Andrea Necchi and colleagues published the results of the KEYNOTE-057 trial, which evaluated the activity and safety of pembrolizumab in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer who were ineligible for or declined radical cystectomy. The study reported a 43·5% 12-month disease-free survival rate, highlighting pembrolizumab’s potential as a treatment option.1 However, there are several areas where the study’s methodology and interpretation could be improved to enhance the robustness and applicability of their findings.