Evidence map›Paper›PMID 39696526›Full record

Trial reportJournal of hematology & oncology2024

Asciminib add-on to imatinib demonstrates sustained high rates of ongoing therapy and deep molecular responses with prolonged follow-up in the ASC4MORE study.

Timothy P Hughes, Giuseppe Saglio, Jan Geissler, Dong-Wook Kim, Elza Lomaia, Jiri Mayer, Anna Turkina, Shruti Kapoor, Ana Paula Cardoso, Becki Nieman and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of hematology & oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03578367 (A Phase 2, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03578367 phase2completednot on this map

A Phase 2, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response

TypeinterventionalSponsorNovartis PharmaceuticalsRan2018 to 2025Enrolled104ConditionsCML, Chronic Myelogenous Leukemia, Leukemia, Myeloid Chronic, Hematologic DiseasesArmsAsciminib add-on, Imatinib, Nilotinib, Asciminib 80mg QD (asciminib single agent (ASAC))
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Pyridine-containing antitumor agents: structure-oriented medicinal chemistry, structure-activity relationships, and ADMET liabilities.Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents · 2026
    Review
  2. Article
  3. Review
  4. Article
  5. Advances in Targeting BCR-ABLMolecules (Basel, Switzerland) · 2026
    Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Timothy P HughesSouth Australian Health and Medical Research Institute and University of Adelaide, Adelaide, SA, Australia. Tim.Hughes@sahmri.com.
Giuseppe SaglioDepartment of Clinical and Biological Sciences, University of Turin, Turin, Italy.
Jan GeisslerCML Advocates Network, Bern, Switzerland.
Dong-Wook KimUijeongbu Eulji Medical Center, Geumo-Dong, Uijeongbu-si, South Korea.
Elza LomaiaAlmazov National Medical Research Centre, St Petersburg, Russia.
Jiri MayerDepartment of Internal Medicine, Hematology and Oncology, Faculty of Medicine, Masaryk University, and University Hospital Brno, Brno, Czech Republic.
Anna TurkinaNational Medical Research Center for Hematology, Moscow, Russia.
Shruti KapoorNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Ana Paula CardosoNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Becki NiemanNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Sara QuenetNovartis Pharmaceuticals Corporation, Basel, Switzerland.
Jorge E CortesGeorgia Cancer Center, Augusta, GA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUp to 65% of patients with chronic myeloid leukemia (CML) who are treated with imatinib do not achieve sustained deep molecular response, which is required to attempt treatment-free remission. Asciminib is the only approved BCR::ABL1 inhibitor that Specifically Targets the ABL Myristoyl Pocket. This unique mechanism of action allows asciminib to be combined with adenosine triphosphate-competitive tyrosine kinase inhibitors to prevent resistance and enhance efficacy. The phase II ASC4MORE trial investigated the strategy of adding asciminib to imatinib in patients who have not achieved deep molecular response with imatinib.

methodsIn ASC4MORE, 84 patients with CML in chronic phase not achieving deep molecular response after ≥ 1 year of imatinib therapy were randomized to asciminib 40 or 60 mg once daily (QD) add-on to imatinib 400 mg QD, continued imatinib 400 mg QD, or switch to nilotinib 300 mg twice daily.

resultsMore patients in the asciminib 40- and 60-mg QD add-on arms (19.0% and 28.6%, respectively) achieved MR

conclusionsOverall, these results support asciminib add-on as a treatment strategy to help patients with CML in chronic phase stay on therapy to safely achieve rapid and deep response, although further investigation is needed before this strategy is incorporated into clinical practice.

trial registrationNCT03578367.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveAdultAgedFemaleFollow-Up StudiesFusion Proteins, bcr-ablHumansMaleMiddle AgedNiacinamideProtein Kinase InhibitorsPyrazolesPyrimidinesTreatment OutcomeasciminibFusion Proteins, bcr-ablImatinib MesylateNiacinamideProtein Kinase InhibitorsPyrazolesPyrimidinesAdd-onASC4MOREAsciminibCMLCombinationDeep molecular responseImatinibTyrosine kinase inhibitors

Identifiers

PMID39696526
PMCPMC11657281

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.