IDH1-mutant vaccine in newly diagnosed astrocytoma: final analysis of the multicenter, single-arm, open-label, first-in-human phase 1 NOA16 trial.
A correction to this paper has been published: the notice, 42547583, from Europe PMC.
Overview
and 7 other authors
Michael Schmitt14, Theresa Bunse1,2,3, Ghazaleh Tabatabai19,21,23,24, Martin Bendszus11, Isabel Poschke1,3,7, Wolfgang Wick3,4,8,25, Michael Platten1,2,3,4,5,6,7,2626 affiliations
- DKTK (German Cancer Consortium) Clinical Cooperation Unit (CCU) Neuroimmunology and Brain Tumor Immunology, German Cancer Research Center (DKFZ),Heidelberg, Germany
- Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg,Mannheim, Germany
- German Cancer Consortium (DKTK), DKFZ, Core Center,Heidelberg, Germany
- Hertie Network of Excellence in Clinical Neuroscience, Tübingen, Germany
- DKFZ-Hector Cancer Institute at University Medical Center Mannheim,Mannheim, Germany
- Cluster of Excellence SynthImmune (EXC 3018/1) “Engineering Immune function with Synthetic Biology”, University of Heidelberg,Mannheim, Germany
- Immune Monitoring Unit, National Center for Tumor Diseases (NCT),Heidelberg, Germany
- Neurology Clinic and European Center for Neurooncology (EZN), Heidelberg University Hospital, University of Heidelberg,Heidelberg, Germany
- NCT Trial Management and Services, NCT, and German Cancer Research Center (DKFZ),Heidelberg, Germany
- Department of Neuropathology, Heidelberg University Hospital, University of Heidelberg,Heidelberg, Germany
- Department of Neuroradiology, Heidelberg University Hospital, University of Heidelberg,Heidelberg, Germany
- DKTK CCU Neuropathology, DKFZ,Heidelberg, Germany
- Department of Medical Oncology, Heidelberg University Hospital, University of Heidelberg,Heidelberg, Germany
- Department of Internal Medicine V, Heidelberg University Hospital, University of Heidelberg,Heidelberg, Germany
- Neurosurgery Clinic, University Hospital Erlangen,Erlangen, Germany
- Department of Medical Oncology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen,Essen, Germany
- Department of Neurosurgery, Charité Medical Center, University of Berlin,Berlin, Germany
- Technische Universität Dresden, Faculty of Medicine and University Hospital Carl Gustav Carus, Department of Neurosurgery,Dresden, Germany
- Cluster of Excellence iFIT (EXC2180) ‘Image-Guided and Functionally Instructed Tumor Therapies’, University of Tübingen,Tübingen, Germany
- Department of Peptide-based Immunotherapy, Institute of Immunology, University and University Hospital Tübingen,Tübingen, Germany
- German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), partner site Tübingen,Tübingen, Germany
- Dr. Senckenberg Institute of Neurooncology,Frankfurt, Germany
- Department of Neurology and Neuro-Oncology, University Hospital Tübingen, Hertie Institute for Clinical Brain Research, Eberhard Karls University Tübingen,Tübingen, Germany
- Center for Neuro-Oncology, CCC Tübingen-Stuttgart in CCC-SW, Tübingen, Germany
- DKTK CCU Neurooncology, DKFZ,Heidelberg, Germany
- Helmholtz Institute for Translational Oncology (HI-TRON) Mainz, German Cancer Research Center,Mainz, Germany
Abstract
The clonal glioma driver mutation IDH1R132H gives rise to a major histocompatibility class II-restricted neoepitope. A multicenter, first-in-human phase 1 trial met its prespecified primary endpoints by demonstrating safety and immunogenicity of an IDH1-R132H peptide vaccine (IDH1-vac) integrated into standard of care in 33 participants with newly diagnosed grade III and IV (World Health Organization classification 2007) IDH1-R132H+ astrocytomas (NOA16). Here we report on the clinical and immunological long-term follow-up of this trial as secondary and translational endpoints. The 8-year progression-free and overall survival (OS) rates were 0.42 (confidence interval (CI): 0.24–0.59) and 0.66 (CI: 0.46–0.79), respectively. For participants with grade IV astrocytoma, median OS was 106.1 months (CI: 39.6–not estimable (NE)), comparing favorably to the published median OS in this population ranging from 31.6–56.4 months. Within the responder group, sustained antibody responses to IDH1-R132H were associated with a favorable long-term clinical course. IDH1-vac-induced T cell responses were detected in the inflamed brain lesion of an IDH1-vac-associated pseudoprogression, whereas no IDH1-vac-induced T cells were found in participants with early progressive disease. The favorable long-term outcome of the NOA16 cohort supports investigating IDH1-vac in persons with newly diagnosed grade 3 and 4 (World Health Organization classification 2021) IDH-mutant astrocytomas in a randomized phase 2 trial (ClinicalTrials.gov identifier: NCT02454634).
Reproduced under the paper's license (CC BY), from the paper cited above.
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Data
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- sra:SRR12880623, at NCBI SRA; found in “Data availability”
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Single-cell RNA-seq data that are associated with Fig. 3 were deposited to the National Center for Biotechnology Information Sequence Read Archive under accession codes SRR12880623 (https://
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Version 2, 28 September 2026
- Publisher: n/a → Nature Portfolio
Version 1, 27 September 2026: the first record
Recorded: type, language, journal, volume, issue, pages, dates, 27 authors, 4 keywords, 13 MeSH terms, 1 funder, 39 references, 2 RRIDs, 1 integrity notice.
Cite
This paper
Bunse, L., Lindner, K., Wick, A., Freitag, A., Lanz, L.-M., Edelmann, D., Suwala, A., Breckwoldt, M. O., Harting, I., Sahm, F., Schlenk, R. F., Schmitt, A., Schnell, O., Hense, J., Misch, M., Krex, D., Denk, M., Walz, J., Steinbach, J. P., . . . Platten, M. (2026). IDH1-mutant vaccine in newly diagnosed astrocytoma: final analysis of the multicenter, single-arm, open-label, first-in-human phase 1 NOA16 trial. Nature cancer, 7(8), 1300-1311. https://
BibTeX
@article{bunse2026idh1,
author = {Bunse, Lukas and Lindner, Katharina and Wick, Antje and Freitag, Angelika and Lanz, Lisa-Marie and Edelmann, Dominic and Suwala, Abigail and Breckwoldt, Michael O. and Harting, Inga and Sahm, Felix and Schlenk, Richard F. and Schmitt, Anita and Schnell, Oliver and Hense, Jörg and Misch, Martin and Krex, Dietmar and Denk, Monika and Walz, Juliane and Steinbach, Joachim P. and von Deimling, Andreas and Schmitt, Michael and Bunse, Theresa and Tabatabai, Ghazaleh and Bendszus, Martin and Poschke, Isabel and Wick, Wolfgang and Platten, Michael},
title = {{IDH1-mutant vaccine in newly diagnosed astrocytoma: final analysis of the multicenter, single-arm, open-label, first-in-human phase 1 NOA16 trial}},
journal = {Nature cancer},
year = {2026},
month = jul,
volume = {7},
number = {8},
pages = {1300--1311},
publisher = {Nature Portfolio},
issn = {2662-1347},
doi = {10.1038/
url = {https://
pmid = {42387024},
pmcid = {PMC13498463}
}
RIS
TY - JOUR
AU - Bunse, Lukas
AU - Lindner, Katharina
AU - Wick, Antje
AU - Freitag, Angelika
AU - Lanz, Lisa-Marie
AU - Edelmann, Dominic
AU - Suwala, Abigail
AU - Breckwoldt, Michael O.
AU - Harting, Inga
AU - Sahm, Felix
AU - Schlenk, Richard F.
AU - Schmitt, Anita
AU - Schnell, Oliver
AU - Hense, Jörg
AU - Misch, Martin
AU - Krex, Dietmar
AU - Denk, Monika
AU - Walz, Juliane
AU - Steinbach, Joachim P.
AU - von Deimling, Andreas
AU - Schmitt, Michael
AU - Bunse, Theresa
AU - Tabatabai, Ghazaleh
AU - Bendszus, Martin
AU - Poschke, Isabel
AU - Wick, Wolfgang
AU - Platten, Michael
TI - IDH1-mutant vaccine in newly diagnosed astrocytoma: final analysis of the multicenter, single-arm, open-label, first-in-human phase 1 NOA16 trial
T2 - Nature cancer
J2 - Nat Cancer
PY - 2026
DA - 2026/
VL - 7
IS - 8
SP - 1300
EP - 1311
SN - 2662-1347
PB - Nature Portfolio
DO - 10.1038/
UR - https://
LA - en
ER -
CSL-JSON
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