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The world’s first vaccine to treat deadly cancerous brain tumors could potentially give patients years of extra life, a global clinical trial has concluded.
A senior NHS doctor, who was one of the trial’s principal investigators, said the evidence showed DCVak resulted in a “stunning” improvement in patient survival.
The breakthrough could benefit 2,500 people a year in the UK who are diagnosed with glioblastoma, the most common form of brain cancer and also one of the most aggressive. People with the disease live an average of only 12-18 months after diagnosis, some even less.
One patient in a multicenter global study of 331 people lived more than eight years after receiving DCVak. In Britain, 53-year-old Nigel French is still alive seven years after he got it.
“The overall results are stunning,” said Professor Kejumars Ashkan, a neurosurgeon at King’s College Hospital in London, who was the European principal investigator of the trial. “The final results of this phase three trial … offer new hope for patients battling glioblastoma.”
“The vaccine has been shown to extend life, interestingly in patients traditionally thought to have a worse prognosis,” such as the elderly and people for whom surgery was not an option, he added.
If approved by medical regulators, DCVak would be the first new treatment in 17 years for patients with newly diagnosed glioblastoma and the first in 27 years for people in whom it has come back.
The researchers found that newly diagnosed patients who received the vaccine survived an average of 19.3 months, compared to 16.5 months for those who received a placebo.
Participants with recurrent glioblastoma who had DCVak lived an average of 13.2 months after receiving it, compared with just 7.8 months for those who did not.
A total of 13% of people who received it lived at least five years after diagnosis, while only 5.7% of those in the control group did, according to the results of the trial, which were published Thursday in the Journal of the American Medical Association Oncology.
A vaccine is a form of immunotherapy, in which the body’s immune system is programmed to find and attack the tumor. It was first developed to fight brain tumors.
“The vaccine works by stimulating the patient’s immune system to fight the patient’s tumor.” It provides a personalized solution, working with the patient’s immune system, which is the most intelligent system known to man,” said Ashkan.
“The vaccine is made by combining proteins from the patient’s own tumor with their white blood cells. This trains the white cells to recognize the tumor.
“When the vaccine is administered, these educated white blood cells then help the rest of the patient’s immune system recognize the tumor as something to fight and destroy.” It’s almost like training a sniffer dog.”
The vaccine is not yet available on the NHS. But Northwest Biotherapeutics, the US company that makes it, plans to seek regulatory approval to make it available.
The brain tumor research charity said “patients who have been starved of new clinical options for too long” must have access to treatment to extend their lives.
“DCVak represents the first emerging therapy to be proven effective in the treatment of glioblastoma since temozolomide chemotherapy in 2005 and what the brain tumor community hopes is that it will become affordable, possibly standard of care – so available on the NHS,” she said. Dr Karen Noble, the charity’s director of research, policy and innovation.
“The average survival time for glioblastoma is devastatingly short – only 12 to 18 months.” Stories like Mr. French’s are rare but incredibly welcome. We are very encouraged by the final results of this trial,” she added.
Twenty of the 331 patients in the eight-year trial were in the UK, either at King’s Hospital or University College London. A total of 232 participants received DCVak and 99 received placebo. All 331 underwent surgery followed by radiotherapy and chemotherapy to remove as much of the tumor as possible, which is the standard treatment for glioblastoma.
Dr Henry Stennett, Research Information Manager at Cancer Research UK, said: “What is particularly exciting is that [the vaccine] it can improve outcomes for people who don’t usually respond well to therapy. Although it still needs to go through strict regulatory approvals, it could be a big step forward in defeating this type of brain tumor.
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