Meeting
2023 ASCO Annual Meeting
EO2401 (E) peptide immunotherapy + nivolumab (N) +/- bevacizumab (B) in recurrent glioblastoma (GB): EOGBM1-18/ROSALIE.
Authors
Wolfgang Wick
Universitätsklinikum Heidelberg and German Cancer Research Center, Heidelberg, Germany
Wolfgang Wick , Ahmed Idbaih , Maria Vieito , François Ghiringhelli , Agostina Stradella , Ghazaleh Tabatabai , Michael C. Burger , Iris Mildenberger , Ulrich Herrlinger , Patrick Y. Wen , Mehdi Touat , Antje Wick , Macarena González , Alice Hervieu , Marta Gil-Martin , Mirjam Renovanz , Ana Maia , Christophe Bonny , Jan Fagerberg , David A. Reardon
Organizations
Universitätsklinikum Heidelberg and German Cancer Research Center, Heidelberg, Germany, Sorbonne Université, AP-HP, ICM, Hôpital Universitaire La Pitié-Salpêtrière, Paris, France, Hospital Universitari Vall d'Hebron, Barcelona, Spain, Centre Georges-François Leclerc, Dijon, France, Medical Oncology Department-Phase 1 Functional Unit | Catalan Institute of Oncology (ICO), Hospitalet De Llobregat, Barcelona, Spain, Universitätsklinikum, Tübingen, Germany, Universitätsklinikum Frankfurt Goethe-Universität, Frankfurt, Germany, Medizinische Fakultät, Mannheim, Germany, Universitätsklinikum, Bonn, Germany, Dana-Farber Cancer Institute, Boston, MA, Hôpital Universitaire La Pitié-Salpêtrière, Paris, France, Universitätsklinikum, Heidelberg, Germany, Medical Oncology Department-Phase 1 Functional Unit | Catalan Institute of Oncology (ICO), Barcelona, Spain, Department of Immunology, Eberhard-Karls-University, Tübingen, Germany, Enterome, Paris, France
Research Funding
Other
Enterome
Background: EO2401 was designed to activate/expand existing memory T cells recognizing specific protein sequences from gut bacteria, which cross-react with tumor associated antigens (TAAs). E contains 3 CD8 HLA-A2 epitopes with mimicry to GB-TAAs (IL13Rα2, BIRC5, and FOXM1) and the CD4 epitope UCP2. Methods: Patients (pt) at 1st progression GB received E (300 µg/peptide, q2w x4 then q4w) with N (3 mg/kg q2w) in cohorts: 1a E x2 → EN; 2a/1, 2a/2 and 2b EN from start; 2c EN x2 → surgery → EN; 3/1 and 3/2 EN + B (10mg/kg q2w) (Table). Results: Among 100 treated pt EN+/-B was well tolerated, with E associated events limited to local skin reactions (45% of pt; 96% Grades 1/2, and 4% Grade 3) and N-/B-tox consistent with historical data. EN induced immune response against all 3 mimics in 94% of 35 tested pt (all pt responded against at least 2 mimics), detectable as early as 2 weeks after first EN, and with durations beyond 10 months. Cross-reactivity against human peptides found in 89%. Conclusions: EN +/- B was well tolerated and generated fast and durable immune responses. EN survival like current standards. Delayed N was not advantageous for outcome. sLDB increased trt duration of EN, and improved efficacy. Continuous B plus EN further improved efficacy. Neo-/adjuvant EN was clinically feasible. Updated data, including C3/2 to confirm C3/1, to be presented. Clinical trial information: NCT04116658.
| Cohort01/16/23 | Ongoing treatment (trt) (pt) | Trt duration@ | Disease Control Rate# | Duration of disease control@ | Objective response rate PR+CR | Progression-free survival@ | Survival@ | Follow-up survival@; pt alive |
|---|---|---|---|---|---|---|---|---|
| 2a/1 (n=23) EN^ | 0% | 1.4 (0.03-11.2) | 22% | 3.6 (1.8-10.2) | 9% | 1.6 (0.4-11.9) | 9.0 (2.8-24.7) | 22.1 9% |
| 1a (n=21*)& E => EN^₤ | 0%₤ | 2.8 (0.03-23.9) | 33% | 4.1 (2.7-24.0) | 5% | 1.8 (0.2-24.0) | 9.5 (0.4-29.4) | 10.0 19% |
| 2a/2 (n=15)& EN^ | 20% | 3.2 (0.5-11.0) | 40% | NR (5.2-9.5) | 13% | 3.6 (0.0-9.5) | 12.6 (1.9-14.7) | 10.8 47% |
| 2b (n=6)& EN$ | 33% | 7.9 (2.3-10.9) | 83% | 9.0 (5.0-9.2) | NA$ | 7.3 (1.9-9.2) | 11.9 (10.1-12.4) | 11.5 50% |
| 2c (n=9)& EN^ peri-op | 67% | NR (0.5-8.5) | 88%€ | NR (0.5-8.0) | NA€ | NR (0.4-8.0) | NR (1.1-8.5) | 5.6 100% |
| 3/1 (n=11) ENB^ | 9% | 5.0 (0.5-20.2) | 91% | 6.0 (3.1-20.2) | 55% | 6.0 (0.0-20.2) | 14.5 (3.0-20.2) | 17.2 45% |
| 3/2 (n=15) ENB^ | 73% | 3.3 (1.4-4.2) | 92%¥ | 3.3 (1.7-3.7) | 33%¥ | 3.0 (0.0-3.7) | NR (1.4-4.4) | 3.0 93% |
NA not applicable; NR not reached.
^Measurable disease; *3 pt in safety lead-in; &Option for symptom driven, time-limited, low-dose B (sLDB; 5 mg/kg q2w), median of 3 doses to 1a=10 pt (56%; NA for 3 pt safety lead-in), 2a/2=5 pt (33%), 2b=1 pt (33%; NA for 3 initial pt), 2c=3 pt (33%); ₤E mono in 1 pt as individual use after 24 mo study period; $Non-measurable disease, adjuvant post-surgery in 4 of 6 pt; #Pt with stable disease (SD), partial- or complete response (PR/CR) per iRECIST; @median (range) in months per Kaplan-Meier; €DCR n=8 (1 pt early), ORR NA, only 2x E admin pre-surgery; ¥DCR and ORR n=12 (3 pt early), ORR also unconfirmed.
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Abstract Details
Session Type
Poster Discussion Session
Session Title
Central Nervous System Tumors
Track
Central Nervous System Tumors
Sub Track
Primary CNS Tumors–Glioma
Clinical Trial Registration Number
NCT04116658
Citation
J Clin Oncol 41, 2023 (suppl 16; abstr 2020)
DOI
10.1200/JCO.2023.41.16_suppl.2020
Abstract #
2020
Poster Bd #
377
Abstract Disclosures
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