Novel Drug Delivery System, TAR-210 Clinical Study, for Bladder Cancer

For patients with non-muscle-invasive bladder cancer (NMIBC), particularly those with intermediate-risk disease, the road to remission can be long, disruptive and uncertain. Recurrence is common and current standard-of-care treatments like intravesical chemotherapy often fall short.

A common intravesical immunotherapy for NMIBC, Bacillus Calmette-Guérin (BCG), has been in short supply for several years, emphasizing the importance of exploring alternative therapeutics or improving the delivery of current options.

Dr. Roger Li, a urologic oncologist in the Genitourinary Oncology Program at Moffitt, saw an opportunity to improve NMIBC care and do things differently. Instead of relying solely on systemic oral drugs or traditional bladder instillations that require frequent hospital visits, what if the treatment could be delivered precisely where it's needed, and stay there longer?

That idea sparked the MoonRISe-1 trial, a global Phase 3 study led by Dr. Li and conducted at Moffitt and other sites throughout the world, evaluating a unique drug delivery system called TAR-210.

The Genesis of a Novel Delivery System

TAR-210 is built on the same technology platform as TAR-200, a pretzel-shaped device that delivers gemcitabine intravesically over time. In the SunRISe-1 trial, TAR-200 achieved an 83.5% complete response rate in patients with BCG-unresponsive high-risk NMIBC. Johnson & Johnson has already submitted a new drug application for TAR-200 based on these results, and there’s growing optimism that TAR-210 could follow a similar path if the MoonRISe-1 findings continue to hold.

The MoonRISe-1 Trial: A Closer Look

TAR-210 uses the same small, pretzel-shaped intravesical system that acts as a drug-eluting stent; however, it delivers erdafitinib, a targeted FGFR inhibitor, directly into the bladder over a sustained three-month period.

In previous studies, erdafitinib showed an overall survival benefit over standard-of-care chemotherapy via both intravesical and oral delivery. However, oral erdafitinib was associated with systemic toxicity, so there was still a need for a sustained delivery of the medication along with limiting systemic toxicity, as Dr. Li explains.

The continuous local release of TAR-210 helps maintain therapeutic levels in the bladder lining while significantly reducing the systemic exposure and side effects associated with oral erdafitinib. It also circumvents the need for frequent procedures, requiring just one surgery to implant the device and allow it to work.

TAR-210 is explicitly designed for patients with FGFR-altered, intermediate-risk NMIBC, a subset of patients who may not respond well to conventional therapies but whose genetic profile makes them candidates for FGFR-targeted treatment.

The global MoonRISe-1 trial is currently enrolling patients at 198 sites across 19 countries, and the results so far have been striking: In early findings from the first-in-human study, TAR-210 achieved a 90% complete response rate at 12 weeks, with 89% of those responses lasting at least nine months.

The success of TAR-210 demonstrates how a thoughtful reimagining of drug delivery can lead to safer, more effective therapies for NMIBC patients. It also shows what’s possible when investigators have the freedom to lead trials that directly reflect clinical needs.

Implications for Clinical Practice

Devices like TAR-210 and TAR-200 represent more than just a technological advance. For patients, they offer a new path with:

• Fewer, less invasive procedures and less time in clinical settings
• Reduced side effects compared to oral or intravenous delivery
• Greater convenience, allowing people to maintain more normal routines during treatment
• Personalized care, tailored to specific genetic mutations like FGFR alterations
• Decreased recurrence rates

For providers, they represent a way to deliver more precise, efficient care that aligns with both genomic medicine and value-based healthcare goals.

Embracing Emerging Therapies

As TAR-210 moves through its final study phase and toward potential FDA approval, referring providers should stay tuned. Clinical trials like this offer eligible patients access to cutting-edge drugs and delivery systems not yet available elsewhere. Moffitt’s infrastructure makes our expert clinicians uniquely equipped to offer them.

With the MoonRISe-1 trial, we’re improving patient outcomes in bladder cancer treatment, but this is just one of the hundreds of clinical studies Moffitt offers. Our robust portfolio of trials is one of the largest in the nation and includes options for breast cancer, lung cancer, skin cancer and much more. We’re dedicated to expanding patients' opportunities throughout their cancer journey.

Community physicians can always refer patients to Moffitt for clinical trial participation or other services, even before a formal cancer diagnosis. We work collaboratively with referring providers to ensure each patient receives the highest level of care and support.

To explore active bladder cancer studies or refer patients, submit a clinical trials inquiry form or contact a Clinical Trial Navigator at 813-937-6988 or 1-877-527-5590 (toll-free).