A new drug delivery system has shown remarkable success in treating a common form of bladder cancer that had stopped responding to standard therapies.
In a phase 2 clinical trial, the device—called TAR-200—eliminated tumors in 82% of patients with high-risk non-muscle-invasive bladder cancer.
In most cases, the cancer was gone within just three months of treatment, and nearly half of the patients remained cancer-free a year later.
“Traditionally, these patients have had very limited treatment options,” said Dr. Sia Daneshmand, director of urologic oncology at Keck Medicine of USC and lead author of the study, published in the Journal of Clinical Oncology.
“This is the most effective therapy reported to date for the most common form of bladder cancer.”
TAR-200 is a small, pretzel-shaped device that holds the chemotherapy drug gemcitabine. Doctors insert it into the bladder through a catheter, where it slowly releases the drug over three weeks during each treatment cycle.
Until now, gemcitabine has been given as a liquid solution that stays in the bladder for only a few hours—too short a time to fully attack the cancer.
The idea behind TAR-200 is simple: by keeping the drug in place for weeks, it can penetrate more deeply into bladder tissue and kill more cancer cells.
The clinical trial, known as SunRISe-1, took place at 144 sites worldwide and included 85 patients with high-risk non-muscle-invasive bladder cancer. This form of cancer is the most common type of bladder cancer.
It’s considered high risk when the chance of the cancer coming back—or spreading to the bladder muscle or other areas—is greater.
The standard treatment for this cancer is an immunotherapy drug called Bacillus Calmette-Guérin (BCG), but it doesn’t work for everyone. All patients in this trial had already been treated with BCG, but their cancer had returned.
For these patients, the usual next step is surgery to remove the bladder and surrounding organs—a life-altering procedure with serious risks. TAR-200 offered a less invasive alternative. Patients received the device every three weeks for six months, then four times a year for two more years.
Of the 85 patients, 70 had no detectable cancer after treatment. Almost half remained cancer-free after a year. Side effects were minimal.
Interestingly, giving TAR-200 together with an immunotherapy drug called cetrelimab was less effective and caused more side effects than TAR-200 alone.
The trial participants will be monitored for another year, but the study is now closed to new patients. The U.S. Food and Drug Administration has granted TAR-200 Priority Review, which could speed up its approval.
“This is an exciting moment,” Daneshmand said. “We are closer than ever to offering lasting remission from bladder cancer without removing the bladder.”
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Source: University of Southern California.
