MoonRISe-1: A Targeted Approach to Intermediate-Risk NMIBC

Roger Li, MD, a genitourinary oncologist at Moffitt Cancer Center in Tampa, Florida, discusses the MoonRISe-1 study (NCT06319820) evaluating TAR-210 in FGFR-altered intermediate-risk non-muscle-invasive bladder cancer (NMIBC). Here, he highlights how this targeted approach compares with the current standard of care of intravesical chemotherapy.

“Not only in my practice, but also just for treatment of intermediate-risk NMIBC in general, there has not traditionally been a targeted approach,” he explains.

The randomized, phase 3 MoonRISe-1 study is evaluating the efficacy of TAR-210 to prevent recurrence within the bladder by inserting the TAR-210 in the bladder every 3 months for up to 1 year, vs intravesical chemotherapy using an induction course of 4 to 6 weekly induction, followed by a 6 to 12 monthly maintenance therapy. The study’s primary end point is disease-free survival.1

Li continues to discuss how erdafitinib (Balversa) has been approved by the FDA in the metastatic setting after 1 line of systemic treatment with progression.² The approval of erdafitinib in January 2024 was specifically for the treatment of patients with locally advanced or metastatic urothelial carcinoma with FGFR3 alterations with disease progression following a prior line of treatment. The approval, which was supported by findings from the THOR study (NCT03390504), showed that erdafitinib led to statistically significant improvements in overall survival, progression-free survival, and overall response rate in this patient population.

“That has really been the only targeted agent that has been approved for use in all of bladder cancer. It is very exciting for us to move to a targeted therapy paradigm, particularly using a drug that is so well tolerated,” he adds.

“Along with the trial, we will also be able to understand potential mechanisms of resistance and understand the mechanisms that are kind of underpinning either resistance to treatment or just progression in general,” Li shares.

REFERENCES:

1. A study to evaluate TAR-210 versus single agent intravesical cancer treatment in participants with bladder cancer (MoonRISe-1). ClinicalTrials.gov. Updated April 27, 2025. Accessed May 14, 2025. https://clinicaltrials.gov/study/NCT06319820

2. FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma. News release. U.S. Food & Drug Administration. January 19, 2024. Accessed May 14, 2025. http://tinyurl.com/3cv6d3ax