The world’s first vaccine to treat deadly cancerous brain tumors can potentially give patients extra years of life, a global clinical trial has concluded.
A senior NHS doctor who was one of the lead investigators on the trial said the evidence showed that DCVax had resulted in “astonishing” improved survival for patients.
The breakthrough could benefit the 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 on average only 12 to 18 months after diagnosis, some even less.
One patient in the global multicenter study of 331 people lived more than eight years after receiving DCVax. In Britain, Nigel French, 53, is still alive seven years after having it.
“The overall results are staggering,” said Professor Keyoumars Ashkan, a neurosurgeon at King’s College London Hospital, who was the trial’s European principal investigator. “The final results of this phase three trial… offer new hope to patients battling glioblastoma.
The vaccine “has been shown to prolong life and, interestingly, in patients traditionally considered to have a worse prognosis,” such as older people and people for whom surgery was not an option, he added.
If approved by medical regulators, DCVax 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 had recurred.
Trial investigators found that newly diagnosed patients who received the vaccine survived for an average of 19.3 months, compared with 16.5 months for those who received a placebo.
Participants with recurrent glioblastoma who received DCVax lived an average of 13.2 months after receiving it, compared with just 7.8 months for those who did not receive it.
Overall, 13% of people who received it lived for at least five years after diagnosis, while only 5.7% of the control group did, according to the trial results, which were published Thursday in the Journal of the American Medical. Oncology Association.
The vaccine is a form of immunotherapy, in which the body’s immune system is programmed to track down and attack the tumor. It is the first developed to deal with brain tumors.
“The vaccine works by stimulating the patient’s own 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,” Ashkan said.
“The vaccine is produced by combining proteins from the patient’s own tumor with their white blood cells. This educates the white blood cells to recognize the tumor.
“When the vaccine is given, these educated white blood cells help the rest of the patient’s immune system recognize the tumor as something to fight and destroy. 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 so it can be made available.
The Brain Tumor Research charity said “patients who have been deprived of new clinical options for too long” needed to be able to access treatment to prolong their lives.
“DCVax represents the first emerging therapy to have demonstrated efficacy in the treatment of glioblastoma since temozolomide chemotherapy in 2005 and what the brain tumor community hopes is that it will be affordable, possibly becoming the standard of care, so widely available in the NHS,” said Dr Karen Noble, the charity’s director of research, policy and innovation.
“The median survival time for glioblastoma is devastatingly short – just 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,” he added.
Twenty of the 331 patients in the eight-year trial were in the UK, either at King’s Hospital or University College London. Overall, 232 participants received DCVax and 99 a placebo. All 331 underwent surgery followed by radiation therapy and chemotherapy to remove as much of their tumor as possible, which is the standard treatment for glioblastoma.
Dr Henry Stennett, Cancer Research UK research information manager, said: “What is particularly exciting is that [the vaccine] it can improve outcomes for people who generally do not respond well to therapy. While it has yet to pass strict regulatory approval, it could be a big step forward in beating this type of brain tumor.”
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