relatively good effect.DISCUSSIONImmunophenotype analysis is necessary to detect the expression of CD7 when encountering pseudo-lymphocytes with multilineage dysplasia and basophilia. FISH and RT-PCR are still indispensable means of diagnosis of fusion genes in hematologic malignancies but can only detect a limited number of known partner genes and fusion genes with known break points. NGS can achieve sequence analysis indiscriminately and detect all fusion transcripts theoretically, greatly improving the detection range. NGS sequencing is required for t(4;12)(q11;p13) in AML that are not accompanied by eosinophilia.

217

项与地西他滨相关的新闻（医药）

2024-11-17

·医药投资部落

又一款国产大药

近日，港股上市的明星Biotech企业亚盛医药发布公告，公司自主研发的新型选择性 Bcl-2抑制剂APG-2575 (拟定中文通用名：力胜克拉片) 的新药上市申请(NDA)，已获国家药品监督管理局(NMPA)药品审评中心(CDE)受理，并被推荐纳入优先审评程序，用于治疗难治或复发性(r/r)慢性淋巴细胞白血病╱小淋巴细胞淋巴瘤(CLL/ SLL)。这是首个在国内提交NDA的国产原研Bcl-2抑制剂，同时有望成为全球第二个上市的Bcl-2抑制剂。 APG-2575是亚盛医药自主研发的新型口服Bcl-2选择性抑制剂，通过选择性抑制Bcl-2蛋白，恢复肿瘤细胞的正常凋亡过程，从而达到治疗肿瘤的目的。 APG-2575在全球层面具同类最佳(Best-in-class) 潜力，有望成为更安全、有效，且便捷的治疗选择。同时，APG-2575正在开展多项注册III期临床试验，分别为：联合BTKi治疗经治 CLL/SLL患者的全球注册III期临床试验(由美国FDA许可); 联合阿可替尼一线治疗初治CLL/SLL患者的全球注册III期临床研究; 联合阿扎胞苷(AZA)一线治疗新诊断老年或不耐受标准化疗的急性髓系白血病(AML)的全球注册III期临床试验; 联合AZA一线治疗新诊断中高危骨髓增生异常综合征(MDS)患者的全球注册III期临床试验。 APG2575是全球第二个、中国首个看到明确疗效、并进入关键注册临床阶段的Bcl-2抑制剂，在多种血液肿瘤和实体瘤治疗领域具备广阔的治疗前景，特别在CLL/SLL 患者中具有单药和联合治疗潜力。目前，全球唯一获批上市的Bcl-2抑制剂是艾伯维和罗氏联合开发的的维奈克拉（Venetoclax），该药于2016年4月在美国获得美国食品药品监督管理局（FDA）的批准上市。 2020年12月，维奈克拉首次在中国获批上市，2023年被纳入了医保，用于与阿扎胞苷或地西他滨或低剂量阿糖胞苷联用，治疗年龄75岁及以上或因合并症不适于接受强诱导化疗的新诊断成人急性髓细胞性白血病（AML）患者。根据艾伯维财报，维奈克拉2018 年、2019 年的全球销售额分别为 3.44 亿美元、7.92 亿美元，同比增长 130％；2022年，维奈克拉的销售额达到了20.1亿美元，同比增长10.4%。2023年收入达到22.8亿美元，同比增长13.9%。根据艾伯维披露的预计数据，维奈克拉的峰值销售有望在2026年达到60亿美元。亚盛医药的APG-2575如果顺利获批，毫无疑问将成为中国创新药产业的又一款国产大药。医药研究报告分享营收集与分享全市场主流医药研究报告每天仅需0.8元畅享超过1900篇精选医药研究报告未来一年新增额外500篇

临床3期财报优先审批上市批准申请上市

2024-11-15

·Firstwordpharma

Syndax clinches approval in key leukaemia population after facing headwinds in another

The FDA on Friday approved Syndax's menin inhibitor Revuforj (revumenib) to treat patients with relapsed or refractory KMT2A-rearranged acute leukaemia. The clearance comes just days after the drugmaker lost a quarter of its valuation when pivotal data for the therapy in a separate patient group — those with NPM1-mutant acute myeloid leukaemia (AML) — failed to impress investors, despite meeting the primary endpoint. Friday's greenlight wasn't without its own hurdles. The decision deadline for Revuforj was pushed back from Sept. 26 after the FDA required more time to review supplemental information provided in response to a data request. The approval did, however, come over a month ahead of the new PDUFA date of Dec. 26. The regulatory win may soothe investor jitters ahead of Syndax's upcoming presentation at the American Society for Hematology (ASH) meeting in December.The company is expected to share updated pivotal data for Revuforj in the KMT2A-rearranged population, as well as from the Phase I/II SAVE study of the menin inhibitor plus decitabine/cedazuridine and venetoclax in with KMTRA-rearranged, NPM1-mutated or NUP98-rearranged AML (see – Spotlight On: Clinical readouts to watch at ASH 2024).Grading response ratesRevuforj's approval was based on data from the AUGMENT-101 trial, which enrolled 104 patients with KMT2A-rearranged acute leukaemia. The menin inhibitor met its primary endpoint, demonstrating a complete remission (CR) or a CR with partial haematological recovery (CRh) rate of 21.2%. The median CR+CRh duration was 6.4 months, with an average time to CR or CRh of 1.9 months.The therapy posted a similar CR+CRh rate in a separate AUGMENT-101 cohort of patients with NPM1-mutant AML that read out earlier this week, though those results seemed to rattle investor confidence in the compound. Syndax reported that 15 of 64 AML patients who received Revuforj achieved CR or CRh, translating to a 23% response rate that met statistical significance. However, the median response duration was 4.7 months and only three patients were still responding at the data cutoff, and the company's shares fell 25% on the news.The drugmaker has projected a $2-billion market opportunity for Revuforj, which factors in approvals in both leukaemia populations (see – Spotlight On: The AML treatment landscape gets personal). FirstWord will be hosting an upcoming call to discuss the impact that up-and-coming menin inhibitors could have on the AML treatment landscape. To be notified of the results, sign up here – KOL Views Preview: How will the current wave of menin inhibitors impact the AML landscape?

临床结果上市批准ASH会议

2024-11-10

·药明康德

总缓解率达96%的创新抗癌疗法；使多种癌症类型患者肿瘤缩小的合成致死疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 阿斯利康（AstraZeneca）双特异性T细胞接合器AZD0486治疗复发/难治性滤泡性淋巴瘤（R/R FL）患者的1期临床试验结果亮眼，接受2.4 mg及以上剂量患者的总缓解率（ORR）高达96%，完全缓解（CR）率达85%。 2. 潜在“first-in-class”的menin抑制剂revumenib联用venetoclax和去甲基化剂（HMA）ASTX727治疗携带特定基因变异的急性白血病患者，在一项1/2期研究中的ORR达88%。 3. 潜在“best-in-class”合成致死疗法TNG462的早期临床结果积极，多种癌症类型患者的肿瘤有缩小。药明康德内容团队整理 AZD0486：公布1期临床试验数据阿斯利康宣布将在今年的美国血液学会（ASH）年会上公布旗下多款血液学管线的临床结果，其中包括该公司的CD19 x CD3靶向双特异性T细胞接合器AZD0486用于复发/难治性滤泡性淋巴瘤患者的1期临床试验结果。结果显示，R/R FL患者对2.4 mg及以上剂量的AZD0486高度应答，患者的ORR高达96%，CR达85%，且患者的最小残留病灶（MRD）阴性比率很高。此外，1期试验中期结果也显示，接受过大量治疗的弥漫大B细胞淋巴瘤（DLBCL）患者也对AZD0486高度应答，患者的CR率高。最新数据还显示AZD0486具有良好的安全性，双倍递增给药方案可有效缓解患者发生细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）事件。 Revumenib：公布1/2期临床试验数据 Syndax Pharmaceuticals公司宣布将在ASH年会上公布其在研疗法revumenib联用venetoclax和去甲基化剂ASTX727（decitabine/cedazuridine）治疗携带KMT2A重排、NUP98重排或NPM1突变的复发/难治性急性髓系白血病（r/r AML）或混合谱系急性白血病（MPAL）儿童和成人患者的1/2期临床试验结果。Revumenib是一种针对menin-KMT2A相互作用的强效、选择性小分子抑制剂。截至2024年7月的数据，共有26名患者入组该试验，ORR为88%（23/26），CR或带部分血液学恢复的完全缓解（CRh）率为58%（15/26）。15名达到CR/CRh的患者中有14名的MRD状态可评估，其中93%（13/14）为MRD阴性。中位随访时间为6.6个月时，患者6个月时的无复发生存率为59%，总生存率为74%。CR/CRh患者的中位缓解持续时间尚未达到。该组合疗法总体上耐受性良好。 TNG462：公布1/2期临床试验数据 Tango Therapeutics公司宣布，基于在研疗法TNG462在1/2期临床试验剂量递增和早期剂量扩展队列中获得的积极数据，该公司已选择TNG462进入全面开发。新闻稿指出，TNG462是一种潜在“best-in-class”的甲硫腺苷（MTA）协同的蛋白精氨酸甲基转移酶5（PRMT5）抑制剂。PRMT5是甲硫腺苷磷酸化酶（MTAP）突变的合成致死靶点。MTAP基因缺失发生在大约10%的癌症中，包括胰腺癌、肺癌和膀胱癌，这些患者体内存在异常升高的MTA水平，从而抑制PRMT5的活性。PRMT5是一种参与基本细胞功能的酶，MTA的升高使得肿瘤细胞对额外PRMT5的抑制变得更为敏感。TNG462是一款基于合成致死理念设计的精准抗癌疗法，它可在抑制MTAP缺失细胞中PRMT5功能的同时，保留健康细胞中的PRMT5功能，从而选择性地杀死肿瘤细胞。截至2024年10月20日，共有59名患者入组，其中39名患者可评估，涵盖13种癌症类型。数据显示，TNG462在多种肿瘤类型中展现了抗癌活性且耐受性良好，包括非小细胞肺癌（NSCLC）和胰腺癌。多种肿瘤类型的肿瘤体积随着持续治疗而缩小，约60%最初被评估为疾病稳定（SD）的患者在之后出现部分缓解（PR）。尽管目前大多数癌症类型的患者数和随访时间不足以准确估算客观缓解率，但在已入组的7名胆管癌患者中，观察到其中3名（43%）患者获得确认的客观缓解。此外，TNG462在活性剂量下具有良好的安全性和耐受性，剂量限制性毒性（DLT）为血小板减少。该药物的其他不良事件（如恶心、呕吐、腹泻和疲劳）发生率低于20%，且主要为1级。 ▲TNG462治疗胆管癌患者的临床试验结果（图片来源：参考资料[4]） ISB 2001：公布1期临床试验的新数据 Ichnos Glenmark Innovation公司宣布将在ASH年会上进行口头报告，展示其三特异性抗体ISB 2001用于复发/难治性多发性骨髓瘤（r/r MM）的1期研究的数据。ISB 2001同时靶向MM细胞上的BCMA和CD38，以及T细胞上的CD3，旨在增加对MM细胞的特异性结合，同时最大限度地减少脱靶效应。截至2024年7月的数据，12名可评估疗效患者的ORR为75%（9/12），其中包括1例MRD阴性的严格CR。安全性方面，ISB 2001具有良好的安全性和耐受性，未观察到DLT，仅有一例高于2级的特殊关注不良事件，且没有因治疗而停药的情况。 Vilastobart（XTX101）：公布1c期临床试验数据 Xilio Therapeutics公司公布了其正在进行的1c期临床试验的初步临床数据，该试验评估了vilastobart（XTX101）联用PD-L1抑制剂atezolizumab治疗晚期实体瘤患者的效果。Vilastobart是一种肿瘤激活、Fc增强、高亲和力结合的抗CTLA-4抗体。截至2024年10月7日，17名患者接受了vilastobart联用atezolizumab的治疗。观察到两名患有难以治疗的、免疫学上为“冷肿瘤”的患者达到了未确认的PR。在1名微卫星稳定型结直肠癌（MSS CRC）患者中观察到转移性肝脏病灶的完全消退。安全性数据显示，该联合治疗总体上耐受良好，vilastobart有潜力成为与PD-1/PD-L1抑制剂联合使用的差异化下一代抗CTLA-4抗体。 VK2735：公布早期临床试验的新数据 Viking Therapeutics在肥胖协会年会肥胖周（ObesityWeek）上公布了其在研减重疗法胰高血糖素样肽1（GLP-1）/葡萄糖依赖性胰岛素促泌肽（GIP）受体联合激动剂VK2735的最新临床试验数据。分析显示，接受每日VK2735口服片剂28天的受试者，其安慰剂调整后平均体重较基线减轻达6.8%。而接受每周VK2735皮下注射治疗13周的肥胖患者的平均体重则较基线减轻达14.7%。值得一提的是，在试验第一周时便观察到接受皮下剂型患者显著的体重减轻效果，近100%患者在停药4周后其体重减轻的大部分效果仍然维持。目前该公司正在规划VK2735注射剂型的3期研究，以及口服剂型的2期研究，详细信息将在接近试验启动时间时公布。 ▲接受口服VK2735治疗28天受试者的体重减轻效果（图片来源：参考资料[1]） ▲接受VK2735皮下注射13周受试者的体重减轻效果（图片来源：参考资料[1]） ▲接受VK2735皮下注射受试者在停药后体重减轻效果持续维持（图片来源：参考资料[1]） AZD5004：公布1期临床试验数据阿斯利康公司公布了在研口服GLP-1疗法AZD5004，在患有2型糖尿病的肥胖患者中进行的1期临床试验的最新结果。AZD5004是一款每日一次、低剂量的小分子GLP-1受体激动剂，该药物在临床前研究中证明具有理想的疗效和安全性。去年11月，阿斯利康与诚益生物（Eccogene）达成独家协议，以潜在18.25亿美元的总额获得小分子GLP-1受体激动剂ECC5004（即AZD5004），用于治疗包括肥胖症、2型糖尿病和其他合并症在内的适应症。此次公布的数据显示，接受剂量为50 mg的AZD5004治疗的患者中，4周后患者体重与基线相比降低5.8%，约为9.4斤。同时，患者的空腹血糖等指标也有所下降。 ▲AZD5004降低患者体重和血糖指标（图片来源：阿斯利康官网） CIN-109、CIN-110：公布1期临床试验数据 CinFina Pharma公司公布了其CIN-110的单剂量递增（SAD）研究的初步中期数据以及CIN-109的多剂量递增（MAD）研究的最终数据。CIN-110是一种强效、高选择性的肽YY（PYY3-36）类似物，具有延长的半衰期，旨在显著减少其他PYY分子观察到的恶心和呕吐，同时促进有效的长期体重减轻。CIN-109是一种新型长效生长分化因子15（GDF-15）类似物，有可能减少食欲、维持能量消耗和促进体重减轻，同时保持瘦体重。两项研究均显示这些候选疗法具有良好的耐受性，并能导致显著的体重减轻。CIN-110的1期研究共纳入24名平均BMI为34 kg/m²的肥胖受试者，在给药一周内，他们的食物摄入量减少了28%，体重最多下降了1.8%。总共报告了3例轻度恶心，通常在给药后12-48小时内出现，并在一天内缓解。在CIN-109的1期研究中，平均BMI为35 kg/m²的肥胖受试者的食物摄入量呈剂量依赖性的减少，最高达50%，患者在1-2个月内体重减轻了多达3.7%。此外，每两周给药一次CIN-109的耐受性更好，大部分减轻的体重来自于脂肪，且未观察到与治疗相关的严重副作用。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Viking Therapeutics Reports New Data from VK2735 Obesity Program at ObesityWeek® 2024. Retrieved November 4, 2024 from https://www.prnewswire.com/news-releases/viking-therapeutics-reports-new-data-from-vk2735-obesity-program-at-obesityweek-2024-302294915.html [2] AZN Meet the Management: Weight Management Virtual Event. Retrieved November 4, 2024, from https://www.astrazeneca.com/content/dam/az/Investor_Relations/events/Weight-Management-Virtual-Event-IR-presentation.pdf [3] Tango Therapeutics Reports Positive TNG462 Clinical Data and Provides Update on PRMT5 Development Program. Retrieved November 6, 2024, from https://ir.tangotx.com/news-releases/news-release-details/tango-therapeutics-reports-positive-tng462-clinical-data-and [4] Tango Therapeutics Corporate Presentation. Retrieved November 6, 2024, from https://ir.tangotx.com/static-files/c49a558d-602e-4fed-9d53-dcbc004ffdf5 [5] AstraZeneca showcases strength of haematology portfolio and pipeline at ASH 2024. Retrieved November 7, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/astrazeneca-showcases-strength-of-haematology-portfolio-and-pipeline-at-ash-2024.html [6] Xilio Therapeutics Announces Initial Clinical Trial Data from Phase 1C Dose Escalation for Vilastobart (XTX101), a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Advanced Solid Tumors. Retrieved November 7, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976781/0/en/Xilio-Therapeutics-Announces-Initial-Clinical-Trial-Data-from-Phase-1C-Dose-Escalation-for-Vilastobart-XTX101-a-Tumor-Activated-Anti-CTLA-4-in-Combination-with-Atezolizumab-in-Pati.html [7] CinFina Pharma Presents Positive Phase 1 Study Results in Poster Session for CIN-109 and in Late-Breaking Poster for CIN-110, Demonstrating the Potential of Next-Generation Mechanisms at ObesityWeek® 2024. Retrieved November 7, 2024 from https://cinrx.com/cinfina-pharma-phase-1-study-results-poster-session-cin-109-late-breaking-poster-cin-110-demonstrating-potential-next-generation-mechanisms-obesityweek-2024 [8] Ichnos Glenmark Innovation (IGI) Announces First Presentation of Data from Phase 1 Study of the Trispecific ISB 2001 in Relapsed/Refractory Multiple Myeloma (r/rMM) at Upcoming ASH Annual Meeting. Retrieved November 7, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2974962/0/en/Ichnos-Glenmark-Innovation-IGI-Announces-First-Presentation-of-Data-from-Phase-1-Study-of-the-Trispecific-ISB-2001-in-Relapsed-Refractory-Multiple-Myeloma-r-rMM-at-Upcoming-ASH-Ann.html [9] Syndax Announces Revumenib Abstracts to Be Presented at the 66th ASH Annual Meeting. Retrieved November 7, 2024 from https://www.prnewswire.com/news-releases/syndax-announces-revumenib-abstracts-to-be-presented-at-the-66th-ash-annual-meeting-302296077.html [10] Oncoinvent Announces Publication of 18-Month Safety and Efficacy Data from the Phase 1/2a Study of Radspherin® in Colorectal Cancer. Retrieved November 5, 2024 from https://www.businesswire.com/news/home/20241101923447/en/Oncoinvent-Announces-Publication-of-18-Month-Safety-and-Efficacy-Data-from-the-Phase-12a-Study-of-Radspherin%C2%AE-in-Colorectal-Cancer/ [11] Arcellx to Present Clinical Data for Its Phase 1 and iMMagine-1 Studies in Patients with Relapsed or Refractory Multiple Myeloma at the 66th ASH Annual Meeting and Exposition and Announces Progress in iMMagine-3 Study. Retrieved November 5, 2024 from https://ir.arcellx.com/news/news-details/2024/Arcellx-to-Present-Clinical-Data-for-Its-Phase-1-and-iMMagine-1-Studies-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma-at-the-66th-ASH-Annual-Meeting-and-Exposition-and-Announces-Progress-in-iMMagine-3-Study/default.aspx [12] Beam Therapeutics to Present Data Across Hematology Franchise, Including First Clinical Data for BEAM-101 in Sickle Cell Disease and ESCAPE Non-human Primate Data, at American Society of Hematology (ASH) Annual Meeting. Retrieved November 5, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2974971/0/en/Beam-Therapeutics-to-Present-Data-Across-Hematology-Franchise-Including-First-Clinical-Data-for-BEAM-101-in-Sickle-Cell-Disease-and-ESCAPE-Non-human-Primate-Data-at-American-Societ.html [13] TScan Therapeutics Announces Upcoming Oral Presentation of Data from the ALLOHA™ Phase 1 Heme Trial at the 66th American Society of Hematology Annual Meeting and Exposition. Retrieved November 5, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2975010/0/en/TScan-Therapeutics-Announces-Upcoming-Oral-Presentation-of-Data-from-the-ALLOHA-Phase-1-Heme-Trial-at-the-66th-American-Society-of-Hematology-Annual-Meeting-and-Exposition.html [14] C4 Therapeutics Announces First Patient Dosed in CFT8919 Clinical Trial. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/06/2975566/0/en/C4-Therapeutics-Announces-First-Patient-Dosed-in-CFT8919-Clinical-Trial.html [15] Nouscom’s Off-the-Shelf Neoantigen Immunotherapy, NOUS-209, Continues to Elicit Potent and Durable Immune Responses in Lynch Syndrome Carriers Highlighting its Potential to ‘Intercept’ Cancer. 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Retrieved November 8, 2024 from https://ir.zymeworks.com/news-releases/news-release-details/zymeworks-announces-first-patient-dosed-phase-1-clinical-trial-0 [18] Ankyra Therapeutics Announces First Visceral Tumor Patient Dosed in Phase 1 ANCHOR Clinical Trial of ANK-101, an Anchored Interleukin-12 (IL-12). Retrieved November 8, 2024 from https://ankyratx.com/press-releases/ankyra-therapeutics-announces-first-visceral-tumor-patient-dosed-in-phase-1-anchor-clinical-trial-of-ank-101-an-anchored-interleukin-12-il-12/ [19] HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200604, a Best-in-Class BTLA Agonist Antibody for the Treatment of Inflammatory and Immunology Diseases. Retrieved November 8, 2024 from https://hifibio.com/hifibio-therapeutics-receives-fda-clearance-of-ind-application-for-hfb200604-a-best-in-class-btla-agonist-antibody-for-the-treatment-of-inflammatory-and-immunology-diseases/ [20] Xencor Doses First Subject in Phase 1/2 Study of XmAb®942 in Development for Patients with Inflammatory Bowel Disease. Retrieved November 8, 2024 from https://investors.xencor.com/news-releases/news-release-details/xencor-doses-first-subject-phase-12-study-xmabr942-development [21] Elicio Therapeutics Presents Updated Translational Data from ELI-002 Phase 1 AMPLIFY-7P Study at the Society for Immunotherapy of Cancer (“SITC”) 2024 Annual Meeting. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2977121/0/en/Elicio-Therapeutics-Presents-Updated-Translational-Data-from-ELI-002-Phase-1-AMPLIFY-7P-Study-at-the-Society-for-Immunotherapy-of-Cancer-SITC-2024-Annual-Meeting.html [22] HotSpot Therapeutics Presents Additional Phase 1 Biomarker Data on Novel CBL-B Inhibitor HST-1011 at 2024 Society for Immunotherapy of Cancer Annual Meeting. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/hotspot-therapeutics-presents-additional-phase-1-biomarker-data-on-novel-cbl-b-inhibitor-hst-1011-at-2024-society-for-immunotherapy-of-cancer-annual-meeting-302298481.html [23] OncoResponse Announces Phase 1 Results of the Clinical Trial of OR502, anti-LILRB2 Antibody, in Subjects with Advanced Cancer. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/oncoresponse-announces-phase-1-results-of-the-clinical-trial-of-or502-anti-lilrb2-antibody-in-subjects-with-advanced-cancer-302298422.html [24] Allogene Therapeutics Announces Positive Phase 1 Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Patients with Advanced Renal Cell Carcinoma at SITC and IKCS. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976851/0/en/Allogene-Therapeutics-Announces-Positive-Phase-1-Data-Demonstrating-the-Potential-of-ALLO-316-in-Heavily-Pretreated-Patients-with-Advanced-Renal-Cell-Carcinoma-at-SITC-and-IKCS.html [25] Bolt Biotherapeutics Presents Updated Preclinical Data for BDC-4182 and Key Learnings from Phase 1 Dose-Escalation Trial of BDC-1001 at SITC 39th Annual Meeting. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976848/0/en/Bolt-Biotherapeutics-Presents-Updated-Preclinical-Data-for-BDC-4182-and-Key-Learnings-from-Phase-1-Dose-Escalation-Trial-of-BDC-1001-at-SITC-39th-Annual-Meeting.html [26] Aummune Announces Results from Phase 1 Trial of its Novel AM003 Immunotherapy for the Treatment of Solid Tumors. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976844/0/en/Aummune-Announces-Results-from-Phase-1-Trial-of-its-Novel-AM003-Immunotherapy-for-the-Treatment-of-Solid-Tumors.html [27] Cellenkos Announces Oral Presentation at ASH Annual Meeting 2024 Highlighting Phase 1b Clinical Data of CK0804 in Myelofibrosis. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/cellenkos-announces-oral-presentation-at-ash-annual-meeting-2024-highlighting-phase-1b-clinical-data-of-ck0804-in-myelofibrosis-302298808.html [28] Indaptus Therapeutics Presents Encouraging Interim Safety Data from Phase 1 Clinical Trial of Decoy20 at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976598/0/en/Indaptus-Therapeutics-Presents-Encouraging-Interim-Safety-Data-from-Phase-1-Clinical-Trial-of-Decoy20-at-the-Society-for-Immunotherapy-of-Cancer-SITC-2024-Annual-Meeting.html [29] Nimbus Therapeutics Presents Positive Updated Data from Phase 1/2 Clinical Trial of HPK1 Inhibitor for Advanced Solid Tumors at SITC 39th Annual Meeting. Retrieved November 8, 2024 from https://www.businesswire.com/news/home/20241107226079/en/Nimbus-Therapeutics-Presents-Positive-Updated-Data-from-Phase-12-Clinical-Trial-of-HPK1-Inhibitor-for-Advanced-Solid-Tumors-at-SITC-39th-Annual-Meeting [30] Indapta Therapeutics Presents Clinical and Preclinical Data of Allogenic Natural Killer Cell Therapy at Society for Immunotherapy of Cancer Meeting. Retrieved November 8, 2024 from https://www.businesswire.com/news/home/20241107081017/en/Indapta-Therapeutics-Presents-Clinical-and-Preclinical-Data-of-Allogenic-Natural-Killer-Cell-Therapy-at-Society-for-Immunotherapy-of-Cancer-Meeting [31] Radella Pharmaceuticals Announces Topline Data from the Phase 1a Study of MD-18, a First-In-Class Peptide Targeting PTP1B for Obesity. Retrieved November 8, 2024 from https://www.businesswire.com/news/home/20241107046414/en/Radella-Pharmaceuticals-Announces-Topline-Data-from-the-Phase-1a-Study-of-MD-18-a-First-In-Class-Peptide-Targeting-PTP1B-for-Obesity#:~:text=Radella%20Pharmaceuticals%20Announces%20Topline%20Data%20from%20the%20Phase,its%20platform%20targeting%20cardiometabolic%20disease%20and%20its%20adjacencies [32] Palisade Bio Announces First Subject Dosed in Phase 1 Clinical Study of PALI-2108 for the Treatment of Moderate-to-Severe Ulcerative Colitis (UC). Retrieved November 8, 2024 from https://palisadebio.com/palisade-bio-announces-first-subject-dosed-in-phase-1-clinical-study-of-pali-2108-for-the-treatment-of-moderate-to-severe-ulcerative-colitis-uc/ [33] SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M17D1 in Advanced Solid Tumors. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/systimmune-inc-announces-fda-clearance-of-ind-application-for-bl-m17d1-in-advanced-solid-tumors-302298993.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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：本文来自药明康德内容团队，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

临床结果临床2期临床1期

100 项与地西他滨相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03665	地西他滨	L01BC08	DB01262

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
难治性贫血	美国	Sun Pharmaceutical Industries Ltd.	2014-01-23
难治性贫血伴原始细胞过多	美国	Sun Pharmaceutical Industries Ltd.	2014-01-23
慢性粒单核细胞白血病	美国	Sun Pharmaceutical Industries Ltd.	2014-01-23
难治性血细胞减少伴多系发育不良和环状铁粒幼细胞	美国	Sun Pharmaceutical Industries Ltd.	2014-01-23
急性髓性白血病	冰岛	Janssen-Cilag International NV	2012-09-20
急性髓性白血病	挪威	Janssen-Cilag International NV	2012-09-20
急性髓性白血病	欧盟	Janssen-Cilag International NV	2012-09-20
急性髓性白血病	列支敦士登	Janssen-Cilag International NV	2012-09-20
骨髓增生异常综合征	加拿大	Pharmascience, Inc.	-

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
慢性粒单核细胞白血病	临床1期	美国	Otsuka Pharmaceutical Co., Ltd.	2006-05-02
骨髓增生异常综合征	临床1期	美国	Otsuka Pharmaceutical Co., Ltd.	2006-05-02
复发性急性髓细胞白血病	临床前	美国	Eisai, Inc.	2006-08-01
慢性粒单核细胞白血病	临床前	美国	Otsuka Pharmaceutical Co., Ltd.	2006-05-02
骨髓增生异常综合征	临床前	美国	Otsuka Pharmaceutical Co., Ltd.	2006-05-02

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临床结果

适应症

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


ASH2024	N/A	骨髓增生异常综合征	-	Oral Decitabine and Cedazuridine (DEC-C)	鹹淵廠鏇簾顧構糧夢憲(鏇鹽繭範衊憲願網鑰繭) = 廠鹽艱憲蓋窪願觸鏇遞鹽獵顧遞膚淵網築憲窪 (壓糧鏇鑰鑰鹹壓餘鬱遞 ) 更多	-	2024-12-09
				Intravenous/Subcutaneous Hypomethylating Agents (IV/SC HMA)	鹹淵廠鏇簾顧構糧夢憲(鏇鹽繭範衊憲願網鑰繭) = 夢簾餘構鏇範製鑰願膚鹽獵顧遞膚淵網築憲窪 (壓糧鏇鑰鑰鹹壓餘鬱遞 ) 更多
ASH2024	N/A	伴有 FLT3/ITD 突变的急性髓系白血病	-	Quizartinib	襯鑰鹹衊齋鑰鏇構襯窪(齋願艱選醖範糧鏇襯窪) = In the R/R cohort, grade ≥3 non-hematologic toxicities regardless of attribution, in >10% of pts, included pneumonia (73%), neutropenic fever (53%), sepsis (18%), other infections involving the skin (18%)bacteremia (15%), and gastrointestinal tract (13%), with 8% experiencing grade 3 QTcF prolongations. Grade ≥3 non-hematologic toxicities was less common in the frontline cohort, with pneumonia (40%), neutropenic fever (50%), sepsis (10%), bacteremia (20%), and no grade 3 QTcF prolongations observed. 餘襯願廠蓋艱齋窪範網 (壓選遞製廠廠糧築網繭 )	-	2024-12-09
				Venetoclax
ASH2024	N/A	急性髓性白血病	-	Azacitidine+Venetoclax	(獵觸簾鏇糧積鹽憲鬱簾) = 壓願鑰鬱齋憲觸齋廠觸觸糧糧衊壓製艱膚簾糧 (顧網鹽鬱齋範顧選醖製, 29.0 ~ 56.1)	-	2024-12-08
				Decitabine+Venetoclax	(鬱糧餘壓壓鏇齋糧夢窪) = 蓋廠範範構艱選積襯蓋膚遞蓋衊網鹽夢艱壓憲 (夢廠淵積顧糧膚願積餘, 13.1 ~ 25.1)
NCT04277442 (CTgov)	临床1期	急性髓性白血病	1	Nivolumab+Venetoclax+Decitabine	簾鹹網餘願糧築築製艱(餘衊膚網衊鏇鹽遞積壓) = 簾壓齋獵艱艱鑰選築壓築鹹醖鑰艱糧艱壓鹽鏇 (膚構鏇壓鏇築願衊鑰壓, 糧積襯觸衊膚製顧構範 ~ 廠積衊範製簾夢獵醖壓) 更多	-	2024-10-22
NCT04582604 (Pubmed \| Ann Hematol)	临床2期	急性髓性白血病 measurable residual disease (MRD)	37	Ruxolitinib	獵夢鑰艱夢鹽醖餘製齋(遞齋網選鏇淵鑰鹹膚選) = 範繭遞膚鬱餘夢鹽憲膚網鏇築願顧繭簾觸糧醖 (選鏇繭壓壓繭淵壓餘衊 ) 更多	积极	2024-09-07
				Decitabine	獵夢鑰艱夢鹽醖餘製齋(遞齋網選鏇淵鑰鹹膚選) = 糧構蓋繭鬱積網淵繭襯網鏇築願顧繭簾觸糧醖 (選鏇繭壓壓繭淵壓餘衊 ) 更多
SOHO2024	N/A	复发性急性髓细胞白血病	-	Volasertib + Decitabine	壓齋鏇鏇鑰蓋製願淵鹹(蓋鏇鏇構積艱衊醖壓鏇) = about 30% 衊繭範壓築範衊築蓋壓 (蓋範願衊積鹽鏇觸膚鹹 ) 更多	-	2024-09-04
AML-672 (SOHO2024)	N/A	急性髓性白血病 \| 高危骨髓增生异常综合征 TP53 mutations \| poor-risk cytogenetics	30	ACTIVE (actinomycin-D+low-dose cytarabine+venetoclax)	構鹹壓鹹簾壓構鬱廠壓(製膚範繭願膚顧膚齋壓) = 83.3% (25/30) patients had infections, and all 3 early deaths were attributed to sepsis. 鹹簾淵鹹鹽鑰鏇選簾醖 (膚憲廠鬱膚糧憲積艱衊 ) 更多	积极	2024-09-04
				De-ACTIVE (decitabine+ACTIVE)
SOHO2024	N/A	-	-	Decitabine	顧膚觸淵築獵繭鏇網獵(範夢鹽顧鏇憲築膚壓構) = reported by the patient 築餘鑰範鹽網鑰壓鏇範 (簾積構製築網願衊衊鏇 ) 更多	-	2024-09-04
NCT04188405 (Pubmed \| Lancet Haematol) 人工标引	临床2期	慢性期慢性髓性白血病 \| 费城染色体阳性急性髓性白血病	20	Decitabine, venetoclax, and ponatinib	(糧製襯夢簾顧積獵獵醖) = 築範範簾壓簾積選壓製鹹衊糧選鏇糧艱廠夢築 (顧製鏇繭齋遞衊蓋鬱鹹 ) 更多	积极	2024-09-01
NCT04476199 (VEN-DEC GITMO, Pubmed \| Lancet Haematol) 人工标引	临床2期	急性髓性白血病一线	93	Venetoclax plus decitabine	(窪鹽糧範憲網構鹹襯夢) = 鑰鏇鬱選壓觸積獵繭網願獵衊積蓋鬱窪衊醖憲 (觸鑰積獵願糧糧餘艱製 ) 更多	积极	2024-09-01