SUMMARY

• SunRISe-5 (NCT06211764) is a phase 3, randomized, open-label, multicenter study that will evaluate the efficacy and safety of TAR-200 vs investigator’s choice of intravesical chemotherapy (mitomycin C or gemcitabine) in patients with recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who received Bacillus Calmette-Guérin (BCG) therapy and have refused or are ineligible for radical cystectomy (RC). Enrollment is planned for approximately 250 patients. The primary endpoint is disease-free survival (DFS).^1-3

BACKGROUND

• TAR-200 (JNJ-17000139) is an investigational intravesical system that is designed to provide local release of gemcitabine in the bladder. TAR-200 contains gemcitabine and urea mini tablets within a dual-lumen silicone tube for gradual release of gemcitabine by an osmotic delivery mechanism throughout the prescribed indwelling period.^4-7
• TAR-200 is inserted intravesically via a urinary placement catheter, after which it self-coils into a bi-oval shape (see Figure: TAR-200 Intravesical System). Removal of TAR-200 can be achieved using grasping forceps and cystoscopy.^5,7

CLINICAL DATA

SunRISe-5 Study

Study Design/Methods

• Phase 3, randomized, open-label, multicenter study planned to evaluate the efficacy and safety of TAR-200 (group A) vs investigator’s choice of intravesical chemotherapy (mitomycin C or gemcitabine; group B) in patients with recurrent, papillary-only
  HR-NMIBC who received BCG therapy and have refused or are ineligible for RC.^1-3
• The primary endpoint is DFS.^1-3
• The target population was defined as:^2,10
  • BCG unresponsive if:
    • Minimum BCG therapy: 5 of 6 doses of adequate induction and either 2 of 3 doses of maintenance therapy, or 2 of 6 doses of second induction
    • Timing of recurrence: high grade (HG) T1 disease at first disease assessment after induction or HG Ta/any T1 disease within 6 months
  • BCG experienced (does not meet BCG-unresponsive definition) if:
    • Minimum BCG therapy: received 5 of 6 doses of adequate induction with or without maintenance therapy
    • Timing of recurrence: recurred with HG Ta/any T1 disease within 12 months
• The study design is shown in Figure: SunRISe-5 Study Design.

• The study is currently enrolling and aims to enroll approximately 250 patients.¹
  • As of November 5, 2024, 98% (~120) of sites are activated and 42% (105/250) of the target population has been randomized.¹⁰

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 16 April 2025.