GU Cancers 2026 | SURE-02: primary analysis of neoadjuvant SG and pembrolizumab in MIBC

For two trial moves in the same line for bladder-sparing approaches, response-adapted bladder-sparing approaches. SURE-2 is a trial that provides a new adjuvant part with combination therapy with Sacituzumab govetican so an ADC targeting of TROP2 and Pembrolizumab. Then the treatment to the bladder which is based on patient decision either radical cystectomy or RT or BT in case of refusal of radical cystectomy and then the third period of treatment with the maintenance or adjuvant Pembrolizumab for one year. The study provided the clinical complete response rate of 40%, so patients who were able to skip radical cystectomy underwent a re-TURBT without any evidence of residual disease and the pathological examination of about 40%. And it should be noted that the entirety of the patients undergoing the re-TURBT, and in particular those who had their clinical CR, did not experience any kind of extravesical relapse. So the metastasis-free survival was 100% in these patients. Also, the event-free survival, with event-free survival definition capturing all the types of events, including high-grade intravesical superficial relapses to the bladder, was quite compelling. 70% in the ITT population that rise up to 90% in the clinical complete responders and also the metastasis-free survival was quite good. So tolerability should be noted. The tolerability with the reduced dose of 7.5 milligrams per kilo of Sacituzumab instead of the standard dose of 10 milligrams was quite good. It was quite good. The treatment was quite well tolerated. There were no grade four or higher side effects. So the treatment was pretty well tolerated also with the GCSF use.

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