Phase 3 SunRISe-2 Study Investigates Novel TAR-200 Therapy in Muscle Invasive Bladder Cancer


Stephen Williams, MD, MBA, MS, FACS, FACHE, discussed updates from the SunRISe-2 study investigating TAR-200 plus cetrelimab vs chemotherapy in muscle invasive bladder cancer.

Bladder Cancer: © SciePro -

Bladder Cancer: © SciePro -

At the 2024 American Urological Association (AUA) Annual Meeting, updates on the phase 3 SunRISe-2 study (NCT04658862),a trial investigating TAR-200, an intravesical targeted release system, plus cetrelimab, an investigational PD-1 monoclonal antibody, vs chemotherapy for the treatment of patients with muscleinvasive bladder cancer were presented.1

TAR-200 has shown promise in the non-muscle invasive disease state in patients with Bacillus Calmette-Guérin (BCG)-unresponsive disease, as demonstratedby recent data from the phase 2b SunRISe-1 study (NCT04640623) presented at the 2024 AUA Meeting. At the January 2, 2024, data cutoff, 82.8% (95% CI, 70.6%-91.4%) of response-evaluable patients who were treated with TAR-200 monotherapy (n = 58) achieved a centrally assessed complete response, and 86.2% (95% CI, 74.6%-93.9%) achieved an investigator-assessed complete response (CR). Additionally, the Kaplan-Meier estimates for CR rate at 6 and 12 months were 75.7% (95% CI, 59.1%-86.3%) and 61.9% (95% CI, 41.1%-77.1%), respectively. Nearly all (98%) CRs were achieved at the first disease assessment at week 12.2

In an interview with Targeted OncologyTM, study investigator Stephen Williams, MD, MBA, MS, FACS, FACHE, professor and chief of the Division of Urology, Department of Surgery at the University of Texas Medical Branch in Galveston, TX, discussed TAR-200 and updates from the SunRISe-2 studythat were presented as part of the Clinical Trials in Progress program at the AUA Annual Meeting.

Stephen Williams, MD

Stephen Williams, MD

Targeted Oncology: What is TAR-200?

Williams: TAR-200is an intravesical device which eludes chemotherapy and includes gemcitabine. Really, this is a device that is instilled within the office by a urologist.Importantly, and concomitantly in the TAR-200 SunRISe-2 trial, we work in a multidisciplinary mannerwhere we want to comparethis treatment, depending upon the trials, or the stage of the diseasevsother conventional treatments.

What is SunRISe-2 evaluating?

SunRISe-2 is a phase 3, randomized, controlled, multicenter, international trial, which is wonderful because we have identified patients with muscle invasive bladder cancer that are either cystectomy ineligible or refusing cystectomy that would like to understand bladder sparing options.We are comparing TAR-200 plus cetrelimab vs trimodal therapy, which is including chemotherapy with systemic therapy as well.

How does the use of TAR-200 vary between the muscle invasive and non-muscle invasive disease states?

There area number ofSunRISe trials from 1 to 4. The easiest way to remember is the even numbers are muscle invasive, and odd numbers are non-muscle invasive bladder cancer. For muscle invasive bladder cancer, there is SunRISe-2, but then there are additional studies looking at different sequences of when to prescribe the treatment and then also systemic therapy. Importantly, in non-muscle invasive bladder cancer, we are looking at either BCG-naive or BCG-refractory disease. That is an exciting space as there area number of agents that have come to market, particularly in the BCG-unresponsive disease state.


What are some of the biggest unmet needs in the muscle invasive disease state?

I think one of the biggest unmet needs is that roughly 50% of patients with muscle invasive bladder cancer received no form of definitive therapy. I think this will allow patients to receive therapy that potentially could be lifesaving, and more importantly, the depth of disease increases exponentially, and that becomes muscle invasive. In doing so, with non-muscle invasive bladder cancer, it obviously provides another additional platform of where we can perhaps add a treatment, in preliminary studies that have been already presented, that has been shown to be a promising treatment in this disease space as well.

1. A study of TAR-200 in combination with cetrelimabversus concurrent chemoradiotherapy in participants with muscle-invasive bladder cancer (MIBC) of the bladder (SunRISe-2). Updated May 22, 2024. Accessed June 11, 2024. 
2. Necchi A, Daneshmand S, Simone G, et al. TAR-200 in patients with Bacillus Calmette–Guérin-unresponsive high-risk non–muscle-invasive bladder cancer: results from SunRISe-1 study. J Urol. Published online May 1, 2024. doi:10.1097/01.JU.0001015816.87470.c9.01
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