First results from cohort 4 of the phase 2b SunRISe-1 study evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with certain types of bladder cancer show the promise of TAR-200 in this patient population with more than an 80 percent disease-free survival (DFS) rate without the need for reinduction and 94 percent of patients able to preserve their bladder.

The high DFS and bladder preservation rate combined with the well-tolerated safety profile in these patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with papillary-only disease (high-grade Ta or T1) show the potential of TAR-200 as a meaningful alternative to surgery.

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 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,” said Félix Guerrero-Ramos*, M.D., PhD, FEBU, Head of Uro-Oncology at Hospital Universitario 12 de Octubre, Madrid, Spain and presenting author. “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.”

“BCG-unresponsive HR NMIBC patients 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 Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, 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.”

First results of this interim analysis from Cohort 4 of the SunRISe-1 study demonstrated 85.3 percent (95 percent Confidence Interval [CI], 71.6-92.7) and 81.1 percent (95 percent CI, 66.7-89.7) DFS rates at six and nine months, respectively, in patients with BCG-unresponsive, HR-NMIBC with papillary-only disease treated with TAR-200 monotherapy.

These high DFS rates are particularly encouraging given the significant risk of recurrence in this population.

 Among patients with high-grade Ta and T1 disease, DFS rates remained consistently strong—85.7 percent (95 percent CI, 66.3-94.4) and 84.7 percent (95 percent CI, 59.7-94.8) at six months, and 82.1 percent (95 percent CI,: 62.3-92.1) and 79.4 percent (95 percent CI, 54.0-91.7) at nine months, respectively.

The strong DFS across both subtypes—despite their differing depths of invasion—underscores the potential of TAR-200 to deliver sustained tissue penetration.

Notably, 94.2 percent of patients avoided radical cystectomy at median follow-up of 12.8 months.

The early progression-free and overall survival rates of 95.6 percent (95 percent CI, 83.5-98.9) and 98 percent (95 percent CI, 86.4-99.7) at nine months, respectively, are reassuring as disease progression or death were highly uncommon among patients treated with TAR-200.

While 12-month DFS data is not yet mature, these preliminary findings show that TAR-200’s sustained intravesical gemcitabine delivery may potentially offer durable disease control while minimising the need for invasive procedures.

These results support continued evaluation in the ongoing Phase 3 SunRISe-5 study (NCT06211764), comparing TAR-200 to chemotherapy in patients with BCG-pretreated, papillary-only HR-NMIBC.

“Surgical removal of the bladder has long been the standard of care for patients suffering from BCG-unresponsive HR-NMIBC with papillary-only disease, a life-altering procedure that drastically impacts a patient's quality of life,” said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine. “These results demonstrate that TAR-200 can be a meaningful alternative to surgery that is both effective and well-tolerated while preserving the bladder.”

Among the 52 patients enrolled, the safety profile of TAR-200 monotherapy was consistent with prior studies, with no new safety signals observed.1 Most treatment-related adverse events (TRAEs) were low grade and resolved quickly, with a median duration of 3.7 weeks.

Common TRAEs included dysuria (40.4 percent), pollakiuria (30.8 percent), and urinary urgency (26.9 percent).1 Grade ≥3 TRAEs occurred in 13.5 percent of patients, most frequently bladder pain (3.8 percent).1 Three patients (5.8 percent) experienced serious TRAEs, and only four (7.7 percent) discontinued treatment due to TRAEs. No treatment-related deaths were reported.

Europe has the highest rate of bladder cancer compared to all continents globally, with nearly a quarter of a million people diagnosed in 2022, representing a 10 percent increase from 2020.5 Despite advancements, the standard of care has remained largely unchanged for over 40 years,6 leaving patients with limited treatment options if initial BCG therapy does not work.

TAR-200 delivers sustained medication directly into the bladder, offering a fresh approach to treat early-stage bladder cancer.

TAR-200 is inserted directly into the bladder by a healthcare professional in a brief outpatient procedure, without the need for anaesthesia.9 Designed to remain in the bladder, it does not interfere with daily activities and provides sustained release of treatment throughout the day.

Source: Johnson & Johnson