Evidence map›Paper›PMID 35639513›Full record

ArticleNeuro-oncology2023

Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: A multicenter, open-label, phase Ib/II trial.

Macarena I de la Fuente, Howard Colman, Mark Rosenthal, Brian A Van Tine, Danijela Levacic, Tobias Walbert, Hui K Gan, Maria Vieito, Mohammed M Milhem, Kathryn Lipford and 8 more

Open access · hybridAbstract readMulticenter StudyClinical Trial, Phase I
In one paragraph

Article in Neuro-oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 1 pooled it
9.6field-weighted citation impact, top 1% of its field
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

53 citing papers in PubMed, 1 synthesis or guideline pooled it, 66 citations in OpenAlex.

  1. SEOM-GEINO clinical guidelines for grade 2 gliomas (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Current and emerging therapies in IDH-mutant glioma.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  8. Review
  9. Recent Advances in Targeted Therapies for Adult Gliomas.Current neurology and neuroscience reports · 2026
    Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
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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 at 10 institutions in 3 countries.

Macarena I de la FuenteSylvester Comprehensive Cancer Center and Department of Neurology, University of Miami, Miami, Florida, USA.
Howard ColmanHuntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
Mark RosenthalPeter MacCallum Cancer Centre Melbourne , Victoria, Australia.
Brian A Van TineWashington University in St. Louis School of Medicine, St. Louis, Missouri, USA.
Danijela LevacicBaylor and Scott White Vasicek Cancer Center, Baylor University Temple, Temple, Texas, USA.
Tobias WalbertHenry Ford Cancer Institute, Henry Ford Health System and Wayne State University, Detroit, Michigan, USA.ORCID 0000-0003-0667-8106
Hui K GanOlivia Newton-John Cancer Wellness and Research Centre Austin Hospital, Heidelberg, Victoria, Australia.
Maria VieitoVall d'Hebron Institute of Oncology, Barcelona, Spain.
Mohammed M MilhemHolden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa, USA.
Kathryn LipfordForma Therapeutics, Inc., Watertown, Massachusetts, USA.
Sanjeev ForsythForma Therapeutics, Inc., Watertown, Massachusetts, USA.
Sylvie M GuichardForma Therapeutics, Inc., Watertown, Massachusetts, USA.
Yelena MikhailovForma Therapeutics, Inc., Watertown, Massachusetts, USA.
Alexander SedkovForma Therapeutics, Inc., Watertown, Massachusetts, USA.
Julie BrevardForma Therapeutics, Inc., Watertown, Massachusetts, USA.
Patrick F KellyForma Therapeutics, Inc., Watertown, Massachusetts, USA.
Hesham MohamedForma Therapeutics, Inc., Watertown, Massachusetts, USA.
Varun MongaHolden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa, USA.
Forma Therapeutics (United States) · USUniversity of Iowa · USAustin Hospital · AUBaylor University · USHenry Ford Health System · USPeter MacCallum Cancer Centre · AUUniversity of Miami · USUniversity of Utah · USVall d'Hebron Institute of Oncology · ESWashington University in St. Louis · US

Funding

Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Christopher K Laubenthal · 2000 to 2026
$70.0M
NCI NIH HHS P30 CA086862
6 · The paper itself

Abstract

backgroundOlutasidenib (FT-2102) is a highly potent, orally bioavailable, brain-penetrant and selective inhibitor of mutant isocitrate dehydrogenase 1 (IDH1). The aim of the study was to determine the safety and clinical activity of olutasidenib in patients with relapsed/refractory gliomas harboring an IDH1R132X mutation.

methodsThis was an open-label, multicenter, nonrandomized, phase Ib/II clinical trial. Eligible patients (≥18 years) had histologically confirmed IDH1R132X-mutated glioma that relapsed or progressed on or following standard therapy and had measurable disease. Patients received olutasidenib, 150 mg orally twice daily (BID) in continuous 28-day cycles. The primary endpoints were dose-limiting toxicities (DLTs) (cycle 1) and safety in phase I and objective response rate using the Modified Response Assessment in Neuro-Oncology criteria in phase II.

resultsTwenty-six patients were enrolled and followed for a median 15.1 months (7.3‒19.4). No DLTs were observed in the single-agent glioma cohort and the pharmacokinetic relationship supported olutasidenib 150 mg BID as the recommended phase II dose. In the response-evaluable population, disease control rate (objective response plus stable disease) was 48%. Two (8%) patients demonstrated a best response of partial response and eight (32%) had stable disease for at least 4 months. Grade 3‒4 adverse events (≥10%) included alanine aminotransferase increased and aspartate aminotransferase increased (three [12%], each).

conclusionsOlutasidenib 150 mg BID was well tolerated in patients with relapsed/refractory gliomas harboring an IDH1R132X mutation and demonstrated preliminary evidence of clinical activity in this heavily pretreated population.

Indexed as

GliomaQuinolinesHumansIsocitrate DehydrogenasePyridinesIDH1 protein, humanIsocitrate DehydrogenaseolutasidenibPyridinesQuinolinesbrain penetrationgliomaIDH1mutantolutasidenib

Identifiers

PMID35639513
PMCPMC9825299
OpenAlexW4282923726

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.