Johnson & Johnson (J&J) announced that new data from the investigational Cohort 4 of the Phase 2b SunRISe-1 study show treatment with gemcitabine intravesical system resulted in high one-year Disease-Free Survival (DFS), Progression-Free Survival (PFS), and Overall Survival (OS) rates in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, papillary-only Non-Muscle Invasive Bladder Cancer (NMIBC). These data were featured as a late-breaking oral presentation at the Society of Urologic Oncology (SUO) 2025 Annual Meeting and build upon data presented at the 2025 American Urological Association (AUA) Annual Meeting.

"The findings are meaningful, as the majority of patients remained free of cancer recurrence at one year despite having papillary tumours that carry a high risk for recurrence and a significant risk of progression to a more aggressive, muscle-invasive stage of disease. 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," said Siamak Daneshmand, MD, Professor of Urology, University of Southern California, and presenting author.

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 tumours. 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 Johnson & Johnson, we are committed to developing innovative treatments for patients with high-risk NMIBC who have few options beyond life-altering surgery. 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," said Christopher Cutie, MD, Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine.

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.