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

Matthew D. Galsky, Christopher J. Hoimes, Andrea Necchi, Neal Shore, J. Alfred Witjes, Gary Steinberg, Jens Bedke, Hiroyuki Nishiyama, Xiao Fang, Ritesh Kataria, Eric Sbar, Xieyang Jia, Arlene Siefker-Radtke

Research output: Contribution to journalArticlepeer-review

12 Scopus citations


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 (</ext-link.

Original languageEnglish
Pages (from-to)3137-3150
Number of pages14
JournalFuture Oncology
Issue number24
StatePublished - Aug 2021


  • Antibody-drug conjugate
  • Immunotherapy
  • Muscle-invasive bladder cancer
  • Nectin-4
  • Pembrolizumab
  • Perioperative
  • Programmed death 1
  • Radical cystectomy


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