dc.contributor
Institut Català de la Salut
dc.contributor
[de la Fuente MI] Sylvester Comprehensive Cancer Center and Department of Neurology, University of Miami, Miami, Florida, USA. [Colman H] Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA. [Rosenthal M] Peter MacCallum Cancer Centre Melbourne, Victoria, Australia. [Van Tine BA] Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA. [Levacic D] Baylor and Scott White Vasicek Cancer Center, Baylor University Temple, Temple, Texas, USA. [Walbert T] Henry Ford Cancer Institute, Henry Ford Health System and Wayne State University, Detroit, Michigan, USA. [Vieito M] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
de la Fuente, Macarena
dc.contributor.author
Colman, Howard
dc.contributor.author
Rosenthal, Mark
dc.contributor.author
Van Tine, Brian
dc.contributor.author
Levacic, Danijela
dc.contributor.author
Walbert, Tobias
dc.contributor.author
Vieito Villar, Maria
dc.date.accessioned
2025-10-25T05:38:26Z
dc.date.available
2025-10-25T05:38:26Z
dc.date.issued
2023-02-14T13:32:23Z
dc.date.issued
2023-02-14T13:32:23Z
dc.identifier
de la Fuente MI, Colman H, Rosenthal M, Van Tine BA, Levacic D, Walbert T, et al. Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: a multicenter, open-label, phase 1b/2 trial. Neuro Oncol. 2023 Jan;25(1):146–56.
dc.identifier
https://hdl.handle.net/11351/8986
dc.identifier
10.1093/neuonc/noac139
dc.identifier
000820020600001
dc.identifier.uri
http://hdl.handle.net/11351/8986
dc.description.abstract
Brain penetration; Mutant; Olutasidenib
dc.description.abstract
Penetració cerebral; Mutant; Olutasidenib
dc.description.abstract
Penetración cerebral; Mutante; Olutasidenib
dc.description.abstract
Background
Olutasidenib (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.
Methods
This 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.
Results
Twenty-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).
Conclusions
Olutasidenib 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.
dc.description.abstract
This study was funded by Forma Therapeutics, Inc., Watertown, MA, USA.
dc.format
application/pdf
dc.publisher
Oxford University Press
dc.relation
Neuro-Oncology;25(1)
dc.relation
https://doi.org/10.1093/neuonc/noac139
dc.rights
Attribution-NonCommercial 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Gliomes - Tractament
dc.subject
Medicaments antineoplàstics - Ús terapèutic
dc.subject
DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Germ Cell and Embryonal::Neuroectodermal Tumors::Neoplasms, Neuroepithelial::Glioma
dc.subject
Other subheadings::Other subheadings::Other subheadings::/drug therapy
dc.subject
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents
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Other subheadings::Other subheadings::/therapeutic use
dc.subject
ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de células germinales y embrionarias::tumores neuroectodérmicos::neoplasias neuroepiteliales::glioma
dc.subject
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
dc.subject
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos
dc.subject
Otros calificadores::Otros calificadores::/uso terapéutico
dc.title
Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: A multicenter, open-label, phase Ib/II trial
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
