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Video

Clinical trials: Immunologic

Session: Abstract Concurrent Session: Clinical Trials - Immunologic

CTIM-25 - EO2401 peptide immunotherapy + nivolumab +/- bevacizumab in first recurrent glioblastoma: the phase 1/2 EOGBM1-18/ROSALIE study (NCT04116658)

Friday, November 17, 2023
8:35 AM – 8:40 AM 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)

  • Ahmed Idbaih

    Sorbonne Université, AP-HP, ICM, Hôpital Universitaire La Pitié-Salpêtrière
    Paris, France

  • Maria Vieito

    Hospital Universitari Vall d'Hebron
    Barcelona, Spain

  • FG

    François Ghiringhelli

    Centre Georges-François Leclerc
    Dijon, France

  • AS

    Agostina Stradella

    Institut Catala D'Oncologia - Hospital Duran i Reynals
    Barcelona, Spain

  • Ghazaleh Tabatabai

    University Hospital Tübingen and Eberhard Karls University Tübingen
    Tübingen, Baden-Wurttemberg, Germany

  • MB

    Michael C. Burger

    Dr Senckenberg Institute of Neurooncology, Goethe University Hospital
    Frankfurt, Germany

  • IM

    Iris Mildenberger

    Medizinische Fakultät Mannheim
    Mannheim, Germany

  • UH

    Ulrich Herrlinger

    Division of Clinical Neurooncology, Department of Neurology and Center for Integrated Oncology, University Hospital Bonn, Bonn, Germany
    Bonn, Germany

  • Patrick Y. Wen

    Dana-Farber Cancer Institute
    Boston, Massachusetts, United States

  • Mehdi Touat

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

  • AW

    Antje Wick

    Universitätsklinikum Heidelberg
    Heidelberg, Germany

  • MG

    Macarena González

    Hospital Universitari Vall d'Hebron
    Barcelona, Spain

  • AH

    Alice Hervieu

    Centre Georges-François Leclerc
    Dijon, France

  • MG

    Marta GilMartin

    Institut Catala D'Oncologia - Hospital Duran i Reynals
    Barcelona, Spain

  • Mirjam Renovanz

    Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospital Tübingen, Hertie Institute for Clinical Brain Research
    Tübingen, Germany

  • CG

    Cécile Gouttefangeas

    Department of Immunology, Eberhard-Karls-University Tübingen
    Tübingen, Baden-Wurttemberg, Germany

  • AM

    Ana Maia

    Department of Immunology, Eberhard-Karls-University Tübingen
    Tübingen, Germany

  • CB

    Christophe Bonny

    Enterome
    Paris, France

  • JP

    Jean-Michel Paillarse

    Enterome
    Paris, France

  • LC

    Laurent Chêne

    Enterome
    Paris, France

  • JF

    Jan Fagerberg

    Enterome
    Paris, United States

  • Wolfgang Wick

    Universitatsklinikum Heidelberg
    Heidelberg, Baden-Wurttemberg, Germany

EO2401 expands existing memory T cells recognizing protein sequences from gut bacteria, which cross-react with tumor associated antigens (TAAs). EO2401 contains three CD8 HLA-A2 epitopes with mimicry to glioblastoma-TAAs (IL13Rα2, BIRC5, and FOXM1) and the CD4 epitope UCP2. Patients received EO2401 (300μg/peptide, q2weeks x4, then every 4weeks) with nivolumab (3mg/kg, q2weeks) in cohorts: C1a (n=21, Ex2→EN; option for symptom directed low-dose bevacizumab [sLDB; 5mg/kg, q2weeks] as anti-edema treatment); C2a/1 (n=23, EN); C2a/2 (n=15, EN+sLDB); C2b (n=6, adjuvant EN+sLDB); C2c (n=9, neoadjuvant ENx2→surgery→adjuvant EN+sLDB); C3 (n=26, EN+bevacizumab, q2weeks, 10mg/kg).EO2401/nivolumab+/-bevacizumab safety profile consistent with profile of nivolumab, and when applicable bevacizumab, except the addition of local administration site reactions which occurred in 39% of patients; 96% of events Grade 1/2 and 4% Grade 3.Immune monitoring (peripheral blood, ELISPOT, tetramer assessments) demonstrated expanded mimic specific CD8 T cells with cross-reactivity against the targeted human TAAs. In C2a/1 (83% tested) and in C3 (81% tested), 89% and 95% of tested patients showed expansion. Expansions were early (week 2 after starting EO2401), durable (up to 23 months), and robust (approximately 30% of all peripheral CD8 T cells were mimic specific in 3 clinical responders). In C2c, surgery specimens after two EO2401/nivolumab doses showed increased tumor T cell infiltration versus pre-treatment tumor in 5 of 6 patients.Addition of sLDB to EO2401/nivolumab prolonged treatment duration vs EO2401/nivolumab alone by reducing edema likely worsened by study therapy induced immune cell infiltration. Integration of bevacizumab with EO2401/nivolumab in C3 further increased efficacy in C3. C2a/1vsC2a/2vsC3: median treatment duration 1.4vs3.2vs4.8 months, disease control rate 22%vs40%vs88%, median PFS 1.6vs3.6vs5.5 months; median survival 9.0vs12.6vstoo early (C3 median FU 8.3 mo, survival ongoing up to 2 years). Further follow-up will be presented.