In an ongoing phase III clinical trial, a brain cancer vaccine has significantly prolonged the life of participants with glioblastoma.
A personalized vaccine still in clinical trials may be helping some people with glioblastoma live longer.
Glioblastoma is a highly aggressive form of cancer that can spread quickly throughout the brain.
According to researchers, the five-year survival rate with standard treatment is less than 5 percent. Median survival stands at 15 to 17 months.
In the largest glioblastoma vaccine study to date, median survival is currently at 23 months.
Among those who were enrolled in the trial for more than three years, 30 percent survived more than 30 months.
The phase III trial enrolled 331 patients at more than 80 sites in the United States, Canada, the United Kingdom, and Germany.
The study is led by researchers at the University of California Los Angeles (UCLA) and Northwest Biotherapeutics Inc., the maker of the vaccine.
Interim findings were published in the Journal of Translational Medicine.
The vaccine is called DCVax-L.
It’s made with tissue from each participant’s brain tumor.
This is combined with dendritic immune cells from the person’s blood. In the lab, these cells are primed to attack tumor cells.
When the vaccine is injected into the patient, it prompts the immune system to fight the cancer.
“The survival rate is quite remarkable compared to what would be expected for glioblastoma,” Dr. Linda Liau, lead author of the study and chair of the neurosurgery department at the David Geffen School of Medicine at UCLA and a member of the UCLA Jonsson Comprehensive Cancer Center, said in a press release.
“What’s particularly impressive about immunotherapy trials is that there seems to be a population of about 20 to 30 percent of patients who are living significantly longer than expected — the long tail of the survival curve,” she continued.
“And those are the people in whom we think there may be a particularly strong immune response against their cancer that is protecting them from getting tumor reoccurrence,” said Liau.
To be eligible for the trial, participants had to be between the ages of 18 and 70 and newly diagnosed with glioblastoma.
All participants received standard care for glioblastoma. That includes surgery, plus a combination of chemotherapy and radiotherapy (chemoradiotherapy).
The participants were divided into two groups.
One group of 232 patients had standard care plus DCVax-L. The other group of 99 patients had standard care and a placebo treatment.
All patients who progressed or experienced a recurrence during the trial were given the vaccine. Almost 90 percent of the study participants ended up receiving the vaccine.
For those enrolled more than three years, 67 patients survived more than 30 months. And 44 patients survived more than 36 months. Median survival for those patients is expected to reach 46 to 88 months.
At the time of the interim analysis, 108 of the 331 participants were still alive.
The researchers continue to monitor patients.
Dr. Santosh Kesari is a neurologist and neuro-oncologist and chair of the Department of Translational Neurosciences and Neurotherapeutics at the John Wayne Cancer Institute at Providence Saint John’s Health Center in California.
Kesari, one of the study’s authors, told Healthline that this trial has the potential to be a breakthrough.
In addition to a positive improvement in survival, Kesari said the vaccine is safe. It doesn’t have the negative impact on quality of life that some other cancer treatments can.
Patients receive the DCVax-L six times during the first year. After that, they get it twice a year.
In the trial, only 7 people (2 percent) had serious adverse events that may have been related to the vaccine. These included cerebral edema, seizures, nausea, and lymph gland infection.
Total adverse events in patients taking the vaccine and those receiving standard care alone are comparable.
“The vaccine is given subcutaneously. There can be an injection site reaction, chills, or fever. Compared with chemotherapy and radiation, the vaccine has very low toxicity,” explained Kesari.
The interim results are promising, but Kesari cautions that it’s too soon to know for certain.
“We have to wait for more data on the longer period of outcomes. 90 percent of the study participants ended up getting the vaccine, so you can’t compare the two arms,” he continued.
“Survival looks really good. But the real question is: Can we do a study in the future and really randomize patients so the control arm doesn’t get the vaccine? That’s what’s really needed,” said Kesari.
Dr. Timothy Byun is a medical oncologist with St. Joseph Hospital’s Center for Cancer Prevention and Treatment in California, a facility that participated in the study.
Byun told Healthline that the study outcome is interesting. But, like Kesari, he suspects the crossover of patients from the placebo arm to DCVax-L on progression may impact the analysis of overall survival.
“It is a well-tolerated therapy, so from [a] safety perspective, I don’t worry much. Since we are still waiting for final data, I don’t know if and when the FDA would approve this therapy,” he said.
Byun noted that dendritic vaccine therapy (Provenge) is already in use in metastatic castrate-resistant prostate cancer.
“However, it is not as widely adopted due to limited efficacy and cost,” he said.
“There have been many studies involving dendritic vaccines in different types of cancer and most were not very successful. But with improved understanding of the immune system, more personalized cancer vaccine studies are underway either as monotherapy or in combination immunotherapy,” said Byun.
The researchers involved in the DCVax-L study hope new clinical trials of combination therapies can begin soon.
Personalized medicine — immunotherapy, targeted therapy, and vaccines — is the wave of the future, according to Kesari.