Eligible patients had clinical stage T2-T4aN0M0 or T1-T4aN1M0 MIBC by central assessment, at least 50% urothelial histology, and an ECOG performance status of 0 to 2, and were cisplatin ineligible per Galsky criteria or declined cisplatin.

Patients received pembrolizumab at 200 mg every 3 weeks for 3 neoadjuvant and 14 adjuvant cycles, with or without enfortumab vedotin at 1.25 mg/kg on days 1 and 8 every 3 weeks for 3 neoadjuvant and 6 adjuvant cycles.

The primary end point was EFS by blinded independent central review; OS and pCR were key secondary end points, and pathologic downstaging (pDS) and safety were additional secondary end points.

The ad hoc ITT population comprised patients randomly assigned between August 2020 and November…