Data from the phase 2b SunRISe-1 trial (NCT04640623) have been published in the Journal of Clinical Oncology, showing that TAR-200 monotherapy achieved high complete response rates and prolonged disease-free survival (DFS) in patients with BCG-unresponsive high-risk non–muscle invasive bladder cancer (NMIBC).1
Overall, the SunRISe-1 trial is assessing the safety and efficacy of TAR-200 in combination with cetrelimab (cohort 1; n = 53), TAR-200 monotherapy (cohort 2; n = 85), and cetrelimab monotherapy (cohort 3; n =28) in patients with BCG-unresponsive high-risk NMIBC with carcinoma in situ (CIS). The trial also includes a fourth cohort assessing TAR-200 monotherapy in patients with BCG-unresponsive papillary disease-only high-risk NMIBC (n = 52).
Cohort 2
Among the 85 patients enrolled in cohort 2 of the trial, the centrally confirmed complete response (CR) rate was 82.4% (95% CI, 72.6 to 89.8). The median duration of response (DOR) was 25.8 months (95% CI, 8.3 to NE), with 52.9% of responders (37 of 70) achieving a DOR of at least 12 months.
According to the authors, high CR rates were observed across all clinically relevant subgroups, including in those with and without concurrent papillary disease (82.1% to 82.5%, respectively).
The 12- and 24-month radical cystectomy-free rates were 86.6% (95% Ci, 76.6 to 92.6) and 75.5% (95% CI, 63.4 to 84.1), respectively. Overall survival (OS) rates at 6- and 12-months were 98.7% (95% CI, 91.2 to 99.8) and 94.7% (95% CI, 86.5 to 98.0), respectively.
Treatment-related adverse events (TRAEs) of any grade were reported in 83.5% of patients. The most common TRAEs included pollakiuria (43.5%), dysuria (40%), micturition urgency (24.7%), and urinary tract infection (21.2%). TRAEs led to treatment interruptions in 31.8% of patients and treatment discontinuation in 3.5% of patients.
Grade 3 or higher AEs were reported in 12.9% of patients, with the most frequent being urinary tract pain (4.7%). Serious TRAEs occurred in 5.9% of patients.
Cohort 4
Cohort 4 of the trial assessed TAR-200 monotherapy in 52 patients with papillary disease-only.
At a median follow-up of 12.8 months, the median DFS was not estimable. DFS rates at 6-, 9-, and 12-months were 85.3% (95% CI, 71.6 to 92.7), 81.1% (95% CI, 66.7 to 89.7), and 70.2 (95% CI, 51.6 to 82.8), respectively. In patients with high-grade Ta and T1 disease, the 12-month DFS rates were 70.0% (95% CI, 44.8 to 85.4) and 72.2% (95% CI, 44.8 to 87.6), respectively.
TRAEs were observed in 80.8% of patients. Grade 3 or higher TRAEs occurred in 13.5% of patients, and serious TRAEs were reported in 5.8% of patients. In total, 4 patients (7.7%) discontinued treatment due to TRAEs.
Cohorts 1 and 3
In cohorts 1 and 3, the CR rates were 67.9% (95% CI, 53.7-80.1) and 46.4% (95% CI, 27.5-66.1), respectively. The median DOR was not estimable in cohort 1 and was 8.6 months (95% CI, 2.8 to NE) in cohort 3. The 12-month DOR rates were 76.3% (95% CI, 58.1 to 87.4) and 38.5% (95% CI, 14.1 to 62.8) in cohorts 1 and 3, respectively.
Grade 3 or higher TRAEs occurred in 37.7% of patients in cohort 1 and 7.1% of patients in cohort 3. Serious TRAEs were reported in 15.1% and 3.6% of patients, respectively.
Based on these data, the authors noted, “TAR-200 monotherapy offered a more favorable risk-benefit profile vs TAR-200 plus cetrelimab or cetrelimab alone in BCG-unresponsive CIS.”
About TAR-200
TAR-200 is an investigational intravesical gemcitabine releasing system that is “designed to provide sustained local delivery of a cancer treatment into the bladder,” according to Johnson & Johnson.2 The FDA recently granted priority review to the new drug application (NDA) for TAR-200 in BCG-unresponsive high-risk NMIBC with CIS with or without papillary tumors based on data from cohort 2 of the SunRISe-1 trial.
“With an 82.4% complete response rate and durable outcomes extending beyond 2 years, TAR-200 sets a new benchmark for bladder-sparing treatment in patients with BCG-unresponsive non–muscle-invasive bladder cancer,” said lead author Siamak Daneshmand, MD, director of urologic oncology at the University of Southern California, in correspondence with Urology Times®. “The SunRISe-1 trial establishes TAR-200 as a promising novel intravesical therapy for patients who are ineligible for or decline radical cystectomy.”
REFERENCES
1. Daneshmand S, Heijden MSV, Jacob JM, et al. TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: Results from the phase IIb SunRISe-1 study. J Clin Oncol. 2025:101200JCO2501651. doi:10.1200/JCO-25-01651
2. Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer. News release. Johnson & Johnson. July 17, 2025. Accessed July 31, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-u-s-fda-priority-review-for-tar-200-nda-in-high-risk-non-muscle-invasive-bladder-cancer