Response-Adapted Bladder Preservation for Patients With Muscle-Invasive Bladder Cancer
Key Clinical Summary:
- Design/Population: The SURE-02 trial is a perioperative, response-adapted study evaluating neoadjuvant sacituzumab govitecan plus pembrolizumab followed by surgery or bladder-sparing approaches and adjuvant pembrolizumab in patients with muscle-invasive bladder cancer.
- Key Outcomes: A subset of patients achieved clinical complete response and were able to avoid cystectomy, with encouraging event-free survival observed, particularly among responders.
- Clinical Relevance: This study supports the feasibility of a patient-driven, response-adapted bladder preservation strategy using antibody-drug conjugates plus immunotherapy, with ongoing efforts to refine biomarker-driven patient selection.
Andrea Necchi, MD, San Raffaele Hospital, Milan, Italy, discusses results from the SURE-02 trial evaluating perioperative sacituzumab govitecan plus pembrolizumab in patients with muscle-invasive bladder cancer.
This response-adapted trial incorporated bladder preservation strategies based on clinical response, with a subset of patients able to avoid cystectomy. These findings support the feasibility of combining antibody-drug conjugates with immunotherapy in a bladder-sparing approach.
Source:
Necchi A, Maiorano BA, Jong JJ, et al. Neoadjuvant sacituzumab govitecan plus pembrolizumab, followed by adjuvant pembrolizumab, in patients with muscle-invasive bladder cancer (SURE-02): A single-arm, phase 2 study. Lancet Oncol. Published online: February 27, 2026. doi:10.1016/S1470-2045(26)00050-1
