Open AccessPerioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303
Author(s) -
Matthew D. Galsky,
Christopher J. Hoimes,
Andrea Necchi,
Neal D. Shore,
J. Alfred Witjes,
Gary D. Steinberg,
Jens Bedke,
Hiroyuki Nishiyama,
Fang Xiao,
Ritesh Kataria,
Eric Sbar,
Xieyang Calvin Jia,
Arlene O. SiefkerRadtke
Publication year - 2021
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2021-0273
Subject(s) - pembrolizumab , medicine , cystectomy , cisplatin , bladder cancer , oncology , durvalumab , lymph node , chemotherapy , perioperative , placebo , cancer , urology , surgery , immunotherapy , pathology , alternative medicine
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 (ClinicalTrials.gov)