The National Institute for Health and Care Excellence (NICE) has recommended the use of Astellas’ enfortumab vedotin with MSD’s KEYTRUDA (pembrolizumab) as a first-line treatment option for patients in England and Wales living with urothelial cancer, which is metastatic or cannot be completely removed by surgery, when chemotherapy is suitable.
Urothelial cancer is the most common type of bladder cancer and results in around 5600 deaths in the UK annually.
About 90% of bladder cancer cases in the UK are urothelial cancer ... and around a quarter of these cases (around 2500 people) present with locally advanced or metastatic disease at the time of diagnosis.
Patients with inoperable or metastatic urothelial cancer currently face poor prognoses with limited treatment options: 5-year survival rates have been low.
For patients at Stage 4, only around 12% of patients survive for more than 5 years.
Today’s recommendation by NICE therefore introduces a new option for first-line treatment in a space where there is a significant unmet clinical need.
Seventy-seven per cent of those diagnosed with metastatic urothelial cancer in England, who are eligible for chemotherapy, could now be eligible for treatment with enfortumab vedotin plus pembrolizumab each year.
Benson Fayehun, Head of Oncology at MSD in the UK, said: “We welcome NICE’s decision to recommend this treatment for advanced bladder cancer – a condition where patients have long faced limited options and poor outcomes."
"The findings from the EV-302/KN-A39 study, which suggest the potential to nearly double both progression-free and overall survival, mark a significant step forward. This recommendation offers patients and clinicians a much-needed alternative care option.”
Alison Stunt, CEO at Fight Bladder Cancer, said: “This decision is a significant advance for people facing the most aggressive form of bladder cancer at diagnosis."
"Access to this combination in the first-line setting means patients will have a new treatment option that shows the potential to extend life and control disease for longer than chemotherapy alone.”
Professor Thomas Powles, MD, Director of Barts Cancer Centre (QMUL), London, UK, and lead investigator in the trial, said: “We are delighted that NICE is recommending this new treatment option for patients. This combination of enfortumab vedotin and pembrolizumab potentially transforms the lives of many patients with this life-limiting disease.”