DCVax®-L is an emerging immunotherapy for glioblastoma that works by training the immune system to recognise and attack tumour cells. It is not available on the NHS and is currently under review by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in adults with both newly diagnosed and recurrent glioblastoma. It has been in development for many years and, having completed a Phase III clinical trial in 2022, is among the personalised cancer vaccines furthest through the clinical development pathway for glioblastoma.
How does DCVax®-L work?
DCVax®-L is a personalised immunotherapy that trains a patient’s immune system to recognise and attack glioblastoma cells.
Normally, immune cells circulate around the body, identifying and destroying cells that show signs of infection, damage or harmful mutations. However, cancer cells are capable of ‘fooling’ the immune system so that they can grow and spread undetected by this natural defence system in a process known as immunosuppression.
DCVax®-L aims to overcome this by training dendritic cells, a type of immune cell, to recognise the tumour. Once activated, these cells help direct the wider immune system to find and attack glioblastoma cells.
What does the treatment entail?
To create the treatment, a small sample of the tumour is taken during surgery and combined with dendritic cells isolated from the patient's blood. These dendritic cells learn to recognise tumour-specific markers, known as antigens. The trained cells are then injected back into the patient, where they stimulate a broader immune response against the tumour, helping to slow its growth and progression.
The process of creating a batch of trained immune cells takes around eight days. The cells are then frozen in individual doses, stored centrally and delivered to the medical team when required.
A patient will have six injections in their upper arm over the course of one year. They will then have two injections a year for maintenance after that.
The vaccination protocol would take place alongside current standard of care for glioblastoma patients, which in the UK consists of surgical removal of the tumour followed by radiotherapy and chemotherapy (temozolomide).
How could the vaccine benefit patients?
The Phase III trial results published in 2022 showed that 232 patients who received DCVax®-L lived for a median (average) of 19.3 months, compared with 16.5 months for those receiving standard treatment alone – known as the control group. More than twice as many patients treated with DCVax®-L survived for at least five years (13% versus 5.7%). The greatest benefit was seen in patients with a methylated MGMT gene, who lived for a median of 30.2 months compared with 21.3 months with standard treatment alone.
However, there are some concerns in the scientific community about how the trial was carried out. One of the main issues is that data for those who received standard treatment alone were taken from the results of other clinical trials. This means it is difficult to unpick what is the impact of the immunotherapy and what could be natural variation in survival times between different groups of patients.
What stage is the research at now?
Developers of DCVax®-L, Northwest Biotherapeutics, applied to the MHRA in 2023 following the results of the international Phase III clinical trial which demonstrated a meaningful extension of median survival in both newly diagnosed and recurrent glioblastoma in patients treated with DCVax®-L.
The MHRA is part of the Department of Health and Social Care and is responsible for regulating medicines, medical devices and blood donation for transfusions within the UK. All medicines and medical devices must obtain a Marketing Authorisation from the MHRA to ensure that they are safe and effective before they can be prescribed or sold within the UK. It is usually following a successful MHRA application that a new medicine will be reviewed by the National Institute for Health and Care Excellence (NICE), which considers clinical effectiveness and value for money before recommending its use on the NHS.
The MHRA review is still pending.
Meanwhile, NHS Blood and Transplant has announced it is working with Northwest Biotherapeutics to support the production of DCVax®-L.
Can people in the UK access DCVax®-L?
DCVax®-L is not available on the NHS, but can be accessed privately on compassionate use. Access to the therapy currently requires fresh frozen tissue taken at the time of surgery.
Does Brain Tumour Research recommend that patients access DCVax®-L privately?
We do not provide medical advice and therefore cannot recommend any one particular treatment course. This is an experimental treatment that has not been licensed for medical use in this country or anywhere else in the world. Although there is encouraging data from the Phase III trial, there are some concerns amongst the scientific community about the way the trial was designed and the conclusions that have been drawn. Due to a lack of innovative treatments and the limited number of clinical trials for brain tumour patients in the UK, progress has been minimal. Faced with few options, some patients are turning to private experimental treatments, without any guarantee of better outcomes or improved quality of life, raising substantial funds to cover these costs. We urgently need to invest in research and expand access to innovative trials in the UK, so patients are not faced with these difficult and costly decisions.