GU Cancers 2026 | SunRISe-2: final results of intravesical gemcitabine and cetrelimab in MIBC

Yeah, SunRISe-2 was a randomized phase 3 trial aimed to compare gemcitabine intravesical system, formerly TR200 plus atezolizumab versus concurrent chemoradiotherapy in patients with T2, T4A, N0, M0, muscle-invasive disease who were refusing or were unfit for radical cystectomy. Patients received a radical TUR or TBT as an excision procedure and then were randomized to receive either the experimental arm, cetrelimab plus intravesical system or chemoradiotherapy. The primary endpoint was the bladder intact and free survival. So the study was initially planned to enroll 550 patients. There was an interim analysis that was planned and was done after the initial 300 patients were enrolled and being eligible for the assessment of the overall response rate at week 18, which was the futility analysis was pre-planned in the study. And based on these results and the totality of the initial data, the IDMC recommended the study to be stopped on September 24. So on September 24, the sponsor amended the study, allowing patients to continue treatment when achieving a complete response in RMA or continuing all the patients randomized to chemoradiation to conclude the treatment. And we present the final analysis, the clinical cut-off date of July 2025, including the final safety data and the estimation of the long-term BIFS data. The data show that the overall response rate was similar between arms, with the CR rate, which was around 50% in both arms. The bladder-intact event-free survival in complete responders was completely overlapping between the two arms, in particular with the estimates of 6 months and 12 months and the coplotmatic curve were completely superimposing. As for the ITT population, the BIEFS was numerically higher in the chemoradiation arm, as compared to TART-100 and ENSAT Trelimab, while MFS, OS, and safety data were pretty much consistent with previous data with both therapeutic strategies and pretty much similar. So the study was at the end a negative study, did not meet the primary endpoint of improving the bladder-intact event for survival, but it should be noted that in both trials the estimates of the 12-month projection of bladder intact EFS were quite compelling and higher than the historical estimates and the CR rate also was quite compelling in both arms. So overall negative study but showing quite positive data in both arms for these patients.

This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.