Dr Cigliola on the Background of the SURE-01 Study in MIBC

Antonio Cigliola, MD, medical oncologist, IRCCS San Raffaele Hospital, discusses the background and safety findings from the phase 2 SURE-01 study (NCT05226117), which evaluated neoadjuvant sacituzumab govitecan-hziy (Trodelvy) in patients with muscle-invasive bladder cancer (MIBC). Notably, these data were shared at the 2024 ASCO Annual Meeting.

Several unmet needs remain for patients with MIBC, particularly for those who are ineligible for cisplatin chemotherapy, Cigliola begins. He shares that approximately 50% of patients with MIBC fall into this category, leaving radical cystectomy or chemoradiation as the standard treatment options. Recognizing the poor prognosis associated with these treatments, the SURE-01 trial was initiated to explore the efficacy of neoadjuvant sacituzumab govitecan in this patient population, Cigliola explains.

The SURE-01 trial is a phase 2 clinical study designed for patients with cT2-4N0M0 MIBC who either could not receive or refused cisplatin-based chemotherapy, he continues. Participants were administered 4 cycles of neoadjuvant sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8, followed by a radical cystectomy. The primary end point of this study was to determine the pathological complete response rate, Cigliola elucidates.

Initially, the study reported treatment-related adverse events (AEs), leading to a protocol amendment after the first 8 patients were treated. Prior to the amendment, several cases of grade 3 or 4 neutropenia and diarrhea were observed, according to Cigliola. Post-amendment, the treatment regimen was well tolerated. Overall, 33.3% of patients experienced grade 3 AEs, and 19.1% of patients experienced grade 4 AEs, with neutropenia and diarrhea being the most common severe AEs, Cigliola shares.

In conclusion, the SURE-01 trial demonstrates promising interim efficacy results with sacituzumab govitecan as a neoadjuvant treatment in cisplatin-ineligible patients with MIBC, with a manageable safety profile post–study amendment, he reports. These findings may pave the way for new treatment approaches in this challenging-to-treat patient population, Cigliola concludes.