TAR-200 boasts impressive DFS rates in papillary disease-only NMIBC

TAR-200 monotherapy poses a promising emerging option for patients with BCG-unresponsive papillary disease-only high-risk non–muscle invasive bladder cancer (NMIBC), according to results from cohort 4 of the SunRISe-1 trial (NCT04640623) presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.¹

Felix Guerrero-Ramos, MD, PhD, FEBU

TAR-200 is a novel intravesical drug releasing system. The therapy was granted a breakthrough therapy designation by the FDA in December 2023 for patients with BCG-unresponsive high-risk NMIBC.²

Data from cohort 4 of the SunRISe-1 trial were presented by Felix Guerrero-Ramos, MD, PhD, FEBU, of the Hospital Universitario 12 de Octubre, Madrid, Spain. In his presentation, Guerrero-Ramos noted that there are currently no approved options for patients with BCG-unresponsive papillary disease-only high-risk NMIBC.

“We urgently need new alternatives for these patients,” he said. “The current standard of care is radical cystectomy, which impairs a significant comorbidity, morbidity and mortality, deterioration of the quality of life, and it is also a life-altering surgery. Currently, there are no options for these patients, no approved treatments, and several other drugs have reported 12-month recurrence or disease-free survival rates ranging between 44% and 55%.”

Overall, data from cohort 4 showed that TAR-200 monotherapy was associated with a disease-free survival (DFS) of 85.3% (95% CI, 71.6% to 92.7%) at 6 months and 81.1% (95% CI, 66.7% to 89.7%) at 9 months. At a median follow-up of 12.8 months, the median DFS was not reached (95% CI, 12.1 to NE). In total, 5.8% (3 of 52) of patients underwent radical cystectomy.

Among patients with high-grade Ta disease, the DFS was 85.7% (95% CI, 66.3% to 94.4%) at 6 months and 82.1% (95% CI, 62.3% to 92.1%) at 9 months. Among patients with T1 disease, DFS was 84.7% (95% CI, 59.7% to 94.8%) at 6 months and 79.4% (95% CI, 54% to 91.7%) at 9 months.

Guerrero-Ramos noted during the presentation, “This shows that regardless of the T stage, TAR-200 is highly active in this population.”

Further, at 9 months, the progression-free survival (PFS) was 95.6% (95% CI, 83.5% to 98.9%), and the overall survival (OS) was 98.0% (95% CI, 86.4% to 99.7%). The median PFS and OS were not estimable at the time of data report. In total, 1.9% (1 of 52) patients progressed to muscle-invasive disease.

Safety data showed no new safety signals. The majority of treatment-emergent adverse events (TEAEs) were grade 1 or 2. These resolved after a median of 3.7 weeks.

In total, 5.8% (3) patients experienced at least 1 serious treatment-related adverse event (TRAE), and 7.7% (4) patients discontinued treatment due to TRAEs. There were no treatment-related deaths.

The insertion success rate for the TAR-200 device was 99.5% (387 of 389).

In total, cohort 4 of the phase 2 SunRISe-1 trial included 52 patients with BCG-unresponsive papillary-only high-risk NMIBC with no carcinoma in situ (CIS). Cohort 4 is part of the larger SunRISe-1 platform, which is also assessing the safety and efficacy of TAR-200 in combination with cetrelimab (cohort 1), TAR-200 monotherapy (cohort 2), and cetrelimab monotherapy (cohort 3) in patients with BCG-unresponsive high-risk NMIBC with CIS.

In cohort 4 of the trial, patients received TAR-200 Q3W (indwelling) for the first 24 weeks, and then Q12W dosing through week 96. The trial did not allow for re-induction therapy for non-responders.

The primary end point for this cohort is DFS. Key secondary end points include safety and tolerability.

“In conclusion, the first results of TAR-200 monotherapy in cohort 4 of SunRISe-1 showed impressive DFS rates in patients with BCG-unresponsive papillary-only disease,” Guerrero-Ramos concluded during the presentation. “Finally, the ongoing phase 3 SunRISe-5 study (NCT06211764) is a randomized trial comparing TAR-200 monotherapy vs intravesical chemotherapy in patients with BCG-unresponsive or experienced papillary-only non–muscle invasive bladder cancer that will provide further evidence on the potential role of TAR-200 in this setting.”

REFERENCES

1. Guerrero-Ramos F, Jacob JM, van der Heijden MS, et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: First results from cohort 4 of SunRISe-1. J Urol. 2025;213(5S):e2. doi:10.1097/01.JU.0001111604.90306.91.04

2. Johnson & Johnson's investigational TAR-200 granted U.S. FDA Breakthrough Therapy Designation for the treatment of high-risk non-muscle-invasive bladder cancer. Johnson & Johnson. December 4, 2023. Accessed April 30, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnsons-investigational-tar-200-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-high-risk-non-muscle-invasive-bladder-cancer