Pfizer and Astellas announced updated results from the Phase 3 EV-302 trial, showing sustained overall survival (OS) and progression-free survival (PFS) benefits with enfortumab vedotin plus pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). After a median follow-up of 29.1 months, the combination therapy continued to demonstrate a significant reduction in the risk of death and disease progression compared to chemotherapy. These findings were presented at the 2025 ASCO GU Symposium.
This updated data solidifies the combination therapy’s position as a standard of care for la/mUC. The sustained efficacy observed over a longer follow-up period provides further confidence in the treatment’s long-term benefits for patients, especially given the historically poor prognosis associated with advanced urothelial cancer. This reinforces the potential for this combination to significantly improve patient outcomes and reshape the treatment landscape.
The combination therapy reduced the risk of death by 49% and extended median OS to 33.8 months compared to 15.9 months with chemotherapy. The risk of disease progression or death was reduced by 52%, with a median PFS of 12.5 months for the combination versus 6.3 months for chemotherapy. The confirmed objective response rate was 67.5% with the combination compared to 44.2% for chemotherapy. Importantly, these benefits were observed across all patient subgroups, including those eligible and ineligible for cisplatin. The safety profile remained consistent with earlier findings.
These results further establish enfortumab vedotin plus pembrolizumab as a crucial first-line treatment for la/mUC. The sustained efficacy observed with longer follow-up, coupled with the previously demonstrated improvements in OS and PFS, indicates the potential for improved long-term survival and disease control for patients with this aggressive cancer type. This continued success supports broader adoption of the combination therapy and suggests further exploration in other stages of urothelial cancer.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
