The subject of nearly a decade of research, SurVaxM is a vaccine designed to prevent a rare and aggressive type of brain cancer called glioblastoma from coming back once it’s been treated. It’s a series of injections given to a patient after surgery and radiation designed to stimulate the patient’s own immune system to target and kill the specific cells that fuel cancer.
People are also reading…
The vaccine was developed by Robert Fenstermaker, MD, Chair of Neurosurgery at Roswell Park, and Michael Ciesielski, PhD, Assistant Professor of Neurosurgery, both of whom have been working on this breakthrough therapy at Roswell continuously since day one.
“It’s exciting for us for how this has developed,” explains Dr. Ciesielski. “When we initially introduced it to a few patients in phase 1, we saw increases in survival. That was the drive for us to continue – it was obviously helping.”
SurVaxM was first tested in a phase 1 clinical trial in 2012 to demonstrate that it’s safe for use in people. Based on the results of that study, the FDA approved a phase 2 clinical trial at five centers to evaluate whether the treatment worked. The results of the latest trial, reported at a meeting of the American Society of Clinical Oncology in 2019, showed that patients lived longer when they got the vaccine combined with standard therapy compared to what is expected for patients who received standard therapy alone.
Those results advanced SurVaxM into late-stage clinical trials that are now underway at research sites around the United States. Roswell was the first to enroll patients in a phase 2B randomized clinical trial in February and has since been joined by 14 additional study sites including the Cleveland Clinic, Dana-Farber Cancer Institute, New York University and the University of California San Francisco. In total, more than 300 people will be enrolled in this clinical trial, which is expected to last about two years.
“In this phase of study, we’re looking for overall response, plus immune response, to the vaccine,” explains Dr. Ciesielski. “We’re interested in what kind of antibodies it produces and how it stimulates patients’ own T-cell production, and we’re trying to determine what levels are best.”
Once this phase of research is complete, Drs. Ciesielski and Fenstermaker hope to use the data they gather to ask the U.S. Food & Drug Administration to advance the research into a phase 3 pivotal study, which is the final study that could allow the vaccine to be approved for wider use.
“Now that we’ve reached late phase trials, we’re starting to appreciate the magnitude of what we’re doing to provide help for patients who really don’t have a lot of other clinical options,” says Dr. Ciesielski. “The field hasn’t changed much in 20 years because it’s a rare disease, and we’re trying to fix that. There are more than 15,000 people in this country diagnosed with this type of cancer each year – that’s a lot of lives.”