Glioblastoma Study Shows Improved Progression Free Survival
California-based AIVITA Biomedical Inc. announced data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1. The analysis focused on the 57 Phase 2 patients who received eight doses of AV-GBM-1 over approximately six months.
At the time of the analysis, surviving patients had completed therapy and followed between 10.1 and 27.6 months from enrollment. The median length of PFS was 10.4 months (95% confidence interval; 8.6 to 11.7 months), an improvement of approximately 50% compared to a median PFS of 6.9 months (95% confidence interval; 5.8 to 8.2 months) in the landmark STUPP study that established the standard of care for patients with newly diagnosed glioblastoma (GBM).
This represents a 42% reduction in the risk of progression or death at 6.9 months.
Median survival has not been reached and will be assessed after the final patient has a minimum follow-up of 15 months. Overall, the treatment was well tolerated. There were 54 serious adverse events among 28 of 57 patients, but none were attributed to the vaccine.
“The potential for AV-GBM-1 to significantly improve Progression Free Survival (PFS) in newly diagnosed GBM patients over and above the current standard of care is very encouraging,” commented Robert O. Dillman, M.D., chief medical officer of AIVITA, in a press release.
“We look forward to confirming this benefit in a randomized Phase 3 multi-center trial.”
AIVITA is currently conducting clinical studies in the United States investigating its platform immunotherapy in patients with GBM.
Glioblastoma, also referred to as a grade IV astrocytoma, is a fast-growing and aggressive brain tumor. It invades the nearby brain tissue but generally does not spread to distant organs.
AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor neoantigens derived from self-renewing tumor-initiating cells isolated from tumors after routine surgical debulking. The treatment is administered to patients via subcutaneous injection. The treatment is uniquely pan-antigenic, targeting multiple antigens, including all neoantigens, from autologous tumor-initiating cells responsible for the tumor growth.
“This milestone is an encouraging first step in the fight against GBM, a disease that has a devastating impact on patients and their families,” said study principal investigator Daniela Bota, M.D., Ph.D., Director, University of California, Irvine (UCI) Alpha Stem Cell Clinical and medical director, UCI Health Comprehensive Brain Tumor Program.
AIVITA Biomedical was founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical, Inc. utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient, and economical manufacturing systems which support its therapeutic pipeline.