Andrea Necchi, MD, highlights final results from the SunRISe-4 trial

In an interview at the 2025 European Society for Medical Oncology (ESMO) Congress, in Berlin, Germany, Andrea Necchi, MD, sat down with Urology Times® to highlight final results from the phase 2 SunRISe-4 trial (NCT04919512).¹ The SunRISe-4 study is assessing neoadjuvant gemcitabine intravesical system (formerly TAR-200) plus cetrelimab vs cetrelimab alone in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for radical cystectomy and are ineligible or refuse neoadjuvant platinum-based chemotherapy.

Previous data from the study were published in Lancet Oncology, showing a high pathological complete response (pCR) rate and manageable safety profile with the combination.²

Necchi is an associate professor of oncology at Vita-Salute San Raffaele University in Milan, Italy, and Director of GU Medical Oncology at San Raffaele Hospital.

In total, the study included 159 patients who were randomly assigned to gemcitabine intravesical system plus cetrelimab (n = 101) or cetrelimab alone (n = 58).

The data presented at ESMO further supported a role for the combination in MIBC. The pCR rate was 38% (95% CI, 28 to 49) in the gemcitabine intravesical system plus cetrelimab arm vs 28% (95% CI, 16 to 44) in the cetrelimab monotherapy arm. The pathologic overall response (pOR), defined as ≤ypT1, was 53% (95% CI, 43 to 64) and 44% (95% CI, 29 to 59), respectively. At 1 year, recurrence-free survival (RFS) was 77% (95% CI, 67 to 85) in the combination arm vs 64% (95% CI, 47 to 77) in the monotherapy arm. The median RFS was not reached in either arm.

There were no new safety signals for TAR-200, cetrelimab, or the combination. Serious treatment-related adverse events were reported in 13.9% of patients in the combination arm and 5.2% of patients in the monotherapy arm.

Biomarker results from the trial showed that the proportion of patients who were utDNA-positive was reduced from baseline to 12 weeks, irrespective of treatment. Further, utDNA-negative status at week 12 was associated with pCR.

REFERENCE

1. Necchi A, Guerrero-Ramos F, Crispen PL, et al. Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results. Presented at: 2025 European Society for Medical Oncology Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA112. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA112.html.pdf