Phase Ib Clinical Trial of IGV-001 for Patients with Newly Diagnosed Glioblastoma.
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500
Informations de publication
Date de publication:
01 04 2021
01 04 2021
Historique:
received:
09
10
2020
revised:
23
11
2020
accepted:
14
01
2021
pubmed:
28
1
2021
medline:
11
3
2022
entrez:
27
1
2021
Statut:
ppublish
Résumé
Despite standard of care (SOC) established by Stupp, glioblastoma remains a uniformly poor prognosis. We evaluated IGV-001, which combines autologous glioblastoma tumor cells and an antisense oligonucleotide against IGF type 1 receptor (IMV-001), in newly diagnosed glioblastoma. This open-label protocol was approved by the Institutional Review Board at Thomas Jefferson University. Tumor cells collected during resection were treated Thirty-three patients were enrolled, and median follow-up was 3.1 years. Six patients had adverse events (grade ≤3) possibly related to IGV-001. Median progression-free survival (PFS) was 9.8 months in the intent-to-treat population (vs. SOC, 6.5 months; IGV-001 was well tolerated, PFS compared favorably with SOC, and evidence suggested an immune-mediated mechanism (ClinicalTrials.gov: NCT02507583).
Identifiants
pubmed: 33500356
pii: 1078-0432.CCR-20-3805
doi: 10.1158/1078-0432.CCR-20-3805
doi:
Substances chimiques
Oligodeoxyribonucleotides, Antisense
0
Receptor, IGF Type 1
EC 2.7.10.1
Banques de données
ClinicalTrials.gov
['NCT02507583']
Types de publication
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1912-1922Informations de copyright
©2021 American Association for Cancer Research.
Références
Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, et al. The 2016 World Health Organization classification of tumors of the central nervous system: a summary. Acta Neuropathol. 2016;131:803–20.
Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y, et al. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2006–2010. Neuro Oncol. 2013;15:ii1–56.
Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352:987–96.
Andrews DW, Resnicoff M, Flanders AE, Kenyon L, Curtis M, Merli G, et al. Results of a pilot study involving the use of an antisense oligodeoxynucleotide directed against the insulin-like growth factor type I receptor in malignant astrocytomas. J Clin Oncol. 2001;19:2189–200.
Resnicoff M, Abraham D, Yutanawiboonchai W, Rotman HL, Kajstura J, Rubin R, et al. The insulin-like growth factor I receptor protects tumor cells from apoptosis in vivo. Cancer Res. 1995;55:2463–9.
Pentimalli F, Grelli S, Di Daniele N, Melino G, Amelio I. Cell death pathologies: targeting death pathways and the immune system for cancer therapy. Genes Immun. 2019;20:539–54.
Wennerberg E, Vanpouille-Box C, Bornstein S, Yamazaki T, Demaria S, Galluzzi L. Immune recognition of irradiated cancer cells. Immunol Rev. 2017;280:220–30.
Morin-Brureau M, Hooper KM, Prosniak M, Sauma S, Harshyne LA, Andrews DW, et al. Enhancement of glioma-specific immunity in mice by “NOBEL”, an insulin-like growth factor 1 receptor antisense oligodeoxynucleotide. Cancer Immunol Immunother. 2015;64:447–57.
Harshyne LA, Hooper KM, Andrews EG, Nasca BJ, Kenyon LC, Andrews DW, et al. Glioblastoma exosomes and IGF-1R/AS-ODN are immunogenic stimuli in a translational research immunotherapy paradigm. Cancer Immunol Immunother. 2015;64:299–309.
Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009;10:459–66.
Wen PY, Chang SM, Van den Bent MJ, Vogelbaum MA, Macdonald DR, Lee EQ. Response assessment in neuro-oncology clinical trials. J Clin Oncol. 2017;35:2439–49.
Okada H, Weller M, Huang R, Finocchiaro G, Gilbert MR, Wick W, et al. Immunotherapy response assessment in neuro-oncology: a report of the RANO working group. Lancet Oncol. 2015;16:e534–e42.
Fortuna D, Hooper DC, Roberts AL, Harshyne LA, Nagurney M, Curtis MT. Potential role of CSF cytokine profiles in discriminating infectious from non-infectious CNS disorders. PLoS One. 2018;13:e0205501.
Guyot P, Ades AE, Ouwens MJ, Welton NJ. Enhanced secondary analysis of survival data: reconstructing the data from published kaplan-meier survival curves. BMC Med Res Methodol. 2012;12:9.
Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, et al. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014;370:709–22.
Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, et al. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014;370:699–708.
Iaccarino C, Orlandi E, Ruggeri F, Nicoli D, Torricelli F, Maggi M, et al. Prognostic value of MGMT promoter status in non-resectable glioblastoma after adjuvant therapy. Clin Neurol Neurosurg. 2015;132:1–8.
Hermisson M, Klumpp A, Wick W, Wischhusen J, Nagel G, Roos W, et al. O6-methylguanine DNA methyltransferase and p53 status predict temozolomide sensitivity in human malignant glioma cells. J Neurochem. 2006;96:766–76.
Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, et al. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005;352:997–1003.
Stupp R, Hegi ME, Gorlia T, Erridge SC, Perry J, Hong YK, et al. Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma with methylated MGMT promoter (CENTRIC EORTC 26071–22072 study): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2014;15:1100–8.
Fry TJ, Mackall CL. Interleukin-7: from bench to clinic. Blood. 2002;99:3892–904.
Larsson O, Girnita A, Girnita L. Role of insulin-like growth factor 1 receptor signalling in cancer. Br J Cancer. 2005;92:2097–101.
Philippou A, Christopoulos PF, Koutsilieris DM. Clinical studies in humans targeting the various components of the IGF system show lack of efficacy in the treatment of cancer. Mutat Res Rev Mutat Res. 2017;772:105–22.
Philippou A, Armakolas A, Koutsilieris M. Evidence for the possible biological significance of the igf-1 gene alternative splicing in prostate cancer. Front Endocrinol. 2013;4:31.
Scartozzi M, Bianconi M, Maccaroni E, Giampieri R, Del Prete M, Berardi R, et al. State of the art and future perspectives for the use of insulin-like growth factor receptor 1 (IGF-1R) targeted treatment strategies in solid tumors. Discov Med. 2011;11:144–53.
Cosaceanu D, Carapancea M, Alexandru O, Budiu R, Martinsson HS, Starborg M, et al. Comparison of three approaches for inhibiting insulin-like growth factor I receptor and their effects on NSCLC cell lines in vitro. Growth Factors. 2007;25:1–8.
Spadaro O, Camell CD, Bosurgi L, Nguyen KY, Youm YH, Rothlin CV, et al. IGF1 shapes macrophage activation in response to immunometabolic challenge. Cell Rep. 2017;19:225–34.
Jenkins EO, Schiff D, Mackman N, Key NS. Venous thromboembolism in malignant gliomas. J Thromb Haemost. 2010;8:221–7.
Xu C, Chen YP, Du XJ, Liu JQ, Huang CL, Chen L, et al. Comparative safety of immune checkpoint inhibitors in cancer: systematic review and network meta-analysis. BMJ. 2018;363:k4226.
Andrews D, Garcia S, Judy J, Harshyne L, Govnindarajan S, Kenyon L, et al. Results of a phase 1b trial of an autologous cell vaccine for newly-diagnosed glioblastoma [abstract]. Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29–Apr 3; Atlanta, GA.
Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019;380:45–56.
Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377:2531–44.
Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1–2 trial. Lancet Oncol. 2019;20:31–42.
Chaichana KL, Cabrera-Aldana EE, Jusue-Torres I, Wijesekera O, Olivi A, Rahman M, et al. When gross total resection of a glioblastoma is possible, how much resection should be achieved?. World Neurosurg. 2014;82:e257–65.
Fukui A, Muragaki Y, Saito T, Maruyama T, Nitta M, Ikuta S, et al. Volumetric analysis using low-field intraoperative magnetic resonance imaging for 168 newly diagnosed supratentorial glioblastomas: effects of extent of resection and residual tumor volume on survival and recurrence. World Neurosurg. 2017;98:73–80.
Ellsworth S, Balmanoukian A, Kos F, Nirschl CJ, Nirschl TR, Grossman SA, et al. Sustained CD4(+) T cell-driven lymphopenia without a compensatory IL-7/IL-15 response among high-grade glioma patients treated with radiation and temozolomide. Oncoimmunology. 2014;3:e27357.
Arcangeli S, Falcone L, Camisa B, De Girardi F, Biondi M, Giglio F, et al. Next-generation manufacturing protocols enriching TSCM CAR T cells can overcome disease-specific T cell defects in cancer patients. Front Immunol. 2020;11:1217.
Das RK, Vernau L, Grupp SA, Barrett DM. Naive T-cell deficits at diagnosis and after chemotherapy impair cell therapy potential in pediatric cancers. Cancer Discov. 2019;9:492–9.