更新于：2024-05-01

Acute Myeloid Leukemia with FLT3/ITD Mutation

伴有 FLT3/ITD 突变的急性髓系白血病

更新于：2024-05-01

基本信息

别名

简介

Acute myeloid leukemia characterized by the presence of a FLT3-internal tandem duplication (ITD) mutation. Patients with this mutation usually present with more aggressive disease and have higher rates of relapse after remission.

关联

项与伴有 FLT3/ITD 突变的急性髓系白血病相关的药物

Quizartinib Hydrochloride

奎扎替尼

靶点

FLT3

作用机制

FLT3抑制剂

在研机构

Daiichi Sankyo Co., Ltd. [+5]

原研机构

Ambit Biosciences Corp.

在研适应症

急性髓性白血病 [+8]

非在研适应症

急性淋巴细胞白血病 [+5]

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期2019-06-18

Gilteritinib Fumarate

富马酸吉瑞替尼

靶点

AXL x FLT3

作用机制

AXL抑制剂 [+1]

在研机构

Astellas Pharma Global Development, Inc. [+4]

原研机构

Astellas Pharma, Inc.

在研适应症

FLT3阳性急性髓性白血病 [+5]

非在研适应症

晚期恶性实体瘤 [+2]

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期2018-09-21

Sorafenib Tosylate

甲苯磺酸索拉非尼

靶点

BRAF x CRAF x FLT3 x PDGFRβ x RET x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit

作用机制

BRAF抑制剂 [+8]

在研机构

Accord Healthcare SLU [+5]

原研机构

Onyx Pharmaceuticals, Inc.

在研适应症

甲状腺癌 [+10]

非在研适应症

异戊酸血症 [+183]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2005-12-01

项与伴有 FLT3/ITD 突变的急性髓系白血病相关的临床试验

NCT06317649 / Not yet recruiting临床2期IIT

A Randomized Phase II Study of Venetoclax and HMA-Based Therapies for the Treatment of Older and Unfit Adults With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial

This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.

开始日期2024-05-30

申办/合作机构

National Cancer Institute

NCT06222580 / Recruiting临床1期

Safety and Efficacy of Dual Menin and FLT3 Inhibition in Patients With Relapsed/Refractory FLT3- Mutated Acute Myeloid Leukemia Containing a Concurrent MLL-Rearrangement or NPM1 Mutation: A Phase I (Ph I) Study of SNDX-5613 + Gilteritinib

This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and/or effective in treating patients with relapsed/refractory FLT3 mutated acute myeloid leukemia.

开始日期2024-02-20

申办/合作机构

Ohio State University Comprehensive Cancer Center

CTR20234244 / Recruiting临床1/2期

XY0206片联合化疗在具有FLT3-ITD突变的初治急性髓系白血病受试者中的安全性、耐受性、药代动力学和初步疗效的多中心、剂量递增和剂量扩展的Ⅰ/Ⅱ期研究

Ⅰ期剂量递增：研究目的： 1、评估XY0206片联合DA（柔红霉素+阿糖胞苷）治疗FLT3-ITD突变的初治AML受试者的安全性和耐受性，观察剂量限值性毒性（DLT），确定Ⅱ期推荐剂量（RP2D）； 2、评估XY0206片联合DA（柔红霉素+阿糖胞苷）治疗FLT3-ITD突变的初治AML受试者的药代动力学（PK）特征； 3、评估XY0206片联合DA（柔红霉素+阿糖胞苷）治疗FLT3-ITD突变的初治AML受试者的初步疗效（如可获得）。 Ⅱ期随机对照研究：研究目的： 1、比较XY0206片联合DA（柔红霉素+阿糖胞苷）与安慰剂联合DA治疗FLT3-ITD突变的初治AML受试者的疗效； 2、比较XY0206片联合DA（柔红霉素+阿糖胞苷）与安慰剂联合DA治疗FLT3-ITD突变的初治AML受试者的安全耐受性； 3、评估XY0206片联合DA（柔红霉素+阿糖胞苷）治疗FLT3-ITD突变的初治AML受试者的药代动力学（PK）特征。

开始日期2024-02-04

申办/合作机构

石家庄以岭药业股份有限公司

100 项与伴有 FLT3/ITD 突变的急性髓系白血病相关的临床结果

登录后查看更多信息

100 项与伴有 FLT3/ITD 突变的急性髓系白血病相关的转化医学

登录后查看更多信息

0 项与伴有 FLT3/ITD 突变的急性髓系白血病相关的专利（医药）

登录后查看更多信息

587

项与伴有 FLT3/ITD 突变的急性髓系白血病相关的文献（医药）

2024-01-29·Cancer research communications

Pim kinase inhibitors increase gilteritinib cytotoxicity in FLT3-ITD acute myeloid leukemia through GSK-3β activation and c-Myc and Mcl-1 proteasomal degradation.

Article

作者: Jonelle K Lee ; Aditi Chatterjee ; Mario Scarpa ; Christopher M Bailey ; Sandrine Niyongere ; Prerna Singh ; Moaath K Mustafa Ali ; Shivani Kapoor ; Yin Wang ; Giovannino Silvestri ; Maria R Baer

Acute myeloid leukemia (AML) with fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) has poor outcomes. FLT3-ITD drives constitutive and aberrant FLT3 signaling, activating STAT5 and upregulating the downstream oncogenic serine/threonine kinase Pim-1. FLT3 inhibitors are in clinical use, but with limited and transient efficacy. We previously showed that concurrent treatment with Pim and FLT3 inhibitors increases apoptosis induction in FLT3-ITD-expressing cells through post-translational downregulation of Mcl-1. Here we further elucidate the mechanism of action of this dual targeting strategy. Cytotoxicity, apoptosis and protein expression and turnover were measured in FLT3-ITD-expressing cell lines and AML patient blasts treated with the FLT3 inhibitor gilteritinib and/or the Pim inhibitors AZD1208 or TP-3654. Pim inhibitor and gilteritinib co-treatment increased apoptosis induction, produced synergistic cytotoxicity, downregulated c-Myc protein expression, earlier than Mcl-1, increased turnover of both proteins, which was rescued by proteasome inhibition, and increased efficacy and prolonged survival in an in vivo model. Gilteritinib and Pim inhibitor co-treatment of Ba/F3-ITD cells infected with T58A c-Myc or S159A Mcl-1 plasmids, preventing phosphorylation at these sites, did not downregulate these proteins, increase their turnover or increase apoptosis induction. Moreover, concurrent treatment with gilteritinib and Pim inhibitors dephosphorylated (activated) the serine/threonine kinase glycogen synthase kinase-3β (GSK-3β), and GSK-3β inhibition prevented c-Myc and Mcl-1 downregulation and decreased apoptosis induction. The data are consistent with c-Myc T58 and Mcl-1 S159 phosphorylation by activated GSK-3β as the mechanism of action of gilteritinib and Pim inhibitor combination treatment, further supporting GSK-3β activation as a therapeutic strategy in FLT3-ITD AML. .

2024-01-17·Cancer research

Foretinib is effective in acute myeloid leukemia by inhibiting FLT3 and overcoming secondary mutations that drive resistance to quizartinib and gilteritinib.

Article

作者: Peihong Wang ; Yvyin Zhang ; Rufang Xiang ; Jie Yang ; Yanli Xu ; Tingfen Deng ; Wei Zhou ; Caixia Wang ; Xinhua Xiao ; Shunqing Wang

FLT3 internal tandem duplication (FLT3-ITD) mutations are one of the most prevalent somatic alterations associated with poor prognosis in patients with acute myeloid leukemia (AML). The clinically-approved FLT3 kinase inhibitors gilteritinib and quizartinib improve the survival of AML patients with FLT3-ITD mutations, but their long-term efficacy is limited by acquisition of secondary drug-resistant mutations. In this study, we conducted virtual screening of a library of 60411 small molecules and identified foretinib as a potent FLT3 inhibitor. An integrated analysis of the BeatAML database showed that foretinib had a lower IC50 value than other existing FLT3 inhibitors in FLT3-ITD AML patients. Foretinib directly bound to FLT3 and effectively inhibited FLT3 signaling. Foretinib potently inhibited proliferation and promoted apoptosis in human AML cell lines and primary AML cells with FLT3-ITD mutations. Foretinib also significantly extended the survival of mice bearing cell-derived and patient-derived FLT3-ITD xenografts, exhibiting stronger efficacy than clinically-approved FLT3 inhibitors in treating FLT3-ITD AML. Moreover, foretinib showed potent activity against secondary mutations of FLT3-ITD that confer resistance to quizartinib and gilteritinib. These findings support the potential of foretinib for treating AML patients with FLT3-ITD mutations, especially for those carrying secondary mutations after treatment failure with other FLT3 inhibitors.

2024-01-10·Pharmacological research

Properties of FDA-approved small molecule protein kinase inhibitors: a 2024 update.

Review

作者: Robert Roskoski

Owing to the dysregulation of protein kinase activity in many diseases including cancer, this enzyme family has become one of the most important drug targets in the 21^st century. There are 80 FDA-approved therapeutic agents that target about two dozen different protein kinases and seven of these drugs were approved in 2023. Of the approved drugs, thirteen target protein-serine/threonine protein kinases, four are directed against dual specificity protein kinases (MEK1/2), twenty block nonreceptor protein-tyrosine kinases, and 43 inhibit receptor protein-tyrosine kinases. The data indicate that 69 of these drugs are prescribed for the treatment of neoplasms. Six drugs (abrocitinib, baricitinib, deucravacitinib, ritlecitinib, tofacitinib, upadacitinib) are used for the treatment of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis). Of the 80 approved drugs, nearly two dozen are used in the treatment of multiple diseases. The following seven drugs received FDA approval in 2023: capivasertib (HER2-positive breast cancer), fruquintinib (metastatic colorectal cancer), momelotinib (myelofibrosis), pirtobrutinib (mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma), quizartinib (Flt3-mutant acute myelogenous leukemia), repotrectinib (ROS1-positive lung cancer), and ritlecitinib (alopecia areata). All of the FDA-approved drugs are orally effective with the exception of netarsudil, temsirolimus, and trilaciclib. This review summarizes the physicochemical properties of all 80 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, polar surface area, potency, solubility, lipophilic efficiency, and ligand efficiency.

项与伴有 FLT3/ITD 突变的急性髓系白血病相关的新闻（医药）

2024-03-12

·Pharmaceutical Technology

MHRA authorises Daiichi Sankyo quizartinib for AML for marketing

Daiichi Sankyo’s quizartinib is indicated for use as a first-line treatment in adults with acute myeloid leukaemia. Credit: Nemes Laszlo / Shutterstock.com. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Daiichi Sankyo for quizartinib (Vanflyta) for use as a first-line treatment in adults with acute myeloid leukaemia (AML) with a FLT3-ITD mutation. The decision allows for the oral administration of quizartinib in combination with chemotherapy – a significant development in the treatment of AML. Taken once daily, quizartinib targets tyrosine kinases to hinder the growth of abnormal bone marrow cells. The treatment duration and dosage are determined by the prescribing physician and may continue post-chemotherapy. The approval is backed by a double-blind, randomised, placebo-controlled Phase III clinical trial in 539 adult subjects aged between 18 and 75 years with newly diagnosed FLT3-ITD positive AML. See Also: MHRA approves Marinus’ ganaxolone for CDKL5 deficiency disorder Innovent’s ROS1 TKI is one step closer to winning the Chinese NSCLC market The study demonstrated a statistically significant improvement in overall survival (time from randomisation to death from any cause) for patients who received quizartinib. Patients receiving quizartinib had a median overall survival of 31.9 months compared to 15.1 months for those receiving a placebo. Abnormal liver enzymes, low blood platelet and white blood cell levels, anaemia, diarrhoea, nausea, stomach pain and headache were the most common side effects linked to the trial. MHRA Healthcare Quality and Access interim executive director Julian Beach stated: “ Our key priorities are keeping patients safe and enabling their access to high quality, safe and effective medical products. “We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all medicines, we will keep its safety under close review.” In another development, the MHRA also gave marketing authorisation to Pfizer for etrasimod (Velsipity) for the treatment of moderately to severely active ulcerative colitis. Etrasimod is prescribed as a long-term treatment and should be initiated only under a doctor’s supervision. The approval is supported by two clinical studies, ELEVATE UC 52 and ELEVATE UC 12, indicating its efficacy for patients where standard treatments were inadequate. The UK National Institute for Health and Care Excellence (NICE) has also published a final guidance recommending etrasimod for ulcerative colitis. With the NICE recommendation, more than 25,000 people in England will be eligible to receive the treatment. The latest development comes after the MHRA approved Marinus Pharmaceuticals ’ ganaxolone, marketed as Ztalmy, an anti-seizure medication for cyclin-dependent kinase-like 5 (CDLK5) deficiency disorder .

上市批准临床3期临床结果

2023-12-04

·GlobeNewswire-Health Care

Kronos Bio Announces Participation in H.C. Wainwright 4th Annual Precision Oncology Virtual Conference

SAN MATEO, Calif. and CAMBRIDGE, Mass., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that Jorge DiMartino M.D., Ph.D., chief medical officer and executive vice president of clinical development, and Charles Lin, Ph.D., senior vice president of TRN mapping will participate in a fireside chat at the H.C. Wainwright 4th Annual Precision Oncology Virtual Conference on Wednesday, December 6, 2023 at 11:00 a.m. ET. A live audio webcast of the event will be available on the Investors and Media section of the Kronos Bio website at www.kronosbio.com. A replay of the webcast will be available for 30 days following the event. About Kronos Bio, Inc. Kronos Bio is a biopharmaceutical company that is advancing two investigational compounds in clinical trials for patients with cancer. The Company is developing the CDK9 inhibitor KB-0742 as a treatment for MYC-amplified solid tumors and other transcriptionally addicted solid tumors and lanraplenib, a next-generation SYK inhibitor, for patients with FLT3-mutated acute myeloid leukemia. The Company also has a maturing discovery pipeline from which they are on track to announce a development candidate in early 2024 for their IRF4 modulator program for use in multiple myeloma. The Company’s scientific focus is on developing medicines that target the deregulated transcription that is the hallmark of cancer and other serious diseases. Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass. For more information, visit https://www.kronosbio.com/ or follow the Company on LinkedIn. Media Contact:Sarah ConnorsVice President of Corporate Affairs, Kronos Bio857-290-7305sconnors@kronosbio.com Investor Contact:Margaux BennettExecutive Director, Business Development and Investor Relations, Kronos Bio650-781-5026mbennett@kronosbio.com

2023-12-01

·BioSpace

Daiichi Sankyo Demonstrates Breadth and Depth of Oncology Portfolio Across Multiple Cancers with New Data at ESMO Asia, SABCS and ASH

Annual R&D Day to provide overview of data and updated strategy across Daiichi Sankyo R&D pipeline BASKING RIDGE, N.J.--(BUSINESS WIRE)-- Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio in multiple types of solid and blood cancers at the 2023 ESMO Asia Congress (#ESMOAsia23), San Antonio Breast Cancer Symposium (#SABCS23) and American Society of Hematology (#ASH23) Annual Meeting prior to its annual R&D Day. Presentation highlights include the first presentation of results from three trials from Daiichi Sankyo’s DXd ADC and hematology portfolio, which include the DESTINY-Gastric06 phase 2 trial of ENHERTU® (trastuzumab deruxtecan) in Chinese patients with previously treated HER2 positive locally advanced/metastatic gastric cancer or gastroesophageal junction adenocarcinoma at ESMO Asia, the DESTINY-Breast08 phase 1b trial of ENHERTU in combination with anastrozole or fulvestrant in patients with HER2 low metastatic breast cancer at SABCS and the VALENTINE-PTCL01 phase 2 trial of valemetostat in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) at ASH. “Our goal is to push the boundaries of science to change the way cancer is treated,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “These data reinforce the breadth and depth of our oncology pipeline and the important progress we are making in developing innovative medicines and exploring combination strategies for patients across a wide range of cancers, including breast, lung, gastric, acute myeloid leukemia and peripheral T-cell lymphoma.” Subgroup analyses of the TROPION-Lung05 phase 2 trial of datopotamab deruxtecan (Dato-DXd) in Asian patients with non-small cell lung cancer (NSCLC) with actionable genomic alterations and the DESTINY-Lung02 phase 2 trial of ENHERTU in Asian patients with HER2 mutant NSCLC will be presented at ESMO Asia. Additional subgroup analyses of the QuANTUM-First phase 3 trial in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), which formed the basis of recent approvals of VANFLYTA® (quizartinib) in the EU, Japan and U.S. will be presented at ASH. Daiichi Sankyo will hold its annual R&D Day for investors, analysts and media on Monday, December 11 at 5:30 - 7:00 pm EST/Tuesday, December 12 at 7:30 - 9:00 am JST. Company executives will provide highlights of Daiichi Sankyo’s research data presented at SABCS and ASH, as well as updates on the company’s R&D strategy. ESMO Asia Data Encore presentations of the TROPION-Lung01 phase 3 trial and TROPION-Lung05 phase 2 trial of datopotamab deruxtecan (Dato-DXd) as well as the DESTINY-PanTumor02 phase 2 trial of ENHERTU will be presented at ESMO Asia from December 1 - 3 in Singapore, along with other data, including: Presentation Title Presenter Abstract Presentation ENHERTU (trastuzumab deruxtecan; T-DXd) Lung Trastuzumab deruxtecan (T-DXd) in Asian patients with human epidermal growth factor receptor 2 (HER2; ERBB2) mutant (HER2m) metastatic non–small cell lung cancer: subgroup analysis of DESTINY-Lung02 Y. Goto 510MO Mini-Oral Session December 2, 2023 9:00 – 10:30 am SGT Pan Tumor Trastuzumab deruxtecan (T-DXd) for pretreated patients with HER2 expressing solid tumors: primary analysis from the DESTINY-PanTumor02 study D. Oh 74MO Mini-Oral Session December 1, 2023 10:45 am – 12 :15 pm SGT Gastric Trastuzumab deruxtecan (T-DXd) in Chinese patients with previously treated HER2 positive locally advanced/ metastatic gastric cancer or gastroesophageal junction adenocarcinoma: primary efficacy and safety from the phase 2 single-arm DESTINY-Gastric06 trial L. Shen 172P Poster Presentation December 2, 2023 Datopotamab deruxtecan (Dato-DXd) Lung Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic non-small cell lung cancer: results of the randomized phase 3 study TROPION-Lung01 M. Ahn 509MO Mini-Oral Session December 2, 2023 9:00 – 10:30 SGT TROPION-Lung05: datopotamab deruxtecan (Dato-DXd) in previously treated non-small cell lung cancer with actionable genomic alterations S. Kitazono 518MO Mini-Oral Session Sunday, December 3 9:00 – 10:30 am SGT TROPION-Lung05: datopotamab deruxtecan (Dato-DXd) in Asian patients with previously treated non-small cell lung cancer with actionable genomic alterations Y. Goto 552P Poster Presentation December 2, 2023 SABCS Data Highlights of Daiichi Sankyo data across several subtypes of breast cancer to be presented at SABCS from December 5 - 9 in San Antonio, Texas, include: Presentation Title Author Abstract Presentation ENHERTU (trastuzumab deruxtecan; T-DXd) HER2 Low Breast Trastuzumab deruxtecan (T-DXd) in combination with anastrozole or fulvestrant in patients with HER2 low HR+ advanced/metastatic breast cancer: a phase 1b, open-label, multicenter, dose-expansion study (DESTINY-Breast08) K. Jhaveri RF02-03 Rapid-Fire Mini-Oral December 7, 2023 12:00 – 12:45 pm CST An open-label, interventional multicenter study of trastuzumab deruxtecan monotherapy in patients with unresectable and/or metastatic HER2 low or HER2 immunohistochemistry 0 breast cancer: DESTINY-Breast15 S. Modi PO2-19-06 Poster Presentation December 6, 2023 5:00 – 7:00 pm CST HER2 Positive Breast European real-world experience of patients with HER2+ advanced/metastatic breast cancer accessing trastuzumab deruxtecan through a named patient program: first interim analysis of EUROPA T-DXd M. De Laurentiis PO3-16-12 Poster Presentation December 7, 2023 12:00 – 2:00 pm CST Real-world experience with trastuzumab deruxtecan in patients with breast cancer: 6 month interim analysis of an all patient post marketing surveillance in Japan J. Tsurutani PO3-17-07 Poster Presentation December 7, 2023 12:00 – 2:00 pm CST Population pharmacokinetics of trastuzumab deruxtecan (T-DXd) in HER2 positive breast cancer subjects: analyses across 12 Phase 1-3 studies C. Li PO3-04-01 Poster Presentation December 7, 2023 12:00 – 2:00 pm CST Exposure-efficacy and exposure-safety analysis of trastuzumab deruxtecan in patients with advanced metastatic HER2+ breast cancer: analyses from phase 3 studies DESTINY-Breast02 and DESTINY-Breast03 C. Li PO3-04-02 Poster Presentation December 7, 2023 12:00 – 2:00 pm CST Datopotamab deruxtecan (Dato-DXd) HR Positive Breast Randomized phase 3 study of datopotamab deruxtecan vs chemotherapy for patients with previously treated inoperable or metastatic hormone receptor positive, HER2 negative breast cancer: results from TROPION-Breast01 A. Bardia GS02-01 Oral Presentation December 7, 2023 8:15 - 8:30 am CST TNBC Durvalumab + datopotamab deruxtecan in patients with PD-L1 positive advanced/metastatic triple negative breast cancer: arm 8 of the phase 1b/2, open label, platform BEGONIA study P. Schmid PO1-19-10 Poster Presentation December 6, 2023 12:00 - 2:00 pm CST ASH Data Highlights of Daiichi Sankyo data from its hematology portfolio to be presented at ASH from December 9 - 12 in San Diego, California, include: Presentation Title Presenter Abstract Presentation Valemetostat (EZHARMIA in Japan only) T-cell Lymphoma Efficacy and safety of valemetostat monotherapy in patients with relapsed or refractory peripheral T-cell lymphomas: primary results of the phase 2 VALENTINE-PTCL01 study S. Horwitz 302 Oral Presentation December 9, 2023 4:15 pm PST Valemetostat for relapsed or refractory peripheral T- cell lymphomas: primary results from a phase 1 trial E. Jacobsen 303 Oral Presentation December 9, 2023 4:30 pm PST B-cell Lymphoma Valemetostat for relapsed or refractory B-cell lymphomas: primary results from a phase 1 trial K. Izutsu 1731 Poster Presentation December 9, 2023 5:30 - 7:30 pm PST VANFLYTA (quizartinib) FLT3-ITD AML QuANTUM-First: FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD)-specific measurable residual disease (MRD) clearance assessed through induction and consolidation is associated with improved overall survival in newly diagnosed FLT3-ITD+ AML patients A. Perl 832 Oral Presentation December 11, 2023 3:30 pm PST QuANTUM-First: safety by treatment phase and by age in newly diagnosed patients with FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) positive acute myeloid leukemia (AML) H. Erba 972 Oral Presentation December 11, 2023 5:45 pm PST Patient-reported outcomes in acute myeloid leukemia patients with FLT3-ITD mutation receiving quizartinib vs. standard chemotherapy: results from the QuANTUM-First trial E. Oliva 918 Oral Presentation December 11, 2023 4:00 pm PST QuANTUM-First: clinical bridging study for FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) companion diagnostic development J. Rohrbach 4260 Poster Presentation December 11, 2023 6:00 - 8:00 pm PST Kinetics of complete remission (CR) and CR duration and its impact on overall survival (OS) and event-free survival (EFS) in QuANTUM-First P. Montesinos 4254 Poster Presentation December 11, 2023 6:00 - 8:00 pm PST About the DXd ADC Portfolio of Daiichi Sankyo The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc., Rahway, NJ. U.S.A. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit .

临床结果临床1期临床3期临床2期抗体药物偶联物