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

Structure/Sequence

Molecular FormulaC20H19Cl2F2N5O3

InChIKeyHGCOOPLEWPBLOY-PFEQFJNWSA-N

CAS Registry2119669-71-3

Clinical Trials associated with Asciminib Hydrochloride

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 Corp.

NCT06629584

/ RecruitingPhase 2IIT

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.

Start Date14 Feb 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT06684964

/ Not yet 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 Date30 Jan 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with Asciminib Hydrochloride

100 Translational Medicine associated with Asciminib Hydrochloride

100 Patents (Medical) associated with Asciminib Hydrochloride

289

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 Apr 2025·MOLECULAR DIVERSITY

Targeting AFP-RARβ complex formation: a potential strategy for treating AFP-positive hepatocellular carcinoma

Article

Author: Dev, Radul R ; Soman, Sowmya ; Banjan, Bhavya ; Raju, Rajesh ; Vishwakarma, Riya ; Rehman, Niyas ; Kalath, Haritha ; Kumar, Pankaj ; Revikumar, Amjesh ; Abhinand, Chandran S ; Ramakrishnan, Krishnapriya

Alpha-fetoprotein (AFP) is a glycoprotein primarily expressed during embryogenesis, with declining levels postnatally. Elevated AFP levels correlate with pathological conditions such as liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Recent investigations underscore AFP's intracellular role in HCC progression, wherein it forms complexes with proteins like Phosphatase and tensin homolog (PTEN), Caspase 3 (CASP3), and Retinoic acid receptors and Retinoid X receptors (RAR/RXR). RAR and RXR regulate gene expression linked to cell death and tumorigenesis in normal physiology. AFP impedes RAR/RXR dimerization, nuclear translocation, and function, promoting gene expression favoring cancer progression in HCC that provoked us to target AFP as a drug candidate. Despite extensive studies, inhibitors targeting AFP to disrupt complex formation and activities remain scarce. In this study, employing protein-protein docking, amino acid residues involved in AFP-RARβ interaction were identified, guiding the definition of AFP's active site for potential inhibitor screening. Currently, kinase inhibitors play a significant role in cancer treatment and, the present study explores the potential of repurposing FDA-approved protein kinase inhibitors to target AFP. Molecular docking with kinase inhibitors revealed Lapatinib as a candidate drug of the AFP-RARβ complex. Molecular dynamics simulations and binding energy calculations, employing Mechanic/Poisson-Boltzmann Surface Area (MM-PBSA), confirmed Lapatinib's stability with AFP. The study suggests Lapatinib's potential in disrupting the AFP-RARβ complex, providing a promising avenue for treating molecularly stratified AFP-positive HCC or its early stages.

01 Mar 2025·Lancet Haematology

Vodobatinib for patients with Philadelphia chromosome-positive chronic myeloid leukaemia resistant or intolerant to multiple lines of previous therapy: an open-label, multicentre, phase 1/2 trial

Article

Author: Alvarado, Yesid ; Hannah, Guy ; Cortes, Jorge E ; Inamdar, Sandeep ; Illés, Árpád ; Lucchesi, Alessandro ; Saxena, Unnati ; Kim, Dong-Wook ; Khattry, Navin ; Yao, Siu-Long ; Charbonnier, Aude ; Badar, Talha ; Tantravahi, Srinivas K ; Chimote, Geetanjali ; Abruzzese, Elisabetta ; García-Gutiérrez, Valentin ; Sreenivasan, Jayasree ; Saikia, Tapan ; Dima, Delia ; Nag, Arijit ; Nicolini, Franck E ; Apperley, Jane F ; Popov, Viola M ; Rathnam, Krishnakumar ; Apte, Shashikant

BACKGROUND:

Resistance or intolerance to the available tyrosine kinase inhibitors (TKIs) remains a treatment challenge for patients with chronic myeloid leukaemia. We aimed to report the safety, antileukaemic activity, and pharmacokinetics of oral vodobatinib, a novel selective BCR::ABL1 TKI, in patients with Philadelphia chromosome-positive (Ph-positive) chronic myeloid leukaemia who previously received at least three TKIs, including ponatinib and asciminib.

METHODS:

This open-label, multicentre, phase 1/2 trial was conducted at 28 clinical sites across ten countries (Belgium, France, Hungary, India, Italy, Romania, South Korea, Spain, UK, and the USA). Patients aged 18 years or older with Ph-positive chronic myeloid leukaemia or acute lymphoblastic leukaemia (eligible only for the phase 1 study), and an Eastern Cooperative Oncology Group performance status of 2 or lower were eligible. Phase 1 included patients who previously received at least three TKIs or had no other available treatment options. Phase 2 required patients to have treatment resistance or intolerance (or both) with loss of response to at least three TKIs and previous ponatinib use. A key exclusion criterion for both phases was presence of the Thr315Ile mutation. Patients self-administered oral vodobatinib (12-240 mg) once per day for each 28-day treatment cycle and for up to 60 months (ie, 65 cycles) unless patient discontinuation due to adverse events, progressive disease, lost to follow-up, or death. The primary endpoints were to determine the maximum tolerated dose (based on dose-limiting toxicities in phase 1) and antileukaemic activity of vodobatinib (ie, major cytogenetic response for chronic-phase and major haematological response for accelerated-phase or blast-phase in phase 2). Assessment of vodobatinib safety, activity, and pharmacokinetics were determined based on the pooled analysis of data from the phase 1 and 2 studies. This trial is registered with ClinicalTrials.gov, NCT02629692 (active). At data cutoff (July 15, 2023), phase 2 enrolment was closed early on June 22, 2023, due to recruitment-related challenges.

FINDINGS:

78 patients were enrolled and received at least one vodobatinib dose (safety and efficacy analysis set). Between April 6, 2017, and June 20, 2023, phase 1 enrolled 58 patients and phase 2 enrolled 20 patients between March 3, 2020, and March 29, 2023. We included 66 (85%) patients with chronic-phase, eight (10%) with accelerated-phase, and four (5%) with blast-phase chronic myeloid leukaemia. 43 (55%) of 78 patients were male and 35 (45%) were female. The median age was 59·0 years (IQR 47·0-66·0). The median follow-up was 22·3 months (IQR 11·1-43·9). Two patients receiving vodobatinib 240 mg had dose-limiting toxicities (one had grade 3 dyspnoea and the other had grade 2 fluid overload), thus the 204 mg dose was considered to be the maximum tolerated dose. 73 (94%) patients had one or more treatment-emergent adverse events, with most events being haematological or gastrointestinal that were grade 2 or lower in severity. Grade 3 or higher treatment-emergent adverse events occurred in 47 (60%) patients and included thrombocytopenia (14 [18%]), neutropenia (10 [13%]), anaemia (nine [12%]), and increased lipase (eight [10%]). Seven (9%) patients died during the study; one death was considered related to treatment by the clinical investigator. At data cutoff, major cytogenetic response was observed in 44 (70%) of 63 patients with chronic-phase chronic myeloid leukaemia, of which 12 (75%) of 16 patients in the phase 2 study had major cytogenetic response. For patients with accelerated-phase chronic myeloid leukaemia, six (86%) of seven patients had a major haematological response (median duration 17·8 [IQR 10·2-24·3]) at data cutoff; major haematological response was observed in three (100%) evaluable patients in the phase 2 study. Major haematological response was reached by two (50%) of four patients with blast-phase chronic myeloid leukaemia and the median duration of response was 6·2 months (IQR 3·2-9·3); no blast-phase patients were enrolled in the phase 2 study.

INTERPRETATION:

Pooled analysis of the phase 1 and 2 studies showed clinically meaningful antileukaemic activity of vodobatinib and a tolerable safety profile in patients with advanced chronic myeloid leukaemia who previously received multiple TKIs, including ponatinib and asciminib, addressing an otherwise unmet clinical need. The phase 2 study was statistically underpowered and warrants further investigation in a phase 3, randomised controlled trial and in an earlier treatment setting of the disease.

FUNDING:

Sun Pharma Advanced Research Company.

105

News (Medical) associated with Asciminib Hydrochloride

19 Feb 2025

·www.echemi.com

NPPA Orders Pharma Firms to Revise Prices After 36 Duty Exemptions

The National Pharmaceutical Pricing Authority (NPPA) has mandated that pharmaceutical companies revise the Maximum Retail Price (MRP) of certain medicines following the recent customs duty exemptions announced in the Union Budget 2025. This directive aims to ensure that consumers benefit from lower prices on essential medications. In a memorandum issued on February 17, the NPPA instructed all drug manufacturers and marketing firms to update their pricing lists to reflect the removal of customs duties on specified life-saving drugs. This includes prominent medications such as onasemnogene abeparvovec, used for treating spinal muscular atrophy, and asciminib, prescribed for chronic myeloid leukemia. The NPPA emphasized that any reduction in customs duties must be accurately represented in the final pricing, in compliance with the Drugs (Price Control) Order, 2013. Manufacturers are required to circulate revised price lists to dealers and regulatory authorities to maintain transparency. This move follows Finance Minister Nirmala Sitharaman's announcement of a full customs duty exemption on 36 life-saving drugs during the budget presentation. The government has allocated significant funds for healthcare, reflecting a 9.78% increase from the previous year, aimed at improving the overall healthcare system. The NPPA's directive highlights the importance of aligning drug prices with government policies to ensure affordability for consumers, particularly in critical health sectors.

24 Jan 2025

·medcitynews.com

Ascentage Has First U.S. Biotech IPO of 2025, Raising $126M to Bring Its Cancer Meds to the World - MedCity News

Ascentage Pharma, a China-based drug developer with global ambitions, now has $126.4 million from a U.S. IPO that will mainly support late-stage clinical development of two medicines that could offer advantages over some currently available cancer therapies. Ascentage has traded on The Stock Exchange of Hong Kong since 2019. In preliminary financial terms set earlier this week for its U.S. stock market debut, the company planned to offer more than 7.3 million American depositary shares (ADS) priced at $20.34 each. Late Thursday, Ascentage, which is based in Suzhou, China, and maintains U.S. operations in Rockville, Maryland, priced its offering at $17.25 per ADS. Those shares will trade on the Nasdaq under the stock symbol “AAPG.” The only commercialized Ascentage product is olverembatinib, a drug approved in China as a treatment for certain patients with chronic myeloid leukemia (CML). This drug is a small molecule inhibitor of tyrosine kinases, enzymes that drive cancer growth. Tyrosine kinase inhibitors (TKIs) are already available, such as the Novartis drugs Scemblix and Gleevec. But CML can become resistant to these therapies, Ascentage said in its IPO filing. Furthermore, first- and second-generation TKIs have not been able to address CML with T315I mutations, which are associated with rapid disease progression and limited patient survival. Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient Ascentage describes olverembatinib as a next-generation drug for CML that is driven by T315I mutations and is also resistant to first- and second-generation TKIs. The company points to real-world data in China showing benefit in patients whose cancers developed resistance to the Novartis drugs. “In a five-year follow-up of CML [in the chronic phase] patients treated with olverembatinib, 73% had remained on the treatment, response rates continued to increase and the prevalence of treatment-related adverse events, or TRAEs, continued to decrease over such period,” Ascentage said in the IPO filing. “Therefore, we believe that olverembatinib, with its real-world patient data in China, where it is approved, has the potential to be a global therapy for CML.” An ongoing Phase 3 clinical program for olverembatinib is enrolling patients in the U.S., Canada, Australia, and China. One of these pivotal studies is testing the drug as a monotherapy for CML. The design of this study is intended to support an FDA new drug application, which Ascentage plans to file in 2026. Additional Phase 3 tests are evaluating olverembatinib in newly diagnosed Philadelphia chromosome-positive acute lymphocytic leukemia and gastrointestinal stromal tumor. Olverembatinib may achieve Ascentage’s global ambitions in the hands of a big pharmaceutical company. Last June, Ascentage granted Takeda Pharmaceuticals International an exclusive option to license olverembatinib for development and commercialization outside of greater China and Russia. Takeda paid $100 million for that option; the option exercise fee and milestone payments could bring Ascentage up to $1.2 billion more, according to the IPO filing. presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical The next drug in Ascentage’s pipeline is lisaftoclax, a small molecule inhibitor of Bcl-2. Overexpression of this protein can contribute to tumor growth and drug resistance. Ascentage is developing lisaftoclax for various types of blood cancers. A new drug application for the molecule is under regulatory review in China for the treatment of advanced cases of chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). If approved, Ascentage plans to launch the lisaftoclax in China in 2025 and then pursue regulatory approvals in multiple countries, according to the filing. Its main competition would be Venclexta, a Bcl-2 inhibitor marketed by partners AbbVie and Genentech. However. Venclexta is not currently approved in China for CLL or SLL. The Ascentage pipeline includes additional small molecules in earlier stages of development, mainly for cancers. Ascentage co-founder Edward Ming Guo is the company’s largest shareholder with a 17.5% post-IPO stake, according to the prospectus. Takeda owns 7.1% of the company. In the nine months ended Sept. 30, 2024, Ascentage reported 876.8 million Chinese yuan (about $124.9 million) in revenue, most of which came from the Takeda option deal. At the end of the third quarter of 2024, Ascentage reported its cash position was $210.8 million. With the IPO proceeds, Ascentage plans to spend $30 million to $40 million for clinical development of olverembatinib in the U.S. and other countries, and to expand the drug’s label to earlier lines of CML treatment among other indications, according to the prospectus. Another $50 million to $60 million is budgeted for the regulatory approval and potential commercial launch in China of lisaftoclax as a treatment for relapsed or refractory CLL. The company also plans to run clinical trials that could support approvals of this drug in the U.S. and other countries. Between $10 million and $20 is set aside to fund R&D of other drug candidates.

Drug ApprovalPhase 3IPOLicense out/inAcquisition

23 Jan 2025

·www.biopharmadive.com

Ascentage prices first biotech IPO of 2025, raising $126M

Dive Brief:Ascentage Pharma, a cancer drug developer based in Suzhou, China, on Thursday raised just over $126 million in the first U.S. initial public offering by a biotechnology company this year.The company, which is already publicly traded in Hong Kong, sold 7,325,000 American depositary shares at $17.25 apiece, a lower price than it had projected earlier this week. Shares will begin trading on the Nasdaq Stock Exchange Friday under the ticker symbol AAPG.Ascentage will use the proceeds to develop treatments for cancer, among them a leukemia drug called olverembatinib thats approved in China. Its IPO comes amid increased dealmaking involving drugs from China, a trend industry watchers expect to continue this year. Ascentage is one such beneficiary, having licensed olverembatinib to Takeda last year.Dive Insight:Ascentages Wall Street debut is a test of U.S. investors interest in the progress Chinas biotech sector has made.Efforts by the Chinese government to boost the countrys capabilities have produced a burgeoning ecosystem of drug companies, many of which are trying to improve on medicines either on the market or in development. That, combined with tight funding in biotech, has led to a flurry of licensing deals.Though relatively few China-based biotechs have reached public markets in the U.S., some, like oncology-focused drug developers Legend Biotech and BeiGene, have prospered.Ascentage is developing small molecule drugs that block or degrade protein targets implicated in cancer. Its most advanced prospect is olverembatinib, which is cleared in China for certain people with chronic myeloid leukemia. Its in multi-country Phase 3 trials in CML, as well as for two other forms of cancer.Though similar drugs, such as Novartis Gleevec and Scemblix, are available, there is room for improvement, as CML can be stubbornly resistant to approved therapies, Ascentage said in its IPO prospectus.A second Ascentage drug, lisaftoclax, is in late-stage testing for blood cancers including chronic lymphocytic leukemia and acute myeloid leukemia and is under regulatory review in China. Ascentage claims it has the potential to become a backbone molecule for combination regimens.Three additional drugs are in clinical testing for a variety of other tumors.Ascentage was formed in Hong Kong in 2009, and has headquarters in Suzhou as well as in Rockville, Maryland. The company generated 877 million yuan in revenue, or about $125 million, over the first nine months of 2024, according to its IPO filing. Most came from the $100 million Takeda paid to license olverembatinib.The IPO could be the first of several to price in the coming weeks. Five companies Maze Therapeutics, Metsera, Aardvark Therapeutics, Sionna Therapeutics and Odyssey Therapeutics outlined IPO plans in January.Overall, however, biotech IPOs have remained stagnant since 2022, with only around two dozen companies going public in each of the past three years, according to BioPharma Dive data. Most trade below their debut price. '

Drug ApprovalIPOPhase 3AcquisitionBiosimilar

100 Deals associated with Asciminib Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11403 D11404	-	-	DB12597

R&D Status

Approved

10 top approved records.

to view more data

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
Philadelphia chromosome positive chronic myelogenous leukemia	United States	Novartis Pharmaceuticals Corp.	29 Oct 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Myelogenous Leukemia	NDA/BLA	China	Beijing Novartis Pharma Co. Ltd.	25 Jun 2024
Chronic Myelogenous Leukemia	NDA/BLA	China	Novartis Pharma Schweiz AG	25 Jun 2024
Chronic Myelogenous Leukemia	NDA/BLA	China	Novartis Pharma Stein AG	25 Jun 2024
Aggressive-Phase Chronic Myelocytic Leukemia	Phase 3	Canada	Novartis AG	19 Jun 2023
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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04971226 (ASC4FIRST, CTgov)	Phase 3	Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	406	Asciminib (Asciminib (All Asciminib ))	kvgxbqfteo = fvvzxtmuje rjtbvqewdp (fiqkpikyvj, qabpfouxnt - hykmkuwwbi) View more	-	10 Mar 2025
				dasatinib+nilotinib+imatinib+bosutinib (Investigator Selected TKI (All Comparators))	kvgxbqfteo = jegvbydhmu rjtbvqewdp (fiqkpikyvj, ydlrlnohdh - ajsltgakdg) View more
NCT03578367 (ASC4MORE, CTgov)	Phase 2	Chronic phase chronic myeloid leukemia \| Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	104	Asciminib add-on+Imatinib (Asciminib 40mg QD + Imatinib 400mg QD)	fqnycmihos = abnwfuentj hzeutgwjxo (tzqfvvvmmk, zjhyforsqe - kjopymqbjs) View more	-	14 Feb 2025
				Asciminib add-on+Imatinib (Asciminib 60mg QD + Imatinib 400mg QD)	fqnycmihos = oraqnsceot hzeutgwjxo (tzqfvvvmmk, tjktjkmbek - tibineowyf) View more
NCT04971226 (ASC4FIRST, NEWS) Manual	Phase 3	Chronic phase chronic myeloid leukemia First line	405	Scemblix® 80mg	czenfyjvss(vvtmeymbkr) = cqwpceedgh uohblclhbv (bkibzcocbl ) View more	Positive	10 Jan 2025
				Standard of Care TKIs	czenfyjvss(vvtmeymbkr) = jculalsvcj uohblclhbv (bkibzcocbl ) View more
NCT03578367 (ASC4MORE, Pubmed \| J Hematol Oncol)	Phase 2	Chronic phase chronic myeloid leukemia \| Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase Add-on	84	Asciminib 40 mg QD add-on to Imatinib 400 mg QD	mljzrockig(agrzatfuub) = ksobsodbpf dndnjahhsy (jhzubfowan ) View more	Positive	18 Dec 2024
				Asciminib 60 mg QD add-on to Imatinib 400 mg QD	mljzrockig(agrzatfuub) = njpesugnnw dndnjahhsy (jhzubfowan ) View more
ASH2024	Not Applicable	Chronic phase chronic myeloid leukemia	-	Asciminib	vpdfszvxao(qpelmubflf) = less frequent in the RW settings eggckbahgi (vmhzykblrf ) View more	-	09 Dec 2024
				Placebo
ASH2024	Not Applicable	Chronic phase chronic myeloid leukemia	-	Asciminib 40 mg BID	gzsvezxeen(idiqxftnxi) = sirfpjrtdd wburmcxedv (ygjdymhzke ) View more	-	09 Dec 2024
				Asciminib 80 mg QD	gzsvezxeen(idiqxftnxi) = oyoyucokow wburmcxedv (ygjdymhzke ) View more
ASH2024	Not Applicable	Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	-	Asciminib 80 mg QD	pkmznopwrm(djcvprmqft) = 16.3% xhnzawrfws (hgveiclnye ) View more	-	08 Dec 2024
ASH2024	Not Applicable	Chronic phase chronic myeloid leukemia	-	Asciminib 80 mg once daily	ipyemoujog(xbqxysysme) = NIL, 2.0% dkyfawfdmd (lahciuqrzs ) View more	-	08 Dec 2024
				Imatinib (IMA)
ASH2024	Not Applicable	Chronic Myelogenous Leukemia	-	Asciminib 200 mg BID	opvlhpoymn(ojqynqtzmu) = 4 [8.3%] rcsnxkefpb (bbemedrnyl ) View more	-	07 Dec 2024
				Ponatinib
NCT03106779 (ASCEMBL, FDA_CDER) Manual	Phase 3	Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	233	SCEMBLIX 40 mg twice daily	padrcrrhdv(vtrkmbdvue) = eouccdjsvw dymqwwhdnw (ydqfbcphdg, 19 - 33) View more	Positive	29 Oct 2024
				Bosutinib 500 mg once daily	padrcrrhdv(vtrkmbdvue) = vkqahvlocw dymqwwhdnw (ydqfbcphdg, 6.5 - 23) View more

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