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Clinical trials: Non-immunologic

Session: Poster Session

CTNI-17 - Application of the GBM-X Data Platform to estimate treatment effects of the experimental therapies of the randomized phase 2 Individualized Screening Trial of Innovative Glioblastoma Therapies

Friday, November 17, 2023
7:30 PM – 9:30 PM PT
Location: Exhibit Hall A/B
Non-CME

    Poster Presenter(s)

  • Rifaquat Rahman

    Department of Radiation Oncology, Dana-Farber/Brigham and Women’s Cancer Center, Boston, MA
    Boston, Massachusetts, United States

    • Author(s)

  • LT

    Lorenzo Trippa

    Dana Farber Cancer Institute
    Boston, Massachusetts, United States

  • GF

    Geoffrey Fell

    Dana-Farber Cancer Institute
    Boston, United States

  • Eudocia Q. Lee

    Dana-Farber Cancer Institute, Boston, MA
    Boston, Massachusetts, United States

  • Isabel Arrillaga-Romany

    Massachusetts General Hospital
    Boston, Massachusetts, United States

  • Mehdi Touat

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

  • JD

    Jan Drappatz

    University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania, United States

  • Mary R. Welch

    Columbia University Irving Medical Center
    New York, New York, United States

  • Evanthia Galanis

    Mayo Clinic
    Rochester, Minnesota, United States

  • Manmeet S. Ahluwalia

    Miami Cancer Institute, Baptist Health South Florida
    Miami, Florida, United States

  • Howard Colman

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

  • Burt Nabors

    Heersink School of Medicine
    Birmingham, Alabama, United States

  • JH

    Jaroslaw Hepel

    Rhode Island Hospital
    Providence, Rhode Island, United States

  • HE

    Heinrich Elinzano

    Rhode Island Hospital
    Providence, Rhode Island, United States

  • David Schiff

    University of Virginia School of Medicine
    Charlottesville,, Virginia, United States

  • Ugonma N. Chukwueke

    Dana-Farber Cancer Institute
    BOSTON, Massachusetts, United States

  • RB

    Rameen Beroukhim

    Center for Neuro-Oncology, Dana-Farber Cancer Institute
    Boston, Massachusetts, United States

  • Lakshmi Nayak

    Dana-Farber Cancer Institute
    Boston, Massachusetts, United States

  • JM

    Jose Ricardo R. McFaline-Figueroa

    Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA
    Boston, United States

  • Tracy T. Batchelor

    Brigham and Women’s Hospital Harvard Medical School
    Boston, Massachusetts, United States

  • MR

    Mikael Rinne

    Dana-Farber Cancer Institute
    Boston, United States

  • TK

    Thomas Kaley

    Memorial Sloan Kettering Cancer Center
    New York, United States

  • Christine Lu-Emerson

    Maine Health Maine Medical Center
    South Portland, Maine, United States

  • Ingo K. Mellinghoff

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

  • Wenya Linda Bi

    Department of Neurosurgery, Brigham and Women’s Hospital, Dana-Farber Cancer Institute, Boston, MA
    Boston, Massachusetts, United States

  • Omar Arnaout

    Department of Neurosurgery, Brigham and Women’s Hospital, Dana-Farber Cancer Institute, Boston, MA
    Boston, Massachusetts, United States

  • PP

    Pier Paolo Peruzzi

    Brigham and Women's Hospital
    Boston, Massachusetts, United States

  • Daphne Haas-Kogan

    Brigham and Women's Hospital, Dana-Farber Cancer Institute, Boston Children's Hospital
    Boston, Massachusetts, United States

  • ST

    Shyam Tanguturi

    Dana-Farber/Brigham and Women's Cancer Center
    Boston, United States

  • DC

    Daniel Cagney

    Radiotherapy Department, Mater Private Network, Dublin, Ireland
    Dublin, Ireland

  • Ayal Aizer

    Dana-Farber/Brigham and Women's Cancer Center
    Boston, Massachusetts, United States

  • LD

    Lisa Doherty

    Dana-Farber Cancer Institute
    Boston, Massachusetts, United States

  • SS

    Sandro Santagata

    Brigham and Women's Hospital
    Boston, Massachusetts, United States

  • David M. Meredith

    Brigham and Women's Hospital
    Boston, Massachusetts, United States

  • E. Antonio Chiocca

    Brigham and Women's Hospital/ Harvard Medical School
    Boston, Massachusetts, United States

  • David A. Reardon

    Center for Neuro-Oncology, Dana-Farber Cancer Institute
    Boston, Massachusetts, United States

  • BA

    Brian Alexander

    Foundation Medicine
    Cambridge, Massachusetts, United States

  • Keith L. Ligon

    Brigham and Women's Hospital
    Boston, Massachusetts, United States

  • Patrick Y. Wen

    Dana-Farber Cancer Institute
    Boston, Massachusetts, United States


Background: Leveraging external data has the potential to increase efficiency and precision of drug development in glioblastoma by complementing or replacing data from in-trial controls. We used an external control arm (ECA) to re-analyze data of the abemaciclib, neratinib and CC-115 arms of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) trial.

Methods: INSIGhT (NCT02977780) is an ongoing phase 2 adaptive platform trial in newly diagnosed MGMT unmethylated glioblastoma with a shared control arm of patients receiving radiation therapy with concurrent and maintenance temozolomide. The initial experimental arms (abemaciclib, neratinib, CC-115) have not shown a survival benefit relative to the shared control arm. We re-analyzed the experimental arm data and replaced the shared control arm with an ECA. The ECA was developed from a collection of trial datasets and real-world data available through the Glioblastoma External (GBM-X) Data Platform (). Propensity score matching was used to adjust for possible differences between pretreatment covariates (age, sex, resection, KPS) in the ECA and shared control arm. Cox proportional hazards models were used to estimate treatment effects.

Results: On INSIGhT, patients were randomized to abemaciclib (n=74), neratinib (n=80), and CC-115 (n=12). There were 687 unmethylated MGMT patients in the GBM-X ECA. After propensity score matching, there was no significant treatment effect associated with abemaciclib (HR 1.091, 95%CI:0.834-1.433, p=0.536), neratinib (HR = 1.043, 95%CI:0.787-1.383, p=0.770), or CC-115 (HR 1.088, 95%CI:0.834-1.433, p=0.794) compared to the ECA.

Conclusion: In comparison to an ECA, there was no significant survival benefit with abemaciclib, neratinib and CC-115. Treatment effects estimates were similar to the primary analyses based on the original shared control arm of INSIGhT. The use of external control arms in early phase testing of new therapies is supported by our findings and could significantly reduce costs and time to conduct trials in newly diagnosed glioblastoma.