First new treatment for advanced bladder cancer in decades given green light
Experts said the approval of the new treatment combination would bring a 'fundamental shift' in care for patients with late-stage disease, saying that until now, the treatment for advanced bladder cancer had not significantly changed since the 1980s.
They said there had been real 'unmet need' for patients with advanced disease, with some 29% of people diagnosed with stage 4 cancer – when the cancer has spread to other parts of the body – surviving for a year after diagnosis.
It is estimated that 1,250 people a year could benefit from the treatment.
The new treatment combination includes enfortumab vedotin, an antibody-drug which is also known as Padcev, made by Astellas and Pfizer – with pembrolizumab, a drug known as a PD-L1 inhibitor, also known as Keytruda, which is made by Merck.
Clinical trials suggest that the treatment combination, when tested against platinum-based chemotherapy, led to improved survival for patients.
'Prior to the EV-302 clinical trial, the treatment of advanced bladder cancer treatment hadn't significantly changed since the 1980s,' Professor Thomas Powles, director of Barts Cancer Institute Biomedical Research Centre (QMUL), UK and primary investigator on the trial, said.
'This guidance will fundamentally reshape first-line treatment for eligible patients.'
Trial data indicated that patients who took the treatment combination survived for an average of 33.8 months compared to 15.9 months with chemotherapy.
Researchers also measured the amount of time people survived without their disease worsening – also known as progression-free survival – and found that people on the combination treatment had just more than a year of progression-free survival compared to half-a-year for those on standard treatment.
Three in 10 (30%) patients had a so-called 'complete response' when getting the combination treatment – meaning there was no evidence of cancer remaining. This was compared to 14.5% of those who received chemotherapy.
One patient said that taking part in the trial had given him more time with his grandson.
Martyn Hewett, 75, from Stratford, east London, received the combination treatment on a trial at Barts Health NHS Trust after surgery to remove his tumours failed.
He said: 'I feel very, very lucky, because if I hadn't been on this trial, I imagine I would be dead by now.
'Immediately after the operation that failed, I asked the doctor what the prognosis was, and he said, most people in your position live for a year, and now, three-and-a-half years later here I am.
'I am going to have an extra few years to see my grandson grow up – and maybe even be around to see him get married.'
The treatment combination will now be available for NHS patients in England following the approval from the National Institute for Health and Care Excellence (Nice) for patients with 'unresectable or metastatic urothelial cancer for people who are eligible for platinum-containing chemotherapy' and is given as an IV infusion in hospitals or clinics.
Dr Timir Patel, medical director of Astellas UK, said: 'The guidance from Nice is excellent news for patients.
'Advanced bladder cancer is in an area where there is a real unmet need.
'This combination therapy changes the standard of care for doctors and their patients.'
Helen Knight, director of medicines evaluation at Nice, said: 'This is a highly promising and effective new drug, with clinical trial results highlighting the tremendous difference it could make to the length and quality of people's lives.
'Advanced bladder cancer is a devastating condition which can have a substantial impact on people's daily lives, often leading to them struggling to work, travel or maintain physical activity.'
Professor Peter Johnson, NHS England's national clinical director for cancer, said: 'This is one of the most hopeful advances in decades for people with bladder cancer who will now be offered a treatment that can almost double their chances of survival, helping thousands to live longer and giving them more precious moments with their loved ones.
'Bladder cancer is often difficult to treat once it has spread, but this new therapy is the first one in years to really help stop the disease in its tracks, and our rollout to NHS patients will make a huge difference to the lives of those affected and their families.'
Jeannie Rigby, chief executive of charity Action Bladder Cancer UK, said: 'This new drug has the potential to increase how long people have before their cancer gets worse and how long they live compared with the current, limited, treatment choices available.'
Around 18,000 people in England are diagnosed with bladder cancer each year.
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