UC Irvine

Abstract

BACKGROUND

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. Previously published compassionate use data showed an overall survival (OS) of 43 weeks (10 months) in patients with a good performance status.

METHODS

In this double-blinded, randomized, phase 2 study bevacizumab-naïve patients with recurrent GBM were randomized after surgery to receive either ERC1671 in combination with GM-CSF and cyclophosphamide plus bevacizumab, or placebo plus bevacizumab. The trial is registered with ClinicalTrials.gov (NCT01903330). Interim

RESULTS

Nine patients, with a KPS 70, were randomized and treated. At the time of further progression, these patients were unblinded, as stipulated by the protocol, which revealed that four had received vaccine, four had received placebo, and one was non-evaluable. Median OS of patients treated with ERC1671 plus bevacizumab was 12 months, with one patient surviving >2 years. In the group treated with placebo plus bevacizumab, median OS was shorter at 7.5 months, with all patients having succumbed within 1 year. Toxicity analysis showed an equal distribution of adverse events (AE) between the vaccine and placebo groups, with no grade 4 or 5 toxicities. The maximal CD4+ T lymphocyte count in the peripheral blood correlated with OS in the ERC1671 but not in the placebo group.

CONCLUSIONS

The addition of ERC1671/GM-CSF/cyclophosphamide to bevacizumab resulted in a potential survival benefit with minimal additional toxicity. The maximal CD4+ T lymphocyte count in the peripheral blood correlated with OS. The study is ongoing with the addition of two other sites.