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).
Future oncology (London, England). 2021 May 19 [Epub ahead of print]
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
Department of Medicine, Icahn School of Medicine at Mount Sinai, NY 10029, USA., Department of Medicine, Duke University, Durham, NC 27710, USA., Department of Medical Oncology, Vita-Salute San Raffaele University & IRCCS San Raffaele Hospital, Milan, 20132, Italy., Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC 29577, USA., Department of Urology, Radboud University, Nijmegen Heyendaal 6500, The Netherlands., Department of Urology, NYU Langone Health, NY 10017, USA., Department of Urology, Eberhard Karls Universität Tübingen, Tübingen, 72076, Germany., Department of Urology, University of Tsukuba, Ibaraki, 305-8577, Japan., Department of Clinical Research, Merck & Co., Inc., Kenilworth, NJ 07033, USA., Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.