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Video

Clinical trials: Non-immunologic

Session: Plenary I

LTBK-09 - Results of BMX-HGG study: a multi-institutional, randomized phase 2 clinical trial of concurrent chemoradiation with or without BMX-001 in patients with newly diagnosed high grade glioma

Friday, November 17, 2023
9:05 AM – 9:15 AM PT
Location: Exhibit Hall C
Non-CME

    Late Breaking Abstract Presenter(s)

  • Katherine B. Peters

    Duke University Medical Center
    Durham, North Carolina, United States

    • Author(s)

  • AC

    Adam L. Cohen

    Inova
    Fairfax, Virginia, United States

  • Nicholas A. Butowski

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

  • John L. Villano

    University of Kentucky
    Lexington, Kentucky, United States

  • JM

    Joe Mendez

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

  • PG

    Pierre Giglio

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

  • Tresa McGranahan

    Scripps Cancer Center
    Seattle, Washington, United States

  • Chi Zhang

    University of Nebraska Medical Center
    Omaha, Nebraska, United States

  • JS

    Jacob P. Smeltzer

    Saint Luke's Cancer Institute
    Lee's Summit, Maryland, United States

  • SR

    Shahzad Raza

    Cleveland Clinic
    Cleveland, Ohio, United States

  • Burt Nabors

    Heersink School of Medicine
    Birmingham, Alabama, United States

  • Mina Lobbous

    Cleveland Clinic Case Western Reserve University
    Cleveland, Ohio, United States

  • JH

    James E. Herndon, II

    Duke Cancer Institute, Department of Biostatistics
    Durham, North Carolina, United States

  • EB

    Evan D. Buckley

    Duke Cancer Institute, Department of Biostatistics
    Durham, North Carolina, United States

  • DM

    David MacLeod

    BioMimetix
    Greenwood Village, Colorado, United States

  • SP

    Sara Penchev

    BioMimetix
    Greenwood Village, Colorado, United States

  • DS

    David S. Silberstein

    BioMimetix
    Greenwood Village, Colorado, United States

  • IB

    Ines Batinic-Haberle

    Duke University Medical Cener
    Durham, North Carolina, United States

  • IS

    Ivan Spasojevic

    Duke University Medical Center
    Durham, North Carolina, United States

  • SG

    Shayne C. Gad

    Gad Consulting Services
    Raleigh, North Carolina, United States

  • DR

    David Radoff

    Duke University Medical Center
    Durham, North Carolina, United States

  • DB

    Daniel P. Barboriak

    Duke University Medical Center
    Durham, North Carolina, United States

  • JC

    James Crapo

    BioMimetix
    Greenwood Village, Colorado, United States

Background: Standard treatment for high grade glioma (HGG) remains neurosurgical resection followed by concurrent radiation therapy (RT) and temozolomide (TMZ). Overall survival (OS) for GBM is roughly 12-16 months. RT is associated with cognitive and quality of life (QoL) impairments. Advances are needed to improve OS while mitigating injury to the normal brain. BMX-001 is a novel metalloporphyrin that radiosensitizes cancer cells and radioprotects normal tissue.

Methods: This multi-institutional, open-label, phase 2 trial randomized newly diagnosed HGG patients to receive RT/TMZ with or without BMX-001 (NCT02655601). Both arms received 6 weeks RT/TMZ (75 mg/m2). BMX-001 was administered as a loading dose of 28 mg sc before RT, followed by 14 mg twice weekly for 8 weeks. Randomization was stratified by tumor grade and institution. Key eligibility criteria include histologically confirmed HGG, age ≥ 18 years, and KPS ≥ 70%. The primary endpoint was OS. Key secondary/exploratory outcomes included cognition, QoL, and white matter integrity using advanced imaging. OS evaluation occurred after 84 deaths when a 1-tailed logrank test (α=0.2) had 90% power to detect a hazard ratio of 0.63. Two interim analyses and a final analysis were conducted using an O'Brien-Fleming stopping boundary.

Results: Of the 160 patients randomized, 72.5% had GBM, and 62.5% were male. Analyses focused on 145 patients who completed RT/TMZ (74 with BMX-001, 71 without BMX-001). Median OS of BMX-001+RT/TMZ group (31.3 [95% CI, 21.6, not reached] months) was longer than RT/TMZ group (24.7 [95% CI, 19.6-32.6] months), HR=0.735; p=0.079 (significant at the predefined α level). Common toxicities (Grade 1-2) attributed to BMX-001 were injection site reactions (64), tachycardia (24), and pruritus (17) with no related Grade 4-5. Diffusion tensor MR imaging indicated mitigation of dose-related white matter damage in BMX-001+RT/TMZ group.

Conclusions: BMX-001 is safe, and there is improved OS in HGG patients receiving BMX-001.