Introduction:

Despite available treatment options for patients with intermediate-risk non–muscle-invasive bladder cancer (IR NMIBC), recurrence rates remain high, underscoring the need for new therapies. FGFR alterations are prevalent in ~50-80% of low-grade NMIBC and function as oncogenic drivers. TAR-210 is a novel intravesical targeted releasing system designed to provide sustained local delivery of erdafitinib (a selective pan-FGFR tyrosine kinase inhibitor) within the bladder while limiting systemic toxicities. In a first-in-human study, TAR-210 was well tolerated with promising clinical activity in FGFR-altered high-risk NMIBC (estimated recurrence-free rate: 90%) and IR NMIBC (complete response rate: 90%) (Vilaseca A, et al. AUA 2024, PD48-02). MoonRISe-1 (NCT06319820) is an open-label, multicenter, phase 3, randomized study evaluating the efficacy and safety of TAR-210 versus investigator’s choice of intravesical mitomycin C or gemcitabine in patients with FGFR-altered IR NMIBC.

Methods:

Eligible patients (Table; N≈540) will be randomized 1:1 (stratification factors in Table) to receive TAR-210 every 12 weeks for 1 year, or intravesical chemotherapy (mitomycin C or gemcitabine) weekly for 4-6 induction doses followed by maintenance therapy for 6 months to 1 year. Assessments of recurrence/progression include urine cytology, cystoscopy, biopsy/TURBT of bladder lesions, ultrasound, and urography. The primary end point is disease-free survival (DFS) defined as time from randomization to first documented recurrence of any-grade NMIBC, disease progression, or death from any cause, whichever occurs first. Secondary end points include time to next-line treatment, high-grade recurrence-free survival, progression-free survival, rate of diagnostic and therapeutic invasive urological interventions, and safety and tolerability. As of August 1, 2024, 9 patients have been randomized, and recruitment is ongoing at ≈70 sites.

Results:

Conclusion:

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