Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303.

Journal Article (Clinical Trial, Phase III;Journal Article)

Muscle-invasive bladder cancer (MIBC) is associated with high rates of recurrence and poor prognosis despite aggressive treatment. Neoadjuvant chemotherapy before radical cystectomy (RC) improves outcomes in cisplatin-eligible patients; however, the improvement in overall survival is modest. Standard of care for cisplatin-ineligible patients remains RC; more effective systemic therapies are needed. Recent Phase Ib/II studies suggest pembrolizumab monotherapy and combination therapy are effective neoadjuvant therapies for MIBC. The randomized Phase III KEYNOTE-866 and KEYNOTE-905/EV-303 studies are being conducted to evaluate efficacy and safety of perioperative pembrolizumab or placebo with chemotherapy in cisplatin-eligible patients with MIBC (KEYNOTE-866) and of pembrolizumab monotherapy versus pembrolizumab plus enfortumab vedotin versus RC plus pelvic lymph node dissection alone in cisplatin-ineligible patients with MIBC (KEYNOTE-905/EV-303). Clinical trial registration: NCT03924856 & NCT03924895 (

Full Text

Duke Authors

Cited Authors

  • Galsky, MD; Hoimes, CJ; Necchi, A; Shore, N; Witjes, JA; Steinberg, G; Bedke, J; Nishiyama, H; Fang, X; Kataria, R; Sbar, E; Jia, X; Siefker-Radtke, A

Published Date

  • August 2021

Published In

Volume / Issue

  • 17 / 24

Start / End Page

  • 3137 - 3150

PubMed ID

  • 34008425

Electronic International Standard Serial Number (EISSN)

  • 1744-8301

Digital Object Identifier (DOI)

  • 10.2217/fon-2021-0273


  • eng

Conference Location

  • England