A global trial that began in 2007 has confirmed that a vaccine for the treatment of the most lethal brain cancer can give patients years of extended life.
Glioblastoma is not only the most common form of brain cancer but is also one of the deadliest. People affected by the disease only live just 12-18 months after the diagnosis, or even less.
Now, thanks to the vaccine DCVax, some 2,500 people who are diagnosed with deadly cancer in the UK could be benefitted.
The vaccine provides a customized solution
Fifty-three-year-old Nigel French is alive seven years after having the vaccine, The Guardian reported. Another person in the 331-person multicenter, global study lived for more than eight years after receiving DCVax.
"The vaccine works by stimulating the patient’s own immune system to fight against the patient’s tumor. It provides a personalized solution, working with a patient’s immune system, which is the most intelligent system known to man," Professor Keyoumars Ashkan, a neurosurgeon at King’s College hospital in London who was the European chief investigator of the trial, told The Guardian.
Phase three trial gives much hope
"The vaccine is produced by combining proteins from a patient’s own tumor with their white blood cells. This educates 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 it needs to fight against and destroy. Almost like training a sniffer dog," said Ashkan.
All 331 participants had the standard treatment for glioblastoma - surgery followed by radiotherapy and chemotherapy to remove as much of their tumor as possible. Among them, 232 had DCVax and 99 a placebo.
"The total results are astonishing," said Ashkan. "The final results of this phase three trial … offer fresh hope to patients battling with glioblastoma.
The vaccine "was shown to prolong life and interestingly so in patients traditionally considered to have a poorer prognosis," such as older people and people for whom surgery was not an option, he told The Guardian.
DCVax prolongs life, by years
According to trial researchers, newly diagnosed patients who received the vaccine survived for 19.3 months on average. This is in comparison with the 16.5 months for those who had taken a placebo.
And participants with recurrent glioblastoma lived for 13.2 months on average after taking DCVax, in contrast with only 7.8 months for those who did not.
In total, 13 percent of people who received the vaccine lived for at least five years after diagnosis, while just 5.7 percent of the control group did so.
First novel treatment for brain cancer in years
The vaccine is currently not available on the NHS. But Northwest Biotherapeutics, the US company that makes it, is currently working on preparations for applications for regulatory approval.
If approved, DCVax would be the first novel treatment in 17 years for newly diagnosed glioblastoma patients. It would also be the first in 27 years for people to whom it has returned.
"What’s particularly exciting is that [the vaccine] can improve outcomes for people who don’t usually respond well to therapy. While it still needs to pass stringent regulatory approval, it could be a big step forwards in beating this type of brain tumor," said Dr. Henry Stennett, research information manager at Cancer Research UK.
The results of the trial were published in the Journal of the American Medical Association Oncology on November 17.
Study Abstract:
Importance: Glioblastoma is the most lethal primary brain cancer. Clinical outcomes for glioblastoma remain poor, and new treatments are needed.
Objective: To investigate whether adding autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) to standard of care (SOC) extends survival among patients with glioblastoma.
Design, Setting, and Participants: This phase 3, prospective, externally controlled nonrandomized trial compared overall survival (OS) in patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM) treated with DCVax-L plus SOC vs contemporaneous matched external control patients treated with SOC. This international, multicenter trial was conducted at 94 sites in 4 countries from August 2007 to November 2015. Data analysis was conducted from October 2020 to September 2021.
Interventions: The active treatment was DCVax-L plus SOC temozolomide. The nGBM external control patients received SOC temozolomide and placebo; the rGBM external controls received approved rGBM therapies.
Main Outcomes and Measures: The primary and secondary endpoints compared overall survival (OS) in nGBM and rGBM, respectively, with contemporaneous matched external control populations from the control groups of other formal randomized clinical trials.
Results: A total of 331 patients were enrolled in the trial, with 232 randomized to the DCVax-L group and 99 to the placebo group. Median OS (mOS) for the 232 patients with nGBM receiving DCVax-L was 19.3 (95% CI, 17.5-21.3) months from randomization (22.4 months from surgery) vs 16.5 (95% CI, 16.0-17.5) months from randomization in control patients (HR?=?0.80; 98% CI, 0.00-0.94; P?=?.002). Survival at 48 months from randomization was 15.7% vs 9.9%, and at 60 months, it was 13.0% vs 5.7%. For 64 patients with rGBM receiving DCVax-L, mOS was 13.2 (95% CI, 9.7-16.8) months from relapse vs 7.8 (95% CI, 7.2-8.2) months among control patients (HR, 0.58; 98% CI, 0.00-0.76; P?
Conclusions and Relevance: In this study, adding DCVax-L to SOC resulted in clinically meaningful and statistically significant extension of survival for patients with both nGBM and rGBM compared with contemporaneous, matched external controls who received SOC alone.
