NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ)today announced new data from Cohort 2 of the pivotal Phase 2b SunRISe-1 study evaluating TAR-200-an intravesical gemcitabine releasing system-for patients with certain types of bladder cancer. The study shows more than 82 percent of patients achieved complete response (CR) with more than half of responders remaining cancer-free at one year after complete response.
The findings demonstrated the highest complete response rate without reinduction with more than half of responders remaining cancer-free for at least 12 months. These results highlight the potential of TAR-200 as a breakthrough for people with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors who are ineligible or refuse radical cystectomy (RC).
The company noted that most treatment-related adverse events (TRAEs) were mild and manageable. Overall, 71 patients (83.5 percent) experienced TRAEs, the majority of which were low-grade urinary symptoms, such as bladder irritation or discomfort. Eleven patients (12.9 percent) experienced Grade 3 or higher TRAEs, and five patients (5.9 percent) reported serious TRAEs. Only three patients (3.5 percent) discontinued treatment due to TRAEs, and there were no treatment-related deaths.
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