TAR-200, an investigational intravesical drug-releasing system delivering sustained gemcitabine, demonstrated high response rates and durable outcomes in patients with bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (NMIBC), according to results from the Phase IIb SunRISe-1 study. The findings highlight TAR-200 monotherapy as a promising bladder-sparing option for patients ineligible for or refusing radical cystectomy.
The trial evaluated TAR-200 alone, TAR-200 in combination with cetrelimab, and cetrelimab monotherapy across parallel cohorts of patients with BCG-unresponsive carcinoma in situ (CIS) with or without papillary disease, as well as patients with papillary disease–only NMIBC. Treatment regimens included TAR-200 dosing through 24 months and cetrelimab through 18 months.
In patients receiving TAR-200 monotherapy for CIS (Cohort 2), the complete response rate was 82.4%, with a median duration of response of 25.8 months. For papillary disease–only patients treated with TAR-200 (Cohort 4), disease-free survival rates were 85.3%, 81.1%, and 70.2% at 6, 9, and 12 months, respectively. Combination therapy with TAR-200 and cetrelimab (Cohort 1) achieved a complete response rate of 67.9%, while cetrelimab alone (Cohort 3) reached 46.4%.
TAR-200 monotherapy was associated with a favorable safety profile compared with the combination or cetrelimab alone. Grade ≥3 treatment-related adverse events occurred in 12.9% of patients receiving TAR-200 monotherapy in Cohort 2 and 7.1% in Cohort 4, with no treatment-related deaths reported. By contrast, higher rates of severe adverse events were observed with TAR-200 plus cetrelimab.
These data suggest TAR-200 offers an effective and tolerable treatment strategy for BCG-unresponsive high-risk NMIBC, providing durable complete responses and meaningful disease-free survival. The results support further evaluation of TAR-200 as a potential alternative to cystectomy in this difficult-to-treat population.
Reference:
Balar A 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; doi:10.1200/JCO-25-01651
