TAR-200 Eliminates Bladder Cancer in 82% of Patients

The drug-releasing system TAR-200 has been found to eliminate tumors in 82% of patients participating in a phase 2 clinical trial for people with high-risk non-muscle-invasive bladder cancer whose disease was previously resistant to treatment.

The development was announced in a news release issued by Keck Medicine of USC. Trial results were also published in the Journal of Clinical Oncology.

Among most patients the cancer disappeared after three months of treatment, with nearly half of patients cancer-free a year later, according to the news release.

“Traditionally, these patients have had very limited treatment options. This new therapy is the most effective one reported to date for the most common form of bladder cancer,” Dr. Sia Daneshmand, director of urologic oncology with Keck Medicine of USC and lead author of the study, said in the news release. “The findings of the clinical trial are a breakthrough in how certain types of bladder cancer might be treated, leading to improved outcomes and saved lives.”

TAR-200, as detailed in the news release, is a pretzel-shaped device containing the chemotherapy gemcitabine and is inserted into the bladder via a catheter, and it slowly releases the drug into the bladder for three weeks each treatment cycle.

“The theory behind this study was that the longer the medicine sits inside the bladder, the more deeply it would penetrate the bladder and the more cancer it would destroy,” said Daneshmand in the news release.

The SunRISe-1 trial enrolled 85 patients and was conducted at 144 locations, according to the news release. All patients had previously received treatment, but their cancer had returned.

“The standard treatment plan for these patients was surgery to remove the bladder and surrounding tissue and organs, which has many health risks and may negatively impact patients’ quality of life,” said Daneshmand in the news release.

Instead, patients received treatment with TAR-200 every three weeks for six months and then four times a year for two years, resulting in the disappearance of cancer in 70 patients. Participants in the trial will be followed for another year.

In July, the U.S. Food and Drug Administration (FDA) granted priority review to the new drug application for TAR-200 for patients with high-risk non-muscle invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin (BCG) and includes carcinoma in situ, with or without papillary tumors. This was announced in a news release from Johnson & Johnson.

"TAR-200 represents an innovation in drug delivery that has not been seen in decades," Dr. Yusri Elsayed, global therapeutic area head, Oncology, Johnson & Johnson Innovative Medicine, said in the news release issued at the time. "The FDA priority review for TAR-200 underscores our mission to fundamentally change the way urologists treat certain types of bladder cancer."

Among patients with BCG-unresponsive, high-risk non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary disease, treatment with TAR-200 elicited high complete response rates, according to data from the phase 2b SunRISe-1 study that were shared during the 2025 American Urological Association Annual Meeting, where investigators highlighted data from Cohort 2 of the trial which evaluated 85 patients within this population. Patients who received TAR-200 were reported to have achieved an overall complete response rate of 82.4% and the 12-month complete response rate was 45.9%.

References

1. “New treatment eliminates bladder cancer in 82% of patients,” news release, Aug. 13, 2025; https://news.keckmedicine.org/new-treatment-eliminates-bladder-cancer-in-82-of-patients/
2. “FDA Grants Priority Review to TAR-200 for Bladder Cancer Subset,” CURE, July 18, 2025; https://www.curetoday.com/view/fda-grants-priority-review-to-tar-200-for-bladder-cancer-subset
3. “TAR-200 Shows High Response Rates in Bladder Cancer Subset,” CURE, April 29, 2025; https://www.curetoday.com/view/tar-200-shows-high-response-rates-in-bladder-cancer-subset

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