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Positive Phase II Results Reported for Brain Cancer Vaccine
Survival rate exceeds 90% at 6 months after surgery (December 16)
The results from a phase II study demonstrated that more than 90% of patients with glioblastoma multiforme (GB) treated with Prophage Series G-200 vaccine (Agenus, Inc.) were alive at 6 months after surgery and that 30% were alive at 12 months. The patients’ median overall survival was approximately 11 months.
The primary objective of the study was to assess the survival rate at 6 months. The findings were published in Neuro-Oncology.
GBM is the most common and most aggressive form of primary brain cancer. Despite approved therapy, patients with GBM have a poor prognosis. Prophage Series vaccines are currently being studied in both newly diagnosed and recurrent GBM.
Prophage Series vaccines are manufactured using a patient’s own tumor after surgical removal. Each vaccine contains the antigenic “fingerprint” of the patient’s particular cancer and is designed to activate the patient’s immune system to specifically target and destroy cancer cells bearing this fingerprint.
The single-arm phase II trial enrolled 41 patients (mean age, 55 years) with surgically resectable recurrent high-grade GBM. Patients underwent surgery to remove at least 90% of their tumors (also referred to as gross total resection), which were then used to manufacture Prophage Series G-200, a patient-specific heat shock protein-based therapeutic vaccine. Eligible patients were treated after surgery with Prophage Series G-200 once weekly for 4 weeks, followed by biweekly injections until vaccine depletion. No serious adverse events were associated with vaccine administration.
The National Cancer Institute (NCI) is currently supporting a study of the Prophage Series G-200 vaccine in a large-scale, randomized phase II trial in combination with bevacizumab (Avastin, Genentech) in patients with surgically resectable recurrent GBM.
Source: Agenus; December 16, 2013.