THE first large-scale clinical trial of a new kind of cancer treatment using a patient’s own natural “killer cells” to destroy solid tumours will begin within a year, scientists have told The Independent on Sunday.
Dozens of patients with advanced cancer will take part in a trial being planned in the US and Europe – including Britain – starting either later this year or early in 2017. It will be the first big test of so-called T-cell therapy in patients with solid tumours where conventional therapies have failed.
The trial is one of several in the new field of “immuno-oncology” in which the body’s immune defences are corralled to fight the disease. Many experts consider it the most exciting advance since the development of chemotherapy half a century ago.
White blood cells called T-cells are a critical part of the immune system because they have evolved to target and destroy invading infections caused by viruses and bacteria. However, scientists are increasingly convinced that a patient’s T-cells can be manipulated to identify and kill cancer cells.
Several clinical trials using T-cell therapy on “liquid” tumours, such as the blood cancers, have produced astonishing results. One of the most famous cases revealed earlier this year was that of a one-year-old girl suffering from an aggressive, incurable form of leukaemia until she was cured after a transfusion of donated, engineered T-cells at Great Ormond Street Hospital in London.
Now scientists hope to show that T-cell therapy can work on the much harder problem of “solid” cancers, which have proved challenging to treat partly because of the difficulty of attacking all the cancer cells hiding deep inside each tumour.
Adaptimmune, a biotech company based near Oxford, has signed a $500m (£350m) deal with the drugs giant GSK to organise the first large clinical trial, involving up to 100 cancer patients, of its genetically engineered T-cell technology, which has been shown to be safe and remarkably effective in earlier, smaller trials on 12 solid-tumour patients.
Another trial reported last year of the T-cell therapy on the liquid tumours of people with advanced multiple myeloma – a cancer of plasma cells in the bone marrow and blood – produced “persistent and prolonged” effects in 16 out of 20 patients, with 14 showing a near-complete or complete response.
The results helped to oil the deal between Adaptimmune, which was set up only in 2008 but now has about 1,000 employees, and GSK. It will allow a trial involving patients with synovial sarcoma, a solid-tumour cancer of the joint membranes, to be accelerated.
“Synovial sarcoma is a particularly intractable cancer of the soft tissues around the joints, which tends to affect younger people – the average age of incidence is mid-thirties. Between 75 and 80 per cent of patients do not survive two years,” said Helen Tayton-Martin, chief operating officer of Adaptimmune.
The only approved drug to treat this aggressive cancer produced a 4 per cent response rate in a trial of 250 patients, but Adaptimmune’s engineered T-cells showed response rates of more than 50 per cent in the initial small-scale trial on a dozen patients.
The baby at Great Ormond Street received donated T-cells, but Adaptimmune takes them from the patient themselves. These are then engineered in the laboratory to target cancer cells before being infused back into the patient’s bloodstream.
The company is hoping to finish the larger trial in time to register its T-cell therapy for sarcoma by the end of the decade. This would make it the first T-cell therapy with an engineered T-cell “receptor” protein targeted at cancer cells to be sold on the open market, Dr Tayton-Martin said.
Adaptimmune is one of several research companies around the world working in immuno-oncology, a field that analysts expect to be worth about $25bn a year in the near future. In the past two years alone, there have been about 50 big deals between pharma giants such as GSK and smaller outfits such as Adaptimmune.