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Vorasidenib in IDH1-mutant or IDH2-mutant low-grade glioma (INDIGO): secondary and exploratory endpoints from a randomised, double-blind, placebo-controlled, phase 3 trial.

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Title: Vorasidenib in IDH1-mutant or IDH2-mutant low-grade glioma (INDIGO): secondary and exploratory endpoints from a randomised, double-blind, placebo-controlled, phase 3 trial.
Authors: Cloughesy TF; Department of Neurology, University of California Los Angeles, Los Angeles, CA, USA., van den Bent MJ; Brain Tumour Center, Erasmus Medical Center, Rotterdam, Netherlands., Touat M; Service de Neuro-oncologie, Pitié Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris, France., Blumenthal DT; Neuro-oncology Service, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel., Peters KB; Department of Neurosurgery, Duke University Medical Center, Durham, NC, USA., Ellingson BM; Department of Radiology, University of California Los Angeles, Los Angeles, CA, USA., Clarke JL; Department of Neurology, University of California San Francisco, San Francisco, CA, USA., Mendez J; Department of Neurosurgery, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, USA., Yust-Katz S; Neuro-Oncology Unit, Davidoff Cancer Center at Rabin Medical Center, Petah Tikva, Israel., Welsh L; Neuro-Oncology Unit, The Royal Marsden Hospital, London, UK., Mason WP; Department of Medicine, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada., Ducray F; Service de Neuro-Oncologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Centre de Recherche en Cancérologie de Lyon, Lyon, France., Umemura Y; Department of Neurology, University of Michigan Medical School, Ann Arbor, MI, USA., Nabors B; Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA., Holdhoff M; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine, Baltimore, MD, USA., Hottinger AF; Department of Oncology, Lundin Family Brain Tumor Research Centre, University Hospital of Lausanne, Lausanne, Switzerland., Arakawa Y; Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan., Sepulveda JM; Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain., Wick W; Department of Neurology, Universitätsklinikum Heidelberg, Heidelberg & German Cancer Research Center, Heidelberg, Germany., Soffietti R; Department of Neuro-Oncology, University of Turin, Turin, Italy., Perry J; Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada., Giglio P; Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, OH, USA., de la Fuente M; Department of Neurology, Sylvester Comprehensive Cancer Center and University of Miami, Miami, FL, USA., Maher E; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA., Bottomley A; Bottomley Consulting Group, Brussels, Belgium., Tron AE; Servier Pharmaceuticals, Boston, MA, USA., Yi D; Servier Pharmaceuticals, Boston, MA, USA., Zhao D; Servier Pharmaceuticals, Boston, MA, USA., Pandya SS; Servier Pharmaceuticals, Boston, MA, USA., Steelman L; Servier Pharmaceuticals, Boston, MA, USA., Hassan I; Servier Pharmaceuticals, Boston, MA, USA., Wen PY; Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Mellinghoff IK; Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: mellingi@mskcc.org.
Corporate Authors: INDIGO trial investigators
Source: The Lancet. Oncology [Lancet Oncol] 2025 Dec; Vol. 26 (12), pp. 1665-1675. Date of Electronic Publication: 2025 Oct 29.
Publication Type: Journal Article; Clinical Trial, Phase III; Randomized Controlled Trial; Multicenter Study
Journal Info: Publisher: Lancet Pub. Group Country of Publication: England NLM ID: 100957246 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-5488 (Electronic) Linking ISSN: 14702045 NLM ISO Abbreviation: Lancet Oncol Subsets: MEDLINE
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  Data: Vorasidenib in IDH1-mutant or IDH2-mutant low-grade glioma (INDIGO): secondary and exploratory endpoints from a randomised, double-blind, placebo-controlled, phase 3 trial.
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  Data: <searchLink fieldCode="AU" term="%22Cloughesy+TF%22">Cloughesy TF</searchLink>; Department of Neurology, University of California Los Angeles, Los Angeles, CA, USA.<br /><searchLink fieldCode="AU" term="%22van+den+Bent+MJ%22">van den Bent MJ</searchLink>; Brain Tumour Center, Erasmus Medical Center, Rotterdam, Netherlands.<br /><searchLink fieldCode="AU" term="%22Touat+M%22">Touat M</searchLink>; Service de Neuro-oncologie, Pitié Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris, France.<br /><searchLink fieldCode="AU" term="%22Blumenthal+DT%22">Blumenthal DT</searchLink>; Neuro-oncology Service, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel.<br /><searchLink fieldCode="AU" term="%22Peters+KB%22">Peters KB</searchLink>; Department of Neurosurgery, Duke University Medical Center, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Ellingson+BM%22">Ellingson BM</searchLink>; Department of Radiology, University of California Los Angeles, Los Angeles, CA, USA.<br /><searchLink fieldCode="AU" term="%22Clarke+JL%22">Clarke JL</searchLink>; Department of Neurology, University of California San Francisco, San Francisco, CA, USA.<br /><searchLink fieldCode="AU" term="%22Mendez+J%22">Mendez J</searchLink>; Department of Neurosurgery, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, USA.<br /><searchLink fieldCode="AU" term="%22Yust-Katz+S%22">Yust-Katz S</searchLink>; Neuro-Oncology Unit, Davidoff Cancer Center at Rabin Medical Center, Petah Tikva, Israel.<br /><searchLink fieldCode="AU" term="%22Welsh+L%22">Welsh L</searchLink>; Neuro-Oncology Unit, The Royal Marsden Hospital, London, UK.<br /><searchLink fieldCode="AU" term="%22Mason+WP%22">Mason WP</searchLink>; Department of Medicine, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Ducray+F%22">Ducray F</searchLink>; Service de Neuro-Oncologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Centre de Recherche en Cancérologie de Lyon, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Umemura+Y%22">Umemura Y</searchLink>; Department of Neurology, University of Michigan Medical School, Ann Arbor, MI, USA.<br /><searchLink fieldCode="AU" term="%22Nabors+B%22">Nabors B</searchLink>; Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.<br /><searchLink fieldCode="AU" term="%22Holdhoff+M%22">Holdhoff M</searchLink>; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine, Baltimore, MD, USA.<br /><searchLink fieldCode="AU" term="%22Hottinger+AF%22">Hottinger AF</searchLink>; Department of Oncology, Lundin Family Brain Tumor Research Centre, University Hospital of Lausanne, Lausanne, Switzerland.<br /><searchLink fieldCode="AU" term="%22Arakawa+Y%22">Arakawa Y</searchLink>; Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.<br /><searchLink fieldCode="AU" term="%22Sepulveda+JM%22">Sepulveda JM</searchLink>; Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Wick+W%22">Wick W</searchLink>; Department of Neurology, Universitätsklinikum Heidelberg, Heidelberg & German Cancer Research Center, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Soffietti+R%22">Soffietti R</searchLink>; Department of Neuro-Oncology, University of Turin, Turin, Italy.<br /><searchLink fieldCode="AU" term="%22Perry+J%22">Perry J</searchLink>; Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Giglio+P%22">Giglio P</searchLink>; Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.<br /><searchLink fieldCode="AU" term="%22de+la+Fuente+M%22">de la Fuente M</searchLink>; Department of Neurology, Sylvester Comprehensive Cancer Center and University of Miami, Miami, FL, USA.<br /><searchLink fieldCode="AU" term="%22Maher+E%22">Maher E</searchLink>; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.<br /><searchLink fieldCode="AU" term="%22Bottomley+A%22">Bottomley A</searchLink>; Bottomley Consulting Group, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Tron+AE%22">Tron AE</searchLink>; Servier Pharmaceuticals, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Yi+D%22">Yi D</searchLink>; Servier Pharmaceuticals, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Zhao+D%22">Zhao D</searchLink>; Servier Pharmaceuticals, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Pandya+SS%22">Pandya SS</searchLink>; Servier Pharmaceuticals, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Steelman+L%22">Steelman L</searchLink>; Servier Pharmaceuticals, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Hassan+I%22">Hassan I</searchLink>; Servier Pharmaceuticals, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Wen+PY%22">Wen PY</searchLink>; Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Mellinghoff+IK%22">Mellinghoff IK</searchLink>; Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: mellingi@mskcc.org.
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  Data: <searchLink fieldCode="CA" term="%22INDIGO+trial+investigators%22">INDIGO trial investigators</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22100957246%22">The Lancet. Oncology</searchLink> [Lancet Oncol] 2025 Dec; Vol. 26 (12), pp. 1665-1675. <i>Date of Electronic Publication: </i>2025 Oct 29.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Lancet+Pub%2E+Group%22">Lancet Pub. Group </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>100957246 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1474-5488 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2214702045%22">14702045 </searchLink><i>NLM ISO Abbreviation: </i>Lancet Oncol <i>Subsets: </i>MEDLINE
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