NICE recommends a new treatment for advanced urothelial cancer, with clinical trials showing survival rates that are almost twice as long compared to standard treatment.
The National Institute for Health and Care Excellence (NICE) has recommended a new first-line treatment for adults with advanced bladder cancer.
Enfortumab vedotin (also known as Padcev and made by Astellas) with pembrolizumab (also known as Keytruda and made by MSD) is recommended for treating unresectable or metastatic urothelial cancer for people who are eligible for platinum-containing chemotherapy.
The combination treatment is a step change in cancer care. Clinical trial evidence shows that it can significantly extend both progression-free survival and overall survival compared to current standard chemotherapy treatments.
“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,” said Helen Knight, director of medicines evaluation at NICE.
“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,” she continued.
It is estimated that more than 1,200 people per year could benefit from this targeted treatment, which is given as an infusion in a clinic or hospital. It is made up of a monoclonal antibody which recognises and kills certain cancer cells.
More than 10,000 people are diagnosed with bladder cancer each year in the UK, and only around 10% of people with Stage 4 bladder cancer will survive five years or more after they are diagnosed.
A leap forward
The recommendation is based on evidence from a clinical trial involving 886 adults with untreated unresectable locally advanced or metastatic urothelial cancer. Progression-free survival almost doubled for people taking enfortumab vedotin and pembrolizumab to 12.5 months compared with 6.3 months for those on chemotherapy, and overall survival increased to a median of 33.8 months for those on the combination treatment compared with 15.9 months for those on chemotherapy.
Around 30% of people on the trial achieved a complete remission following treatment with enfortumab vedotin and pembrolizumab, meaning all detectable signs of the disease had disappeared.
The news was welcomed by medical professionals.
“The NICE recommendation is a major leap forward for urothelial cancer care,” said Ian Pearce, president of the British Association of Urological Surgeons.
“For patients battling advanced bladder cancer, the prospect of having increased rates of progression-free survival and overall survival, combined with lesser side-effects compared to traditional treatment methods, is nothing short of transformative,” he added.
“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,” said Jeannie Rigby, chief executive of charity Action Bladder Cancer UK. “It’s also of importance that this treatment can mean these patients can experience a better quality of life with less hard-to-tolerate side effects,” she continued.
