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Video

Clinical trials: Non-immunologic

Session: Abstract Concurrent Session: Clinical Trials - Non-Immunologic

CTNI-64 - Efficacy and Safety of Erdafitinib in Patients With High-grade and Low-grade Gliomas and Prespecified Fibroblast Growth Factor Receptor Alterations (FGFRalt) in the RAGNAR Trial

Friday, November 17, 2023
4:25 PM – 4:35 PM PT
Location: Room 109-110
Non-CME

    Oral Abstract Presenter(s)

  • David A. Reardon

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

    • Author(s)

  • LW

    Liam Welsh

    The Royal Marsden NHS Foundation Trust
    London, United Kingdom

  • Kent Shih

    Sarah Cannon Research Institute and Tennessee Oncology
    Nashville, Tennessee, United States

  • TS

    Toshio Shimizu

    Wakayama Medical University Hospital, National Cancer Center Hospital
    Wakayama, United States

  • JG

    Jean-Charles Goeminne

    CHU-UCL-Namur, site Sainte-Elisabeth
    Namur, United States

  • BG

    Birgit Geoerger

    Gustave Roussy Cancer Center, Department of Paediatric and Adolescent Oncology, INSERM 1015, Université Paris-Saclay
    Villejuif, France

  • CB

    Capucine Baldini

    Drug Development Department (DITEP), Gustave Roussy
    Villejuif, France

  • CM

    Christophe Massard

    Université Paris-Saclay, Le Kremlin Bicêtre – France INSERM U1030, Molecular Radiotherapy, Gustave Roussy, Université Paris-Saclay, Paris, France
    Villejuif, France

  • YL

    Yohann Loriot

    Gustave Roussy, Université Paris-Saclay
    Villejuif, France

  • SP

    Shubham Pant

    The University of Texas MD Anderson Cancer Center
    Houston, Texas, United States

  • SS

    Sameer Farouk F. Sait

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

  • ST

    Shibu Thomas

    Janssen Research & Development
    Spring House, Pennsylvania, United States

  • CH

    Constance Hammond

    Janssen Research & Development
    Spring House, Pennsylvania, United States

  • SN

    Saltant Najmi

    Janssen Research & Development
    Spring House, Pennsylvania, United States

  • ST

    Spyros Triantos

    Janssen Research & Development
    Spring House, Pennsylvania, United States

  • LC

    Lauren Crow

    Janssen Research & Development
    Spring House, Pennsylvania, United States

  • HS

    Hussein Sweiti

    Janssen Research & Development
    Spring House, Pennsylvania, United States

  • OW

    Olaf Witt

    Hopp Children’s Cancer Center Heidelberg (KiTZ), Heidelberg University Hospital and German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT)
    Heidelberg, Germany

Background Erda is an oral selective pan-FGFR tyrosine kinase inhibitor approved to treat adults with locally advanced/metastatic urothelial carcinoma with susceptible FGFR3/2alt who have progressed during/after ≥1 line of platinum-based chemotherapy. RAGNAR interim results demonstrated tumor-agnostic efficacy in adults/adolescents with previously-treated advanced solid tumors with prespecified FGFRalt. Here we report results for patients with HGG/LGG.Methods Patients with HGG/LGG harboring prespecified FGFR1-4alt (mutations/fusions), disease progression after ≥1 line of systemic therapy, and who exhausted standard therapies received oral erda until disease progression or intolerable toxicity. Primary endpoint: ORR by independent review committee (IRC). Secondary endpoints: DOR, disease control rate (DCR), investigator-assessed efficacy, and safety. Response was based on RANO criteria.ResultsAt data cutoff, 37 HGG (n=30)/LGG (n=7) patients received erda. In HGG (glioblastoma, n=25 [83%]; median (m) age 54.5y [range 13-70]), 29 (97%) had FGFR fusions (FGFR3-TACC3, n=24); all (100%) underwent initial resection (if feasible) and received radiotherapy/chemotherapy per institution (eg, Stupp protocol); patients received median 2 prior therapies (range 1-6; 37% with prior bevacizumab). ORR in HGG was 10% by IRC (95%CI, 2-27) and 20% by Investigator (95%CI, 8-39); mDOR was not reached (m-F/U, 18.0mo); DCR was 57% (95%CI, 37-75). In LGG (m-age 22y; range 12-32), 4 (57%) had FGFR1 mutation (all FGFR1-K656E); 3 (43%) had FGFR fusion. ORR in LGG was 29% by IRC (95%CI, 4-71) and 14% by Investigator (95%CI, 0-58); mDOR was not reached; DCR was 71% (95%CI, 29-96). 17 HGG patients (57%) had TERT co-alterations; 9 (30%) had PTEN deletions. No HGG/LGG patients had IDH1/2 mutations. Most common (≥40%) adverse events (AEs): hyperphosphatemia, diarrhea, dry skin, dry mouth. 43% had serious AEs (treatment-related, 16%). 19% discontinued due to AEs. No treatment-related deaths occurred.ConclusionsErda demonstrated clinically meaningful activity in heavily pre-treated HGG/LGG with FGFRalt. Safety was consistent with known safety profile of erda.