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

NCT06514534

/ Recruiting临床2期

A Phase II, Multi-center, Prospective, Open-label Study of Asciminib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) or Accelerated Phase (CML-AP) With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.

The objective of this Phase II study is to assess the potential of asciminib in managing CML-CP or CML-AP in patient carrying the T315I mutation. The presence of this mutation introduces treatment difficulties due to the limited available options. The study seeks to collect additional data on the effectiveness and safety of asciminib for these patients. By determining the drug's capacity to manage the disease and enhance patients outcomes, the study is designed to fill the unmet medical need and potentially offer a new therapeutic path for patients at a treatment deadlock.

开始日期2025-02-18

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT06629584

/ Recruiting临床2期

Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia

This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy.

开始日期2025-02-14

申办/合作机构

Novartis AG

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317

项与阿思尼布相关的文献（医药）

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Population pharmacokinetic modeling of asciminib in support of exposure-response and ethnic sensitivity analyses in patients with chronic myeloid leukemia

Article

作者: Darstein, Christelle ; Kawakita, Yasunori ; Sy, Sherwin K B ; Wu, Shengyuan ; Yoon, Deokyong ; Grosch, Kai ; Yang, Yiqun ; Dasgupta, Kohinoor ; Kapoor, Shruti ; Hoch, Matthias

BACKGROUND:

The original population pharmacokinetics (popPK) model for asciminib in patients with chronic myeloid leukemia in chronic phase (CML-CP) was refined to address drug development needs in support of drug submission, namely, attainment of target drug exposure in specific patient populations, populating individual daily exposures for exposure-response analyses of key efficacy and safety endpoints, confirmation of comparability in exposure between 40 mg b.i.d. and 80 mg q.d., and assessment of ethnic insensitivity.

METHODS:

Participants from two organ dysfunction studies, patients with CML in blast and acute phases and acute lymphoblastic leukemia and patients from a phase III efficacy study in newly diagnosed Ph + CML-CP, and data from a dedicated phase II study in the Chinese patients previously treated with at least two prior tyrosine kinase inhibitors, and a phase IIIb study comparing two dose regimens of asciminib (40 mg b.i.d. and 80 mg q.d.) were included in the revised popPK model. Covariates evaluated were line of therapy, baseline renal and hepatic functions, Chinese or Japanese ethnicity.

RESULTS:

The apparent clearance and steady-state volume of distribution of asciminib were 6.84 L/h and 110 L, respectively, for a typical individual of 70 kg weight and 90 mL/min absolute glomerular filtration rate. Both the 40 mg b.i.d. and 80 mg q.d. resulted in a steady-state daily AUC of 12,600 ng.h/mL, and there was no difference between lines of therapy. Effects of renal or hepatic impairment on clearance were not clinically relevant. Chinese and Japanese exhibited similar PK as that of the global population.

CONCLUSIONS:

The 40 mg b.i.d. and 80 mg q.d. regimens are comparable in their daily exposure, supporting the use of the two dosing regimens in newly diagnosed and previously treated CML-CP patients. The PK of asciminib is insensitive to ethnic differences and no dose adjustment is required for severe renal and hepatic impaired patients.

2025-06-01·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Which Is the Best Tyrosine Kinase Inhibitor for Newly Diagnosed Chronic Myelogenous Leukemia?

Review

作者: Hughes, Timothy P. ; Osborn, Michael ; Shanmuganathan, Naranie

The choice of frontline therapy for a patient with chronic phase chronic myeloid leukemia (CP-CML) can have a profound effect on the long-term clinical outcome. Currently, five tyrosine kinase inhibitors (TKIs—imatinib, dasatinib, nilotinib, bosutinib, and asciminib) are available for frontline therapy, but no single TKI is optimal for all patients. EUTOS long-term survival (ELTS) risk score, comorbidities, and treatment-free remission (TFR) priority are the key determinants of frontline TKI selection. Higher ELTS score, low age and comorbidity score, and a high priority for achievement of TFR would all favor the frontline use of a more potent TKI than imatinib. However, no TKI has improved survival compared with imatinib. In children with CP-CML, imatinib, dasatinib, and nilotinib have similar long-term efficacy, with ease of administration and impact of toxicities on quality of life being key considerations. Recent adult trials of reduced-dose dasatinib frontline showed that efficacy may be equivalent to standard-dose dasatinib with a better tolerability and safety profile, but experience is limited in patients with high-risk ELTS scores. The ASC4FIRST trial has confirmed that tolerability and molecular response with asciminib are superior to those with both imatinib and the second-generation (2G)-TKIs. While the overall treatment failure rate was lower with asciminib, the rate of BCR::ABL1 mutations that emerged with asciminib appeared to be higher. The risk of emergent mutations appears to be highly associated with the presence of ASXL1 mutations in the CML cells at diagnosis, but more work is needed to understand the implications of this finding.

2025-05-13·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Chronic Myeloid Leukemia

Review

作者: Jabbour, Elias ; Kantarjian, Hagop

Importance:

Chronic myeloid leukemia (CML) has an annual incidence of 2 cases per 100 000 people and is newly diagnosed in approximately 9300 individuals per year in the US. Approximately 150 000 people in the US and 5 million worldwide have CML.

Observations:

Chronic myeloid leukemia is a myeloproliferative neoplasm characterized by the presence of the Philadelphia chromosome, which is defined by the BCR::ABL1 oncogene that develops after fusion of the ABL1 proto-oncogene to the constitutively active BCR gene. Approximately 90% of people with CML present with an indolent chronic phase of CML, defined as blasts of less than 10% in the blood or bone marrow, absence of extramedullary evidence of leukemia, basophils of less than 20%, and platelet counts of 100 to 1000 × 109/L. The most advanced stage is CML blastic phase (CML-BP), characterized by the World Health Organization as 20% or more blasts/immature cells and by the MD Anderson Cancer Center and European LeukemiaNet as 30% or more. Approximately 1% to 2% of patients with CML present with CML-BP. Since 2000, first-generation tyrosine kinase inhibitors (TKIs) targeting BCR::ABL1, such as imatinib, and second-generation TKIs, such as bosutinib, dasatinib, and nilotinib, have improved CML-related mortality from 10% to 20% per year to 1% to 2% per year, such that patients with CML have survival rates similar to those of a general age-matched population. Six BCR::ABL1 TKIs have been approved by the US Food and Drug Administration, including 5 that are first-line treatment (imatinib, dasatinib, bosutinib, nilotinib, and asciminib) and 5 approved for treatment after disease progression despite initial therapy (dasatinib, bosutinib, nilotinib, ponatinib, asciminib). Effects on improved survival are similar with all TKIs, although more patients are able to promptly achieve and maintain BCR::ABL1 clearance with second- and third-generation TKIs. Medication adherence is important to maintain treatment responsiveness. All TKIs are associated with hematologic toxicity, such as myelosuppression, with additional agent-specific adverse effects, such as pleural effusion (dasatinib), arterio-occlusive events such as myocardial infarction, stroke, and peripheral artery disease (nilotinib, ponatinib), gastrointestinal disturbance (bosutinib), or increased amylase and lipase with pancreatitis (ponatinib, asciminib, nilotinib). These adverse effects should be considered when selecting a TKI. Allogeneic hematopoietic stem cell transplant is a reasonably safe therapy, with cure rates ranging from 20% to 60% based on the stage of CML at the time of transplant. Stem cell transplant is reserved for patients with CML who do not respond to second-generation TKIs, those with intolerance to multiple TKIs, or those with accelerated-phase CML or CML-BP.

Conclusions and Relevance:

Chronic myeloid leukemia is a myeloproliferative neoplasm that can typically be effectively treated with TKIs, improving survival similar to that of a general age-matched population. Many patients require continuous TKI therapy. Therefore, TKI therapy should be selected with consideration of adverse effects, and patients should be helped to maximize adherence to TKI treatment.

261

项与阿思尼布相关的新闻（医药）

21 小时之前

·药明康德

有望2-3个月给药一次的哮喘疗法；疾病控制率超90%的ADC…… | 一周盘点

本期看点1. 抗体偶联药物（ADC）CX-2051在晚期结直肠癌（CRC）中取得了积极的1期临床试验结果，总缓解率（ORR）为28%，疾病控制率（DCR）达94%。2. IL-4Rα靶向单抗APG808在治疗哮喘的1b期临床试验中表现亮眼，该疗法在12周内对一种与哮喘恶化相关的2型炎症生物标志物具有强效且持续的抑制作用，有望支持其实现每两个月或更长时间一次的给药方案。3. FDA批准了Lantern Pharma公司的新型“合成致死”小分子药物LP-184的IND申请。CX-2051：公布1期临床试验的中期数据CytomX Therapeutics公布了其ADC疗法CX-2051在晚期结直肠癌（CRC）中的积极1期中期数据。CX-2051是一种条件激活型ADC，其使用的细胞毒性有效载荷是喜树碱的衍生物。喜树碱是一种拓扑异构酶-1抑制剂，这类药物已在ADC领域针对多个靶点显示出强大的临床抗癌活性。CX-2051已在包括结直肠癌在内的多个临床前模型中显示出强大的临床前活性和耐受性。截至2025年4月7日的数据，ORR为28%（5/18），其中10 mg/kg剂量组的ORR达到43%（3/7），显著高于目前三线及三线以上结直肠癌治疗药物的缓解率（通常仅有个位数的百分比）。DCR为94%（17/18），中位无进展生存期为5.8个月。截至数据截止时，18名患者中有10名仍在接受治疗。安全性方面，CX-2051的耐受性良好，未出现剂量限制性毒性（DLT），大多数治疗相关不良事件为1级或2级。APG808：公布1b期临床试验的中期数据Apogee Therapeutics公司公布了其候选单抗APG808用于治疗轻度至中度哮喘患者的1b期临床试验的积极中期数据。APG808是一种新型、皮下注射、半衰期延长的IL-4Rα靶向单抗，具有用于治疗哮喘、慢性阻塞性肺病（COPD）及其他炎症与免疫学适应症的潜力。IL-4Rα是一个已在八种2型过敏性疾病中得到临床验证的靶点。在1期临床试验中，APG808的药代动力学（PK）特征有望支持每2-3个月一次的维持治疗给药方案。此次公布的结果显示，多剂量给药APG808可使FeNO（一种与哮喘恶化相关的2型炎症生物标志物）较基线大幅下降53%，并在12周时仍维持约50%的抑制水平，显示出对哮喘的持续控制能力。APG808的优化配方和潜在“best-in-class”的PK特征，结合在12周内对FeNO的强效且持续的抑制作用，有望支持其实现每两个月或更长时间一次的给药方案，相较于目前每两周一次的标准治疗具有优势。此外，APG808整体耐受性良好，安全性特征与已有的抗IL-4Rα疗法一致。Soquelitinib：公布1期临床试验中队列1-3的数据Corvus Pharmaceuticals公司公布了其小分子白细胞介素-2诱导的T细胞激酶（ITK）抑制剂soquelitinib用于治疗中度至重度特应性皮炎的1期临床试验数据。ITK是一种主要表达于T细胞中的酶，在T细胞和自然杀伤（NK）细胞的免疫功能中起重要作用。通过抑制ITK，soquelitinib有望抑制自身免疫和炎症反应。此次公布的结果显示，所有3个队列中，soquelitinib治疗组在具有临床意义的终点湿疹面积和严重度指数较基线减少75%（EASI 75）和研究者总体评估（IGA）评分为0/1（皮肤症状清除或几乎清除）上，均显示出相较于安慰剂的显著疗效。与队列1和队列2（100 mg每天两次和200 mg每天一次，每日总剂量200 mg）相比，队列3（200 mg每天两次，每日总剂量400 mg）的缓解更早且更深。安全性方面，soquelitinib的耐受性良好，在所有队列中均未观察到DLT，也未出现具有临床意义的实验室指标异常。此外，所有队列中均未发生中断给药的情况。▲治疗第28天达到终点IGA 0/1、EASI 75的患者占比（图片来源：参考资料[1]）ELVN-001：公布1期临床试验的新数据Enliven Therapeutics公司公布其小分子激酶抑制剂ELVN-001治疗慢性粒细胞白血病（CML）患者的1期临床试验的新数据。ELVN-001是一种强效、高选择性、潜在“best-in-class”的小分子激酶抑制剂，专门针对CML患者的致癌驱动因子BCR-ABL融合蛋白。ELVN-001还具有针对耐药性最强的BCR-ABL1耐药突变体T315I和其他已知耐药突变体的活性。截至2025年1月21日的数据，在36例可评估的患者中，44%（16/36）在24周时达到主要分子学缓解（MMR），其中最后一线治疗时对酪氨酸激酶抑制剂（TKI）耐药的患者中有40%（10/25）达到了MMR，曾接受asciminib或ponatinib治疗的患者中也有36%（9/25）达到MMR，包括1例携带已知asciminib耐药突变的患者。所有达到或维持MMR的患者在数据截止时仍保持缓解。在该临床试验中所纳入的患者群体此前接受过大量治疗的情况下，ELVN-001与已获批的针对BCR-ABL融合蛋白的TKI在1期试验中所观察到的MMR相比，结果依然更好。安全性方面，ELVN-001在所有剂量组中仍表现出良好的耐受性，与其选择性激酶谱一致。LP-184：IND申请获得FDA许可Lantern Pharma公司宣布，FDA已批准其抗癌新药LP-184的IND申请。LP-184将与免疫检查点抑制剂联用，针对携带KEAP1和/或STK11突变和PD-L1低表达的非小细胞肺癌（NSCLC）患者开展1b/2期临床试验。LP-184是一种新型“合成致死”小分子药物，其作用机制是在前列腺素还原酶1（PTGR1）的激活下诱导DNA双链断裂。PTGR1在KEAP1突变型肿瘤中显著过表达。临床前研究表明，LP-184对NSCLC细胞系的杀伤力与PTGR1的表达水平呈正相关。该公司专有的RADR平台驱动的计算机分析和临床前研究表明，LP-184对DNA损伤修复（DDR）缺陷型癌症特别有效，包括携带KEAP1和STK11突变的NSCLC。此外，PTGR1会在肿瘤细胞内将LP-184由前药转化为具有生物活性的细胞毒性物质，而正常组织由于PTGR1表达水平低，基本不受影响。这使得LP-184有望在具有强效抗肿瘤活性的同时降低全身毒性。值得注意的是，LP-184的作用机制不受TP53突变状态影响。该突变是导致当前多种疗法产生耐药性的常见共突变因素。参考资料（可上下滑动查看）[1] Corvus Pharmaceuticals Announces Data from Cohorts 1-3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis. Retrieved May 16, 2025, from https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-data-cohorts-1-3-placebo[2] MaaT Pharma Announces Promising Final Data Readout for Phase 1b Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS). Retrieved May 16, 2025, from https://www.businesswire.com/news/home/20250511855391/en/MaaT-Pharma-Announces-Promising-Final-Data-Readout-for-Phase-1b-Evaluating-MaaT033-in-Amyotrophic-Lateral-Sclerosis-ALS[3] Cantargia announces successful Phase 1 results: PK/PD data of subcutaneously administered CAN10 confirms every 4-week dosing choice in Phase 2. Retrieved May 16, 2025, from https://cantargia.com/en/press-releases/cantargia-announces-successful-phase-1-results-pk-pd-data-of-subcutaneously-administered-can10-confirms-every-4-week-dosing-choice-in-phase-2[4] Apogee Therapeutics Announces Positive Interim Results from the Phase 1b Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody, in Patients with Mild-to-Moderate Asthma. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/12/3078912/0/en/Apogee-Therapeutics-Announces-Positive-Interim-Results-from-the-Phase-1b-Trial-of-APG808-its-Novel-Half-life-Extended-IL-4R%CE%B1-Antibody-in-Patients-with-Mild-to-Moderate-Asthma.html[5] CytomX Announces Positive Interim Data From Phase 1 Dose Escalation Study of EpCAM Antibody Drug Conjugate (CX-2051) Candidate in Patients with Advanced Colorectal Cancer (CRC). Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/12/3078935/37704/en/CytomX-Announces-Positive-Interim-Data-From-Phase-1-Dose-Escalation-Study-of-EpCAM-Antibody-Drug-Conjugate-CX-2051-Candidate-in-Patients-with-Advanced-Colorectal-Cancer-CRC.html[6] MavriX Bio Announces FDA Clearance of IND Application to Initiate First-in-Human Study of Gene Therapy for Angelman Syndrome. Retrieved May 16, 2025, from https://www.prnewswire.com/news-releases/mavrix-bio-announces-fda-clearance-of-ind-application-to-initiate-first-in-human-study-of-gene-therapy-for-angelman-syndrome-302451763.html[7] Ensoma Announces FDA Clearance of IND Application for First In Vivo HSC-Directed Gene Insertion Therapy. Retrieved May 16, 2025, from https://ensoma.com/press-release/ensoma-announces-fda-clearance-of-ind-application-for-first-in-vivo-hsc-directed-gene-insertion-therapy/[8] Faron Pharmaceuticals presents promising Phase 1/2 data from BEXMAB Study at MDS 2025 plenary session. Retrieved May 16, 2025, from https://faron.com/releases-and-publications/faron-pharmaceuticals-presents-promising-phase-1-2-data-from-bexmab-study-at-mds-2025-plenary-session/[9] Lantern Pharma Secures FDA Clearance for Planned Phase 1b/2 Trial of LP-184 in Biomarker-Defined, Treatment-Resistant NSCLC Patients with High Unmet Clinical Need. Retrieved May 16, 2025, from https://ir.lanternpharma.com/news-events/press-releases/detail/179/lantern-pharma-secures-fda-clearance-for-planned-phase-1b2[10] Innovo Therapeutics Announces Positive Phase 1 Results for INV-101, a Novel Immuno-Metabolic Modulator for Autoimmune Diseases. Retrieved May 16, 2025, from https://www.businesswire.com/news/home/20250512131551/en/Innovo-Therapeutics-Announces-Positive-Phase-1-Results-for-INV-101-a-Novel-Immuno-Metabolic-Modulator-for-Autoimmune-Diseases[11] Capsida Receives FDA IND Clearance for Its First-in-Class, IV-administered Gene Therapy for STXBP1 Developmental and Epileptic Encephalopathy. Retrieved May 16, 2025, from https://capsida.com/capsida-receives-fda-ind-clearance-for-its-first-in-class-iv-administered-gene-therapy-for-stxbp1-developmental-and-epileptic-encephalopathy/[12] AAVantgarde presents positive clinical data from its AAVB-081 program for Usher 1B and preclinical data from its AAVB-039 program for Stargardt at the ARVO 2025 annual meeting. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/12/3078987/0/en/AAVantgarde-presents-positive-clinical-data-from-its-AAVB-081-program-for-Usher-1B-and-preclinical-data-from-its-AAVB-039-program-for-Stargardt-at-the-ARVO-2025-annual-meeting.html[13] Artiva Biotherapeutics Announces Longer-term Phase 1/2 Data Demonstrating Prolonged Durability for AlloNK® in Combination with Rituximab in Patients with B-cell-Non-Hodgkin Lymphoma at the ASGCT 28th Annual Meeting. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/13/3080625/0/en/Artiva-Biotherapeutics-Announces-Longer-term-Phase-1-2-Data-Demonstrating-Prolonged-Durability-for-AlloNK-in-Combination-with-Rituximab-in-Patients-with-B-cell-Non-Hodgkin-Lymphoma.html[14] Sernova Biotherapeutics Provides Positive Interim Data from Ongoing Phase 1/2 Clinical Trial of Cell Pouch Bio-hybrid Organ in Patients Living with Type 1 Diabetes. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/14/3080975/0/en/Sernova-Biotherapeutics-Provides-Positive-Interim-Data-from-Ongoing-Phase-1-2-Clinical-Trial-of-Cell-Pouch-Bio-hybrid-Organ-in-Patients-Living-with-Type-1-Diabetes.html[15] Enliven Therapeutics Announces Updated Positive Data from Phase 1 Clinical Trial of ELVN-001 in CML and Oral Presentation at the EHA 2025 Congress. Retrieved May 16, 2025, from https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-updated-positive-data-from-phase-1-clinical-trial-of-elvn-001-in-cml-and-oral-presentation-at-the-eha-2025-congress-302455412.html[16] AbCellera Receives Authorization from Health Canada to Initiate the Phase 1 Clinical Trial of ABCL635 for Vasomotor Symptoms Due to Menopause. Retrieved May 16, 2025, from https://investors.abcellera.com/news/news-releases/2025/AbCellera-Receives-Authorization-from-Health-Canada-to-Initiate-the-Phase-1-Clinical-Trial-of-ABCL635-for-Vasomotor-Symptoms-Due-to-Menopause/default.aspx[17] Biomea Fusion’s BMF-500 Selected for Poster Presentation at EHA 2025 Highlighting Phase I Data in Relapsed/Refractory Acute Leukemia. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/14/3081603/0/en/Biomea-Fusion-s-BMF-500-Selected-for-Poster-Presentation-at-EHA-2025-Highlighting-Phase-I-Data-in-Relapsed-Refractory-Acute-Leukemia.html[18] Athira Pharma to Present Data from First-in-Human Phase 1 Clinical Trial of ATH-1105 at the 4th Annual ALS Drug Development Summit. Retrieved May 16, 2025, from https://investors.athira.com/news-releases/news-release-details/athira-pharma-present-data-first-human-phase-1-clinical-trial[19] Rocket Pharmaceuticals Presents Preliminary Data from Phase 1 Clinical Trial of RP-A601 for PKP2 Arrhythmogenic Cardiomyopathy at 28th Annual Meeting of the American Society of Gene and Cell Therapy. Retrieved May 16, 2025, from https://ir.rocketpharma.com/news-releases/news-release-details/rocket-pharmaceuticals-presents-preliminary-data-phase-1[20] START Doses First U.S. Patient in Moderna's Phase 1 Clinical Trial of mRNA-4106, a Pan-Tumor Antigen Therapy Candidate, in Solid Tumors. Retrieved May 16, 2025, from https://www.prnewswire.com/news-releases/start-doses-first-us-patient-in-modernas-phase-1-clinical-trial-of-mrna-4106-a-pan-tumor-antigen-therapy-candidate-in-solid-tumors-302455728.html[21] Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site. Retrieved May 16, 2025, from https://ir.pasithea.com/news-events/press-releases/detail/120/pasithea-therapeutics-announces-initiation-of-phase-11b免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新2

临床1期临床结果抗体药物偶联物临床2期临床申请

23 小时之前

·药事纵横

诺华双星落地中国：治疗乳腺癌与白血病

前言2025年5月，诺华制药宣布其两款突破性药物正式获得中国国家药监局批准上市：瑞波西利（Ribociclib）联合非甾体芳香酶抑制剂（NSAI）被批准用于HR阳性/HER2阴性早期乳腺癌术后辅助治疗；阿思尼布（Asciminib）获批用于新诊断的费城染色体阳性慢性髓细胞白血病（Ph+ CML）慢性期成人患者的一线治疗。这两款药物凭借创新的作用机制和显著的临床获益，有望为中国肿瘤治疗领域注入新动能。瑞波西利瑞波西利（Ribociclib）是全球第二款获批的CDK4/6抑制剂，通过选择性抑制细胞周期蛋白依赖性激酶4/6（CDK4/6），阻断肿瘤细胞从G1期向S期的过渡，从而抑制肿瘤增殖。此次在华获批用于HR+/HER2-早期乳腺癌术后辅助治疗，标志着其适应症从晚期转移性阶段向早期阶段的重大拓展。HR+/HER2-亚型占中国乳腺癌患者的70%以上，传统治疗以内分泌疗法为主，但高危患者（如淋巴结阳性、高肿瘤负荷）复发风险仍较高。瑞波西利的引入将“内分泌治疗+靶向强化”模式变为现实，为早期患者提供了更积极的治疗选择。III期NATALEE研究（NCT03701334）的全球多中心数据显示，中位随访33.3个月时，瑞波西利联合非甾体芳香酶抑制剂（NSAI）组的3年无侵袭性疾病生存率（iDFS）达90.7%，显著高于NSAI单药组的87.6%（HR=0.749，p=0.0006），疾病复发或死亡风险降低25.1%。亚组分析进一步显示，在淋巴结阳性（≥4枚）患者中，3年iDFS绝对获益达5.1%（86.0% vs 80.9%）；即便是淋巴结阴性（N0）患者，仍可观察到2.6%的绝对提升（93.2% vs 90.6%）。次要终点方面，瑞波西利组无远处转移生存期（DDFS）和无复发生存期（RFS）风险分别降低25.1%和27.3%，提示其对远处转移和局部复发的双重控制作用。安全性数据与既往研究一致，主要不良事件为中性粒细胞减少（28.6%）、白细胞减少（14.3%）等血液学毒性，但≥3级不良事件发生率可控（19.7%），未出现新的安全性信号。瑞波西利的疗效优势使其在全球市场快速放量。2024年，其全球销售额突破30.33亿美元，同比增长45.82%，成为诺华肿瘤管线中增长最快的产品之一。在中国市场，尽管已有礼来阿贝西利（Abemaciclib）和恒瑞医药达尔西利（Dalpiciclib）等CDK4/6抑制剂获批，但瑞波西利凭借更广泛的适用人群（覆盖绝经前/后患者）和针对高危患者的强化治疗优势，展现出差异化竞争力。例如，阿贝西利的MonarchE研究纳入人群以绝经后患者为主，而NATALEE研究纳入了44%的绝经前患者，且允许联用卵巢功能抑制（OFS），更贴近中国年轻乳腺癌患者占比高的临床现状。此外，瑞波西利的用药方案（每日一次口服，连续3周后停药1周）兼顾疗效与便捷性，患者依从性显著优于部分需持续用药的竞品。真实世界研究显示，其治疗中断率低于10%，为长期辅助治疗的可持续性提供了保障。诺华还计划在中国开展针对亚洲人群的长期随访研究，进一步验证其生存获益与安全性特征。阿思尼布阿思尼布（Asciminib）是全球首个通过特异性靶向BCR-ABL1蛋白肉豆蔻酰口袋（STAMP机制）的慢性髓细胞白血病（CML）治疗药物。与传统酪氨酸激酶抑制剂（TKI）通过竞争性抑制ATP结合位点不同，阿思尼布通过稳定BCR-ABL1的无活性构型，直接靶向肉豆蔻酰口袋，克服了TKI耐药及T315I突变等难题。这一创新机制不仅为耐药/不耐受患者提供了新选择，更在一线治疗中展现了突破性疗效。在III期ASC4FIRST试验（NCT04971226）中，阿思尼布作为一线治疗新诊断费城染色体阳性CML慢性期（Ph+ CML-CP）成人患者的48周主要分子学应答率（MMR）达67.7%，显著优于研究者选择的传统TKI组（伊马替尼、尼洛替尼、达沙替尼、博舒替尼）的49.0%（p<0.001）；与伊马替尼单药相比，MMR率提升至69.3%（vs 40.2%）。长期随访数据显示，中位随访2.2年时，阿思尼布组第96周MMR率较所有传统TKI组增加22%，较伊马替尼组增加近30%，且深度分子应答（MR4和MR4.5）率显著更高。此外，与二代TKI相比，阿思尼布的MMR率仍高出15.1%（72% vs 56.9%）。安全性方面，阿思尼布表现优异：≥3级不良事件（AE）发生率低于传统TKI组，因AE导致的剂量调整和停药率分别减少50%以上。例如，在ASC4FIRST试验中，阿思尼布组因AE停药率仅为5.8%，而对照TKI组高达21.1%。这一优势与其独特的作用机制密切相关，避免了传统TKI对非靶点激酶的广泛抑制，从而减少脱靶毒性。阿思尼布的临床价值不仅体现在耐药患者中。其一线适应症的获批使适用人群扩大约4倍，并获NCCN指南1类推荐，成为新诊断CML患者的一线优选。目前，中国已有6款Bcr-Abl抑制剂上市，包括一代药物伊马替尼、二代药物达沙替尼/尼洛替尼，以及第三代药物奥雷巴替尼等。然而，阿思尼布在三线治疗中仍展现显著优势：关键III期ASCEMBL试验（NCT03106779）显示，其48周MMR率为25.5%（vs 伯舒替尼13.2%），且长期随访中第96周MMR率持续提升至37.6%（vs 15.8%）。随着阿思尼布在中国获批一线适应症，其治疗关口前移有望延缓疾病进展至加速期或急变期，显著改善患者生存质量。未来，结合BCR-ABL1突变检测的精准分层，阿思尼布或可进一步优化耐药患者的管理策略，巩固其作为CML治疗新标准的地位。最后诺华瑞波西利和阿思尼布的获批，体现了从晚期到早期、从跟随到创新的研发策略。瑞波西利通过降低早期乳腺癌复发风险，助力患者实现临床治愈；阿思尼布以机制革新破解白血病耐药难题，树立CML治疗新标准。参考：诺华官网药事纵横投稿须知：稿费已上调，欢迎投稿

临床结果上市批准突破性疗法

2025-05-17

·CPHI制药在线

3个1类创新药国内上市；最高超10亿美元！石药集团与Cipla就伊立替康脂质体注射液达成授权合作 | 制药在线一周药闻复盘

点击蓝字关注我们本周，热点很多。首先是审评审批方面，最值得关注的就是3个1类创新药国内上市，分别是北海康成的注射用维拉苷酶β、海思科的安瑞克芬注射液以及轩竹生物的吡洛西利片；其次是研发方面，多个药取得重要进展，其中，百济神州BTK降解剂又启动一项头对头礼来匹妥布替尼的Ⅲ期临床研究；最后是交易及投融资方面，交易很多，值得一提的是，石药集团就伊立替康脂质体注射液达成授权合作，总交易额超10亿美元。本期盘点包括审评审批、研发以及交易及投融资三大板块，统计时间为2025.5.12-5.16，包含28条信息。视频点个审评审批NMPA上市批准1、5月14日，NMPA官网显示，诺华的盐酸阿思尼布片获批上市，用于治疗新诊断的费城染色体阳性的慢性髓细胞白血病（Ph+CML）慢性期（CP）成人患者。阿思尼布是一款基于ABL肉豆蔻酰口袋（STAMP）创新机制的靶向药物，可实现深度缓解率翻倍和不良事件相关停药风险减半，延缓疾病进展，为CML患者提供了全新治疗选择。2、5月14日，NMPA官网显示，诺华的CDK4/6抑制剂瑞波西利片（商品名：凯丽隆）获批新适应症，适用于与芳香化酶抑制剂联合使用，作为激素受体（HR）阳性、人类表皮生长因子受体2（HER2）阴性高复发风险的早期乳腺癌患者的辅助治疗。3、5月15日，NMPA官网显示，北海康成1类新药注射用维拉苷酶β（商品名：戈芮宁）已通过优先审评审批程序批准上市，适用于12岁及以上青少年和成人Ⅰ型和Ⅲ型戈谢病患者的长期酶替代治疗。维拉苷酶β是一款针对戈谢病开发的酶替代疗法（ERT）。4、5月15日，NMPA官网显示，轩竹生物1类新药吡洛西利片（商品名：轩悦宁）获批上市，适用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性晚期或转移性乳腺癌成人患者：与氟维司群联合用于既往接受内分泌治疗后出现疾病进展的患者；单药用于既往转移性阶段接受过两种及以上内分泌治疗和一种化疗后出现疾病进展的患者。5、5月15日，NMPA官网显示，海思科1类新药安瑞克芬注射液（HSK21542）获批上市，用于治疗腹部手术后的轻、中度疼痛。安瑞克芬（HSK21542）是一款外周kappa阿片受体选择性激动剂。除了注射液剂型，海思科也在开发HSK21542的口服制剂，目前正在开展临床研究。申请6、5月12日，CDE官网显示，百济神州1类新药索托克拉片新适应症申报上市，拟用于治疗既往接受过抗CD20治疗和BTKi治疗的套细胞淋巴瘤（MCL）成人患者。索托克拉片的该项上市申请已经被CDE纳入优先审评。7、5月14日，CDE官网显示，勃林格殷格翰的口服选择性磷酸二酯酶4B（PDE4B）抑制剂那米司特片（nerandomilast）第二个适应症申报上市，用于治疗成人进展性肺纤维化（PPF）。2025年2月，首个适应症用于治疗成人特发性肺纤维化（IPF）的上市申请已递交。临床批准8、5月14日，CDE官网显示，信念医药的BBM-P002注射液获批临床。BBM-P002注射液利用AAV载体将多巴胺合成所需的表达基因递送到患者大脑壳核中持续表达，有望实现“一次给药、长期有效”的帕金森病治疗。9、5月14日，CDE官网显示，百济神州1类新药BGB-16673片获批两项临床，拟开发治疗慢性自发性荨麻疹。BGB-16673是一种口服靶向布鲁顿氏酪氨酸激酶（BTK）的嵌合式降解激活化合物（CDAC），是百济神州CDAC平台首款在研药物。10、5月14日，CDE官网显示，基石药业的注射用CS2009获批临床，用于晚期实体瘤。这是该药首次在国内获批临床。CS2009是一款同时靶向PD-1/VEGFA/CTLA-4三特异性抗体，在实体瘤治疗领域具有广阔的临床应用前景。优先审评11、5月14日，CDE官网显示，德国默克申报的盐酸匹米替尼胶囊（ABSK021胶囊）拟纳入优先审评，用于需要系统性治疗的腱鞘巨细胞瘤（TGCT）成人患者。匹米替尼是和誉医药研发的一种新型、口服、高选择性且高效的小分子CSF-1R抑制剂。德国默克拥有该产品的全球商业化权利。12、5月16日，CDE官网显示，科伦博泰申报的注射用芦康沙妥珠单抗拟纳入优先审评，用于既往接受过内分泌治疗且在晚期或转移性阶段接受过其他系统治疗的不可切除的局部晚期或转移性激素受体阳性（HR+）且人表皮生长因子受体2阴性（HER2-）乳腺癌成人患者。芦康沙妥珠单抗是一款新型TROP2靶向抗体偶联药物（ADC），此前已经在中国获批两项适应症。突破性疗法13、5月16日，CDE官网显示，和誉医药1类新药ABSK-011胶囊拟纳入突破性治疗，适应症为：经免疫检查点抑制剂（ICI）和多靶点酪氨酸激酶抑制剂（mTKI）治疗的成纤维细胞生长因子19（FGF19）过表达的晚期肝细胞癌（HCC）。ABSK-011是一款具有高选择性的FGFR4小分子抑制剂。FDA上市批准14、5月14日，FDA官网显示，艾伯维的c-Met靶向ADC药物telisotuzumab vedotin（Teliso-V，ABBV-399）获批上市，用于治疗既往接受过治疗的c-Met蛋白过表达、表皮生长因子受体（EGFR）野生型晚期/转移性非鳞状非小细胞肺癌（NSCLC）成人患者。该药物是c-Met赛道首款获批上市的ADC产品，也是艾伯维首款自研ADC产品。15、5月16日，FDA官网显示，中国生物制药与清普生物合作开发的非阿片类镇痛新药美洛昔康注射液（II）（商品名：QAMZOVA）获批上市。普坦宁不仅成为了中国首款一日一次24h长效的非甾体抗炎药（NSAID）注射液，也是中国首款获得FDA批准的镇痛新药和全球唯一在售的长效NSAID注射液。研发临床状态16、5月13日，正大天晴公布了1类新药盐酸安罗替尼胶囊联合派安普利单抗注射液一线治疗晚期肝细胞癌（HCC）的关键注册Ⅲ期临床（APOLLO研究）结果，一线治疗晚期HCC取得无进展生存期（PFS）和总生存期（OS）双终点阳性结果。安罗替尼联合派安普利单抗一线治疗晚期肝细胞癌已于2024年11月递交上市申请。17、5月13日，GSK和iTeos宣布，由于中期临床数据未能达到预期效果，双方决定终止合作开发TIGIT抗体belrestotug。该药物是GSK于2021年6月以6.25亿美元的预付款，最高可达14.5亿美元总里程碑付款从iTeos获得。双方将合作开发和推广TIGIT抗体Belrestotug，共同承担Belrestotug全球开发成本。18、5月15日，clinicaltrial官网显示，百济神州启动了一项Ⅲ期临床（CaDAnCe-304），旨在评估BGB-16673（200mg，每日1次）对比Pirtobrutinib（200mg，每日1次）治疗既往接受过共价BTK抑制剂（cBTKi）治疗的复发或难治性（R/R）慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）患者的疗效和安全性，主要终点是无进展生存期（PFS）。19、5月16日，诺诚健华宣布，其研发的ICP-332治疗非节段型白癜风的Ⅱ/Ⅲ期临床试验在中国完成首例患者给药。ICP-332是一款在研的1类创新药，是高效、高选择性的新型口服TYK2抑制剂，正在被开发用于治疗各种T细胞相关的自身免疫性疾病，包括白癜风、特应性皮炎、结节性痒疹等。20、5月16日，信达生物宣布，胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂玛仕度肽在中国超重或肥胖合并代谢相关脂肪性肝病（MAFLD）受试者中的一项Ⅲ期临床（GLORY-3）完成首例受试者给药。本研究是一项在中国超重或肥胖合并MAFLD受试者中比较玛仕度肽与一款GLP-1单受体激动剂有效性和安全性的多中心、随机、开放标签的Ⅲ期临床研究（NCT06884293）。临床数据21、5月11日，礼来公布了SURMOUNT-5研究的详细结果。该研究是一项开放标签Ⅲb期临床，旨在针对肥胖或伴有至少一种合并症（如高血压、血脂异常、阻塞性睡眠呼吸暂停、心血管疾病）的超重成人（且不合并糖尿病）患者，评估GIP/GLP-1双受体激动剂替尔泊肽与GLP-1单受体激动剂司美格鲁肽的有效性与安全性。替尔泊肽组平均体重减轻了50.3磅（22.8公斤），司美格鲁肽组平均体重减轻了33.1磅（15.0公斤）。22、5月12日，诺和诺德公布了Ⅲ期REAL8篮子试验的数据，结果显示：每周给药一次的Sogroya在改善小于胎龄儿（SGA）、努南综合征（NS）、特发性矮小症（ISS）的青春期前儿童的年生长速率（通过52周时身高生长速度HV测量）方面，与每日给药一次的生长激素Norditropin相当。此外，在患有努南综合征（NS）的儿童中，Sogroya较每日一次的生长激素具有优越性，同时在小于胎龄儿（SGA）的儿童中，Sogroya较每日低剂量的生长激素也具有优越性。23、5月13日，邦耀生物公布了CRISPR/Cas9基因编辑的异体抗CD19CAR-T细胞（TyU19）治疗复发/难治性系统性红斑狼疮（SLE）数据。研究结果表明，TyU19细胞在SLE治疗中可实现快速、深度的临床缓解，同时展现出优异的临床安全性。24、5月16日，爱科百发宣布，其开发的新一代抗纤维化药物AK3280的Ⅱ期验证性临床研究取得积极成果。AK3280是基于已有的IPF药物结构优化的新一代抗纤维化药物，临床前数据显示其抗纤维化作用更强，药代动力学更佳，有望改善现有药物的胃肠道耐受性和其他毒副作用。交易及投融资25、5月14日，GSK宣布，与BostonPharmaceuticals达成协议，将收购其主要资产efimosferminalfa。根据协议，GSK将支付高达20亿美元的现金对价总额，包括12亿美元的预付款和高达8亿美元的里程碑付款。GSK还将向诺华支付该药物的分级特许权使用费。该药是一种可每月1次皮下注射给药的潜在同类最佳FGF21（成纤维细胞生长因子21）长效类似物。26、5月14日，诺和诺德宣布，与Septerna达成一项独家全球合作，双方将共同致力开发并商业化针对肥胖症、2型糖尿病及其他心脏代谢疾病的口服小分子药物。根据协议，Septerna将有资格从诺和诺德获得总计约22亿美元的付款，包括首付款及研发、商业化里程碑款项，其中超过2亿美元为预付款及近期里程碑付款。Septerna还可获得上市产品的分层特许权使用费。诺和诺德将承担合作项目的全部研发费用。27、5月15日，石药集团宣布，与Cipla就伊立替康脂质体注射液达成协议。根据协议，石药同意授予Cipla独家许可。石药将收取1500万美元首付款，最高达2500万美元潜在首次商业销售及最高达10.25亿美元的里程碑付款。该产品为一种拓朴异构酶1抑制剂，含有43mg/10ml伊立替康。目前用于治疗多种实体瘤，如转移性、结直肠癌、肺癌及宫颈癌等。28、5月16日，科霸生物宣布，已与三菱田边制药签署合作协议。双方将围绕一个全球首创的免疫细胞类靶点。科霸生物率先提出并实践了一种全新的ADC开发理念，即靶向肿瘤免疫微环境中的免疫细胞受体，尤其是大量存在的髓系抑制细胞、肿瘤相关巨噬细胞（TAM）等关键免疫抑制性细胞类型。END领取CPHI & PMEC China 2025展会门票【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

上市批准优先审批临床3期申请上市

100 项与阿思尼布相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11403 D11404	-	-	DB12597

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
慢性期费城染色体阳性慢性粒细胞白血病	美国	Novartis Pharmaceuticals Corp.	2024-10-29
T315I 突变的慢性期费城染色体阳性慢性粒细胞白血病	美国	Novartis Pharmaceuticals Corp.	2024-10-29
费城染色体阳性慢性粒细胞白血病	美国	Novartis Pharmaceuticals Corp.	2021-10-29

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
慢性粒细胞性白血病	申请上市	中国	Novartis Pharma Stein AG	2024-06-25
慢性粒细胞性白血病	申请上市	中国	北京诺华制药有限公司	2024-06-25
慢性粒细胞性白血病	申请上市	中国	Novartis Pharma Schweiz AG	2024-06-25
加速期慢性骨髄性白血病	临床3期	加拿大	Novartis AG	2023-06-19
费城染色体阳性急性淋巴细胞白血病	临床3期	美国	Novartis Pharma AG	2022-08-30
费城染色体阳性急性淋巴细胞白血病	临床3期	日本	Novartis Pharma AG	2022-08-30
费城染色体阳性急性淋巴细胞白血病	临床3期	阿根廷	Novartis Pharma AG	2022-08-30
费城染色体阳性急性淋巴细胞白血病	临床3期	奥地利	Novartis Pharma AG	2022-08-30
费城染色体阳性急性淋巴细胞白血病	临床3期	巴西	Novartis Pharma AG	2022-08-30
费城染色体阳性急性淋巴细胞白血病	临床3期	保加利亚	Novartis Pharma AG	2022-08-30

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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


NCT04971226 (ASC4FIRST, CTgov)	临床3期	费城染色体阳性慢性粒细胞白血病	406	Asciminib (Asciminib (All Asciminib ))	選簾壓廠襯廠簾膚築構 = 糧壓糧選餘壓蓋衊憲範鹹壓糧淵蓋鹽餘遞鬱選 (憲餘顧夢蓋淵窪壓憲淵, 簾夢鏇製醖鏇鑰鬱鏇築 ~ 廠積範鹹製選範選鹽夢) 更多	-	2025-03-10
				dasatinib+nilotinib+imatinib+bosutinib (Investigator Selected TKI (All Comparators))	選簾壓廠襯廠簾膚築構 = 憲鑰衊壓鹽網願製鹹窪鹹壓糧淵蓋鹽餘遞鬱選 (憲餘顧夢蓋淵窪壓憲淵, 鑰齋襯壓鏇餘糧醖願艱 ~ 齋積顧鏇範淵壓鹽醖餘) 更多
NCT03578367 (ASC4MORE, CTgov)	临床2期	慢性期慢性髓性白血病 \| 慢性期费城染色体阳性慢性粒细胞白血病	104	Asciminib add-on+Imatinib (Asciminib 40mg QD + Imatinib 400mg QD)	廠構膚夢獵遞窪顧夢鬱 = 簾鬱遞鹹蓋鹹夢繭艱鬱鬱壓簾壓獵觸獵襯餘襯 (鹽範鏇構願夢餘壓觸繭, 鑰顧憲範築鹽襯鹽鹽艱 ~ 淵觸鑰襯遞餘糧窪築壓) 更多	-	2025-02-14
				Asciminib add-on+Imatinib (Asciminib 60mg QD + Imatinib 400mg QD)	廠構膚夢獵遞窪顧夢鬱 = 鑰淵鏇範鏇鹽遞蓋廠製鬱壓簾壓獵觸獵襯餘襯 (鹽範鏇構願夢餘壓觸繭, 鹽繭醖網艱網糧夢鹽壓 ~ 夢糧淵醖鏇觸艱蓋鹹簾) 更多
NCT04971226 (ASC4FIRST, NEWS) 人工标引	临床3期	慢性期慢性髓性白血病一线	405	Scemblix® 80mg	夢選餘糧獵衊獵鹽築鹽(網鏇獵淵鬱構範壓淵廠) = 構廠窪範顧窪夢膚餘襯蓋構顧構範壓獵獵築餘 (積構範膚簾網艱壓鹽繭 ) 更多	积极	2025-01-10
				Standard of Care TKIs	夢選餘糧獵衊獵鹽築鹽(網鏇獵淵鬱構範壓淵廠) = 艱鑰鏇醖醖衊膚艱簾廠蓋構顧構範壓獵獵築餘 (積構範膚簾網艱壓鹽繭 ) 更多
NCT03578367 (ASC4MORE, Pubmed \| J Hematol Oncol)	临床2期	慢性期慢性髓性白血病 \| 慢性期费城染色体阳性慢性粒细胞白血病追加	84	Asciminib 40 mg QD add-on to Imatinib 400 mg QD	鹹製憲願製鹹艱製廠憲(願選壓齋築夢餘願鹽構) = 願衊鬱艱簾蓋鬱簾鬱願襯遞觸築廠簾遞糧網廠 (製憲齋窪窪鬱選夢膚簾 ) 更多	积极	2024-12-18
				Asciminib 60 mg QD add-on to Imatinib 400 mg QD	鹹製憲願製鹹艱製廠憲(願選壓齋築夢餘願鹽構) = 鑰鹹齋構餘壓廠鹽遞衊襯遞觸築廠簾遞糧網廠 (製憲齋窪窪鬱選夢膚簾 ) 更多
ASH2024	N/A	慢性期慢性髓性白血病	-	Asciminib	夢齋鏇蓋餘鹽膚範顧築(餘顧夢積簾繭顧觸廠簾) = less frequent in the RW settings 艱壓蓋壓鹽選顧憲遞窪 (艱積鹽顧積鏇遞觸壓憲 ) 更多	-	2024-12-09
				Placebo
ASH2024	N/A	慢性期慢性髓性白血病	-	Asciminib 80 mg once daily	製構廠蓋選繭範膚選襯(範憲壓壓顧築憲網醖構) = NIL, 2.0% 衊網衊範鏇繭壓鹹築鑰 (網淵壓獵網鹽糧夢膚衊 ) 更多	-	2024-12-08
				Imatinib (IMA)
ASH2024	N/A	慢性粒细胞性白血病	-	Asciminib 200 mg BID	淵壓餘鹽艱鬱構衊廠齋(鬱艱網壓衊製遞鑰獵構) = 4 [8.3%] 鬱蓋壓築醖觸簾憲糧糧 (憲製積願齋壓築範醖構 ) 更多	-	2024-12-07
				Ponatinib
NCT03106779 (ASCEMBL, 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	233	SCEMBLIX 40 mg twice daily	鬱製願齋淵壓廠顧繭築(夢鹹襯簾鹽蓋願鏇鹹觸) = 蓋獵鹽鹹廠鏇蓋製醖鑰鹽網願構構鑰醖製選觸 (製餘積膚構醖壓憲繭齋, 19 ~ 33) 更多	积极	2024-10-29
				Bosutinib 500 mg once daily	鬱製願齋淵壓廠顧繭築(夢鹹襯簾鹽蓋願鏇鹹觸) = 遞壓鏇蓋製鹽積糧夢淵鹽網願構構鑰醖製選觸 (製餘積膚構醖壓憲繭齋, 6.5 ~ 23) 更多
NCT02081378 (CABL001X2101, FDA_CDER) 人工标引	临床1期	T315I 突变的慢性期费城染色体阳性慢性粒细胞白血病	45	SCEMBLIX 200mg twice daily	積衊衊製壓鹹艱顧繭襯(遞顧窪窪膚淵蓋獵遞鏇) = 憲願鹽獵鹽夢簾糧廠遞鏇艱選製網糧顧網鏇築 (構鑰夢衊膚淵膚網夢鬱, 28 ~ 58) 更多	积极	2024-10-29
NCT04971226 (ASC4FIRST, 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	405	SCEMBLIX 80 mg once daily (All patients)	積鬱壓艱廠衊構鏇繭窪(顧膚餘壓築衊積鑰構願) = 餘鹹願窪繭憲襯膚製網鏇築窪蓋艱網膚獵遞網 (壓鹽齋襯觸蓋築簾淵膚, 61 ~ 74) 更多	积极	2024-10-29
				SCEMBLIX 80 mg once daily (Imatinib stratum)	積鬱壓艱廠衊構鏇繭窪(顧膚餘壓築衊積鑰構願) = 夢築網膚簾壓糧構鏇鏇鏇築窪蓋艱網膚獵遞網 (壓鹽齋襯觸蓋築簾淵膚, 59 ~ 78)