Delving into the Latest Updates on Asciminib Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Asciminib, 阿思尼布, 阿西米尼

+ [7]

Target

Bcr-Abl x STAMP

Action

inhibitors

Mechanism

Bcr-Abl inhibitors(Bcr-Abl tyrosine kinase inhibitors), STAMP inhibitors(tubulin tyrosine ligase like 5 inhibitors)

Therapeutic Areas

NeoplasmsHemic and Lymphatic DiseasesImmune System Diseases+ [1]

Active Indication

Philadelphia chromosome-positive chronic myeloid leukemia in chronic phasePhiladelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutationChronic Myelogenous Leukemia+ [10]

Inactive Indication

Chronic Kidney DiseasesRenal Insufficiency

Originator Organization

Novartis AG

Active Organization

China Novartis Institutes for BioMedical Research Co., Ltd.Novartis Pharma AG

Novartis Pharmaceuticals Canada, Inc.

+ [10]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (29 Oct 2021),

Philadelphia chromosome positive chronic myelogenous leukemia

RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia)

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Structure/Sequence

Molecular FormulaC20H19Cl2F2N5O3

InChIKeyHGCOOPLEWPBLOY-PFEQFJNWSA-N

CAS Registry2119669-71-3

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.

Start Date01 Jun 2025

Sponsor / Collaborator

Gruppo Italiano Malattie EMatologiche dell'Adulto

NCT06684964

/ RecruitingNot Applicable

Real-World Evidence Non-interventional Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib After Two Previous TKIs in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) in Saudi Arabia. (ASC4REAL)

This is a non-interventional, prospective, observational single arm study describing the real-world effectiveness, tolerability, adherence, Healthcare Resource Utilization (HCRU) and Patient-Reported Outcome (PRO) data of asciminib in patients with Ph+ Chronic Myelogenous Leukemia - Chronic Phase (CML-CP) previously treated with ≥2 Tyrosine Kinase Inhibitor (TKIs) in routine clinical practice in Kingdom of Saudi Arabia.

Start Date24 Mar 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06514534

/ RecruitingPhase 2

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.

Start Date18 Feb 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

100 Clinical Results associated with Asciminib Hydrochloride

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100 Translational Medicine associated with Asciminib Hydrochloride

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100 Patents (Medical) associated with Asciminib Hydrochloride

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324

Literatures (Medical) associated with Asciminib Hydrochloride

01 Dec 2025·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

Author: Darstein, Christelle ; Sy, Sherwin K B ; Kawakita, Yasunori ; Wu, Shengyuan ; Yoon, Deokyong ; Grosch, Kai ; Dasgupta, Kohinoor ; Yang, Yiqun ; 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.

01 Jun 2025·Clinical Lymphoma Myeloma & Leukemia

SOHO State of the Art Updates and Next Questions: Combination Therapy in Chronic Myeloid Leukemia in Chronic Phase

Review

Author: Costa, Alessandro ; Breccia, Massimo

Therapeutic strategies for chronic myeloid leukemia (CML) are rapidly evolving, with novel agents emerging to address the limitations of current treatments. Goals of CML management are disease control and achieve a deep and sustained molecular response for a possible successful treatment-free remission (TFR). However, a significant proportion of patients fail to reach adequate molecular response and require sequential therapies. A crucial aspect of treatment resistance lies in the persistence of leukemic stem cells (LSCs), which serve as a reservoir for disease recurrence. Increasing focus is placed on combination strategies to overcome the constraints of TKI monotherapy. Various strategies have been explored, starting with the combination of interferon (IFN) and TKIs. The investigation of alternative administration methods, dosing regimens, or extended treatment durations in clinical trials involving IFN represents potential avenues to address current conflicting results. Additionally, the combination of ATP-competitive TKIs with asciminib has shown encouraging preclinical and clinical results, with further data needed for a comprehensive safety profile. Recently, efforts to inhibit other signaling pathways have been explored but with contrasting results. Despite ongoing advancements, TKIs remain the cornerstone of both current and future combination therapies. Their integration with personalized approaches is crucial to overcome complex biological challenges and ensure long-term, effective and safe treatment for CML patients.

01 Jun 2025·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

Author: 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.

113

News (Medical) associated with Asciminib Hydrochloride

27 May 2025

·www.fiercepharma.com

Novartis expands strategic collaboration with Shanghai Pharma in China to cover eye drugs

China has been one of Novartis’ priority geographies, alongside the U.S., Germany and Japan. With the goal to become a top 3 pharma company in China, Novartis has been busy tapping into the expertise of local drugmakers.In its latest collaboration, Novartis has signed a strategic agreement with Shanghai Pharma to help sell the Swiss company’s mature ophthalmic products in China, Shanghai Pharma said (Chinese) Monday.Novartis will leverage Shanghai Pharma’s omni-channel integrated marketing services and broad market coverage capabilities to accelerate the reach of some Novartis drugs for ocular infections and glaucoma in smaller territories not currently targeted by Novartis, according to the Chinese company.The two companies did not disclose the specific products covered by the deal. Ophthalmology is not a Novartis focus area. The company is now focused on four core therapeutic areas: cardiovascular-renal-metabolic, immunology, neuroscience and oncology.The new partnership builds on a longstanding relationship between Novartis and Shanghai Pharma.Also on Monday, the two firms unveiled (Chinese) the opening of a cardiovascular health management platform to offer patients continuous support before and after diagnosis. The platform includes a cloud-based service to offer medication guidance, test results tracking and follow-up visits.The partners labeled the platform as a part of a “specialty pharmacy” that now covers treatments for skin disease, breast cancer, high cholesterol and high blood pressure. In November 2024, Novartis China signed on (Chinese) Shanghai Pharma and C.Q. Pharmaceutical to build a supply chain for its radioligand therapies. The deal came after Novartis in July broke ground on a 600 million Chinese yuan ($83 million) on a radioligand therapy manufacturing facility in the province of Zhejiang, near Shanghai. The company expects the facility to be operational by the end of 2026.China has been one of Novartis’ priority geographies, alongside the U.S., Germany and Japan. In China, Novartis’ goal is to become a top-three multinational pharma company by sales, and CEO Vas Narasimhan recently said the company may achieve that goal this year. To contribute toward that goal, Novartis earlier this month won Chinese approvals for Kisqali as an adjuvant treatment for early-stage HR-positive, HER2-negative breast cancer and for Scemblix in newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia.In 2024, Novartis saw sales from China grow 21% at constant exchange rates year-over-year to $3.9 billion. Novartis likely won’t be able to pull it off all by itself in China. Shanghai Pharma is one of the country’s largest pharma distributors and contract sales organizations (CSO). In 2024, Shanghai Pharma’s CSO business managed 65 drugs, contributing to 8 billion Chinese yuan ($1.1 billion) of those products’ annual revenue, up 177% year-over-year, according to the company’s annual report. Alongside Novartis’ radioligand therapy pact, Shanghai Pharma in November inked (Chinese) a group of commercialization deals, including with Pfizer on vaccines and with Gilead Sciences on long-acting HIV therapy, among others.Besides Shanghai Pharma, Novartis has also been working with China’s state-owned behemoth Sinopharma, which markets Novartis’ Gleevec (also known as Glivec) in the country since 2023. In January, the two signed (Chinese) a strategic collaboration to focus on oncology drugs in the future.

Drug Approval

26 May 2025

·www.echemi.com

Novartis Breakthrough Drug Asciminib Gains China Approval Bringing Hope to Over 75 Countries

On May 14, Novartis achieved a major regulatory milestone as asciminib tablets were officially approved by China’s NMPA for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). This decision adds China to the growing list of over 75 countries, including the United States, Japan, and EU nations, where the therapy has already received market authorization. What sets asciminib apart is its revolutionary STAMP (Specifically Targeting the ABL Myristoyl Pocket) mechanism, a first-in-class and only-in-class approach that enables high specificity and reduces unwanted side effects. Instead of binding to the ATP pocket like traditional TKIs, asciminib interacts with a distinct allosteric site on the BCR-ABL protein, altering its conformation and enhancing patient tolerability. Approved initially in October 2021 by the U.S. FDA under an accelerated pathway, asciminib has rapidly expanded its reach across major global markets. In October 2024, the FDA further extended its approval to include first-line use, solidifying its role as a frontline therapy. China’s greenlight for this drug marks a significant advancement for patients with TKI resistance or intolerance. With six existing BCR-ABL inhibitors already approved in China, asciminib enters a crowded but critical landscape, offering a novel and more tolerable option. This approval strengthens Novartis’ position in oncology innovation and provides new hope for thousands of patients who previously had limited options.

Drug ApprovalAccelerated ApprovalCSCOClinical Study

16 May 2025

·www.fiercepharma.com

Fierce Pharma Asia—Pfizer partner's trial win; Roche's $300M China plant; Hengrui's HK IPO plan

Positive data from a Pfizer-partnered antibody-drug conjugate, Roche's new investment in China and Hengrui's upcoming dual listing in Hong Kong made our news this week. Pfizer and RemeGen's HER2 antibody-drug conjugate delivered positive phase 3 results in a bladder cancer trial in China. Roche plans to invest nearly $300 million to build a new Chinese plant to produce Vabysmo. China's Hengrui Pharma is looking to raise up to $1.27 billion in its Hong Kong IPO. And more.1. Pfizer partner RemeGen says HER2 ADC prolongs life in newly diagnosed bladder cancerRemeGen’s Pfizer-partnered HER2 antibody-drug conjugate, disitamab vedotin, was successful in a phase 3 study among Chinese patients with first-line HER2-expressing bladder cancer. The ADC, used alongside Junshi Biosciences’ PD-1 inhibitor toripalimab, outperformed chemotherapy regardless of patients' eligibility for cisplatin or HER2 expression levels. The trial win bodes well for Pfizer’s global DV-001 study, also called Keynote-D74.2. Roche pledges nearly $300M to establish new Vabysmo production plant in ChinaRoche is investing about 2 billion Chinese yuan ($282 million) to build a new biologics plant in Shanghai. The plant will occupy about 25,000 square meters (269,000 square feet) of real estate and will mainly be used for domestic production of the eye med Vabysmo. Construction is expected to finish in 2029, and production could kick off by 2031, according to Roche.3. Hengrui looks to raise up to $1.27B in Hong Kong IPO (Morningstar)Jiangsu Hengrui Pharmaceutical, already listed in Shanghai, is planning to raise up to HK$9.89 billion ($1.27 billion) in a Hong Kong IPO. The plan involves selling 224.52 million shares at a price range of HK$41.45 to HK$44.05 each. The Chinese pharma giant expects to finalize pricing by May 21 and start trading from May 23.4. Qilu Pharmaceutical pays $38M upfront for greater China rights to Minghui's ADCThe B7-H3 target has yielded another deal. Qilu Pharmaceutical is paying 280 million Chinese yuan ($38 million) upfront for greater China rights to Minghui Pharmaceutical’s B7-H3 ADC, MHB088C. Also in the B7-H3 ADC field, Merck & Co. has licensed ifinatamab deruxtecan from Daiichi Sankyo, GSK got a candidate from Hansoh and BioNTech partnered with Duality Bio.5. CSPC licenses Onivyde copycat to Cipla despite Ipsen patent dispute (release, PDF)Despite a pending patent infringement lawsuit from Ipsen, CSPC Pharmaceutical has penned a deal to license its irinotecan liposome injection in the U.S. to Cipla for $15 million upfront. Milestone payments from the pact could exceed $1 billion. In a lawsuit filed in August 2024, Ipsen alleges that the CSPC candidate infringes a patent for the French pharma’s irinotecan liposome product Onivyde.6. Novartis cancer drugs Kisqali, Scemblix win China approvals (releases, Chinese)In two approvals for Novartis’ business in China, local authorities approved the company’s Kisqali for the adjuvant treatment of early-stage HR-positive, HER2-negative breast cancer, as well as Scemblix for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia. Both indications have been cleared in the U.S. and are considered major growth drivers for the Swiss pharma.Other News of Note:7. Merck KGaA drops China surcharge on orders after US-China tariff deal (Reuters)8. Sino-American siRNA biotech Sirius Therapeutics raises $50M (release)

Drug ApprovalPhase 3ADCClinical Result

100 Deals associated with Asciminib Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D11403 D11404	-	-	DB12597

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	United States	Novartis Pharmaceuticals Corp.	29 Oct 2024
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutation	United States	Novartis Pharmaceuticals Corp.	29 Oct 2024
Chronic Myelogenous Leukemia	Japan	Novartis Pharmaceuticals KK	28 Mar 2022
Philadelphia chromosome positive chronic myelogenous leukemia	United States	Novartis Pharmaceuticals Corp.	29 Oct 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Philadelphia positive acute lymphocytic leukaemia	Phase 3	United States	Novartis Pharma AG	30 Aug 2022
Philadelphia positive acute lymphocytic leukaemia	Phase 3	Japan	Novartis Pharma AG	30 Aug 2022
Philadelphia positive acute lymphocytic leukaemia	Phase 3	Argentina	Novartis Pharma AG	30 Aug 2022
Philadelphia positive acute lymphocytic leukaemia	Phase 3	Austria	Novartis Pharma AG	30 Aug 2022
Philadelphia positive acute lymphocytic leukaemia	Phase 3	Brazil	Novartis Pharma AG	30 Aug 2022
Philadelphia positive acute lymphocytic leukaemia	Phase 3	Bulgaria	Novartis Pharma AG	30 Aug 2022
Philadelphia positive acute lymphocytic leukaemia	Phase 3	Canada	Novartis Pharma AG	30 Aug 2022
Philadelphia positive acute lymphocytic leukaemia	Phase 3	Czechia	Novartis Pharma AG	30 Aug 2022
Philadelphia positive acute lymphocytic leukaemia	Phase 3	Denmark	Novartis Pharma AG	30 Aug 2022
Philadelphia positive acute lymphocytic leukaemia	Phase 3	France	Novartis Pharma AG	30 Aug 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03595917 (Phase I study, ASCO2025)	Phase 1	ABL1 T315I \| p190 \| p210 ... View more	15	Asciminib 80 mg/d	xfufhmoxhl(nldcfnmbeo) = czjuvmtvcm nvghhcakiq (fweumdorzq ) View more	Positive	30 May 2025
				Dasatinib 140 mg/d	jifopzlzop(lciyvchsip) = antoadxonf ucmrpxxiqj (upybiinveg )
NCT05384587 (ASC2ESCALATE, ASCO2025)	Phase 2	Chronic phase chronic myeloid leukemia BCR::ABL1	101	Asciminib 80 mg once daily	dnkjzxhaix(wrzvhuieyj) = AEs led to dose adjustment/interruption in 27 pts (26.7%). AEs led to discontinuation in 4 pts; 1 of these AEs occurred >30 d after last ASC dose. No arterial-occlusive events or on-Tx deaths occurred. fdpmgfgbfk (bblitupioq )	Positive	30 May 2025
NCT05456191 (ASC4START, ASCO2025)	Phase 3	Chronic phase chronic myeloid leukemia	-	Asciminib 80 mg	dpwxfhpuak(peemiydeil): cause-specific hazard ratio = 0.45 (95% CI, 0.25 - 0.81) View more	Positive	30 May 2025
				Nilotinib 300 mg
NCT04925479 (ASC4Kids, ASCO2025)	Phase 1/2	Chronic phase chronic myeloid leukemia T315I mutation	19	Pediatric Formulation of Asciminib 1.3 mg/kg BID	zgvzisqtrw(upkkdnnrjt) = 18 pts experienced adverse events (AEs; any grade); 2 had Grade ≥3 AEs lwyxdzdbtb (lngjjadynl ) View more	Positive	30 May 2025
PB2728 (EHA2025)	Not Applicable	Chronic Myelogenous Leukemia Second line	15	Asciminib	owhffjhcnx(ytjxgymcsl) = huivvolooc fpwkoreocg (xxpbkxpmha, 29 - 80) View more	Positive	14 May 2025
NCT04971226 (ASC4FIRST, EHA2025)	Phase 3	Philadelphia chromosome positive chronic myelogenous leukemia	405	Asciminib	imfllfuniq(nzkrzryktx) = xghshvqemb wbexeqftmf (jsakbjobwp ) View more	Positive	14 May 2025
				Investigator-Selected Tyrosine Kinase Inhibitors	imfllfuniq(nzkrzryktx) = mmvigixogi wbexeqftmf (jsakbjobwp ) View more
ASCIMINIB AFTER ONE PRIOR TYROSINE KINASE INHIBITOR IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA (EHA2025)	Not Applicable	Chronic Myelogenous Leukemia	255	Asciminib	nuucapkbco(etwvhwofba) = fatigue (8.6%), headache (7.1%), rash (4.3%), abdominal pain (2.4%) lpvbjqprtb (aqdjaejkcg ) View more	Positive	14 May 2025
NCT05384587 (ASC2ESCALATE, EHA2025)	Phase 2	Chronic phase chronic myeloid leukemia BCR::ABL1	101	ASC 80 mg once daily	gjgeutlakn(pjyxmnshcp) = vyakzdlfnk nfvfuvopzz (ajikejcmef ) View more	Positive	14 May 2025
PF594 (EHA2025)	Not Applicable	Chronic phase chronic myeloid leukemia BCR::ABL1 \| t315i	36	ASCIMINIB	jfpmezxltf(uheesiafsk) = fusthwgnur fbbwutsjum (ssgmqlhnew ) View more	Positive	14 May 2025
				Placebo	saubyvudhb(wokvkpmxqc) = ndwwkslxfq gwxtsxeshb (druyzaeolv )
NCT05143840 (HJKC3, EHA2025)	Phase 2	Chronic Myelogenous Leukemia	50	Asciminib 40 mg	vkcckvbtpm(uqhcnalkbo) = zqsnujkoac jnbvptqrku (cqgvxkruxi ) View more	Positive	14 May 2025
				Asciminib 80 mg	omsmqfqslh(tiyjjaljmw) = vxwylajuev yufzhjropf (pylisshxdr ) View more