Subgroup Analysis of SunRISE-2

At the 2026 ASCO Genitourinary Cancers Symposium, Dr Andrea Necchi shared the final results of the SunRISe-2 phase 3 trial, which compared the efficacy of the Gemcitabine Intravesical System (Gem-iDRS) plus cetrelimab against the standard-of-care chemoradiotherapy (CRT) for patients with muscle-invasive bladder cancer. This specific patient population consisted of individuals who were either ineligible for or chose to refuse a radical cystectomy, making bladder-sparing alternatives a high priority for their clinical management.

Dr Necchi emphasized the striking consistency of the data throughout the final analysis. He noted that the primary results were supported by uniform findings across all pre-specified subgroups, which will be further detailed in the forthcoming manuscript's forest plots. No specific patient characteristics or baseline tumor demographics appeared to significantly deviate from the overall trend, suggesting that the treatment's performance was predictable across the study population.

Despite the innovative approach of combining intravesical drug delivery with systemic immunotherapy, the trial concluded that the experimental arm did not achieve superiority over the established standard of chemoradiotherapy. The data showed that the rates for bladder-intact event-free survival, metastasis-free survival, and overall survival at the 24-month mark were statistically comparable between the two groups.

Ultimately, Dr Necchi highlighted that while the study did not displace CRT as the preferred standard, it provided a rigorous benchmark for future bladder-preservation research. The safety profile remained manageable and consistent with previous observations, reinforcing that while the Gem-iDRS and cetrelimab combination is a viable biological approach, chemoradiotherapy remains a formidable and effective hurdle to overcome in the treatment of muscle-invasive disease.