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Clinical Oncology NewsStudy Provides New First-Line Standard for Advanced Bladder Cancer

Enfortumab Vedotin-ejfv Plus Pembrolizumab Sets New First-Line Standard


A groundbreaking international phase 3 study, EV302, has established a new first-line standard for advanced bladder cancer treatment. The study, presented at the 2023 annual congress of the European Society for Medical Oncology (ESMO), demonstrated that the combination of enfortumab vedotin-ejfv and pembrolizumab significantly outperforms chemotherapy.

Key Points

  • The median overall survival (OS) with enfortumab vedotin-ejfv plus pembrolizumab was 31.5 months, compared to 16.1 months with chemotherapy.
  • The risk of death was reduced by 53% compared to chemotherapy treatment.
  • Progression-free survival (PFS) was also significantly improved, with a median PFS of 12.5 months compared to 6.3 months with chemotherapy.
  • The superiority of enfortumab vedotin-ejfv plus pembrolizumab was consistent across subgroups, including cisplatin-eligible and -ineligible patients and patients with varying levels of PD-L1 expression.
  • Grade 3 and higher treatment-related adverse events (TRAEs) occurred in 56% of the enfortumab vedotin-ejfv plus pembrolizumab group and 70% of the chemotherapy group.

According to the American Cancer Society, about 83,730 new cases of bladder cancer will be diagnosed in the United States in 2023.


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