Adding AIVITA Biomedical’s experimental and personalized cancer vaccine, AV-GBM-1, to post-surgery standard treatment slows disease progression in adults newly diagnosed with glioblastoma — the most aggressive type of brain cancer — according to two-year data from a Phase 2 clinical trial.
“The improvement in glioblastoma patients who were treated with AV-GBM-1, compared to studies with the standard of care, is a very promising indication that our therapy confers benefit to patients in need,” Robert O. Dillman, MD, AIVITA’s chief medical officer, said in a press release.
The results represent “a major victory against glioblastoma, a devastating disease that has evaded treatment for far too long,” said Hans S. Keirstead, PhD, AIVITA’s chairman and CEO.
AV-GBM-1 works by promoting immune responses against the complete and unique array of molecules — the molecular signature — at the surface of a patient’s own cancer-initiating cells. These molecules are responsible for the rapid growth and spread of the disease, as well as its resistance to standard treatment.
The new personalized therapy approach involves the collection of a patient’s cancer cells and dendritic cells (a type of immune cell) and the modification of the dendritic cells in the lab to present all cancer-specific proteins at their surface. The modified cells are then delivered back to the patient through a series of under-the-skin (subcutaneous) injections.
Dendritic cells tell T-cells, another type of immune cell, what their targets should be by presenting them with certain proteins. Here, AV-GBM-1 is expected to re-educate T-cells to identify and destroy the patient’s cancer cells.
Targeting all cancer-specific proteins, rather than a select few as in other approaches, is expected to be more effective in the fight against cancer, according to AIVITA. Specifically, the therapy is expected to target mutated or dormant tumor-initiating cells, the company notes on its website.
Launched in 2018, the open-label Phase 2 trial (NCT03400917) is evaluating the safety and effectiveness of adding AV-GBM-1 to standard treatment in 57 newly diagnosed patients with glioblastoma who underwent surgery to remove their tumors.
The participants, enrolled at eight sites across the U.S., were scheduled to receive up to eight injections of AV-GBM-1 over six months, in addition to standard care, namely chemotherapy and radiation therapy.
The trial’s main goal is to assess the patients’ overall survival, while secondary goals include several measures of overall survival and progression-free survival (PFS), or the time participants lived without signs of disease progression.
Previous data from the trial, presented at the 35th Annual Meeting of the Society for the Immunotherapy of Cancer, showed that 76% of participants were alive at both 12 and 15 months.
This represented a survival benefit when compared with the overall survival rates at one year — of 61% — and 48% at 15 months of an external, historical group of 287 newly diagnosed glioblastoma patients receiving standard of care only.
At the time of the new analysis, focused on PFS, surviving patients had completed therapy and had been followed between 7.2 and 24.2 months (about two years).
The results showed that participants had lived without signs of disease progression for a median of 10 months — an improvement of about 45% when compared with the historical group of patients, who showed a PFS of 6.9 months.
This reflected a 38% reduction in risk of progression or death at 6.9 months of treatment for patients receiving AV-GBM-1 in addition to standard treatment.
AIVITA’s cancer vaccine platform also is being evaluated as a potential treatment for ovarian cancer in a Phase 2 trial (NCT02033616) and for melanoma — a type of skin cancer — in a Phase 1 study (NCT03743298). Both U.S.-based trials are currently enrolling patients; more information on the ovarian cancer study can be found here and on the melanoma trial here.
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