Enfortumab vedotin (Padcev) + Pembrolizumab (Keytruda) granted EU approval for first-line treatment of unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.

Astellas announced European Union (EU) approval of enfortumab vedotin (EV/Padcev; Nectin-4 ADC) in combination with pembrolizumab (P/Keytruda; anti-PD-1) for first-line treatment of unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.

Key Highlights:

• this approval follows the positive opinion given by the CHMP in July 2024
  • EV+P has already been approved for 1L la/mUC in the US in Dec 2023, South Korea in July 2024, and Canada (Aug 2024)
  • Astellas has also disclosed filings for EV+P in Japan (Astellas est. approval in Q4 2024) and China (Mar 2024)
• The approval was based on the transformative results from the P3 EV-302/KEYNOTEA39 trial, which was presented at ESMO 2023 (#LBA6) and published in NEJM
  • In the trial, EV+P nearly doubled both PFS (12.5 vs 6.3 mo; HR 0.45) and OS (31.5 vs 16.1 mo; HR 0.47) versus platinum-based chemo
  • The safety profile of EV+P was generally consistent with previous clinical trials, with key signals including rash and peripheral neuropathy
• As the global 1L standard of care, EV+P sets the bar for future regimens including for potential Trodelvy development
  • Both ESMO and EAU bladder cancer treatment guidelines were updated earlier in the year to list EV+P as the preferred regimen and new standard of care