On 10 February 2025, Pfizer and Astellas Pharma announced positive results from their Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The trial evaluated the efficacy and safety of Padcev® (enfortumab vedotin-ejfv) in combination with MSD’s Keytruda® (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The results demonstrated a sustained overall survival and progression-free survival benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up.
The combination therapy was approved in China in January 2025 for adult patients with locally advanced or metastatic urothelial cancer. It has received several other approvals over the past 12 months, including in the UK (October 2024) the EU (September 2024), Japan (September 2024), Canada (August 2024), and the US (December 2023).