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

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.

• Authors: 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
• Journal: CNS oncology (CNS Oncol) Vol. 7 Issue 3 Pg. CNS22 (07 01 2018) ISSN: 2045-0915 [Electronic] England
• PMID: 30157683 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Immunological
• Bevacizumab
• Granulocyte-Macrophage Colony-Stimulating Factor
• Cyclophosphamide

Topics

• Aged
• Antineoplastic Agents, Immunological (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Bevacizumab (therapeutic use)
• Brain Neoplasms (drug therapy, pathology)
• CD4-Positive T-Lymphocytes (pathology)
• Cyclophosphamide (therapeutic use)
• Double-Blind Method
• Female
• Glioblastoma (drug therapy, pathology)
• Granulocyte-Macrophage Colony-Stimulating Factor (therapeutic use)
• Humans
• Immunomodulation
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Neoplasm Recurrence, Local
• Treatment Outcome