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Ref Type Abstract
Authors Michael Platten, Daniela Schilling, Lukas Bunse, Antje Wick, Theresa Bunse, Dennis Riehl, Irini Karapanagiotou-Schenkel, Inga Harting, Felix Sahm, Anita Schmitt, Joachim Peter Steinbach, Astrid Weyerbrock, Jörg Hense, Martin Misch, Dietmar Krex, Stefan Stevanovic, Ghazaleh Tabatabai, Andreas von Deimling, Michael Schmitt, Wolfgang Wick
Title A mutation-specific peptide vaccine targeting IDH1R132H in patients with newly diagnosed malignant astrocytomas: A first-in-man multicenter phase I clinical trial of the German Neurooncology Working Group (NOA-16)
Journal Journal of Clinical Oncology
Vol 36
Issue no. 15_suppl
Date May 20, 2018
Abstract Text Background: Hot-spot point mutations in the gene for isocitrate dehydrogenase type 1 (IDH1R132H) are a frequent founder event in gliomas and other tumors. Preclinical studies have defined IDH1R132H as a clonal neoantigen presented on MHC class II to induce tumor-specific therapeutic T helper cell responses. Methods: NOA-16 (NCT02454634) is a first-in-man, multicenter, phase I trial, which enrolled 33 patients with newly diagnosed WHO °III and °IV astrocytomas with IDH1R132H mutations. After completion of radiochemotherapy a total of eight vaccinations with an IDH1R132H peptide in incomplete Freund’s adjuvant produced at a central GMP site was to be administered subcutaneously with topical imiquimod over a period of 32 weeks together with maintenance temozolomide. The primary end points were safety and immunogenicity. Results: The safety dataset comprised 249 vaccines administered to 32 patients. One patient withdrew after screening. 29 patients received all eight vaccines. Vaccine-related adverse events (AE) were restricted to grade 1 reactions, according to common toxicity criteria for AE(CTCAE v4.0). Two serious AE were observed in two patients; one probably related to the peptide vaccine. 28/30 patients (93.3%) evaluable for immunogenicity displayed IDH1R132H-specific T cellular (detected by ELISPOT assays in 24/30 (80%)) or humoral (detected by ELISA in 26/30 patients (87%)) immune responses not detectable before vaccination. Until end of study (EOS, week 32), 4/32 (12.5 %) patients had progressive disease (PD) according to RANO criteria, all other patients (N = 28, 87.5%) had stable disease (SD). 12/32 (37.5%) patients displayed pseudoprogressions. Single-cell T cell receptor (TCR) sequencing allowed for the identification of IDH1R132H-specific TCRs. Conclusions: NOA-16 met its primary endpoints by demonstrating safety and immunogenicity of a mutation-specific IDH1R132H peptide vaccine. Pseudoprogressions observed after the initiation of the vaccine may indicate intratumoral immune reactions warranting further development, including TCR cell therapy. Clinical trial information: NCT02454634.


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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH1 R132H malignant astrocytoma predicted - sensitive IDH1 R132H peptide vaccine Phase I Actionable In a Phase I trial (NOA-16), treatment with IDH1 R132H peptide vaccine demonstrated safety in patients with malignant astrocytoma harboring IDH1 R132H and led to stable disease in 87.5% (28/32) of patients (J Clin Oncol 36, no. 15_suppl (May 20, 2018) 2001; NCT02454634). detail...