New slow-release bladder cancer therapy shows 82% success rate

New targeted bladder cancer treatment TAR-200 achieves unprecedented remission results

LOS ANGELES: A new targeted drug delivery system known as TAR-200 has achieved extraordinary results in treating high-risk non-muscle-invasive bladder cancer (NMIBC), according to a phase 2 clinical trial published in the Journal of Clinical Oncology.

Researchers found that 82% of patients saw complete tumor disappearance within just three months of treatment. Nearly half remained cancer-free after a year — a result experts are calling “the most effective therapy to date” for this common type of bladder cancer.

“Traditionally, these patients have had very limited treatment options. This new therapy represents a major breakthrough,” said Dr. Sia Daneshmand, Director of Urologic Oncology at Keck Medicine of USC and lead author of the study.

How TAR-200 works

TAR-200 is a small, pretzel-shaped slow-release device that delivers the chemotherapy drug gemcitabine directly into the bladder through a catheter. Once placed, it gradually releases the drug over a three-week period per treatment cycle, ensuring continuous exposure of cancer cells to chemotherapy.

Conventional gemcitabine therapy keeps the drug in the bladder for only a few hours — often limiting its effectiveness. The TAR-200 approach allows deeper penetration and longer exposure, resulting in a significantly higher rate of tumor eradication.

“The longer the medication stays in contact with the bladder wall, the more effective it becomes,” explained Dr. Daneshmand.

Inside the clinical trial

The SunRISe-1 trial, conducted at 144 locations worldwide, included 85 patients with high-risk NMIBC who had not responded to the standard Bacillus Calmette-Guérin (BCG) immunotherapy. These patients typically face surgical bladder removal — a procedure with severe quality-of-life impacts.

Instead, participants received TAR-200 treatments every three weeks for six months, followed by quarterly maintenance doses for up to two years. Results showed:

• 82% (70 of 85) achieved complete response after three months
• ~50% remained cancer-free after 12 months
• Minimal side effects compared to other therapies
• TAR-200 alone outperformed TAR-200 combined with immunotherapy (cetrelimab)
• The therapy was well tolerated, with only mild urinary symptoms reported.

A new chapter for bladder cancer treatment

The trial’s success has prompted the U.S. Food and Drug Administration (FDA) to grant TAR-200 Priority Review, expediting its potential approval.

“We are at an exciting moment in oncology,” said Daneshmand. “Delivering cancer-fighting medication directly and continuously to the tumor site could redefine how we treat bladder cancer.”

The research team continues to follow patients for long-term outcomes, while additional trials are underway to test TAR-200 in combination with other treatments and for different bladder cancer stages.

If approved, TAR-200 could become a bladder-sparing alternative for thousands of patients who previously faced surgery — offering renewed hope and quality of life.

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