A phase III clinical trial of the DCVax®-L cancer vaccine, conducted at the University of Rochester's Wilmot Cancer Institute and other centers internationally, has shown that the vaccine extended survival in patients with newly diagnosed and recurrent glioblastoma brain cancer. This marks the first time in nearly 20 years for such an advance among patients with newly diagnosed glioblastoma and the first time in nearly 30 years that a treatment has shown such survival extension in patients with recurrent glioblastoma.
“We are excited to see the meaningful survival extensions among glioblastoma patients treated with the vaccine in this trial,” said Kevin A. Walter, M.D., a Wilmot researcher and professor of Neurosurgery and Oncology who served as the principal investigator of the trial at the University of Rochester Medical Center (URMC). “Brain cancer is such an aggressive disease, and so many diverse treatments have failed in clinical trials, it is gratifying to be able to help advance a potential new treatment option for patients.”
The trial results, reported in JAMA Oncology, show that newly diagnosed patients treated with the vaccine survived for a median of 22.4 months after surgery, and 13 percent of patients survived at least five years. Newly diagnosed patients who had methylated MGMT gene, which has been associated with improved outcomes for glioblastoma patients, had a median survival of 33 months after surgery.
Patients with recurrent glioblastoma who were treated with the vaccine survived for a median of 13.2 months from recurrence; 20.7 percent of the patients survived for 24 months after recurrence and 11 percent of the patients survived for 30 months.
Glioblastoma is the most common and most lethal form of primary brain cancer. Standard of care treatment has been virtually unchanged for nearly 20 years. With standard-of-care treatments, patients typically survive about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence. Only about five percent of patients who receive standard-of-care treatment survive five or more years after diagnosis.
“Clinical research is a crucial piece of the Wilmot Cancer Institute’s mission,” said Jonathan W. Friedberg, M.D., M.M.Sc., director of the Wilmot Cancer Institute and Samuel E. Durand Chair in Medicine at URMC. “Clinical trials, like this one, provide local and regional patients with access to promising novel treatments and help us advance medicine and cancer care for all.”
Out of the estimated 348 patients who were enrolled in the phase III trial across all 86 study sites, 12 were patients from our region who were enrolled at Wilmot.
The vaccine was made from a patient’s own immune cells and antigens from a sample of the patient’s tumor. The vaccine was administered by an intradermal shot in the upper arm, with six treatments in the first year, and two treatments per year for maintenance thereafter.
According to the phase III clinical trial, the DCVax®-L vaccine was well tolerated. Out of 2,151 doses administered in the trial, there were only five serious adverse events that were deemed at least “possibly related” to the treatment (three cases of intracranial edema, one case of nausea and one case of lymph node infection).
“This personalized immune therapy could be a game-changer for a disease this is so deadly and difficult to treat,” said Walter. “For the first time in 20 to 30 years, there is hope to meaningfully extend patients’ lives.”
This treatment is not yet approved by the U.S. Food and Drug Administration. Based on these promising data, the researchers and trial sponsor, Northwest Biotherapeutics, will work with the FDA to determine how best to bring this vaccine to patients.