A new bladder cancer treatment called TAR-200 has shown impressive results in a recent clinical trial.
The study found that 82% of patients with high-risk non-muscle-invasive bladder cancer had their tumors completely disappear after receiving this therapy. Even more encouraging, nearly half of the patients were still cancer-free one year later.
This trial is a breakthrough for patients who haven’t responded to standard treatments like BCG immunotherapy. Dr. Sia Daneshmand, lead researcher and director of urologic oncology at Keck Medicine of USC, called TAR-200 “the most effective therapy reported so far” for this common type of bladder cancer.
TAR-200 is a small device shaped like a pretzel. It slowly releases a cancer-fighting drug called gemcitabine directly inside the bladder. The device is placed in the bladder using a catheter, where it stays for three weeks during each treatment cycle.
This slow, steady release helps the medicine reach deeper layers of the bladder, increasing its ability to kill cancer cells.
The global trial, named SunRISe-1, involved 85 patients across 144 medical centers, including Keck Hospital of USC. All patients had high-risk bladder cancer that had resisted earlier BCG treatment.
Without new treatment, these patients often needed surgery to remove the entire bladder and nearby organs—a major operation with serious risks and long-term impact on quality of life.
Instead, patients received TAR-200 every three weeks for six months, followed by occasional treatments over the next two years. Out of the 85 participants, 70 experienced complete disappearance of their tumors, and about half stayed cancer-free for at least a year. Side effects were minimal, making the therapy a safer option compared to surgery.
Researchers also tried combining TAR-200 with another cancer drug called cetrelimab, but the combination caused more side effects and was less effective than TAR-200 on its own.
The study adds to growing interest in slow-release cancer therapies. These new approaches are designed to keep medicine at the tumor site for longer, allowing more time to fight the cancer. Dr. Daneshmand has been studying this method since 2016 and believes it could change the way bladder cancer is treated.
Thanks to these successful trial results, TAR-200 has now been approved by the U.S. Food and Drug Administration (FDA) and is available under the name INLEXZO™. This approval opens the door to a new, less invasive treatment option for people with hard-to-treat bladder cancer.
Researchers will continue to monitor patients for long-term results, but these early findings are a major step forward in cancer care.
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The study is published in the Journal of Clinical Oncology.
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