The targeted drug release device TAR-200 shows promising response and disease-free survival rates in specific populations of patients with non-muscle-invasive bladder cancer.
Johnson & Johnson’s investigational drug-device product elicited durable response rates in certain patients with high-risk non-muscle-invasive bladder cancer during a mid-stage trial.
In an investor note on Sunday, Guggenheim Partners said that TAR-200’s overall performance was “robust,” though it nevertheless fell “slightly below investor expectations.” Still, doctors that the analysts spoke to “appear impressed overall by TAR-200’s efficacy.”
“We expect the product to obtain accelerated approval later this year,” Guggenheim wrote in a Friday note, in anticipation of the Phase IIb SunRISe-1 readout. In January, J&J initiated a rolling application for TAR-200 with the FDA.
The latest SunRISe-1 data were presented Saturday at the 2025 Annual Meeting of the American Urological Association, and come from the trial’s carcinoma in situ cohort whose cancers have not invaded other tissues, which includes 85 patients who are ineligible for or decline radical cystectomy, and who are unresponsive to Bacillus Calmette-Guérin treatment. At the time of the readout, 82.4% of these patients had a complete response to TAR-200, showing no signs of cancer.
52.9% of these responders still had undetectable levels of cancer at one year—an effect that J&J called “sustained disease control.” The median duration of response was 25.8 months, indicating that “many patients remained cancer-free for over two years without the need for reinduction therapy,” according to the pharma.
Also on Saturday, J&J presented findings from cohort 4 of SunRISe-1, which focused on patients with papillary-only disease and tested the value of TAR-200 as an alternative option to surgery. Results, from 52 enrolled patients showed that the drug-device combo elicited a disease-free survival rate of more than 80%, without the need for reinduction.
Additionally, 94% of treated patients were able to preserve their bladders, according to J&J.
In terms of safety, TAR-200 had an overall acceptable side effect profile in both studies, according to J&J. Most side effects were mild, resolved quickly or manageable. Serious events were rare and seven patients discontinued treatment due to toxicities across both studies. There were no treatment-related deaths.
TAR-200 is a drug-device combination that is designed to be easily installed to allow targeted and controlled release of gemcitabine, a classic chemotherapeutic agent first approved in the U.S. in 1996, into the bladder. The investigational product won the FDA’s Breakthrough Therapy Designation in December 2023.
