Aivita Biomedical announced positive data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1, in patients with newly diagnosed glioblastoma (GBM). The data from the trial was presented at the 35th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC).
The single-arm, open-label phase II clinical trial enrolled 57 patients with newly diagnosed glioblastoma (GBM) to receive an autologous dendritic cell vaccine consisting of autologous dendritic cells loaded with autologous tumor-associated antigens (AV-GBM-1). The patients were scheduled to receive up to eight doses of AV-GBM-1 over approximately six months. The primary endpoint of the trial was overall survival (OS) from enrollment date, and secondary endpoints included progression-free survival (PFS) from enrollment date and OS measured from date of surgery during which tumor was collected to grow the tumor initiating cells. At the time of the analysis, surviving patients had completed therapy and had been followed between 7.2 and 24.2 months. The median length of progression free survival was 10.0 month, an improvement of approximately 45% compared to a median of 6.9 months progression free survival in the landmark study that established the standard of care for patients with newly diagnosed GBM. This represented a 38% reduction in risk of progression or death at 6.9 months of treatment.
AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor-initiating cells. The treatment is administered in a series of subcutaneous injections. The treatment is uniquely pan-antigenic, targeting multiple antigens from autologous tumor-initiating cells that are responsible for the rapid growth of the disease.