Johnson & Johnson's INLEXZO™ (gemcitabine intravesical system) delivers 74 percent disease-free survival at one year in BCG-unresponsive, high-risk, papillary-only NMIBC

Core Insights - New data from the Phase 2b SunRISe-1 study indicate that over 95% of patients with high-risk, non-muscle invasive bladder cancer remained progression-free at one year, with more than 92% avoiding bladder removal surgery [1][2][3] Company Overview - Johnson & Johnson is committed to developing innovative treatments for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who have limited options beyond radical cystectomy [2] - The company is focusing on the gemcitabine intravesical system, which has shown promising results in clinical trials for patients unresponsive to Bacillus Calmette-Guérin (BCG) therapy [1][5] Study Details - Cohort 4 of the SunRISe-1 study involved 52 patients with papillary-only, high-risk NMIBC who did not respond to BCG therapy and were ineligible for or declined radical cystectomy [2][5] - The therapy was administered every three weeks for six months, followed by every 12 weeks for up to an additional 18 months [2] Efficacy Results - At a median follow-up of 15.9 months, the one-year disease-free survival (DFS) rate was 74.3%, with progression-free survival (PFS) at 95.6% and overall survival (OS) at 98% [3] - Notably, 92.3% of patients did not undergo radical cystectomy, indicating the treatment's potential to preserve bladder function [3] Safety Profile - The therapy was generally well-tolerated, with 80.8% of patients experiencing low-grade treatment-related side effects, primarily mild urinary symptoms [4] - Serious side effects were uncommon, occurring in 13.5% of patients, and no treatment-related deaths were reported [4] Industry Context - High-risk non-muscle invasive bladder cancer represents a significant challenge in oncology, with traditional treatment options often leading to radical cystectomy, which can severely impact patients' quality of life [2][7] - The ongoing need for effective bladder preservation therapies highlights the importance of studies like SunRISe-1 in addressing unmet medical needs in this patient population [2][7]