Dr Jacob on the Potential for TAR-200 to Shift the Treatment Paradigm in NMIBC

“[TAR-200] allows us to give steady, good doses in the bladder for a much longer period of time.”

Joseph Jacob, MD, MCR, a medical oncologist specializing in bladder cancer, discussed how the emerging data for TAR-200 could represent a significant shift in the treatment paradigm for patients with high-risk, non–muscle-invasive bladder cancer (NMIBC).

TAR-200, a novel intravesical drug delivery system utilizing gemcitabine, differs from traditional intravesical therapies, which are typically administered via catheter-based instillations held in the bladder for 1 to 2 hours. In contrast, TAR-200 provides sustained local drug release that may enhance therapeutic exposure and reduce the logistical burden on patients, Jacob explained.

Data from the phase 2b SunRISe-1 study (NCT04640623) presented by Jacob during the 2025 AUA Annual Meeting showed that in cohort 2 (n = 85), patients with BCG-unresponsive, high-risk NMIBC with carcinoma in situ with or without papillary disease treated with TAR-200 experienced a complete response (CR) rate of 82.4% (95% CI, 72.6%-89.8%), and patients achieved a 12-month CR rate of 45.9%. The estimated 12- and 24-month CR rates were 52.4% (95% CI, 40.7%-62.8%) and 44.7% (95% CI, 33.1%-55.7%), respectively.

The broader implications of these findings could include future updates to clinical guidelines, which currently prioritize radical cystectomy following lack of response to BCG; Jacob emphasized that the data for TAR-200 provide a strong argument for offering patients a bladder-sparing alternative, particularly given the durability and tolerability observed.

Furthermore, Jacob highlighted that TAR-200 introduces a new approach to the treatment of bladder cancer through the use of a device-based intravesical platform. This innovation could facilitate the delivery of not only gemcitabine but also other therapeutic agents in future clinical development.

Continued investigation into the long-term outcomes and broader applications of TAR-200 will be important to fully characterize its role in the NMIBC treatment landscape, Jacob concluded.