Evidence map›Paper›PMID 40204896›Full record

ArticleLeukemia2025

Asciminib in combination with imatinib, nilotinib, or dasatinib in patients with chronic myeloid leukemia in chronic or accelerated phase: phase 1 study final results.

Jorge E Cortes, Fabian Lang, Delphine Rea, Andreas Hochhaus, Massimo Breccia, Yeow Tee Goh, Michael C Heinrich, Timothy P Hughes, Jeroen J W M Janssen, Philipp le Coutre and 8 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Leukemia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

18 authors.

Jorge E CortesGeorgia Cancer Center at Augusta University, Augusta, GA, USA. jorge.cortes@augusta.edu.ORCID 0000-0002-8636-1071
Fabian LangDepartment for Hematology/Oncology, Goethe University Hospital, Frankfurt am Main, Germany.ORCID 0000-0003-2890-029X
Delphine ReaHôpital Saint-Louis, Paris, France.
Andreas HochhausUniversitätsklinikum Jena, Jena, Germany.ORCID 0000-0003-0626-0834
Massimo BrecciaDepartment of Translational and Precision Medicine-Az., Policlinico Umberto I-Sapienza University, Rome, Italy.ORCID 0000-0003-1163-6162
Yeow Tee GohDepartment of Haematology, Singapore General Hospital, Singapore, Singapore.ORCID 0000-0002-7069-0997
Michael C HeinrichDepartment of Medicine, Division of Hematology and Oncology, Portland VA Health Care System and Oregon Health & Science University, Knight Cancer Institute, Portland, OR, USA.ORCID 0000-0003-3790-0478
Timothy P HughesSouth Australian Health and Medical Research Institute and University of Adelaide, Adelaide, SA, Australia.ORCID 0000-0002-0910-3730
Jeroen J W M JanssenDepartment of Hematology, Radboud University Medical Center, Nijmegen, Netherlands.
Philipp le CoutreCharité-Universitätsmedizin Berlin, Berlin, Germany.
Hironobu MinamiKobe University Hospital, Kobe, Japan.
Koji SasakiMD Anderson Cancer Center, The University of Texas, Houston, TX, USA.ORCID 0000-0002-9140-0610
Daniel J DeAngeloDana-Farber Cancer Institute, Boston, MA, USA.ORCID 0000-0001-7865-2306
Gessami Sanchez-OlleNovartis Pharma AG, Basel, Switzerland.
Nathalie PognanGlobal Drug Development, Novartis Pharma S.A.S., Rueil-Malmaison, France.
Meng CaoNovartis Pharma AG, Basel, Switzerland.ORCID 0000-0002-3338-304X
Matthias HochNovartis Pharma AG, Basel, Switzerland.
Michael J MauroMemorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0002-2251-4032

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Oregon Clinical and Translational Research Institute - The National COVID Cohort Collaborative (N3C)UL1TR002369 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI Cynthia D Morris, Christopher G. Slatore · 2017 to 2026
$78.4M
BLRD VA I01 BX005358NCATS NIH HHS UL1 TR002369NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Data from in vitro and animal studies suggest that asciminib, the first BCR::ABL1 inhibitor that Specifically Targets the ABL Myristoyl Pocket (STAMP), synergizes with adenosine triphosphate (ATP)-competitive tyrosine kinase inhibitors (TKIs) to prevent emergence of and overcome resistance. Combination therapy may provide new treatment options for patients with chronic myeloid leukemia (CML) with suboptimal responses to ATP-competitive TKI monotherapy. Preliminary analysis of asciminib combined with nilotinib, imatinib, or dasatinib in a phase 1 dose-escalation study suggested promising efficacy and safety for patients with CML in chronic phase or accelerated phase treated with prior ATP-competitive TKIs; herein, we present final results from the 3 combination therapy arms. Asciminib, in combination with ATP-competitive TKIs, demonstrated rapid efficacy offset by a decreased tolerability compared with asciminib monotherapy. Based on these safety, tolerability, and preliminary efficacy results, asciminib 40 mg twice daily (BID) plus nilotinib 300 mg BID, asciminib 40 or 60 mg once daily (QD) plus imatinib 400 mg QD, and asciminib 80 mg QD plus dasatinib 100 mg QD were identified as recommended doses for expansion. The maximum tolerated dose was reached at asciminib 60 mg QD plus imatinib 400 mg QD and was not reached with asciminib plus nilotinib or dasatinib.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Accelerated PhaseAdultAgedDasatinibFemaleHumansImatinib MesylateMaleMiddle AgedNiacinamideProtein Kinase InhibitorsPyrazolesPyrimidinesYoung AdultasciminibDasatinibImatinib MesylateNiacinamidenilotinibProtein Kinase InhibitorsPyrazolesPyrimidines

Identifiers

PMID40204896
PMCPMC12055575

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.