New data from Cohort 2 of the Phase 2b SunRISe-1 study evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with certain types of bladder cancer demonstrates the highest complete response rate without reinduction with more than half of responders remaining cancer-free for at least 12 months.

These results highlight the potential of TAR-200 as a breakthrough for people with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumours who are ineligible or refuse radical cystectomy (RC).

These results were featured in the Paradigm-Shifting, Practice-Changing Clinical Trials in Urology plenary session at the 2025 American Urological Association (AUA) Annual Meeting.

“The durability of response we’re seeing with TAR-200 is particularly noteworthy in a population where recurrence is common and the standard of care treatment often comes at the cost of patient comfort and quality of life,” said Andrea Necchi, M.D., of Italy's Vita-Salute San Raffaele University and the IRCCS San Raffaele Hospital and Scientific Institute.

“These data underscore the potential of TAR-200 to address significant unmet need in high-risk non-muscle invasive bladder cancer, delivering sustained, localised therapy through a novel intravesical gemcitabine releasing system that supports lasting disease management, without adding to the treatment burden.”

“In high-risk non-muscle invasive bladder cancer where patients have typically faced limited treatment options, these TAR-200 data represent significant hope,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “Achieving the high and durable complete response rates observed in this population with a therapy designed to fit into patients’ lives, not interrupt them, reflects the real promise of innovation in bladder cancer care. With these results, TAR-200 offers the potential of not just advancing treatment, but helping shape a future where efficacy and quality of life go hand-in-hand.”

As of March 2025, 82.4 percent of the 85 enrolled patients in the study achieved a complete response (CR) (95 percent Confidence Interval [CI], 72.6-89.8), meaning their cancer was undetectable following treatment.

This high response rate translated into sustained disease control, with 52.9 percent of responders maintaining complete response at one year.

The median duration of response (DOR) was 25.8 months (95 percent CI, 8.3-not estimable), indicating that many patients remained cancer-free for over two years without the need for reinduction therapy.

At 12 months, 86.6 percent (95 percent CI, 76.6-92.6) of responders remained cystectomy-free.1 Importantly, the treatment was well-tolerated, with most adverse events being mild urinary symptoms. These findings show that TAR-200 offers a highly effective and durable treatment option for patients with certain types of BCG-unresponsive HR-NMIBC.

“Bladder cancer is one of the ten most common cancers worldwide, yet treatment options have remained largely unchanged for over 40 years, leaving patients with few choices if initial BCG therapy does not work,” said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine. "TAR-200 is designed to allow for sustained delivery of medication directly into the bladder through a brief and routine procedure, which benefits patients. These data now show patients can remain cancer-free for a meaningful period of time, marking a significant step forward for those facing this challenging disease.”

Most treatment-related adverse events (TRAEs) were mild and manageable.

Overall, 71 patients (83.5 percent) experienced TRAEs, the majority of which were low-grade urinary symptoms, such as bladder irritation or discomfort.1 Eleven patients (12.9 percent) experienced grade 3 or higher TRAEs, and five patients (5.9 percent) reported serious TRAEs.

 Only three patients (3.5 percent) discontinued treatment due to TRAEs, and there were no treatment-related deaths.

TAR-200 is inserted directly into the bladder by a healthcare professional in a brief outpatient procedure, without the need for anaesthesia.2 Designed to remain in the bladder, it does not interfere with daily activities and provides sustained release of treatment throughout the day. 

Earlier results from Cohort 2 were previously presented at the 2024 European Society of Medical Oncology (ESMO) Congress3 and at the 2024 American Urological Association (AUA) Annual Meeting.

Source: Johnson & Johnson