TAR-200, an intravesical chemotherapy releasing system, demonstrated responses in certain high-risk subgroups of patients with bladder cancer, according to data from Cohort 4 of the phase 2 SunRISe-1 study.
Specifically, TAR-200 demonstrated high disease-free survival (DFS) and bladder preservation rates in Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer with papillary-only disease (high-grade Ta or T1).
The DFS rate without the need for reinduction was more than 80%. Additionally, 94.2% of patients were able to preserve their bladder with this approach, according to the news release. Notably, these data were shared in a news release from Johnson & Johnson, as well as featured in a session entitled, "Paradigm-Shifting, Practice-Changing Clinical Trials in Urology" at the 2025 American Urological Association (AUA) Annual Meeting, in which the results were also shared.
“The majority of patients remained free of cancer recurrence during this critical early study period, highlighting the potential of TAR-200 as a highly effective treatment for these patients who may have limited options beyond bladder removal,” Dr. Félix Guerrero-Ramos, presenting author of the study, said. “As we continue monitoring patients through the 12-month mark and beyond, our focus remains on assessing TAR-200’s long-term efficacy in maintaining disease-free survival and improving outcomes for this high-risk patient population.”
The interim analysis of Cohort 4 of the SunRISe-1 study demonstrated 85.3% and 81.1% DFS rates at six and nine months, respectively, in patients with papillary-only disease treated with TAR-200. Notably, these results stayed consistent among patients with high-grade Ta and T1 disease at 85.7% and 84.7% at six months, as well as 82.1% and 79.4% at nine months, respectively. Additionally, patients showed early progression-free and overall survival rates of 95.6% and 98%, respectively, at nine months.
Although 12-month DFS data remain immature, these initial findings suggest that TAR-200 may provide durable disease control while reducing the need for invasive procedures, the news release emphasized. These results support the continued investigation of TAR-200 in the ongoing phase 3 SunRISe-5 study, which is comparing TAR-200 to chemotherapy in this patient population.
“BCG-unresponsive [patients] with high-risk non-muscle-invasive bladder currently face life-changing decisions during their treatment journeys. For many years, the standard of care for these patients has remained stagnant: surgical removal of the bladder,” said Dr. Henar Hevia, senior director and EMEA Therapeutic Area Lead of Oncology at Johnson & Johnson Innovative Medicine. “These results give hope for a new era of precision delivery of therapeutics in this patient population with a well-tolerated and effective bladder-sparing alternative, with the potential to drive better quality of life outcomes for patients.”
More Information on TAR-200 and Its Safety Profile
High-risk non-muscle-invasive bladder cancer is likely to recur or spread beyond the lining of the bladder, causing the disease to progress to muscle-invasive bladder cancer. This high-risk cancer is characterized by a high-grade, large tumor size, presence of multiple tumors and carcinoma in situ; it makes up 15% to 44% of patients with non-muscle-invasive bladder cancer.
Moreover, the current standard of care for this patient population is radical cystectomy and is recommended for patients whose disease fails to respond to BCG therapy, with over 90% cancer-specific survival if performed prior to muscle-invasive progression. However, because many patients with this disease are typically older, the patient population may be unwilling or unfit to undergo this procedure, meaning that recurrence of disease or progression can lead to morbidity and distress for these patients.
Based on these unmet needs, investigators are investigating TAR-200. TAR-200 is placed directly into the bladder by a healthcare professional during a short outpatient procedure that does not require anesthesia. Designed to stay in the bladder, it continuously releases treatment throughout the day without disrupting daily activities.
The ongoing phase 2b trial, SunRISe-1, is a randomized, open-label, multi-center study assessing the efficacy and safety of TAR-200 in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer who are either ineligible for or have declined radical cystectomy. Cohort 4 specifically enrolls patients with papillary-only disease and treats them with TAR-200 monotherapy and the primary end point is DFS rate; key secondary end points include safety and tolerability.
This approach is designed to provide sustained and extended local release of gemcitabine into the bladder for patients. Notably, the safety and efficacy of this approach is being investigated in the phase 2 and phase 3 SunRISe-1, SunRISe-3 and SunRISe-5 for those with non-muscle-invasive bladder cancer. TAR-200 is also being evaluated for patients with muscle invasive bladder cancer in the SunRISe-4 trial.
Among the 52 participants who were enrolled and evaluated for this treatment, the safety profile of TAR-200 remained consistent with previous studies, with no new safety concerns identified. Most treatment-related side effects were low grade and resolved quickly, with a median duration of 3.7 weeks. Common treatment-related side effects included dysuria (40.4%), pollakiuria (30.8%) and urinary urgency (26.9%). Grade 3 or higher treatment-related side effects were reported in 13.5% of patients, with the most common one being bladder pain (3.8%). Serious treatment-related side effects occurred in three patients (5.8%), and four patients (7.7%) discontinued treatment due to treatment-related side effects. No treatment-related deaths were reported.
“Surgical removal of the bladder has long been the standard of care for patients suffering from BCG-unresponsive high-risk non-muscle-invasive bladder cancer with papillary-only disease, a life-altering procedure that drastically impacts a patient's quality of life,” Dr. Christopher Cutie, vice president and Disease Area Leader, Bladder Cancer, at Johnson & Johnson Innovative Medicine, concluded. “These results demonstrate that TAR-200 can be a meaningful alternative to surgery that is both effective and well-tolerated while preserving the bladder.”
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