SMC backs first-line metastatic bladder cancer combination after trial results

The Scottish medicines consortium has recommended the reimbursement of enfortumab vedotin with pembrolizumab for adults with unresectable or metastatic urothelial cancer who are eligible for platinum‑containing chemotherapy.Astellas Pharma said the decision means doctors and patients in Scotland will be able to access a treatment that substantially increases overall survival through the NHS.Bladder cancer is the ninth most common cause of cancer death in the UK, with around 200 people in Scotland diagnosed each year with unresectable or metastatic disease. Survival remains poor, with only 29% of stage IV patients living more than one year after diagnosis.Professor Rob Jones, Professor of Clinical Cancer Research at the University of Glasgow, said:“Bladder cancer is common, and while most cases remain localised, those that spread are usually fatal. Historically, treatment in Scotland was limited to chemotherapy or immunotherapy. “The combination of enfortumab vedotin and immunotherapy is a step‑change as it is significantly more effective than previously‑used treatments allowing many patients to live longer, healthier lives despite this devastating diagnosis.“I’m delighted that this drug will now be widely available in NHS Scotland and would like to pay tribute to the Scottish patients who took part in the trial which enabled this progress to be made.”The recommendation is based on the EV‑302 phase 3 clinical trial, which compared the combination against platinum‑based chemotherapy in previously untreated unresectable or metastatic bladder cancer.The study showed a median overall survival of 33.8 months for the combination compared with 15.9 months for chemotherapy. Median progression‑free survival was 12.5 months versus 6.3 months, representing a 55% reduction in the risk of progression or death. A confirmed complete response was achieved by 30.4% of patients receiving the combination and 14.5% receiving chemotherapy.Dr Tim Patel, Medical Director at Astellas UK, said: “I am thrilled that we’ve been able to deliver reimbursement for m/UC patients across Scotland. The decision reflects Astellas’ commitment to making the latest innovations accessible in Scotland so doctors and their patients can benefit.”Professor Thomas Powles, Director of Barts Cancer Institute Biomedical Research Centre and primary investigator on the EV‑302 trial, added: “Prior to the EV‑302 clinical trial, the treatment of advanced bladder cancer treatment hadn’t significantly changed since the 1980s. This guidance will fundamentally reshape first‑line treatment for eligible patients.”The SMC decision follows earlier approvals of the combination by the US Food and Drug Administration and the European Commission.