- New data from Cohort 4 of the SunRISe-1 study show more than 95 percent of patients remained progression free at one year, with more than 92 percent not undergoing bladder removal
- Patients with this type of bladder cancer have limited choices beyond radical cystectomy, highlighting the need for newer therapies for bladder preservation
“The findings are meaningful, as the majority of patients remained free of cancer recurrence at one year despite having papillary tumors that carry a high risk for recurrence and a significant risk of progression to a more aggressive, muscle-invasive stage of disease,” said Siamak Daneshmand*, M.D., Professor of Urology, University of Southern California, and presenting author. “Bladder removal has traditionally been the primary path forward for these patients, a life-altering procedure that can have a significant impact on a patient’s quality of life.”“At Johnson & Johnson, we are committed to developing innovative treatments for patients with high-risk NMIBC who have few options beyond life-altering surgery,” said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine. “Those with papillary-only disease face particularly difficult decisions, as surgical removal of the bladder has long been the standard of care for patients who are unresponsive or resistant to BCG.”
Cohort 4 of the Phase 2b SunRISe-1 study focused on 52 patients with papillary-only, high-risk NMIBC whose disease did not respond or stopped responding to BCG therapy and who were ineligible for or declined radical cystectomy. The therapy was administered every three weeks for six months, followed by every 12 weeks for up to an additional 18 months, to evaluate its potential to prevent the recurrence or progression of high-grade papillary tumors.1 The results support continued evaluation in the ongoing Phase 3 SunRISe-5 study (NCT06211764) comparing gemcitabine intravesical system to chemotherapy in patients with previously BCG-treated, papillary-only NMIBC.
At median follow-up of 15.9 months (range, 4-20 months), the one-year DFS rate was 74.3 percent (95 percent confidence interval [CI], 59.2-84.6), meaning nearly three out of four patients remained free from cancer recurrence. Results were similar across patients with high-grade Ta and T1 papillary tumors, 74.8 percent and 74.1 percent, respectively (95 percent CI, 54.3-87.1 and 48.5-88.3). At one year, PFS was 95.6 percent (95 percent CI, 83.5-98.9) and OS was 98 percent (95 percent CI, 86.6-99.7). Notably, 92.3 percent of patients did not undergo radical cystectomy, and median time to cystectomy was not reached. Overall Health Status and Physical Functioning scores were maintained during treatment with gemcitabine intravesical system.1
The therapy was generally well-tolerated. Most patients (80.8 percent) experienced treatment-related side effects that were low grade, such as mild urinary symptoms, including burning, frequency, or urgency. More serious side effects (13.5 percent) were uncommon and most often involved bladder pain. A small number of patients (7.7 percent) discontinued treatment due to side effects, and no treatment-related deaths were reported.1
- Daneshmand, S., & colleagues. (2025). Gemcitabine intravesical system (TAR-200) monotherapy in patients with Bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: 1-year disease-free survival results from SUNRISE-1. Abstract presented at the Society of Urologic Oncology (SUO) Annual Meeting.