A new, pretzel-shaped implant called TAR-200 has shown remarkable success in treating high-risk non-muscle-invasive bladder cancer that has not responded to traditional BCG treatment. In a recent study, the device cured 82.4% of patients with advanced disease, including those who had previously failed BCG therapy.
TAR-200 is designed to slowly release chemotherapy over several weeks, allowing the medication to stay in contact with the bladder lining for an extended period. This approach is supported by FDA guidance and has been found to be effective in delaying or avoiding life-changing surgery.
The study, known as SunRISe-1, tested TAR-200 alone and in combination with a PD-1 inhibitor. Results showed that patients who received the implant alone achieved an 82.4% complete response rate, with responses lasting up to 25.8 months. Patients with papillary-only tumors saw similar disease-free survival rates, ranging from 70.2% at 12 months.
While cetrelimab, a PD-1 inhibitor, showed promise in some studies, it did not improve complete responses and increased side effects when added to TAR-200. Notably, no treatment-related deaths were reported in any group.
The FDA has granted Priority Review to TAR-200, paving the way for a potential approval decision soon. This breakthrough could change the conversation for patients who have relapsed after BCG treatment, offering a simple and effective treatment option that may preserve bladder function and quality of life.
Source: https://scienceblog.com/slow-release-chemo-device-clears-most-bladder-tumors-in-key-trial