Introduction:

Up to 50% of patients with high-risk non–muscle-invasive bladder cancer (HR NMIBC) recur after Bacillus Calmette-Guérin (BCG) therapy and have limited treatment options. Therefore, there is a high unmet need to develop bladder-sparing, localized treatments for patients with papillary-only recurrent HR NMIBC. TAR-200 is a novel targeted releasing system designed to provide local, sustained release of gemcitabine within the bladder. Interim data from SunRISe-1 (NCT04640623) support further investigation of TAR-200 monotherapy in patients with HR NMIBC (Jacob J, et al. J Urol. 2024: 211(5S2):e1). SunRISe-5 (NCT06211764) is a randomized, open-label, multicenter phase 3 study that evaluates the safety and efficacy of TAR-200 compared with investigator’s choice of intravesical chemotherapy in patients with papillary-only HR NMIBC that recurs within the first year of BCG treatment who either refuse or are ineligible for radical cystectomy (RC).

Methods:

Eligible patients are aged ≥18 years, have ECOG performance status of 0-2, and were diagnosed ≤90 days of informed consent with histologically confirmed recurrent, papillary-only HR NMIBC (high-grade Ta, any T1, without carcinoma in situ) with last dose of BCG ≤12 months, who are ineligible for or decline RC. Patients will be stratified based on T stage and prior BCG. 250 patients will be randomized 1:1 to receive TAR-200 Q3W and Q12W for induction and maintenance phases, respectively, or to receive intravesical mitomycin C or gemcitabine weekly during induction and monthly during the maintenance phase. The primary end point is disease-free survival. Secondary end points include recurrence-free survival, time to next intervention, time to disease worsening, time to progression, overall survival, safety and tolerability, and patient-reported health-related quality of life outcomes. As of August 1, 2024, 25 patients have been randomized, and recruitment is ongoing at ≈106 sites.

Results:

Conclusion:

Funding: Janssen Research & Development, LLC, a Johnson & Johnson company