(UroToday.com) The 2024 SUO annual meeting included a urothelial carcinoma session, featuring a presentation by Dr. Roger Li discussing Moonrise-1, a phase 3 study of TAR-210, an erdafitinib intravesical targeted releasing system, versus intravesical chemotherapy in patients with FGFR-altered intermediate-risk non muscle invasive bladder cancer (NMIBC).
Despite available treatment options for patients with intermediate risk 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: 82%) and intermediate risk NMIBC (complete response rate: 87%). MoonRISe-1 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 intermediate risk NMIBC.
Eligible patients (~n = 540) will be randomized 1:1 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 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
- Safety
- Tolerability
The MoonRISe-1 study opened for enrollment on April 10, 2024 and recruitment is planned at 200 sites. As of November 6, 2024, 82 patients have been randomized, and recruitment is ongoing at 163 sites:
Presented by: Roger Li, MD, Moffitt Cancer Center, Tampa, FL
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2024 Society of Urologic Oncology (SUO) Annual Meeting, Dallas, TX, Tues, Dec 3 – Fri, Dec 6, 2024.