(UroToday.com) Muscle-invasive bladder cancer is a systemic disease as >40% of patients ultimately develop recurrence after radical cystectomy. For patients who cannot receive or refuse cisplatin-based chemotherapy, there is no standard-of-care neoadjuvant therapy. Single-agent pembrolizumab, given in the neoadjuvant setting in patients with T2-4N0M0 muscle-invasive bladder cancer, documented a 42% pathologic complete response-rate (ypT0N0) in the previously published PURE-01 trial.1 However, there is a huge proportion of patients who do not benefit from single-agent immune-checkpoint inhibitors. Sacituzumab govitecan is an antibody-drug conjugate composed of a humanized anti-Trop-2 antibody, SN-38 payload (a parent compound of irinotecan), and a hydrolysable linker for SN-38 release. Based on preliminary data from the TROPHY-U-01 trial, sacituzumab govitecan got fast-track designation for urothelial carcinoma by the US FDA. At the 2021 GU ASCO annual meeting, Dr. Andrea Necchi presented the trial design for the SURE trial, aiming to evaluate the efficacy of neoadjuvant sacituzumab govitecan either as a single-agent (SURE-01) or combined with pembrolizumab (SURE-02) before radical cystectomy.