Phase II study of ERC1671 plus bevacizumab versus bevacizumab plus placebo in recurrent glioblastoma: interim results and correlations with CD4+ T-lymphocyte counts

Daniela A Bota; Jinah Chung; Manisha Dandekar; Jose A Carrillo; Xiao-Tang Kong; Beverly D Fu; Frank PK Hsu; Axel H Schönthal; Florence M Hofman; Thomas C Chen; Raphael Zidovetzki; Chrystel Pretto; Ankie Strik; Virgil EJC Schijns; Apostolos Stathopoulos

doi:10.2217/cns-2018-0009

CNS Oncology (Jul 2018)

Phase II study of ERC1671 plus bevacizumab versus bevacizumab plus placebo in recurrent glioblastoma: interim results and correlations with CD4+ T-lymphocyte counts

Daniela A Bota,
Jinah Chung,
Manisha Dandekar,
Jose A Carrillo,
Xiao-Tang Kong,
Beverly D Fu,
Frank PK Hsu,
Axel H Schönthal,
Florence M Hofman,
Thomas C Chen,
Raphael Zidovetzki,
Chrystel Pretto,
Ankie Strik,
Virgil EJC Schijns,
Apostolos Stathopoulos

Affiliations

Daniela A Bota: 1Department of Neurology, University of California Irvine, Irvine, CA 92868, USA
Jinah Chung: 3Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, CA 92868, USA
Manisha Dandekar: 3Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, CA 92868, USA
Jose A Carrillo: 1Department of Neurology, University of California Irvine, Irvine, CA 92868, USA
Xiao-Tang Kong: 1Department of Neurology, University of California Irvine, Irvine, CA 92868, USA
Beverly D Fu: 1Department of Neurology, University of California Irvine, Irvine, CA 92868, USA
Frank PK Hsu: 2Department of Neurological Surgery, University of California Irvine, Irvine, CA 92868, USA
Axel H Schönthal: 4Department of Molecular Microbiology & Immunology, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA
Florence M Hofman: 5Department of Pathology, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA
Thomas C Chen: 6Department of Neurosurgery, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA
Raphael Zidovetzki: 7Cell Biology & Neuroscience, University of California, Riverside, CA 92507, USA
Chrystel Pretto: 8Epitopoietic Research Corporation, Gembloux, 5032 Isnes, Belgium
Ankie Strik: 6Department of Neurosurgery, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA
Virgil EJC Schijns: 8Epitopoietic Research Corporation, Gembloux, 5032 Isnes, Belgium
Apostolos Stathopoulos: 8Epitopoietic Research Corporation, Gembloux, 5032 Isnes, Belgium

DOI: https://doi.org/10.2217/cns-2018-0009
Journal volume & issue: Vol. 7, no. 3

Abstract

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Aim: ERC1671 is an allogeneic/autologous therapeutic glioblastoma (GBM) vaccine – composed of whole, inactivated tumor cells mixed with tumor cell lysates derived from the patient and three GBM donors. Methods: In this double-blinded, randomized, Phase II study bevacizumab-naive patients with recurrent GBM were randomized to receive either ERC1671 in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine® or sargramostim) and cyclophosphamide plus bevacizumab, or placebo plus bevacizumab. Interim results: Median overall survival (OS) of patients treated with ERC1671 plus bevacizumab was 12 months. In the placebo plus bevacizumab group, median OS was 7.5 months. The maximal CD4+ T-lymphocyte count correlated with OS in the ERC1671 but not in the placebo group. Conclusion: The addition of ERC1671/GM-CSF/cyclophosphamide to bevacizumab resulted in a clinically meaningful survival benefit with minimal additional toxicity.

Published in CNS Oncology

ISSN: 2045-0907 (Print); 2045-0915 (Online)
Publisher: Taylor & Francis Group
Country of publisher: United Kingdom
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.tandfonline.com/journals/icns20

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