Antigenics (NASDAQ: AGEN) today announced that the Brain Tumor Research Center at the University of California, San Francisco (UCSF), has presented an update on a Phase 2 clinical trial of Oncophage (vitespen) for recurrent high grade glioma (brain cancer) at the 2009 Joint Meeting of SNO (Society for Neuro-Oncology) and AANS/CNS Section on Tumors 2009 in New Orleans, LA. Data were presented in Sunrise Session #6: Immunotherapy: Current Status of Clinical Trials on Saturday, October 24.
Data reported in the first 20 patients treated with Oncophage show a median survival of 10.1 months. While survival data continues to accrue on all patients in the study, to date six patients (30 percent) have survived at or beyond 12 months. These early data show an improvement in overall survival over the previous long standing historical median survival of 6.5 months, and slightly favorable to the recently reported median survival of 9.2 months with bevacizumab (Avastin®) in patients with recurrent high-grade glioma.
“These are encouraging results that suggest activity with Oncophage in this challenging patient population,” said Andrew T. Parsa, MD, PhD, associate professor in the department of neurological surgery at UCSF, and principal investigator of the trial, who presented the update. “Quality of life is particularly important and to date there have been no significant events or toxicity considered attributable to the vaccine. The recent expansion of our trial to additional sites will help validate these initial results through increased accrual “
The Phase 2 single-arm trial is designed to enroll about 50 patients with recurrent high-grade glioma. The overall goal of this NIH-sponsored, investigator-initiated, open-label study is to evaluate median overall survival, progression-free survival and immunologic response to vaccine treatment.
Patients undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines. Patients receive four weekly doses of Oncophage and then bi-weekly doses thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion.
To date, side effects observed in this study have been minor and have included injection-site reaction, fatigue, and headaches. The trial is supported through a grant from the National Institutes of Health.
An additional Phase 2 study is underway evaluating Oncophage in combination with Temodar® (temozolomide) in newly diagnosed glioma patients.