Swiss drug regulators have approved the world’s first therapeutic vaccine to treat brain cancer, six months ahead of schedule. The new vaccine, known as DCVax-Brain, uses a patient’s own immune system to attack the tumour, and is expected to be available to selected Swiss physicians later this year. Patients using the vaccine can hope to see their life expectancy more than double, and delayed nearly threefold rates of brain cancer recurrence, based on the results of ongoing clinical trials by US manufacturer Northwest Biotherapeutics (NWB).
‘When patients are diagnosed with primary brain cancer they have a median survival time of 12 months after radiation and surgery,’ commented Navid Malik, an analyst at Collins Stewart, NWB’s house broker. ‘A typical chemotherapy drug gives them only an additional two months. With this product, so far half the patients in the trial are still alive after 33 months, an additional 20 months over standard care – and continuing.’
One of the other big advantages of DCVax-Brain is the lack of side effects, such as vomiting, hair loss and neurotoxicity, associated with conventional chemotherapy drugs, including Temodar (Schering-Plough) and Gliadel Wafer (MGI Pharma). Malik said the vaccine allows patients ‘to carry on their normal lives’. The company plans to sell the treatment to healthcare agencies at a total cost of $66 000/patient over three years, compared with a selling price of $75 000/patient for Temodar for just one year.
DCVax products are personalised treatments, made by combining a patient’s own master immune (dendritic) cells with cancer biomarkers displayed by their own tumour. Precursors of the master immune cells circulate continuously in a patient’s blood and are obtained by a blood draw. The master immune cells are then matured and ‘educated’ through exposure to the patient’s tumour biomarkers, before being stored frozen in single-dose vials ready for injection back into the patient as needed.
The key to the product’s cost-effectiveness, the company claims, is a proprietary batch manufacturing process that produces enough of the treatment for each patient for at least three years.
Other cancer experts urge caution, however. Kat Arney, science information officer at Cancer Research UK, commented: ‘We welcome any new research that could lead to improved survival for people with brain cancer and cancer vaccines have great potential. But it’s important to remember that this treatment hasn’t yet been through large-scale clinical trials for brain cancer.’
EU and US approval will have to wait until after the results of ongoing trials in 141 cancer patients in the US, expected to complete at the end of next year. Until then, brain cancer patients seeking to use the vaccine will need to travel to Switzerland to receive treatment. Collins Stewart expects the company to deliver sales of $15m next year and $36m by 2009 in Switzerland alone, Malik said, noting that there are roughly 1000 people in Switzerland with brain cancer and about 40 000 with primary brain cancer in the EU.
One of the first personalised cancer vaccines, DCVax-Brain promises to be a platform technology against most cancers, NWB claims. The vaccine is about to start Phase III trials in prostate cancer later this year and has also received clearance from the US Food & Drug Administration for clinical trials in five other cancers, including lung cancer – the leading cause of cancer deaths worldwide. In future, NWB will also look to extend the trials to other types of brain cancers beyond primary tumours, formed by metastases from cancers elsewhere in the body, Malik commented, potentially opening up a much bigger market.
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