- Cohort 4 of the Phase 2b SunRISe-1 study involved 52 patients with high-risk NMIBC.
- Gemcitabine intravesical system was administered every three weeks for six months, then every 12 weeks for up to 18 months.
- At one year, disease-free survival was 74.3%, progression-free survival was 95.6%, and overall survival was 98%.
- 92.3% of patients avoided radical cystectomy, with no treatment-related deaths reported.
Study Overview
The Phase 2b SunRISe-1 study's Cohort 4 focused on 52 patients with high-risk, papillary-only non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guérin (BCG) therapy. These patients were either ineligible for or declined radical cystectomy.
Treatment Protocol
Patients received the gemcitabine intravesical system every three weeks for six months, followed by administration every 12 weeks for up to an additional 18 months. The aim was to prevent recurrence or progression of high-grade papillary tumors.
Key Results
At a median follow-up of 15.9 months, the one-year disease-free survival (DFS) rate was 74.3%, with progression-free survival (PFS) at 95.6% and overall survival (OS) at 98%. Notably, 92.3% of patients did not undergo radical cystectomy, and the median time to cystectomy was not reached.
Side Effects
The treatment was generally well-tolerated, with 80.8% of patients experiencing low-grade side effects such as mild urinary symptoms. More serious side effects were uncommon, occurring in 13.5% of patients, primarily involving bladder pain. A small number of patients, 7.7%, discontinued treatment due to side effects, and no treatment-related deaths were reported.
