Padvec–Keytruda combination approved by NICE for metastatic urothelial cancer
NICE has approved the use of Padcev™ (enfortumab vedotin) with Keytruda® (pembrolizumab) as a first-line treatment for adults with metastatic urothelial cancer.
Padvec (from Astellas Pharma, Tokyo, Japan) in combination with Keytruda (produced by MSD, RJ, USA) has been approved for prescription for unresectable or metastatic urothelial cancer. This will make the drugs available through the NHS in England and Wales for bladder cancer patients eligible for platinum‑containing chemotherapy. Approximately 5600 patients diagnosed with bladder cancer die annually in the UK, with only 29% of those diagnosed surviving for longer than a year. The NICE approval is significant in meeting an unmet need in treatment options.
Stephen Kinnock, the Minister for Health hailed the combined therapy approach, commenting that: “This breakthrough treatment will give people precious extra time with their families. This is exactly what modern healthcare looks like – saving lives by providing access to the best support available.”
Slow–release gemcitabine device targets bladder cancer more effectively
The TAR-200 device, which releases a common chemotherapy agent over 3 weeks, eliminated tumors in 80% of patients studied.
Preclinical data suggests that Padcev, an antibody-drug conjugate, works by binding to Nectin-4, a highly expressed cell surface protein found in bladder cancers. This is followed by the emission of an anti-tumour agent– resulting in cancer cell death. Whilst Keytruda’s mechanism of action is to bind to the PD-1 receptor and block its interaction with PD‑L1 and PD‑L2, helping to restore the immune response.
The approval is based on data from EV-302, an ongoing, open-label, randomized, controlled Phase III trial with 886 participants diagnosed with untreated, unresectable advanced urothelial cancer (accounting for 90% of all bladder cancers). The trial shows that overall survival is double with the combined treatment, at 33.8 months compared 15.9 months for those patients undergoing chemotherapy. There are similar statistics for progression free survival, with 12.5 months compared to 6.3 months on chemotherapy alone. A notable number of patients, around 30%, achieved complete remission.
Helen Knight, Director of Medicines Evaluation at NICE gushed about the therapy, stated: “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.”