A new clinical trial offers hope for patients with muscle-invasive bladder cancer (MIBC) who cannot tolerate or choose not to undergo standard chemotherapy. The phase 2 SURE-02 trial tested a combination of the targeted therapies Sacituzumab Govitecan (Trodelvy) and Pembrolizumab (Keytruda) as an alternative to radical bladder removal.
The study included 49 patients, with a median age of 66, who were ineligible for or declined cisplatin-based chemotherapy. Participants received four cycles of the dual therapy, and those who responded well were offered a less invasive procedure instead of full bladder surgery, followed by maintenance pembrolizumab. Results were encouraging: 39% of patients achieved a complete clinical response, meaning no visible cancer on imaging or biopsy, and all of them successfully avoided bladder removal.
Safety was manageable, with only 16% experiencing severe side effects, mainly diarrhea, and no treatment-related deaths. During a 14-month follow-up, all patients in the complete response group remained free of metastasis, though two had minor local recurrences. This trial suggests that targeted therapies and immunotherapy could allow nearly 40% of select MIBC patients to keep their bladder while maintaining strong cancer control.