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

doi:10.2217/fon-2021-0273

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 journal › Article › peer-review

12 Scopus citations

Abstract

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)</ext-link.

Original language	English
Pages (from-to)	3137-3150
Number of pages	14
Journal	Future Oncology
Volume	17
Issue number	24
DOIs	https://doi.org/10.2217/fon-2021-0273
State	Published - Aug 2021

Keywords

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

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10.2217/fon-2021-0273

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Galsky, M. D., Hoimes, C. J., Necchi, A., Shore, N., Witjes, J. A., Steinberg, G., Bedke, J., Nishiyama, H., Fang, X., Kataria, R., Sbar, E., Jia, X., & Siefker-Radtke, A. (2021). Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncology, 17(24), 3137-3150. https://doi.org/10.2217/fon-2021-0273

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

abstract = "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)",

keywords = "Antibody-drug conjugate, Immunotherapy, Muscle-invasive bladder cancer, Nectin-4, Pembrolizumab, Perioperative, Programmed death 1, Radical cystectomy",

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

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year = "2021",

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doi = "10.2217/fon-2021-0273",

language = "English",

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AU - Shore, Neal

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AU - Steinberg, Gary

AU - Bedke, Jens

AU - Nishiyama, Hiroyuki

AU - Fang, Xiao

AU - Kataria, Ritesh

AU - Sbar, Eric

AU - Jia, Xieyang

AU - Siefker-Radtke, Arlene

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AB - 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)

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KW - Programmed death 1

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

Abstract

Keywords

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