Dr. Li on the design of the phase 3 MoonRISe-1 trial in NMIBC

In this video, Roger Li, MD, highlights the background and design of the phase 3 MoonRISe-1 trial (NCT06319820), which was presented during the 2024 American Urological Association Annual Meeting with the session, “MoonRISe-1: Phase 3 study of TAR-210, an erdafitinib intravesical delivery system, versus intravesical chemotherapy in patients with intermediate-risk non–muscle-invasive bladder cancer with susceptible FGFR alterations.” Li is a urologic oncologist at Moffitt Cancer Center in Tampa, Florida.

Video Transcript:

The MoonRISe-1 study is launched off of the heels of the first-in-human study. Now we've established that there is an ablative efficacy using the TAR-210 device in the intermediate-risk in the NMIBC patient population. We want to also test whether this drug can be used in the adjuvant setting. So, after all of the tumors have been resected. As you know, the standard of care now is with intravesical chemotherapy. With BCG being in shortage over the last several years, there hasn't been any enthusiasm of using BCG in this intermediate-risk [population]. We're sparing that for the high-risk population. So, even though intravesical chemotherapy has been used for a long time, the efficacy hasn't been there. These patients are plagued with a lot of recurrences in their bladder, requiring a lot of procedures, TURBTs. And these are all older patients, so you can imagine that this causes significant burden in terms of morbidity, as well as just the cost of the health care system and [to] the patients themselves. So, in the MoonRISe-1 study, we're studying 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, compared to intravesical chemotherapy, either mitomycin C, or gemcitabine, using an induction course of 4 to 6 weekly induction, followed by a 6 to 12 monthly maintenance therapy. The primary end point is disease free survival, independent of the tumor stage or the grade.

So far, as of April the 10th, 2024, there's 4 different sites–3 sites here in the US and 1 site in Israel. We're hoping to open 200 additional sites over 4 different continents to enroll a total of 540 patients in both arms and these patients are going to be randomized 1:1, stratified by whether they have recurrence or primary disease, whether they were diagnosed with PDD or standard white light cystoscopy, and some of the other characteristics. We're definitely looking forward to the readout from the efficacy results, hopefully in the near future.

This transcription has been edited for clarity.