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Cancer Therapy AdvisorEnfortumab Vedotin Plus Pembrolizumab Nearly Doubles PFS, OS in Bladder Cancer

Enfortumab vedotin plus pembrolizumab was associated with a 55% reduction in the risk of progression or death and a 53% reduction in the risk of death.


In a study presented at the ESMO Congress 2023, researchers revealed that the combination of enfortumab vedotin and pembrolizumab significantly improved survival outcomes in patients with previously untreated, locally advanced or metastatic bladder cancer.

Key Points

  • The study, known as the EV-302/KEYNOTE-A39 trial, included 886 patients with previously untreated, locally advanced or metastatic urothelial carcinoma.
  • Patients were randomly assigned to receive either enfortumab vedotin and pembrolizumab (n=442) or chemotherapy (n=444).
  • The combination of enfortumab vedotin and pembrolizumab was associated with a 55% reduction in the risk of progression or death and a 53% reduction in the risk of death.
  • The median progression-free survival (PFS) was 12.5 months with the combination therapy, compared to 6.3 months with chemotherapy.
  • The median overall survival (OS) was 31.5 months with the combination therapy, compared to 16.1 months with chemotherapy.

This is the first time we’ve managed to beat chemotherapy in the first-line setting for overall survival, despite multiple previous attempts.
Thomas B. Powles, MD, Barts Cancer Institute at Queen Mary University of London in the UK


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