Date: 2014-07-01
Type of information: Results
phase: 2
Announcement: results
Company: Agenus (USA)
Product: Prophage autologous cancer vaccine
Action
mechanism: Prophage is an autologous cancer vaccine. Each patient receives vaccine prepared from their own surgically resected tumor. As a result, the vaccine appears to help stimulate the patient’s immune system to attack the tumor based on the spectrum of mutant proteins expressed by their own tumor. After the patient undergoes surgery to remove cancerous tumor tissue, the tumor is shipped frozen in a specially designed kit provided by the company to Agenus’ Lexington, Massachusetts facility. Each Prophage Series vaccine is produced in about 10 hours, after which it undergoes extensive quality testing which takes about 2 weeks. The turnaround time from the date of surgery is about 3 to 4, weeks which generally fits well with the patient’s recovery time from surgery. Once the vaccine is released from Agenus, it is shipped frozen overnight to the hospital pharmacy or clinician. Prophage Series vaccines are given as a simple intradermal injection and have a shelf life of up to 24 months.
Disease: newly diagnosed glioblastoma multiforme
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The Phase 2 single-arm trial of Prophage in patients with newly diagnosed GBM undergoing gross total resection includes 46 patients treated at eight centers (UCSF, Columbia, UPENN, Miami, Valley Hospital, Northern Westchester Hospital, Oklahoma, Johns Hopkins, and Northwestern) across the US. Patients were treated with surgical resection, radiation and temozolomide as the standard of care in addition to Prophage vaccination. The cohort was comparable to patients with surgically resectable newly diagnosed GBM on prognostic factors such as age, Karnofsky Performance Score, and MGMT methylation status. Analyses of data collected to date show more than 50% of the patients were alive at two years and patients continued to be followed. These results indicate considerable improvement when compared to expectations for patients treated with the standard of care (gross total resection plus radiation and temozolomide), which is 26% of patients alive at 24 months.
Latest
news: * On July 1, 2014, Agenus announced final results from a single-arm, multi-institutional, open-label, Phase 2 study showing that patients with newly diagnosed glioblastoma multiforme (GBM) who received Agenus’ Prophage autologous cancer vaccine added to the standard of care treatment, lived nearly twice as long as expected. In this Phase 2 study, 50% of the patients lived for two years, an encouraging result for a cancer that often kills patients within one year. Prophage patients demonstrated a median overall survival of approximately 24 months and 33% of patients remain alive at 2 years and continue to be followed for survival. In addition to the long-term survival data, vaccine treated patients had a median progression-free survival (PFS) of nearly 18 months, approximately two to three-times longer than patients treated with radiation and temozolomide alone1. Importantly, 22% of patients were alive and without progression at 24 months and continue to be followed for survival. Interestingly, the response to Prophage seems to be more pronounced in those patients with less expression of the checkpoint ligand PDL-1 on the white blood cells, suggesting that combinations of Prophage with checkpoint modulators like PD-1 antagonists might make Prophage even more effective in a greater percentage of patients with GBM. Median overall survival (OS), the primary endpoint of the trial, is 23.8 months and remains durable in patients treated with Prophage. For the standard of care alone, median OS survival rate is 14.6 months.1 PFS data remains durable with previous reports with a median PFS of 17.8 months and nearly 22% of patients alive without progression at 24 months.
