Brain cancer clinical trial shows promising results

A vaccine using patients’ immune cells to target brain cancer can extend survival by many months or even years in some cases, the new trial results suggest.

The trial has been running for ten years and involves more than 300 patients from the UK, the US, Canada and Germany – all of whom had been diagnosed with glioblastoma, the most aggressive form of adult brain tumour.

The early findings were published yesterday (29 May) in the Journal of Translational Medicine. Patients who took part in the trial, the largest so far of an immunotherapy vaccine (DCVax-®L) survived for more than 23 months on average following surgery.

Of the 331 people who took part in the trial, almost one third (100) are classed as ‘extended survivors’ who at the time of the researchers’ analysis had lived for 40.5 months on average following surgery. The longest survivors have lived for more than seven years after surgery.

Unlike chemotherapy and radiotherapy, the immunotherapy vaccine caused no reported side effects in the vast majority of patients. Only seven of the 331 patients who took part reported any significant adverse effects which may have been related to their treatment.

Professor Ashkan, Professor of Neurosurgery at King’s, said: “The interim results of this phase 3 trial give new hope to the patients and clinicians battling with this terrible disease.

“Although definitive judgment needs to be reserved until the final data is available, the paper published today hints at a major breakthrough in the treatment of patients with glioblastoma.

“This is significant and much-needed, given that the last widely accepted major advancement in the field occurred over a decade ago.

“Cautious optimism is welcome in an area where for so long the disease and suffering have had the upper hand.”

DCVax-®L has been developed by US company Northwest Biotherapeutics. It is created for each patient individually by isolating specific immune cells, known as dendritic cells, from his or her blood.

These cells are then primed with biomarkers from a sample of the patient’s tumour. When the vaccine containing the cells is injected back into the patient, they share that information so that the body’s entire immune system recognises the target to attack.

All of the participants in the trial underwent the standard treatment for glioblastoma of surgery followed by radiotherapy and chemotherapy.

Two thirds (232 patients) were then injected regularly with DCVax-®L along with further chemotherapy (temozolomide).

The remaining third were given a placebo – an indistinguishable and harmless substitute for the vaccine – along with temozolomide.

Neither the patients nor the clinicians involved knew which participants were being given the vaccine and which the placebo.

However, every patient whose tumour recurred during the trial was automatically offered DCVax-®L, so that almost nine out of ten of all trial participants (86.4%) received the vaccine at some point.

The researchers call for further follow-up and analysis, but conclude that ‘the patients in this Phase 3 trial are living longer than expected’.