Asciminib as Single Agent or in Combination With Nilotinib in the 1st-line Treatment of BCR-ABL1+ Chronic Myeloid Leukemia: a Randomized GIMEMA-GELMC Phase II Study PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML

A phase 2, interventional, randomized unblinded study will be conducted in newly diagnosed CP CML patients, to investigate the efficacy and the safety of asciminib at a dose of 80 mg QD as single agent (arm A) or 40 mg BID in combination with nilotinib 300 mg BID (arm B).
All patients in both arm A and arm B will be treated for a minimum of 2 years (core phase). If they will have achieved a DMR (MR4), or if it will be in the interest of the patient, the treatment will be continued.
During the consolidation phase (2 years) asciminib will be continued at the same dose in both arms; in the combination arm the nilotinib dose will be reduced to 300 mg daily.
The patients maintaining a stable MR4 up to the end of the fourth year will discontinue the treatment (TFR phase). The rate of TFR at 5 year (1 year after discontinuation) will be evaluated.

开始日期2025-06-01

申办/合作机构

Gruppo Italiano Malattie EMatologiche dell'Adulto

IRCT20200623047902N17

/ SuspendedN/A

Bioequivalence study of Nilotinib 200mg capsule manufactured by Rooyan darou versus Tasigna 200 mg in healthy volunteers in the fasted condition

开始日期2024-10-22

申办/合作机构-

CTIS2024-514448-10-00

/ Not yet recruiting临床1期

- BLCL-NIL-FDA-02

开始日期2024-08-09

申办/合作机构

Bluepharma Indústria Farmacêutica SA

100 项与尼洛替尼相关的临床结果

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100 项与尼洛替尼相关的转化医学

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100 项与尼洛替尼相关的专利（医药）

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4,583

项与尼洛替尼相关的文献（医药）

2025-12-31·Hematology

Second-line use of dasatinib and nilotinib in a real-world patient population with chronic phase chronic myeloid leukemia

Article

作者: Toptas, Tayfur ; Yilmaz, Asu Fergun ; Kaygusuz Atagunduz, Isik ; Menguc, Meral ; Demirtas, Derya ; Yanik, Ahmet Mert ; Candan, Ozlem ; Salim, Secil ; Tuglular, Tulin ; Arikan, Fatma

BACKGROUND:

While there has been no direct head-to-head comparison, it is assumed that second-line treatment with dasatinib and nilotinib has comparable efficacy but distinct safety profiles in the treatment of patients with chronic phase chronic myeloid leukemia (CML-CP). Our aim was to conduct a real-world analysis to compare the efficacy and safety profiles of these two agents.

METHODS:

Data from 73 CML-CP patients, who received either dasatinib or nilotinib in second-line treatment, were analyzed. The primary interest of the efficacy assessment was a major molecular response (MMR) at the 12-month, 5-year cumulative incidence of treatment failure, and overall survival.

RESULTS:

A total of 73.5% of 34 patients in the dasatinib and 76.9% of 39 patients in the nilotinib group achieved MMR at 12 months. Five-year cumulative probability of treatment failure in patients, who previously achieved MMR was 0 and 7.6% for patients receiving dasatinib and nilotinib, respectively (p = 0.25). Eight-year OS was 82.7 and 86.3% for dasatinib and nilotinib groups, respectively (p = 0.90). Pleural effusions were more common in the dasatinib group, leading to treatment discontinuation, while cardiovascular events and thrombotic incidents were more prevalent in the nilotinib group.

CONCLUSION:

Dasatinib and nilotinib exhibit similar efficacy in the CML-CP treatment. Individualized patient management should consider patient comorbidities and safety profiles.

2025-06-01·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Computational phytochemical screening for Parkinson's disease therapeutics: c-Abl and beyond

Article

作者: Sola, Piyong ; Yasmine, Jesmina ; Dutta, Bhaskar Jyoti ; Buragohain, Sankarkishor ; Rymbai, Emdormi

Parkinson's disease (PD), a rapidly growing neurodegenerative disorder, is characterized by intracellular α-synuclein aggregates. The tyrosine kinase c-Abl plays a critical role in PD pathogenesis. This study aimed to identify novel c-Abl inhibitors from natural products using molecular docking and dynamics simulations. We explored phytochemicals from Indian Medicinal Plants, Phytochemistry and Therapeutics (IMPPAT) database and employed molecular docking and molecular dynamics to discover c-Abl inhibitors. Three potential hits: IMPHY008934, IMPHY009589, and IMPHY006310 were identified. These compounds demonstrated comparable binding affinity to Nilotinib, a comparison drug. Toxicity predictions revealed IMPHY008934 and IMPHY009589 exhibited lower toxicity than Nilotinib. Molecular dynamics simulations confirmed the stability of IMPHY009589 and IMPHY008934 with c-Abl. Density functional theory (DFT) analysis showed that IMPHY006310 and IMPHY008934 displayed enhanced reactivity and polarizability. Our findings suggest these natural compounds may target c-Abl in PD pathogenesis and possibly downregulate the overexpressed α-synuclein and may serve as promising leads for PD therapy.

2025-06-01·ANTI-CANCER DRUGS

Association between nilotinib-induced hyperbilirubinemia and UGT1A1 polymorphisms in a chronic myeloid leukemia patient

Article

作者: Roldán, Alicia Martín ; Alarcón-Payer, Carolina ; Morales, Alberto Jimnez ; Sánchez Suárez, María Del Mar

We present the case of a young woman diagnosed with chronic myeloid leukemia who began de-novo treatment with nilotinib, which led to increased plasma levels of total bilirubin and QT interval. An evaluation of the genetic profile of uridine diphosphate glucuronosyltransferase was made, as nilotinib inhibits the activity of this enzyme causing hyperbilirubinemia, with higher risk in slow metabolizers, such as those ones with *6/*6 genotype. This type of patient can be identified by genetic profiling, and adjustment in the dose of nilotinib could be made to avoid tyrosine kinase inhibitor switching.

204

项与尼洛替尼相关的新闻（医药）

2025-04-25

·ioncology

2025 ASCO大会前瞻丨血液肿瘤领域有哪些重磅研究入选？一文速览

点击蓝字关注我们编者按：2025年美国临床肿瘤学会年会（ASCO）将于美国东部时间（GMT-5）5月30日至6月3日在芝加哥召开。作为全球规模最大、学术水平最高、最具权威性的国际肿瘤会议之一，2025年ASCO年会将汇聚顶级肿瘤专家、学者和行业领袖，共探肿瘤领域的前沿研究成果和先进治疗方法。日前，2025 ASCO入选摘要标题（包括Late-Breaking Abstracts）已发布。摘要具体内容将在2025年5月22日发布，Late-breaking摘要内容将在会议当天发布。《肿瘤瞭望-血液时讯》特别整理血液肿瘤领域的重磅研究，包括1项LBA、27项口头报告、27项快速口头报告，助力大家提前了解会议的重磅内容。01Plenary Session当地时间：6月1日13:00-16:00报告地点：Hall B1摘要号：LBA3英文标题：Results from VERIFY, a phase 3, double-blind, placebo (PBO)-controlled study of rusfertide for treatment of polycythemia vera (PV)中文标题：：rusfertide治疗真性红细胞增多症（PV）的三期、双盲、安慰剂（PBO）对照VERIFY研究结果讲者：Andrew Tucker Kuykendall, MD| Moffitt Cancer Center02Oral Abstract Session淋巴瘤与慢性淋巴细胞白血病当地时间：5月30日14:45–17:45报告地点：S100a摘要号：7000英文标题：Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial中文标题：通过PhasED-Seq对国家试验中DLBCL患者治疗结束ctDNA MRD的前瞻性验证讲者：Steven Wang, MD | Amsterdam UMC Location Vrije Universiteit摘要号：7001英文标题：Revision of staging system for natural killer T-cell lymphoma: A multicenter study from the Chinese Southwest Oncology Group and Asia Lymphoma Study Group中文标题：自然杀伤性 T 细胞淋巴瘤分期系统修订：中国西南肿瘤学组及亚洲淋巴瘤研究组多中心研究讲者：林桐榆（四川省肿瘤医院）摘要号：7002英文标题：Molecular landscape of distinct follicular lymphoma histologic grades: Insights from genomic and transcriptome analyses中文标题：不同组织学分级滤泡性淋巴瘤的分子图谱：来自基因组和转录组分析的见解讲者：孙聪（天津医科大学肿瘤医院）摘要号：7003英文标题：A phase 1 study of KITE-363 anti-CD19/CD20 chimeric antigen receptor (CAR) T-cell therapy in patients (pts) with relapsed/refractory (R/R) B-cell lymphoma (BCL)中文标题：KITE-363抗CD19/CD20嵌合抗原受体（CAR）T细胞治疗复发/难治性B细胞淋巴瘤患者的Ⅰ期临床研究讲者：Saurabh Dahiya, MD, FACP | Stanford University School of Medicine摘要号：7004英文标题：Multi-virus specific T cells to enhance the activity of bispecific antibodies in lymphoma中文标题：多病毒特异性T细胞用于增强双特异性抗体在淋巴瘤中的治疗活性讲者：Akiva Diamond, MD | Department of Medicine, Section of Hematology-Oncology, Baylor College of Medicine; Baylor St.Luke’s Medical Center; Dan L Duncan Comprehensive Cancer Center摘要号：7005英文标题：WaveLINE-003: Phase 2/3 trial of zilovertamab vedotin plus standard of care in relapsed/refractory diffuse large B-cell lymphoma中文标题：WaveLINE-003：zilovertamab vedotin联合标准治疗用于复发/难治性弥漫大B细胞淋巴瘤的Ⅱ/Ⅲ期临床试验讲者：Philippe Armand, MD, PhD | Dana-Farber Cancer Institute摘要号：7006英文标题：Sintilimab (anti-PD-1 antibody) combined with chidamide (an oral subtype-selective HDACi) followed by P-GemOx regimen in patients with treatment-naïve extranodal natural killer/T cell lymphoma (TN-ENKTL): A multicenter, open-label, single-arm, phase II study (SCENT-2 trial)中文标题：信迪利单抗（抗PD-1抗体）联合西达本胺（一种口服HDACi）继以 P-GemOx 方案治疗初治结外自然杀伤性 /T 细胞淋巴瘤（TN-ENKTL）患者的多中心、开放标签、单臂、II 期研究（SCENT-2 试验）讲者：黄慧强（中山大学肿瘤防治中心）摘要号：7007英文标题：Sintilimab (anti-PD-1) plus ifosfamide, carboplatin, and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind phase 3 study (ORIENT-21)中文标题：信迪利单抗（抗PD-1）联合依托泊苷（ICE）方案用于二线治疗经典霍奇金淋巴瘤（cHL）：一项多中心、随机、对照、双盲 III 期研究（ORIENT-21）的结果讲者：刘鹏（中国医学科学院肿瘤医院）摘要号：7008英文标题：Results from the completed dose-finding part of phase 2 study of the innate cell engager acimtamig (AFM13) in combination with AlloNK (AB-101) in relapsed or refractory classical Hodgkin lymphoma (LuminICE-203)中文标题：先天细胞接合剂acimtamig（AFM13）联合AlloNK（AB-101）治疗复发或难治性经典型霍奇金淋巴瘤的Ⅱ期临床试验剂量探索部分结果（LuminICE-203）讲者：Joseph E. Maakaron, MD | Division of Hematology, Oncology and Transplantation, Department of Medicine, Masonic Cancer Center, University of Minnesota白血病、骨髓增生异常综合征与异基因造血干细胞移植当地时间：6月2日15:00-18:00报告地点：S100a摘要号：6500英文标题：Ropeginterferon alfa-2b versus anagrelide for the treatment of essential thrombocythemia: Topline results of the phase 3 SURPASS-ET trial中文标题：Ropeginterferon alfa-2b vs. anagrelide治疗原发性血小板增多症：SURPASS-ET Ⅲ期临床试验的主要结果讲者：Ruben A. Mesa, MD | Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Wake Forest University School of Medicine摘要号：6501英文标题：Primary endpoint results of the phase 3b ASC4START trial of asciminib (ASC) vs nilotinib (NIL) in newly diagnosed chronic phase chronic myeloid leukemia (CML-CP): Time to treatment discontinuation due to adverse events (TTDAE)中文标题：asciminib（ASC）vs. nilotinib（NIL）用于新诊断慢性期慢性粒细胞白血病（CML-CP）患者的不良事件导致治疗中断时间（TTDAE）:ASC4START Ⅲb期临床试验主要终点结果讲者：Andreas Hochhaus, MD | Klinik für Innere Medizin II, Universitätsklinikum Jena摘要号：6502英文标题：Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study中文标题：CADENZA研究中pivekimab sunirine（PVEK）治疗母细胞性浆细胞样树突状细胞肿瘤（BPDCN）患者的疗效与安全性讲者：Naveen Pemmaraju, MD | The University of Texas MD Anderson Cancer Center摘要号：6503英文标题：Phase II study of cladribine, low-dose cytarabine, and venetoclax, alternating with azacitidine and venetoclax, in higher-risk chronic myelomonocytic leukemia and myelodysplastic syndromes中文标题：克拉屈滨、低剂量阿糖胞苷联合维奈克拉与阿扎胞苷联合维奈克拉交替治疗高危慢性粒单核细胞白血病和骨髓增生异常综合征的Ⅱ期临床研究讲者：Guillermo Montalban-Bravo, MD | The University of Texas MD Anderson Cancer Center摘要号：6504英文标题：An all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients (pts) with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts中文标题：全口服方案decitabine-cedazuridine（DEC-C）联合维奈克拉（VEN）用于不适合强化诱导化疗的新诊断急性髓系白血病（AML）患者：来自101例患者的Ⅱ期队列研究结果讲者：Amer Methqal Zeidan, MBBS | Yale University School of Medicine摘要号：6505英文标题：Phase 1b/2 study of lisaftoclax (APG-2575) combined with azacitidine (AZA) in patients (pts) with treatment-naïve (TN) or prior venetoclax (VEN)-exposed myeloid malignancies中文标题：lisaftoclax（APG-2575）联合阿扎胞苷（AZA）治疗初治或既往接受过维奈克拉（VEN）治疗的髓系恶性肿瘤患者的Ⅰb/Ⅱ期临床研究讲者：Michael Francis Leahy, FRACP, FRCP, FRCPath, MBChB | Royal Perth Hospital摘要号：6506英文标题：Ziftomenib in relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML): Phase 1b/2 clinical activity and safety results from the pivotal KOMET-001 study中文标题：Ziftomenib治疗复发/难治性（R/R）NPM1突变急性髓系白血病（AML）：关键KOMET-001研究中Ⅰb/Ⅱ期临床疗效和安全性结果讲者：Eunice S. Wang, MD | Roswell Park Comprehensive Cancer Center摘要号：6507英文标题：γ9δ2 T-cell activation (γδTCA) with ICT01 combined with azacitidine-venetoclax (AV) for older/unfit adults with newly diagnosed (ND) AML: Preliminary efficacy and dose selection in phase 1/2 study EVICTION中文标题：γ9δ2 T细胞激活（γδTCA）联合ICT01和阿扎胞苷-维奈克拉（AV）治疗高龄/unfit新诊断急性髓系白血病（AML）成年患者：EVICTION Ⅰ/Ⅱ期研究中的初步疗效和剂量选择讲者：Pierre Yves Dumas, MD, PhD| CHU摘要号：6508英文标题：Long-term outcomes of patients surviving beyond 2 years post–allogeneic stem cell transplantation中文标题：接受异基因造血干细胞移植后存活超过2年患者的长期结局讲者：Arjun Datt Law, MD, DM, MBBS, FCRP | Princess Margaret Cancer Centre浆细胞病当地时间：6月3日09:45-12:45报告地点：S100bc摘要号：7500英文标题：MRD-driven strategy following IsaKRD induction in transplant-eligible NDMM: Primary endpoints of the phase 3 MIDAS trial中文标题：在适合移植的新诊断多发性骨髓瘤（NDMM）患者中，IsaKRD诱导后MRD驱动策略：MIDAS Ⅲ期临床试验的主要终点讲者：Aurore Perrot, MD, PhD | Toulouse University, CHU Oncopole摘要号：7501英文标题：Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial中文标题：皮下注射达雷妥尤单抗（Dara）+硼替佐米/来那度胺/地塞米松（VRd）联合达雷妥尤单抗+来那度胺（DR）维持治疗适合移植（TE）新诊断多发性骨髓瘤（NDMM）患者：PERSEUS Ⅲ期临床试验中持续微小残留病（MRD）阴性的分析讲者：Philippe Moreau, MD, PhD | University Hospital Hôtel-Dieu摘要号：7502英文标题：Sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial)中文标题：卡非佐米-来那度胺-地塞米松联合或不联合艾沙妥昔单抗（Isatuximab）治疗新诊断多发性骨髓瘤患者：Ⅲ期IsKia临床试验中的持续微小残留病（MRD）阴性分析讲者：Francesca Gay, MD, PhD | Division of Hematology, AOU Città della Salute e della Scienza di Torino, University of Torino and Department of Molecular Biotechnology and Health Sciences, University of Torino摘要号：7503英文标题：Randomized, multi-center study of carfilzomib, lenalidomide, and dexamethasone (KRd) with or without daratumumab (D) in patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trial中文标题：卡非佐米、来那度胺和地塞米松（KRd）联合或不联合达雷妥尤单抗（D）治疗新诊断多发性骨髓瘤（NDMM）患者的随机多中心研究：ADVANCE临床试验讲者：Carl Ola Landgren, MD, PhD | Myeloma Program and Experimental Therapeutics Program, University of Miami摘要号：7504英文标题：Elranatamab in combination with daratumumab and lenalidomide (EDR) in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant: Initial results from MagnetisMM-6 part 1中文标题：Elranatamab联合达雷妥尤单抗和来那度胺（EDR）治疗不适合接受移植的新诊断多发性骨髓瘤（NDMM）患者：MagnetisMM-6 part 1的初步结果讲者：HANG QUACH, MD, FRACP, FRCPA | St Vincent’s Hospital Melbourne, University of Melbourne摘要号：7505英文标题：First-in-human study of JNJ-79635322 (JNJ-5322), a novel, next-generation trispecific antibody (TsAb), in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Initial phase 1 results中文标题：JNJ-79635322（JNJ-5322）新型三特异性抗体（TsAb）在复发/难治性多发性骨髓瘤（RRMM）患者中的首次人体研究：初步Ⅰ期结果讲者：Niels W.C.J. van de Donk, MD, PhD | Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Department of Hematology摘要号：7506英文标题：Isatuximab (Isa) subcutaneous (SC) via an on-body delivery system (OBDS) vs Isa intravenous (IV), plus pomalidomide and dexamethasone (Pd) in relapsed/refractory multiple myeloma (RRMM): Results of the randomized, non-inferiority, phase 3 IRAKLIA study中文标题：艾沙妥昔单抗（Isa）通过体外输送系统（OBDS）皮下（SC）给药vs. Isa静脉注射（IV），联合泊马度胺和地塞米松（Pd）治疗复发/难治性多发性骨髓瘤（RRMM）：随机非劣效性Ⅲ期IRAKLIA研究结果讲者：Xavier P. Leleu, MD, PhD | Service d'Hématologie et Thérapie Cellulaire, CHU and CIC Inserm 1402摘要号：7507英文标题：Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM)中文标题：CARTITUDE-1研究中接受ciltacabtagene autoleucel（cilta-cel）治疗的复发/难治性多发性骨髓瘤（RRMM）患者的长期（≥5年）缓解与生存情况讲者：Peter M. Voorhees, MD | Atrium Health / Levine Cancer Institute, Wake Forest University School of Medicine摘要号：7508英文标题：Safety and efficacy data from Nexicart-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, Nxc-201中文标题：Nexicart-2的安全性与疗效数据：CAR-T在R/R轻链淀粉样变中的首次美国试验（Nxc-201）讲者：Heather Jolie Landau, MD | Memorial Sloan Kettering Cancer Center03Rapid Oral Abstract Session白血病、骨髓增生异常综合征与异基因造血干细胞移植当地时间：5月30日13:00-14:30报告地点：E450a摘要号：6509英文标题：A phase I study of asciminib in combination with dasatinib, prednisone, and blinatumomab for Ph-positive acute leukemia in adults中文标题：asciminib联合达沙替尼、泼尼松和贝林妥欧单抗治疗成人Ph阳性急性白血病的Ⅰ期临床研究讲者：Marlise R Luskin, MD | Dana-Farber Cancer Institute摘要号：6510英文标题：MRD negativity after end of induction in the phase 3 PhALLCON trial: A post hoc analysis中文标题：PhALLCON Ⅲ期临床试验中诱导治疗结束后的MRD阴性率：事后分析讲者：Ibrahim Aldoss, MD | City of Hope – Duarte摘要号：6511英文标题：Reduced dose PTCy in patients with acute myeloid leukemia receiving matched unrelated donor allogeneic hematopoietic stem cell transplantation中文标题：减量PTCy用于接受配型无关供者异基因造血干细胞移植的急性髓系白血病患者讲者：Nihar Desai, MD, DM | Princess Margaret Hospital摘要号：6512英文标题：Overall survival (OS) and duration of response for transfusion independence (TI) in erythropoiesis stimulating agent (ESA)–naive patients (pts) with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS) treated with luspatercept (LUSPA) vs epoetin alfa (EA) in the COMMANDS trial中文标题：COMMANDS研究中luspatercept（LUSPA）对比促红素α（epoetin alfa，EA）治疗未使用促红素治疗的极低、低或中危骨髓增生异常综合征（MDS）患者的总体生存期（OS）与获得输血独立（TI）后反应持续时间分析讲者：Guillermo Garcia-Manero, MD | University of Texas MD Anderson Cancer Center摘要号：6513英文标题：Efficacy of macrophage checkpoint Clever-1 inhibition with bexmarilimab plus azacitidine in myelodysplastic syndrome: Results from the ph1/2 BEXMAB study中文标题：bexmarilimab联合阿扎胞苷抑制巨噬细胞检查点Clever-1治疗骨髓增生异常综合征的疗效：BEXMAB Ⅰ/Ⅱ期研究结果讲者：Naval Guastad Daver, MD | Department of Leukemia, The University of Texas MD Anderson Cancer Center摘要号：6514英文标题：Dosing decitabine and venetoclax for terminal differentiation to improve outcomes in TP53 mutant MDS and AML中文标题：地西他滨和维奈克拉用于诱导终末分化，以改善TP53突变型MDS和AML的治疗结局讲者：Mendel Goldfinger, MD | Montefiore Einstein Comprehensive Cancer Center摘要号：6515英文标题：IMproveMF update: Phase 1/1B trial of imetelstat (IME)+ruxolitinib (RUX) in patients (pts) with intermediate (INT)-1, INT-2, or high-risk (HR) myelofibrosis (MF)中文标题：IMproveMF更新：imetelstat（IME）联合芦可替尼（RUX）治疗中危1（INT-1）、中危2（INT-2）或高危（HR）骨髓纤维化（MF）患者的Ⅰ/Ⅰb期临床试验讲者：John Mascarenhas, MD | Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai摘要号：6516英文标题：Efficacy and safety of asciminib (ASC) in patients (pts) with chronic-phase chronic myeloid leukemia (CML-CP) after 1 tyrosine kinase inhibitor (TKI): Interim analysis (IA) of the phase 2 ASC2ESCALATE trial中文标题：asciminib（ASC）治疗接受过1种酪氨酸激酶抑制剂（TKI）治疗的慢性期慢性髓性白血病（CML-CP）患者的疗效和安全性：Ⅱ期ASC2ESCALATE试验的中期分析（IA）讲者：David Jacob Andorsky, MD | Rocky Mountain Cancer Centers, US Oncology Research摘要号：6517英文标题：Age-related macular degeneration in individuals with clonal hematopoiesis中文标题：克隆性造血个体的年龄相关性黄斑变性讲者：Keishla Marie Arce-Ruiz, BS | McGraw/Patterson Center for Population Sciences, Dana-Farber Cancer Institute淋巴瘤与慢性淋巴细胞白血病当地时间：5月31日08:00-09:30报告地点：E450a摘要号：7009英文标题：Combination of zanubrutinib (zanu) + venetoclax (ven) for treatment-naive (TN) CLL/SLL: Results in SEQUOIA arm D中文标题：zanubrutinib（zanu）联合维奈克拉（ven）治疗初治慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）：SEQUOIA研究D组结果讲者：Mazyar Shadman, MD, MPH | Fred Hutchinson Cancer Center and University of Washington摘要号：7010英文标题：Phase 1/2 studies of DZD8586 in CLL/SLL patients after covalent or non-covalent BTK inhibitors and BTK degraders中文标题：DZD8586 在经共价或非共价 BTK 抑制剂及 BTK 降解剂治疗后的 CLL/SLL 患者中的I/II期研究讲者：李建勇（江苏省人民医院）摘要号：7011英文标题：SEQUOIA 5-year follow-up in arm C: Frontline zanubrutinib monotherapy in patients with del(17p) and treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)中文标题：SEQUOIA研究5年随访，C组：前线zanubrutinib单药治疗del(17p)及未经治疗的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者讲者：Constantine Si Lun Tam, MD, FRACP, FRCPA, MBBS | Alfred Hospital and Monash University摘要号：7012英文标题：A phase 1/2 study to evaluate the safety and efficacy of XNW5004, a selective EZH2 inhibitor, in subjects with relapsed/refractory non-Hodgkin lymphoma中文标题：一项1/2期研究：评估选择性 EZH2 抑制剂 XNW5004 在复发/难治性非霍奇金淋巴瘤患者中的安全性与有效性讲者：邱录贵[中国医学科学院血液病医院（中国医学科学院血液学研究所）]摘要号：7013英文标题：CD79b-targeted antibody-drug conjugate (ADC) SHR-A1912 in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) in relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL): Data from a phase 1b/2 study中文标题：以 CD79b 为靶点的抗体偶联药物（ADC）SHR - A1912 联合R - GemOx方案用于复发 / 难治性（R/R）弥漫性大 B 细胞淋巴瘤（DLBCL）患者的1b/2期研究数据讲者：李亚军（湖南省肿瘤医院）摘要号：7014英文标题：Fixed duration subcutaneous (SC) mosunetuzumab (Mosun) in patients with previously untreated high-tumor burden follicular lymphoma (FL): Interim results from the phase II MorningSun study中文标题：固定疗程皮下（SC）莫妥珠单抗（Mosun）治疗既往未治疗的高肿瘤负担滤泡性淋巴瘤（FL）患者：Ⅱ期MorningSun研究的中期结果讲者：Ian W. Flinn, MD, PhD | Tennessee Oncology and OneOncology摘要号：7015英文标题：Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO中文标题：格菲妥单抗联合吉西他滨和奥沙利铂（Glofit-GemOx）治疗复发/难治性（R/R）弥漫大B细胞淋巴瘤（DLBCL）患者：STARGLO研究2年随访结果讲者：Jeremy S. Abramson, MD | Massachusetts General Hospital Cancer Center摘要号：7016英文标题：Worldwide experience of chronic active EBV infection: Retrospective cohort study中文标题：全球慢性活动性EBV感染经验：回顾性队列研究讲者：王欣然（华中科技大学同济医学院附属同济医院）摘要号：7017英文标题：Efficacy and safety of first-line ibrutinib plus venetoclax in patients with mantle cell lymphoma (MCL) who were older or had TP53 mutations in the SYMPATICO study中文标题：伊布替尼联合维奈克拉一线治疗年龄较大或存在TP53突变的套细胞淋巴瘤（MCL）患者的疗效和安全性：SYMPATICO研究讲者：Michael Wang, MD | Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center创新性治疗—免疫疗法当地时间：6月1日11:15-12:45报告地点：S406摘要号：2514英文标题：Preliminary results from the dose-escalation stage of a phase I trial of an anti-CCR8 antibody in patients with relapsed/refractory cutaneous T-cell lymphoma (R/R CTCL)中文标题：靶向CCR8抗体治疗复发/难治性皮肤T细胞淋巴瘤（R/R CTCL）的Ⅰ期临床试验剂量递增阶段初步结果讲者：李志铭（中山大学肿瘤防治中心）浆细胞病当地时间：6月2日08:00-09:30报告地点：E450b摘要号：7509英文标题：Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) for high-risk (HR) newly diagnosed multiple myeloma (NDMM): First-time report of the full cohort of transplant-eligible (TE) patients in the GMMG-CONCEPT trial中文标题：艾沙妥昔单抗、卡非佐米、来那度胺和地塞米松（Isa-KRd）治疗高危（HR）新诊断多发性骨髓瘤（NDMM）：GMMG-CONCEPT研究中适合移植（TE）患者全队列的首次报告讲者：Lisa B. Leypoldt, MD | University Medical Center Hamburg-Eppendorf摘要号：7510英文标题：Linvoseltamab (LINVO) + bortezomib (BTZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): First results from the LINKER-MM2 trial中文标题：Linvoseltamab（LINVO）联合硼替佐米（BTZ）治疗复发/难治性多发性骨髓瘤（RRMM）患者：LINKER-MM2研究的首次结果讲者：Xavier P. Leleu, MD, PhD | Hematology, CIC 1082, U1313, CHU, University摘要号：7511英文标题：Heterogeneity in the expression of GPRC5D between patients with multiple myeloma中文标题：多发性骨髓瘤患者中GPRC5D表达的异质性讲者：Harsh Parmar | John Theurer Cancer Center, Hackensack University Medical Center摘要号：7512英文标题：Belantamab mafodotin plus lenalidomide/dexamethasone in newly diagnosed intermediate-fit & frail multiple myeloma patients: Long-term efficacy and safety from the phase 1/2 BELARD clinical trial中文标题：Belantamab mafodotin联合来那度胺/地塞米松治疗新诊断的中度fit和虚弱多发性骨髓瘤患者：来自Ⅰ/Ⅱ期BELARD临床试验的长期疗效和安全性结果讲者：Evangelos Terpos, MD, PhD | Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine摘要号：7513英文标题：Linvoseltamab (LINVO) + carfilzomib (CFZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Initial results from the LINKER-MM2 trial中文标题：Linvoseltamab（LINVO）联合卡非佐米（CFZ）治疗复发/难治性多发性骨髓瘤（RRMM）患者：LINKER-MM2研究的初步结果讲者：Salomon Manier, MD, PhD | Hematology Department, Lille University Hospital摘要号：7514英文标题：Phase 1, first-in-human study of ISB 2001: A BCMAxCD38xCD3-targeting trispecific antibody for patients with relapsed/refractory multiple myeloma (RRMM)—Dose escalation (DE) results中文标题：ISB 2001的Ⅰ期首次人体研究：一种针对BCMAxCD38xCD3的三特异性抗体治疗复发/难治性多发性骨髓瘤（RRMM）患者——剂量递增（DE）结果讲者：Eben I. Lichtman, MD | UNC Lineberger Comprehensive Cancer Center摘要号：7515英文标题：Minimal residual disease (MRD) negativity (neg) in patients (pts) with relapsed or refractory multiple myeloma (RRMM) treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide, bortezomib, and dexamethasone (PVd): Analysis from the DREAMM-8 trial中文标题：belantamab mafodotin联合泊马度胺和地塞米松（BPd）与泊马度胺、硼替佐米和地塞米松（PVd）治疗复发/难治性多发性骨髓瘤（RRMM）患者的微小残留病（MRD）阴性率比较：来自DREAMM-8研究的分析讲者：Suzanne Trudel, MD | Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre摘要号：7516英文标题：Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study中文标题：达雷妥尤单抗联合硼替佐米、来那度胺和地塞米松（DVRd）治疗新诊断多发性骨髓瘤（NDMM）患者：Ⅲ期CEPHEUS研究中不适合移植（TIE）患者的亚组分析讲者：Saad Z Usmani, MD, MBA, FRCP, FASCO | Memorial Sloan Kettering Cancer Center（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果ASCO会议临床1期细胞疗法免疫疗法

2025-04-21

·亚盛医药

2025 CSCO指南更新：亚盛医药APG-2575首获推荐，耐立克®获升级推荐

亚盛医药（纳斯达克代码：AAPG；香港联交所代码：6855）今日宣布，公司自主研发的两款重磅创新药均获纳入2025年中国临床肿瘤学会（CSCO）系列指南：在研品种新型口服Bcl-2选择性抑制剂Lisaftoclax（APG-2575）首次获《CSCO淋巴瘤诊疗指南》推荐。公司原创1类新药、新一代酪氨酸激酶抑制剂（TKI）奥雷巴替尼片（商品名：耐立克®）获《CSCO儿童及青少年白血病诊疗指南》升级推荐；延续《CSCO恶性血液病诊疗指南》相关推荐。Bcl-2抑制剂Lisaftoclax（APG-2575）首次获CSCO 指南推荐作为全球第二个递交新药上市申请（NDA）的Bcl-2抑制剂、中国首个递交NDA并进入优先审评的国产原研Bcl-2抑制剂，Lisaftoclax（APG-2575）凭借其优异的临床数据，获2025版《CSCO淋巴瘤诊疗指南》推荐，用于单药治疗复发/难治性（R/R）慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者。这是Lisaftoclax（APG-2575）首次获纳入CSCO 指南，并且是唯一获得指南推荐的中国原研Bcl-2抑制剂，标志着亚盛医药在推动该创新品种真正惠及患者的道路上迈出里程碑式一步，同时标志着中国原研创新药在血液肿瘤领域的重大突破。马军教授哈尔滨血液病肿瘤研究所Lisaftoclax（APG-2575）此次被纳入CSCO指南，标志着该药物的循证证据获得国内顶级学术机构认可。Lisaftoclax（APG-2575）单药总缓解率高，起效时间快，为快速控制疾病提供了可能，肿瘤溶解综合征发生率远低于同类Bcl-2抑制剂早期数据，其安全性优势可能改变临床风险管理模式。我们期待Lisaftoclax（APG-2575）通过优先审评快速上市，进一步积累真实世界数据，让创新成果更快落地临床。未来，中国创新药必将以更高质量证据参与全球竞争！2024年11月，Lisaftoclax（APG-2575）单药治疗R/R CLL/SLL的NDA申请已获国家药监局药品审评中心（CDE）受理并纳入优先审评。Lisaftoclax（APG-2575）针对CLL/SLL领域正在全球范围内同步推进两项注册III期临床： Lisaftoclax（APG-2575）联合BTK抑制剂针对BTK抑制剂经治CLL/SLL患者的全球注册III期临床研究（GLORA研究）；Lisaftoclax（APG-2575）联合阿可替尼对比免疫化疗治疗针对初治CLL/SLL患者的全球注册III期临床研究（GLORA-2研究），从而进一步拓展治疗边界。国内首个BCR-ABL抑制剂奥雷巴替尼获升级推荐此次2025版《CSCO儿童及青少年白血病诊疗指南》在针对费城染色体阳性急性淋巴细胞白血病（Ph+ ALL）儿童患者的治疗中，首次将奥雷巴替尼升级为I级推荐治疗方案用于BCR-ABL1激酶区T315I突变患者。这标志着奥雷巴替尼在儿童血液领域开启了全新篇章。竺晓凡教授中国医学科学院血液病医院奥雷巴替尼作为我国自主研发的第三代TKI，在儿童Ph+ ALL治疗领域取得了突破性进展。2025版CSCO指南将其对T315I突变患者的推荐等级提升至I级，这一重要更新充分体现了其临床价值。未来，我们期待更多研究进一步验证其长期疗效，并探索更优化的联合治疗方案，为儿童Ph+ ALL患者带来更多治愈希望。同时在2025年《CSCO恶性血液病诊疗指南》中，奥雷巴替尼在CML治疗领域延续多项重要推荐，巩固了其在CML治疗中的关键地位。在CML-慢性期（CP）治疗中，奥雷巴替尼是任何线T315I突变的Ⅰ级推荐治疗方案；也是尼洛替尼或达沙替尼一线治疗失败后的二线治疗，以及对≥2种TKI不耐受或/且治疗失败后的三线治疗的Ⅰ级推荐治疗方案。在CML-进展期治疗中，奥雷巴替尼也作为I级推荐治疗方案用于CML-加速期（AP）伴T315I患者，以及从CP进展为AP、从CP或AP进展为BP患者。该指南还强调了在应对多种BCR::ABL1突变（包括T315I、V299L、F317L/V/I/C、T315A、Y253H、E255K/V、F359C/V/I等）以及任意其他突变（包括复合突变）时的治疗优势。此外，在Ph+ ALL领域，针对诱导缓解以及R/R患者的治疗中，奥雷巴替尼均延续I级推荐。奥雷巴替尼是亚盛医药原创1类新药，获国家“重大新药创制"专项支持。作为中国首个获批上市的第三代BCR-ABL抑制剂，目前奥雷巴替尼已获批用于TKI耐药、并伴有T315I突变的CML- CP或CML-AP成年患者的治疗；对一代和二代TKI耐药和/或不耐受的CML-CP成年患者的治疗，且获批适应症均已被纳入国家医保药品目录，极高地提升了患者的可及性。奥雷巴替尼在中国的商业化推广由亚盛医药和信达生物共同负责。翟一帆博士亚盛医药首席医学官CSCO指南是中国临床医生进行肿瘤临床诊断和治疗的重要依据，是国内最具有学术影响力的诊疗指南之一。奥雷巴替尼和Lisaftoclax（APG-2575）的双双纳入意味着公司创新实力获高度认可。特别是Lisaftoclax（APG-2575）作为全球第二个递交NDA的Bcl-2抑制剂，此次首次被纳入CSCO指南，体现了临床专家对创新疗法的前瞻性认可，为临床诊疗提供了新的参考，将填补治疗空白。同时，奥雷巴替尼在儿童急淋治疗领域的升级推荐也非常令人振奋。未来，我们期待更多的临床数据支持这两款创新药在指南中的推荐升级。我们也将加速推进在研药物临床进展与商业化进程，惠及更多患者！关于亚盛医药亚盛医药是一家综合性的全球生物医药企业，致力于研发创新药，以解决肿瘤等领域全球患者尚未满足的临床需求。2019年10月28日，公司在香港联交所主板挂牌上市，股票代码：6855.HK；2025年1月24日，公司在美国纳斯达克证券交易所挂牌上市，股票代码：AAPG。亚盛医药已建立丰富的创新药产品管线，包括抑制Bcl-2和 MDM2-p53 等细胞凋亡通路关键蛋白的抑制剂；新一代针对癌症治疗中出现的激酶突变体的抑制剂等，为全球唯一在细胞凋亡通路关键蛋白领域均有临床开发品种的创新公司。公司核心品种耐立克®已在中国获批上市，且获批适应症均被成功纳入国家医保药品目录。公司另一重磅品种，新型Bcl-2选择性抑制剂Lisaftoclax（APG-2575）的新药上市申请（NDA）已获CDE受理，并被纳入优先审评。截至目前，公司4个在研新药共获16项FDA和1项欧盟孤儿药资格认定，2项FDA快速通道资格以及2项FDA儿童罕见病资格认证。凭借强大的研发能力，亚盛医药已在全球范围内进行知识产权布局，并与武田、默沙东、阿斯利康、辉瑞、信达等领先的生物制药公司，以及梅奥医学中心（Mayo Clinic）、丹娜法伯癌症研究院（Dana-Farber Cancer Institute）、美国国家癌症研究所（NCI）和密西根大学等学术机构达成全球合作关系。亚盛医药已在原创新药研发与临床开发领域建立经验丰富的国际化人才团队，以及成熟的商业化生产与市场营销团队。亚盛医药将不断提高研发能力，加速推进公司产品管线的临床开发进度，真正践行"解决中国乃至全球患者尚未满足的临床需求"的使命，以造福更多患者。前瞻性声明本新闻稿包含根据美国《1995年私人证券诉讼改革法案》，以及经修订的《1933年证券法》第27A条和《1934年证券交易法》第21E条所界定的前瞻性陈述。除历史事实陈述外，本新闻稿中的所有内容均可能构成前瞻性陈述，包括亚盛医药对未来事件、经营成果或财务状况所发表的意见、预期、信念、计划、目标、假设或预测。这些前瞻性陈述受到诸多风险和不确定性的影响，具体内容已在亚盛医药向美国证券交易委员会（SEC）提交的文件中详细说明，包括2025年1月21日提交的经修订的F-1表格注册说明书和2025年4月16日提交的20-F表格中的"风险因素"和"关于前瞻性陈述及行业数据的特别说明"章节、2019年10月16日提交的首次发行上市招股书中的“前瞻性声明”、“风险因素”章节，以及我们不时向SEC或HKEX提交的其他文件。这些因素可能导致实际业绩、运营水平、经营成果或成就与前瞻性陈述中明示或暗示的信息存在重大差异。本前瞻性声明中的陈述不构成公司管理层的利润预测。因此，该等前瞻性陈述不应被视为对未来事件的预测。本新闻稿中的前瞻性陈述仅基于亚盛医药当前对未来发展及其潜在影响的预期和判断，且仅代表截至陈述发表之日的观点。无论出现新信息、未来事件或其他情况，亚盛医药均无义务更新或修订任何前瞻性陈述。

CSCO会议优先审批临床3期上市批准临床申请

2025-04-21

·亚盛医药

APG-2575 and Olverembatinib Recommended in CSCO 2025 Guidelines

Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) today announced that two of its proprietary novel drugs have been included in the 2025 Chinese Society of Clinical Oncology (CSCO) Guidelines.Lisaftoclax (APG-2575), the company’s investigational novel oral Bcl-2 selective inhibitor, received its first recommendation in the CSCO Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies.Olverembatinib, the company’s novel next-generation tyrosine kinase inhibitor (TKI), received an upgraded recommendation in the CSCO Guidelines for the Diagnosis and Treatment of Leukemias in Children and Adolescent, and retained its recommendations in the CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies.Bcl-2 inhibitor lisaftoclax (APG-2575) receives its first CSCO Guidelines recommendationAs the world’s second Bcl-2 inhibitor to submit a New Drug Application (NDA) and the first China-developed Bcl-2 inhibitor to submit an NDA and receive Priority Review designation in China, lisaftoclax (APG-2575), supported by its robust clinical data, has been recommended in the CSCO 2025 Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies, as a monotherapy for the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first CSCO Guidelines recommendation for lisaftoclax (APG-2575), making it the only China-developed Bcl-2 inhibitor recommended in the CSCO Guidelines. This marks a milestone achieved by Ascentage Pharma in advancing the development of this innovative drug to bring meaningful benefit to patients as well as a major breakthrough in the field of hematological malignancies.Prof. Jun MaHarbin Institute of Hematology and OncologyThese CSCO Guidelines recommendations for lisaftoclax (APG-2575) indicate recognition of the drug’s robust data by a top medical association in China. In the data, lisaftoclax (APG-2575) monotherapy showed a high overall response rate and a fast onset of action that can enable rapid disease control. Moreover, the incidence of tumor-lysis syndrome in patients treated with lisaftoclax (APG-2575) was far lower than was shown in the early data of other Bcl-2 inhibitors, highlighting a favorable tolerability profile that could potentially change the clinical risk management in CLL/SLL. We look forward to lisaftoclax (APG-2575)’s approval in China through the Priority Review pathway, which will bring this innovative therapeutic to patients in need.In November 2024, the NDA for lisaftoclax (APG-2575) monotherapy for the treatment of R/R CLL/SLL was accepted and granted the Priority Review designation by the Center for Drug Evaluation (CDE) of China National Medical Product Administration (NMPA). Globally, lisaftoclax (APG-2575) is being evaluated in two registrational Phase III studies for the treatment of CLL/SLL, including an international registrational Phase III study of lisaftoclax (APG-2575) combined with a BTK inhibitor in patients with CLL/SLL who had previously received BTK inhibitors (the GLORA Trial); and an international registrational Phase III study evaluating lisaftoclax (APG-2575) combined with acalabrutinib, versus immunochemotherapy in treatment-naïve patients with CLL/SLL (the GLORA-2 Trial). These studies were designed to further broaden the treatment window of lisaftoclax (APG-2575).The first China-approved BCR-ABL inhibitor olverembatinib receives an upgraded recommendation in the CSCO GuidelinesIn the CSCO 2025 Guidelines for the Diagnosis and Treatment of Leukemias in Children and Adolescent, the recommendation for olverembatinib for the treatment of children with Ph+ ALL who harbor the T315I BCR-ABL1 kinase domain mutation was upgraded to Level I, thus opening a whole new chapter for olverembatinib in pediatric hematology.Prof. Xiaofan Zhuthe Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical SciencesAs a China-developed third-generation TKI, olverembatinib has achieved a major breakthrough in the treatment of children with Ph+ ALL. In the CSCO 2025 Guidelines, the recommendation for olverembatinib in the treatment of patients with Ph+ ALL who harbor the T315I BCR-ABL1 kinase domain mutation or are intolerant to dasatinib has been upgraded to Level I, an update that reflects the drug’s promising clinical utility. Looking ahead, we hope to see more studies further evaluating olverembatinib’s long-term efficacy and searching for more optimized combinations of the drug that can bring greater hope for curative care to children with Ph+ ALL.In the CSCO 2025 Guidelines for the Diagnosis and Treatment of Hematological Malignancies, olverembatinib retained a number of major recommendations which solidified the drug’s vital role in the treatment of CML. In chronic-phase CML (CML-CP), olverembatinib retained a Level I recommendation for the treatment of all lines of T315I mutant CML-CP; a Level I recommendation for the second-line treatment of patients who had failed first-line treatment with nilotinib or dasatinib and the third-line treatment of patients who are intolerant to and/or failed on two or more TKIs. In progressive-phase CML, olverembatinib retained a Level I recommendation as a treatment option for patients with T315I mutant CML-AP, and those who progressed from CML-CP to CML-AP, or from CML-CP/AP to CML-BP. Moreover, the CSCO 2025 Guidelines emphasized olverembatinib’s advantages in addressing a range of BCR::ABL1 mutations (including T315I, V299L, F317L/V/I/C, T315A, Y253H, E255K/V, and F359C/V/I) and any other mutation (including complex/compound mutations).In Ph+ ALL, olverembatinib has retained its Level I recommendation for response induction and the treatment of relapsed/refractory patients.Olverembatinib is a novel drug developed by Ascentage Pharma with support from China’s National Major New Drug Development Program. As the first approved third-generation BCR-ABL inhibitor in China, olverembatinib is indicated for the treatment of adult patients with TKI-resistant CML-CP or -AP harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs. Furthermore, all approved indications of olverembatinib have been included in the China National Reimbursement Drug List (NRDL) which has greatly improved the drug’s accessibility to patients. Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics.Dr. Yifan ZhaiChief Medical Officer of Ascentage PharmaCSCO Guidelines are among the most recognized clinical guidelines in China, providing crucial guidance to Chinese physicians on the diagnosis and treatment of malignancies. The recommendations for both olverembatinib and lisaftoclax (APG-2575) in the updated guidelines are a testament to our strong and innovative pipeline. In particular, the CSCO Guidelines’ very first recommendations for lisaftoclax (APG-2575), the second Bcl-2 inhibitor to reach NDA submission anywhere in the world, reflect the clinical experts’ forward-looking recognition of this innovative drug, providing much needed new guidance to clinical practices and the answer to a major treatment gap. Meanwhile, we are greatly encouraged by the Guidelines’ upgraded recommendation for olverembatinib in pediatric patients with ALL.In the future, we hope to see additional positive clinical data that can pave the way for upgraded recommendations for these two innovative drugs. We will continue to accelerate the clinical development and commercialization of our drug candidates for the benefit of more patients.*Lisaftoclax (APG-2575) and olverembatinib are investigational drugs and not yet approved in the US.About Ascentage PharmaAscentage Pharma is a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily in hematological malignancies. Ascentage Pharma has been listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK since October 2019 and has also been listed on the Nasdaq Global Market under the ticker symbol “AAPG” since January 2025.The company has built a rich pipeline of innovative drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53; and next-generation TKIs that target kinase mutants emergent during cancer treatment. Ascentage Pharma is also the only company in the world with active clinical programs targeting all known key apoptosis regulators.Olverembatinib, one of the company’s lead assets, is already approved in China with all of its approved indications included into the China National Reimbursement Drug List (NRDL). Meanwhile, a New Drug Application (NDA) for another one of Ascentage Pharma’s key drug candidates, the novel Bcl-2 selective inhibitor lisaftoclax (APG-2575), has already been accepted and granted the Priority Review designation by the China CDE.To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies such as Takeda, AstraZeneca, Merck, Pfizer and Innovent; and research and development relationships with leading research institutions such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan.The company has built a talented team with a wealth of global experience in the discovery and development of innovative drugs and fully functional commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025 and the Form 20-F filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management.As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CSCO会议临床1期临床结果临床终止

100 项与尼洛替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06413	尼洛替尼	L01XE08	DB04868

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
加速期慢性骨髄性白血病	美国	Novartis Pharmaceuticals Corp.	2014-01-22
加速期费城染色体阳性慢性粒细胞白血病	美国	Novartis Pharmaceuticals Corp.	2007-10-29
慢性期费城染色体阳性慢性粒细胞白血病	美国	Novartis Pharmaceuticals Corp.	2007-10-29
费城染色体阳性慢性粒细胞白血病	瑞士	Novartis Pharma Schweiz AG	2007-07-24

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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
慢性期慢性髓性白血病	申请上市	欧盟	Novartis Europharm Ltd.	2024-06-27
阿尔茨海默症	临床3期	-	KeifeRx LLC初创企业	2022-02-01
急性转化期慢性粒细胞性白血病	临床3期	哥伦比亚	Novartis Pharmaceuticals Corp.	2009-01-01
急性转化期慢性粒细胞性白血病	临床3期	委内瑞拉	Novartis Pharmaceuticals Corp.	2009-01-01
脑瘫	临床3期	韩国	Novartis AG	2009-01-01
转移性胃肠道间质瘤	临床3期	德国	Novartis Pharmaceuticals Corp.	2008-11-01
转移性胃肠道间质瘤	临床3期	意大利	Novartis Pharmaceuticals Corp.	2008-11-01
胃肠道间质瘤	临床3期	美国	Novartis Pharmaceuticals Corp.	2007-03-01
胃肠道间质瘤	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2007-03-01
胃肠道间质瘤	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2007-03-01

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适应症

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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


S23.008 (AAN2025)	临床2期	路易体病 CSF HVA \| CSF ratio of pTau181/Aβ42	43	Nilotinib 200mg	窪網醖憲鬱構製鬱製艱(觸餘糧憲鬱築糧醖鏇鑰) = 顧鹹製壓醖衊獵窪醖鏇觸鹹範蓋範憲齋鏇網積 (獵壓顧衊淵淵鏇衊憲鹹, 0 ~ 6.34) 更多	积极	2025-04-07
				Placebo	艱構顧選鑰壓鹽選鬱網(廠簾構構衊膚艱構鏇蓋) = 積淵網淵繭醖膚繭選壓簾觸壓鹹獵鬱糧構齋鹽 (繭夢餘願淵築憲膚窪鹽 )
ASH2024	N/A	费城染色体阳性慢性粒细胞白血病	-	Imatinib	膚顧築選範夢鬱遞網網(積築顧衊願壓築網廠衊): HR = 3.11 (95% CI, 1.25 ~ 7.77), P-Value = 0.015	-	2024-12-09
				Nilotinib
ASH2024	N/A	费城染色体阳性慢性粒细胞白血病	-	Nilotinib	獵蓋艱範艱構衊遞網糧(鑰糧壓鏇糧選鏇淵鬱築) = increased creatinine and thyroid disease in flumatinib group 蓋窪齋艱餘構淵獵壓淵 (醖醖齋鏇襯顧鹹鬱繭憲 ) 更多	-	2024-12-09
				Dasatinib
NCT01698905 (ENESTop, FDA_CDER) 人工标引	临床2期	慢性期费城染色体阳性慢性粒细胞白血病	126	Nilotinib (without loss of MMR or confirmed loss of MR4)	選憲網艱顧淵襯鹹鑰艱(鏇顧醖夢餘選醖衊構遞) = 鬱夢壓築積願鏇蓋觸積鬱齋鹽鏇膚網窪遞襯夢 (齋積獵網艱築醖願鏇衊, 51.2 ~ 68.9) 更多	积极	2024-11-07
				Nilotinib (Loss of MMR or confirmed loss of MR4)	選憲網艱顧淵襯鹹鑰艱(鏇顧醖夢餘選醖衊構遞) = 窪廠餘構窪獵衊觸選壓鬱齋鹽鏇膚網窪遞襯夢 (齋積獵網艱築醖願鏇衊 ) 更多
NCT01784068 (ENESTfreedom, FDA_CDER) 人工标引	临床2期	慢性期费城染色体阳性慢性粒细胞白血病一线	190	Nilotinib	廠鏇觸齋廠淵鹹鹹觸鏇(觸鹽鏇襯鹽鹽夢廠範齋) = 窪餘餘簾淵淵鏇淵齋鏇範淵鑰艱鏇廠構鹹鑰糧 (鑰觸積醖窪窪範餘餘簾, 54.8 ~ 69.0) 更多	积极	2024-11-07
				Nilotinib (Loss of MMR)	廠鏇觸齋廠淵鹹鹹觸鏇(觸鹽鏇襯鹽鹽夢廠範齋) = 壓醖膚憲窪窪餘醖鹹繭範淵鑰艱鏇廠構鹹鑰糧 (鑰觸積醖窪窪範餘餘簾 ) 更多
NCT00109707 (CAMN107A2101, FDA_CDER) 人工标引	临床1/2期	慢性期费城染色体阳性慢性粒细胞白血病 \| 加速期费城染色体阳性慢性粒细胞白血病	458	Nilotinib (Ph+ CML-CP)	鬱鏇獵獵窪鏇蓋餘鑰艱(餘觸選範構選獵繭餘範) = 選製網鑰顧積築簾製獵簾餘窪窪襯積獵鹽廠衊 (繭鑰選糧繭鹹積艱餘顧, 46 ~ 57) 更多	积极	2024-11-07
				Nilotinib (Ph+ CML-AP)	蓋夢構選膚淵範繭鬱廠(鬱窪醖鏇壓獵選衊獵淵) = 齋夢鏇壓鬱鏇網選鹽窪積選蓋遞簾簾築鏇遞顧 (醖簾積網築窪鹽遞膚製, 31 ~ 48) 更多
NCT00471497 (ENESTnd, FDA_CDER) 人工标引	临床3期	慢性期费城染色体阳性慢性粒细胞白血病一线	-	Nilotinib 300 mg Twice Daily	鹹憲淵夢鑰獵壓窪淵築(窪築築鬱簾網鹽淵觸積) = 觸鑰鑰鹹淵餘範窪鹽鑰觸鬱鑰鹽夢選壓鏇窪簾 (鹽製顧餘淵獵選蓋餘餘, 38.4 ~ 50.3) 更多	积极	2024-11-07
				Imatinib 400 mg Once Daily	鹹憲淵夢鑰獵壓窪淵築(窪築築鬱簾網鹽淵觸積) = 壓鹽繭獵鬱醖簾遞鏇遞觸鬱鑰鹽夢選壓鏇窪簾 (鹽製顧餘淵獵選蓋餘餘, 17.6 ~ 27.6) 更多
ESC2024	N/A	费城染色体阳性慢性粒细胞白血病	-	Nilotinib	憲遞膚蓋願顧淵築糧艱(觸遞選壓鑰網膚繭鹽遞) = 齋糧艱顧艱製範觸糧衊顧淵衊衊願鏇窪簾繭齋 (觸壓醖遞獵繭鬱製襯構, 15.7 ~ 26.2) 更多	-	2024-08-30
NCT01863745 (CTgov)	临床2期	胃肠道间质瘤	15	nilotinib	壓獵醖齋淵鹽蓋襯窪齋 = 蓋選襯構構夢齋糧鑰鬱鹹鑰獵鏇蓋齋鑰積鑰製 (積夢鏇齋觸觸選衊願選, 鹽衊範齋顧蓋淵壓鏇觸 ~ 鹽願壓鹹壓觸膚廠獵構) 更多	-	2024-08-19
NCT02611492 (GRAAPH-2014, Pubmed \| Blood) 人工标引	临床3期	费城染色体阳性急性淋巴细胞白血病巩固 ABL1	155	Nilotinib + Cytarabine	淵簾衊願選憲壓鏇壓醖(壓鏇製膚範遞鑰齋衊蓋) = 構製範艱選鬱繭糧鑰網糧遞餘鹹鹹獵艱憲簾膚 (鑰膚觸簾壓鬱願淵鹽繭 ) 更多	积极	2024-06-06
				Nilotinib	淵簾衊願選憲壓鏇壓醖(壓鏇製膚範遞鑰齋衊蓋) = 繭餘網廠衊壓醖糧蓋艱糧遞餘鹹鹹獵艱憲簾膚 (鑰膚觸簾壓鬱願淵鹽繭 ) 更多