Johnson & Johnson's TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC

Core Insights - The first results from Cohort 4 of the Phase 2b SunRISe-1 study indicate that TAR-200 shows strong disease-free survival rates and bladder preservation potential in patients with high-grade papillary bladder cancer [1][2][3] - Over 95% of patients demonstrated a progression-free survival rate at 9 months, highlighting the effectiveness of TAR-200 in a high-risk patient population [1][2] Company Overview - Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, is focused on innovative treatments for bladder cancer, particularly targeting patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [1][5] - The company aims to provide alternatives to radical cystectomy, which has been the standard treatment for HR-NMIBC patients for over 40 years [1][4] Product Details - TAR-200 is an investigational intravesical gemcitabine releasing system designed for sustained local release of gemcitabine into the bladder, offering a new approach to treating early-stage bladder cancer [3][4] - The product is administered in an outpatient setting without the need for anesthesia, allowing for a more convenient treatment option for patients [2][3] Clinical Study Insights - The interim analysis from Cohort 4 of the SunRISe-1 study reported disease-free survival rates of 85.3% at six months and 81.1% at nine months for patients treated with TAR-200 monotherapy [1][2] - A significant 94.2% of patients avoided radical cystectomy at a median follow-up of 12.8 months, indicating the potential of TAR-200 to provide durable disease control [1][2] Safety Profile - The safety profile of TAR-200 was consistent with previous studies, with most treatment-related adverse events being low grade and resolving quickly [2][3] - Common treatment-related adverse events included dysuria (40.4%), pollakiuria (30.8%), and urinary urgency (26.9%), with no treatment-related deaths reported [2][3]