Joseph Jacob, MD, on the durability of TAR-200 in NMIBC

Data from cohort 2 of the SunRISe-1 study (NCT04640623), looking at TAR-200 monotherapy in patients with BCG-unresponsive high-risk non–muscle invasive bladder cancer (NMIBC) carcinoma in situ, were presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.¹ Presenting author Joseph M. Jacob, MD, MCR, sat down with Urology Times® at the meeting to discuss these results in-depth.

“If you look at the data, it's phenomenal data. It's the highest [complete response] CR rate reported to date. It's at 82.4%, and the cool thing about today was we talked about durability. So, it's a high CR rate, but it's a durable response. Patients had responses that would last 12 months, even 2 years. If you look at the duration of response, [the] duration of response rate was about 52.9%.”

Patient-reported outcomes, specifically mean Global Health Status and Physical Functioning scores on EORTC-QLQ-C30, were high at baseline and remained stable throughout treatment.

TAR-200 was also well-tolerated, according to the authors. In total, 83.5% of patients experienced a treatment-related adverse event (TRAE), with the majority being low-grade urinary tract AEs. Further, 12.9% of patients experienced a grade 3 or higher TRAE, 5.9% experienced a serious TRAEs, and 3.5% had TRAEs leading to treatment discontinuation.

In total, cohort 2 of the SunRISe-1 trial included 85 patients with a median age of 71. This cohort is part of the larger SunRISe-1 study, which is assessing TAR-200 across 4 cohorts of patients: TAR-200 plus cetrelimab (cohort 1), TAR-200 alone (cohort 2), cetrelimab alone (cohort 3), and TAR-200 alone in patients with papillary disease only.²

Based on these findings, the authors concluded, “TAR-200 monotherapy was well tolerated with the highest CR rate reported in BCG-unresponsive HR NMIBC. Responses were highly durable, and the majority of responders were disease-free at 1 y. Overall health status and high PF were maintained on TAR-200 treatment.”

REFERENCES

1. Jacob JM, Guerrero-Ramos F, Necchi A, et al. TAR-200 monotherapy in patients with bacillus calmette-guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. Presented at: 2025 American Urological Association Annual Meeting. April 26-29, 2025. Las Vegas, Nevada.

2. A study of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone in participants with non-muscle invasive bladder cancer (NMIBC) unresponsive to intravesical bacillus calmette-guérin who are ineligible for or elected not to undergo radical cystectomy (SunRISe-1). ClinicalTrials.gov. Last updated April 3, 2025. Accessed April 27, 2025. https://clinicaltrials.gov/study/NCT04640623