The vaccine significantly improved a survival outcome over standard-of-care treatment in patients with newly diagnosed glioblastoma.
Treatment with AV-GBM-1, a personalized cancer vaccine, was associated with a significant survival outcome improvement compared to standard-of-care therapies in patients with newly diagnosed glioblastoma, according to the vaccine’s manufacturer, AIVITA Biomedical Inc.
Among 57 patients who had received eight doses of the vaccine over approximately six months, the median progression-free survival (time during and after treatment when the patient lives without disease progression) was 10.4 months with AV-GBM-1 compared to the 6.9 months that had been observed with radiotherapy plus the chemotherapy temozolomide in a different study; this translated to about a 50% improvement over the established standard of care for this population.
At the time of the analysis, patients had completed therapy and had been followed between 10.1 months and 27.6 months from enrollment. The median overall survival (length of time from either diagnosis or start of treatment that a patient is still alive) had not yet been reached and will be evaluated after the last patient has had a minimum follow-up of 15 months.
Moreover, the vaccine was found to be well tolerated, overall, with 54 serious side effects reported in 28 patients; however, none of these toxicities were determined to be associated with the treatment.
“This milestone is an encouraging first step in the fight against (glioblastoma), a disease that has a devastating impact on patients and their families,” said the study’s lead author Dr. Daniela Bota, medical director of the University of California, Irvine Health Comprehensive Brain Tumor Program, in a news release.
The manufacturer is conducting two studies of the vaccine in the United States in patients with glioblastoma and melanoma.
“The potential for AV-GBM-1 to significantly improve (progression-free survival) in newly diagnosed (glioblastoma) patients over and above current standard of care is very encouraging,” AIVITA’s chief medical officer Dr. Robert O. Dillman said in the release.
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