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1. Supplementary Table ST6 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Outcome related to location

Published
2023

2. Supplementary Table ST8 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Outcome related to location - Midline

Published
2023

3. Supplementary Figure SF4 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Radiological necrosis in a cerebral Grade III tumor

Published
2023

4. Supplementary Figure SF1 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Tumor grade vs imaging characteristics

Published
2023

5. Supplementary Figure SF12 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Survival curves of Event Free Survival (EFS) and Overall Survival (OS) of patients with and without leptomeningeal metastatic (LMM) dissemination

Published
2023

6. Supplementary Table ST1 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Raw Study Data

Published
2023

7. Supplementary Figure SF9 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Example of Pseudoprogression

Published
2023

8. Supplementary Table ST7 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Outcome related to location - Cerebral

Published
2023

9. Supplementary Figure SF3 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Radiological necrosis in a thalamic Grade III tumor

Published
2023

10. Supplementary Figure SF10 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Survival curves of Event Free Survival (EFS) and Overall Survival (OS) of H3 F3A_K27 mutant vs other midline tumours

Published
2023

11. Supplementary Figure SF2 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Histone status vs imaging characteristics

Published
2023

12. Supplementary Table ST10 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Outcome measures related to location and major mutation groups for patients with leptomeningeal dissemination (LMM)

Published
2023

13. Supplementary Figure SF5 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Significantly different radiological characteristics of H3 K27M-mutants compared to other Midline wild-type cases

Published
2023

14. Supplementary Table ST2 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Demographics of major mutational groups

Published
2023

15. Data from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Purpose:The HERBY trial evaluated the benefit of the addition of the antiangiogenic agent Bevacizumab (BEV) to radiotherapy/temozolomide (RT/TMZ) in pediatric patients with newly diagnosed non-brainstem high-grade glioma (HGG). The work presented here aims to correlate imaging characteristics and outcome measures with pathologic and molecular data.Experimental Design:Radiological, pathologic, and molecular data were correlated with trial clinical information to retrospectively re-evaluate event-free survival (EFS) and overall survival (OS).Results:One-hundred thirteen patients were randomized to the RT/TMZ arm (n = 54) or the RT/TMZ+BEV (BEV arm; n = 59). The tumor arose in the cerebral hemispheres in 68 patients (Cerebral group) and a midline location in 45 cases (Midline group). Pathologic diagnosis was available in all cases and molecular data in 86 of 113. H3 K27M histone mutations were present in 23 of 32 Midline cases and H3 G34R/V mutations in 7 of 54 Cerebral cases. Total/near-total resection occurred in 44 of 68 (65%) Cerebral cases but in only 5 of 45 (11%) Midline cases (P < 0.05). Leptomeningeal metastases (27 cases, 13 with subependymal spread) at relapse were more frequent in Midline (17/45) than in Cerebral tumors (10/68, P < 0.05). Mean OS (14.1 months) and EFS (9.0 months) in Midline tumors were significantly lower than mean OS (20.7 months) and EFS (14.9 months) in Cerebral tumors (P < 0.05). Pseudoprogression occurred in 8 of 111 (6.2%) cases.Conclusions:This study has shown that the poor outcome of midline tumors (compared with cerebral) may be related to (1) lesser surgical resection, (2) H3 K27M histone mutations, and (3) higher leptomeningeal dissemination.

Published
2023

16. Supplementary Table ST4 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Resection rates for tumor grades

Published
2023

17. Supplementary Figure SF7 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Incidence of tumor resection in Cerebral versus Midline tumors

Published
2023

18. Supplementary Table ST5 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Leptomeningeal metastatic (LMM) dissemination

Published
2023

19. Supplementary Table ST9 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Outcome related to tumor grade

Published
2023

20. Supplementary Figure SF6 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Significantly different radiological characteristics of H3 G34-mutant compared to other Cerebral wild-type cases

Published
2023

21. Supplementary Figure SF8 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Left thalamic non-enhancing diffuse midline glioma

Published
2023

22. Supplementary Table ST3 from Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial

Author

Tim Jaspan, Paul S. Morgan, Jacques Grill, Gilles Vassal, Josep Garcia, Gudrun Zahlmann, Raphael F. Rousseau, Frank Saran, Marie-Cécile Le Deley, Amedeo A. Azizi, Maura Massimino, Adela Cañete, Darren R. Hargrave, Raphael Calmon, Esther Sánchez Aliaga, Monika Warmuth-Metz, Daniel Warren, Alan Mackay, Pascale Varlet, Chris Jones, and Daniel Rodriguez Gutierrez

Abstract

Resections rates for treatment arms

Published
2023

23. Abstract 1238: Comprehensive ctDNA monitoring provides early signal of clinical benefit with a novel personalized neoantigen directed immunotherapy for late-stage cancer patients

Author

Desiree Schenck, Rita Zhou, Alexis Mantilla, Oliver Spiro, Taylor Patch, Adrienne Johnson, Daniel Navarro Gomez, Brian S. Henick, Chih-Yi Liao, Sameek Roychowdhury, Steve Maron, Benjamin Solomon, Alexander I. Spira, Daniel V. Catenacci, Andrew R. Fergusson, Raphael F. Rousseau, Karin Jooss, and Matthew J. Davis

Subjects
Cancer Research, Oncology
Abstract

Neoantigen directed immunotherapy holds promise to increase the likelihood of patients with solid tumor devoid of immune infiltration benefiting from immune checkpoint immunotherapy (CPI). A heterologous prime-boost vaccination approach consisting of Chimpanzee Adenovirus (ChAd) prime and multiple self-amplifying mRNA (SAM) boosts, delivering 20 neoantigens, has been evaluated in a Phase 1/2 clinical trial in late-stage solid tumor patients in combination with nivolumab and ipilimumab (NCT03639714). Neoantigen dynamics, tumor burden and genomic correlates of response were studied over time in 20 patients (8 GEA, 2 NSCLC, 10 MSS-CRC). Exome sequences from archival (sample used for neoantigen selection), baseline (start of immunization) and on-treatment biopsies were analyzed for 20, 16 and 10 patients respectively. Paired pre- and post-vaccine tumor transcriptomes were analyzed for 6 patients. Personalized capture baits were designed for all non-synonymous mutations detected in archival biopsies (mean 146; range: 67-402) for ctDNA monitoring. Longitudinal ctDNA samples were collected monthly on treatment (mean 7; range: 1-18). ctDNA duplex UMI libraries were captured and sequenced to a target mean raw depth >80,000x and reduced to 3x per strand consensus duplex reads. The majority of vaccine neoantigens were detected in ctDNA (87%; range 45%-100%) and mean neoantigen variant allele frequency (VAF) strongly correlated with all monitored mutations VAF (R2 = 0.90, p < 0.0001) through treatment. The percentage of vaccine neoantigens detected was higher than that for all monitored mutations in the same samples with a median of 80% (21%-98%) in ctDNA and 70% (44%-100%) in biopsies. Five of 9 MSS-CRC patients with measurable baseline ctDNA achieved molecular responses (MR, >50% reduction in ctDNA from baseline) that correlated with OS and PFS, and in some patients, was accompanied by radiologic tumor shrinkage. One MSS-CRC patient with MR for >7 months acquired novel biallelic loss-of-function mutations in TAP1 following 1 year of study treatment. Differential gene expression analysis from paired pre- and post-vaccine biopsies (including 2 MSS-CRC pairs with MR) demonstrated significant upregulation in gene signatures associated with immune-inflamed tumor microenvironments including interferon alpha and gamma responses. We demonstrate that tumor-informed neoantigen selection and vaccine manufacturing while patients receive chemotherapy is feasible, since the majority of neoantigens are retained in the tumor post-chemotherapy. Further, neoantigen-directed immunotherapy appears to drive clinical benefit in patients with advanced MSS-CRC tumors, where CPI alone has provided minimal benefit. Comprehensive ctDNA longitudinal monitoring enables real time assessment of clinical response and acquired resistance. Citation Format: Desiree Schenck, Rita Zhou, Alexis Mantilla, Oliver Spiro, Taylor Patch, Adrienne Johnson, Daniel Navarro Gomez, Brian S. Henick, Chih-Yi Liao, Sameek Roychowdhury, Steve Maron, Benjamin Solomon, Alexander I. Spira, Daniel V. Catenacci, Andrew R. Fergusson, Raphael F. Rousseau, Karin Jooss, Matthew J. Davis. Comprehensive ctDNA monitoring provides early signal of clinical benefit with a novel personalized neoantigen directed immunotherapy for late-stage cancer patients [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 1238.

Published
2022

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