Clinical Trial Investigating an Immunotherapy Vaccine for Patients with GBM to Open in 2020

A new immunotherapy medication has been developed to treat glioblastoma (GBM) and will be available to patients through a clinical trial in 2020.

GBM is an aggressive type of cancer that can occur in the brain or spinal cord, and although rare, it can be difficult to treat. It affects roughly 15,000 people each year in the United States.

Researchers from Roswell Park Comprehensive Cancer Center in Buffalo, New York, discovered SurVaxM, a type of medication that stimulates the patient’s own immune system, similar to the flu vaccine, Dr. Michael Ciesielski, one of the vaccine developers explained in an interview with CURE®.

Newly diagnosed patients who have already undergone standard of care — surgical removal of the tumor, radiation therapy and chemotherapy — for GBM would receive a shot of the medication in their arm every two weeks for four doses. Every three months, they would come back for a booster.

“What that does is it stimulates a patient’s lymphocytes, white blood cells and antibodies to home in and attack the tumor cells, so it’s your own immune cells that are going after the tumor and hopefully destroying it,” Ciesielski, an assistant professor of neurosurgery in the department of neurosurgery at Roswell Park, said.

The team has already investigated the medication in a small phase 2 clinical trial that included 63 patients with GBM. The study compared results with historical standard of care data and found that 93% of patients were still alive one year after receiving the vaccine compared with 65% of those who had received standard of care. In addition, the median overall survival in those who received SurVaxM was 30.5 months compared with 14.8 months in those who received standard of care. “We have pretty much doubled the expected survival,” Ciesielski said.

The only side effect seen in this study were skin reactions or rashes around the injection site. “It’s a synthetic vaccine so it’s made of natural amino acids and the body breaks that down as it creates the immune response, so the side effects are minimal,” he said.

Ciesielski hopes the 2020 clinical trial will open in the spring at 20 cancer centers across the United States and China, with Roswell Park serving as the central location. They’re looking to enroll 250 patients with newly diagnosed GBM who have gotten through standard of care. The researchers then plan to use the data from this trial to approach the Food and Drug Administration with more detailed information that could potentially lead to an approval of the vaccine.

The last approved drug for GBM was Temodar (temozolomide) in 2005, explained Ciesielski. Therefore, there is a crucial need for effective therapies to help treat these patients. "The landscape of available options for brain tumor patients is dismal," he said. "We're excited about immunotherapy because it has taken hold in the last few years and had tremendous strides in a number of other cancers. With a lack of side effects and (the fact that) it's an easy therapy to add on top of other things, (SurVaxM) is something we can combine with radiation and chemotherapy. It's the perfect area to be trying to help these patients.”

To keep up-to-date with the upcoming clinical trial, visit Roswell Park Comprehensive Cancer Center’s website.