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Padcev–Keytruda Cuts Recurrence and Death Risk in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

The companies plan regulatory discussions after presenting the late-stage results at ESMO.

Enfortumab Vedotin Plus Pembrolizumab Shows First-Line Activity in PD-L1+ Recurrent/Metastatic HNSCC
Astellas Pharma's logo is pictured at its headquarters in Tokyo, Japan, December 3, 2019. REUTERS/Kim Kyung-Hoon
Padcev is in line to be the first approved antibody-drug conjugate approved for perioperative bladder cancer following data presented at the European Society of Medical Oncology (ESMO) 2025 Congress. Credit: [Inna Kot]/Shutterstock

Overview

  • Phase III EV-303/KEYNOTE-905 tested the combination before and after surgery versus surgery alone in patients who were ineligible for or declined cisplatin.
  • The regimen reduced the risk of tumor recurrence, progression, or death by 60% compared with surgery alone.
  • An estimated 74.7% on the combination were event-free at two years versus 39.4% with surgery alone.
  • Overall survival improved with a 50% reduction in risk of death, with two-year survival reported at 79.7% versus 63.1%, though severe adverse events were more frequent (71.3% vs 45.9%).
  • Separately at ESMO, a phase 2 EV-202 cohort in PD-L1–positive recurrent/metastatic head and neck cancer showed a 39.0% objective response rate, with grade 3 or higher treatment-related events in 41.5% and median overall survival not yet reached.