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
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.
