Evidence map›Paper›PMID 39819505›Full record

Trial reportJournal of hematology & oncology2025

Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial.

Jorge E Cortes, Gail J Roboz, Maria R Baer, Brian A Jonas, Gary J Schiller, Karen Yee, P Brent Ferrell, Jay Yang, Eunice S Wang, William G Blum and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IMulticenter Study
In one paragraph

Trial report in Journal of hematology & oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02719574 (A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT02719574 phase1 / phase2completednot on this map

A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

TypeinterventionalSponsorForma Therapeutics, Inc.Ran2016 to 2024Enrolled336ConditionsAcute Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplastic SyndromeArmsFT-2102 (olutasidenib), Azacitidine, Cytarabine
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Haematologica · 2026
    Article
  5. Review
  6. Molecularly targeted therapy and immunotherapy in leukemias.Journal of hematology & oncology · 2026
    Review
  7. Epigenetic Targeting in Myeloid Malignancies.Advances in experimental medicine and biology · 2026
    Review
  8. Review
  9. Article
  10. Review
  11. Review
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, 1410 Laney Walker Rd., CN2222, Augusta, GA, 30912, USA. jorge.cortes@augusta.edu.
Gail J RobozCornell University Weill Medical College, New York, NY, USA.
Maria R BaerGreenebaum Comprehensive Cancer Center, University of Maryland, Baltimore, MD, USA.
Brian A JonasDavis Comprehensive Cancer Center, University of California, Sacramento, CA, USA.
Gary J SchillerRonald Reagan UCLA Medical Center, Los Angeles, CA, USA.
Karen YeePrincess Margaret Cancer Centre, Toronto, Canada.
P Brent FerrellVanderbilt University Medical Center, Nashville, TN, USA.
Jay YangKarmanos Cancer Institute, Detroit, MI, USA.
Eunice S WangRoswell Park Cancer Institute, Buffalo, NY, USA.
William G BlumEmory Winship Cancer Institute, Atlanta, GA, USA.
Alice MimsThe Ohio State University, Columbus, OH, USA.
Hua TianRigel Pharmaceuticals, Inc., South San Francisco, CA, USA.
Aaron SheppardRigel Pharmaceuticals, Inc., South San Francisco, CA, USA.
Stéphane de BottonHematologie Clinique, Institut Gustave Roussy, Villejuif, France.
Pau MontesinosPM-Hematology Department, Hospital Universitari I Politècnic La Fe, Valencia, Spain.
Antonio CurtiInstitute of Hematology, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Bologna, Italy.
Justin M WattsSylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA.
Olutasidenib Combination Therapy Study Group

Funding

NCI R50 Clinician Scientist AwardR50CA276013 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI Brian A. Jonas · 2023 to 2026
$349k
NCI NIH HHS R50 CA276013
6 · The paper itself

Abstract

backgroundOlutasidenib is a potent, selective, oral, small molecule inhibitor of mutant IDH1 (mIDH1) which induced durable remissions in high-risk, relapsed/refractory (R/R) mIDH1 AML patients in a phase 1/2 trial. We present a pooled analysis from multiple cohorts of the phase 1/2 trial of patients with R/R AML who received combination olutasidenib and azacitidine therapy.

methodsAdult patients with mIDH1

resultsSixty-seven patients with R/R mIDH1

conclusionsOlutasidenib plus azacitidine induced high response rates and durable remissions with a tolerable side effect profile in patients with R/R AML with diverse treatment histories. The results represent another therapeutic option for patients with mIDH1 AML who may benefit from a targeted therapy.

trial registrationNCT02719574.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAzacitidineIsocitrate DehydrogenaseLeukemia, Myeloid, AcutePyridinesAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedQuinolinesRemission InductionAzacitidineIDH1 protein, humanIsocitrate DehydrogenaseolutasidenibPyridinesQuinolinesAMLCombination therapyHypomethylating agentIsocitrate dehydrogenase-1Mutant IDH1 inhibitorRefractoryRelapsed

Identifiers

PMID39819505
PMCPMC11736922

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.