Phase II study of ERC1671 plus bevacizumab versus bevacizumab plus placebo in recurrent glioblastoma: interim results and correlations with CD4+ T-lymphocyte counts. (29th August 2018)

• Record Type: Journal Article
• Authors: Bota, Daniela A; Chung, Jinah; Dandekar, Manisha; Carrillo, Jose A; Kong, Xiao-Tang; Fu, Beverly D; Hsu, Frank PK; Schönthal, Axel H; Hofman, Florence M; Chen, Thomas C; Zidovetzki, Raphael; Pretto, Chrystel; Strik, Ankie; Schijns, Virgil EJC; Stathopoulos, Apostolos
• Is Part Of: CNS oncology. Volume 7:Number 3(2018)
• Publication Date: 2018-08-29
• Subjects: allogeneic -- autologous -- bevacizumab -- CD4+ T lymphocyte -- ERC1671 -- GBM -- GBM vaccine -- glioma surgery -- immunotherapy; Central nervous system -- Tumors -- Periodicals; 616.99481
• DOI: 10.2217/cns-2018-0009
• Languages: English
• ISSNs: 2045-0907

Abstract

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.