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