@article{2615d8a8d5464b5b84e367c2db853292,
title = "KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC",
abstract = "Background: Nonmuscle-invasive bladder cancer (NMIBC) is the most common form of bladder cancer, with high rates of disease recurrence and progression. Current treatment for high-risk NMIBC involves Bacillus Calmette-Gu{\'e}rin (BCG) therapy, but treatment options are limited for patients with recurrent or BCG-unresponsive disease. Aberrant programmed death 1 signaling has been implicated in BCG resistance and bladder cancer recurrence and progression, and pembrolizumab has shown efficacy in patients with BCG-unresponsive high-risk NMIBC. To describe the rationale and design for the randomized, comparator-controlled Phase III KEYNOTE-676 study, which will evaluate the efficacy and safety of pembrolizumab in combination with BCG in patients with persistent/recurrent high-risk NMIBC after BCG induction therapy. Trial registration number: NCT0371103.",
keywords = "Bacillus Calmette-Gu{\'e}rin, bladder cancer, immunotherapy, nonmuscle-invasive bladder cancer, pembrolizumab, programmed death 1, programmed death ligand 1",
author = "Kamat, {Ashish M.} and Neal Shore and Noah Hahn and Shaheen Alanee and Hiroyuki Nishiyama and Shahrokh Shariat and Kijoeng Nam and Ekta Kapadia and Tara Frenkl and Gary Steinberg",
note = "Funding Information: Medical writing and/or editorial assistance was provided by Matthew Grzywacz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding Information: S Alanne has a consultant/advisory role with Merck and AstraZeneca, has received research funding from Merck, and has received travel/accommodations/expenses from AstraZeneca. H Nishiyama received personal fees during the conduct of the study from Merck Sharp & Dohme. S Shariat has received honoraria and travel expenses/accommodations from Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Cepheid, Ferring, Ipsen, Janssen, Lilly, Merck, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda and Urogen; is a stockholder for Urogen and Sanochemia; and has received research funding (institution) from Sanofi, Roche and Astellas. K Nam and E Kapadia are employees of Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and stockholders in the company. T Frenkl was an employee of Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, at the time of development of this manuscript and a stockholder in the company and is a current employee of GlaxoSmithKline. G Steinberg had a consultant/advisory role for Merck, Cold Genesys, Urogen, Fidia, Ferring, FKD, MDxHealth, Photocure, Natera, QED Therapeutics and Taris Biomedical. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: {\textcopyright} 2020 Merck Sharp & Dohme Corp.",
year = "2020",
month = apr,
doi = "10.2217/fon-2019-0817",
language = "English (US)",
volume = "16",
pages = "507--516",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Taylor and Francis Ltd.",
number = "10",
}