Real-world Uptake of Enfortumab Vedotin plus Pembrolizumab after US Food and Drug Administration Approval Among Patients with Advanced Urothelial Cancer

European Urology |
2024
Research Categories

Background:
The phase 3 EV-302 trial demonstrated that enfortumab vedotin plus pembrolizumab (EV + P) significantly improved overall survival over platinum-based chemotherapy in advanced urothelial cancer. EV + P received accelerated FDA approval (AA) in April 2023 for cisplatin-ineligible patients and full approval (FA) in December 2023 for all patients. This study examines real-world EV + P uptake in the United States post-approval.

Methods:
Using Flatiron Health electronic health records (EHRs) from 280+ US clinics, we analyzed 2,838 patients who initiated first-line therapy before (July 1, 2020 – April 3, 2023) and after (April 4, 2023 – March 30, 2024) EV + P approval. Linear probability models estimated changes in treatment selection.

Results:
EV + P use increased significantly post-approval:

  • Post-AA: +21.1% (95% CI, 18.5–23.6%)
  • Post-FA: +42.1% (95% CI, 37.1–47.2%)
    Platinum-based chemotherapy and immunotherapy alone declined. After FA, 50% of patients received EV + P.

Conclusion:
EV + P rapidly replaced platinum chemotherapy as standard first-line therapy in advanced urothelial cancer. Findings reflect community-based practices, with further research needed on long-term impact.

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