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Video

Quality of Life

Session: Town Hall: Debating Unanswered Questions in Neuro-Oncology

QOL-26 - A randomized, double-blind Phase 3 study of vorasidenib vs placebo in patients with mutant IDH1/2 diffuse glioma (INDIGO): analysis of health-related quality of life, neurocognition and seizures

Saturday, November 18, 2023
3:01 PM – 3:09 PM PT
Location: Exhibit Hall C
Non-CME Award Winner

    Plenary Abstract Presenter(s)

  • Katherine B. Peters

    Duke University Medical Center
    Durham, North Carolina, United States

    • Author(s)

  • Ingo K. Mellinghoff

    Memorial Sloan Kettering Cancer Center
    New York, New York, United States

  • Martin J. van den Bent

    Erasmus MC Cancer Institute
    Rotterdam, Netherlands

  • DB

    Deborah T. Blumenthal

    Tel Aviv Medical Center, Tel Aviv University
    Tel Aviv, Tel Aviv, Israel

  • Mehdi Touat

    Pitié Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP) Sorbonne Université
    Paris, Massachusetts, France

  • Jennifer L. Clarke

    University of California San Francisco
    San Francisco, California, United States

  • JM

    Joe Mendez

    Huntsman Cancer Institute at the University of Utah
    Salt Lake City, Utah, United States

  • Shlomit Yust-Katz

    Davidoff Cancer Center at Rabin Medical Center
    Petach Tikva, HaMerkaz, Israel

  • WM

    Warren P. Mason

    Princess Margaret Cancer Centre
    Toronto, Canada

  • Francois Ducray

    Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Centre de Recherche en Cancérologie de Lyon
    Lyon, France

  • Yoshie Umemura

    Ivy Brain Tumor Center at Barrow Neurological Institute
    Phoenix, Arizona, United States

  • LN

    L. Burt Nabors

    University of Alabama at Birmingham
    Birmingham, Alabama, United States

  • Matthias Holdhoff

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland, United States

  • AH

    Andreas F. Hottinger

    University Hospital of Lausanne
    Lausanne, Switzerland

  • Yoshiki Arakawa

    Department of Neurosurgery, Kyoto University Graduate School of Medicine
    Kyoto, Kyoto, Japan

  • JS

    Juan M. Sepúlveda

    Hospital Universitario 12 de Octubre
    Madrid, Spain

  • Wolfgang Wick

    Universitatsklinikum Heidelberg
    Heidelberg, Baden-Wurttemberg, Germany

  • Riccardo Soffietti

    University of Turin
    Torino, Piemonte, Italy

  • James Perry

    Sunnybrook Health Sciences Centre, University of Toronto
    Toronto, Ontario, Canada

  • PG

    Pierre Giglio

    The Ohio State University Wexner Medical Center
    Columbus, Ohio, United States

  • Macarena I. de la Fuente

    Sylvester Comprehensive Cancer Center
    Miami, Florida, United States

  • EM

    Elizabeth A. Maher

    University of Texas Southwestern Medical Center
    Dallas, Texas, United States

  • AB

    Andrew Bottomley

    Bottomley Consulting Group
    Overijse, Belgium

  • DZ

    Dan Zhao

    Servier Pharmaceuticals
    Boston, Massachusetts, United States

  • SP

    Shuchi S. Pandya

    Servier Pharmaceuticals
    Boston, Massachusetts, United States

  • LS

    Lori Steelman

    Servier Pharmaceuticals
    Boston, Massachusetts, United States

  • IH

    Islam Hassan

    Servier Pharmaceuticals
    Boston, Massachusetts, United States

  • Patrick Y. Wen

    Dana-Farber Cancer Institute
    Boston, Massachusetts, United States

  • Timothy F. Cloughesy

    University of California Los Angeles
    Los Angeles, California, United States


Introduction: The Phase 3 INDIGO study (NCT04164901) is a randomized, double-blind evaluation of vorasidenib, an oral, brain-penetrant inhibitor of mutant isocitrate dehydrogenase (mIDH) 1/2 enzymes, compared with placebo, in patients with grade 2 mIDH1/2 diffuse gliomas, whose only prior treatment was surgery. The primary endpoint, radiographic progression-free survival by blinded independent review committee, and the key secondary endpoint, time-to-next-intervention, were significantly improved with vorasidenib versus placebo. As these patients are young, with several years’ life expectancy, impact of treatments on health-related quality of life (HRQoL), cognition and symptomatic burden is of interest.

Methods: HRQoL, assessed by Functional Assessment of Cancer Therapy-Brain (FACTBr) questionnaire, was a secondary endpoint. FACT-Br was collected at baseline, Cycles 2 and 3, then every 3 months. Scores were interpreted using an estimate of clinically meaningful deterioration change from baseline for each arm. Exploratory endpoints included neurocognitive function, assessed by a validated battery of cognitive performance instruments, and seizure frequency and severity, assessed using a subject diary.

Results: 331 patients were randomized to vorasidenib (n=168) or placebo (n=163) (median age, 40.0 years; Karnofsky performance scale=100, 53.5%; ongoing medical history of seizures, 54.1%). Median follow-up was 14.2 months. No clinically meaningful deterioration from baseline FACT-Br total score and subscales were observed at any timepoint through the median treatment duration (Cycle 13) in either arm. At baseline, active seizures (≥ 1 seizure in the previous 30 days) were reported in 20/168 (11.9%) vorasidenib patients and 20/163 (12.3%) placebo patients. On-treatment seizure frequencies and cognition outcomes will be presented by arm.

Conclusion: INDIGO is the first randomized Phase 3 study of targeted therapy in grade 2 mIDH1/2 diffuse glioma. HRQoL, as measured by FACT-Br, was maintained during treatment with vorasidenib. These data support the clinical benefit of vorasidenib in this patient population for whom chemotherapy and radiotherapy are being delayed.