989TiP - KEYNOTE-905: A phase III study of cystectomy plus perioperative pembrolizumab versus cystectomy alone in cisplatin (cis)-ineligible patients (pts) with muscle-invasive bladder cancer (MIBC)

Current standard of care for pts with MIBC who are ineligible for neoadjuvant cis-based chemotherapy is radical cystectomy (RC) + pelvic lymph node dissection (PLND). Due to high rates of recurrence and relatively poor overall survival (OS) with RC + PLND alone, there is an urgent need for novel perioperative systemic therapy regimens. A recent single-arm study (PURE-01; NCT02736266) showed clinical activity of pembrolizumab as single-agent neoadjuvant therapy in pts with MIBC and that high PD-L1 expression was associated with a higher pathologic complete response rate. KEYNOTE-905 (NCT03924895) is a randomized, global, multicenter, phase 3 trial of perioperative pembrolizumab plus RC versus RC alone in cis-ineligible pts with MIBC. Approximately 610 adult (≥18 years) pts with histologically confirmed diagnosis of MIBC (T2-T4aN0M0) with predominant (≥50%) urothelial histology are eligible. Pts must be ineligible to receive cis, have an ECOG PS score of 0-2, and must not have previously received any systemic anticancer therapies for MIBC. Pts will be stratified by clinical T stage (T2 vs T3/4), PD-L1 combined positive score (CPS) (≥10 vs