J&J(JNJ) Prnewswire·2025-04-26 17:50Core Insights - Johnson & Johnson announced promising results from the Phase 2b SunRISe-1 study of TAR-200, showing over 82% of patients achieved complete response (CR) and more than half remained cancer-free for at least one year [1][4] - TAR-200 is positioned as a transformative treatment for patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer (HR-NMIBC), particularly those ineligible for radical cystectomy [1][8] Company Overview - Johnson & Johnson is focused on healthcare innovation, aiming to provide less invasive and more effective treatment options for complex diseases [9] - The company has initiated a new drug application with the FDA for TAR-200 under the Real-Time Oncology Review program, following its Breakthrough Therapy Designation [6][4] Study Details - The SunRISe-1 study enrolled 85 patients, with a complete response rate of 82.4% and a median duration of response of 25.8 months [1][7] - The study specifically targets patients with carcinoma in situ, with or without papillary disease, who have not responded to BCG therapy [7] Treatment Efficacy - The treatment demonstrated a high level of sustained disease control, with 52.9% of responders maintaining CR at one year and 86.6% remaining cystectomy-free [1][2] - Most treatment-related adverse events were mild, with only 3.5% of patients discontinuing treatment due to adverse effects [2] Market Context - Bladder cancer is among the ten most common cancers globally, with limited treatment options available for patients who do not respond to initial BCG therapy [1][8] - High-risk non-muscle invasive bladder cancer accounts for 15-44% of NMIBC cases, characterized by high-grade tumors and a tendency to recur [8]