Peer-reviewed Phase 3 data showed durable complete responses, low progression to muscle-invasive disease and no Grade 3 or higher treatment-related adverse events in high-risk BCG-unresponsive NMIBC.
CG Oncology said The Lancet Oncology published results from the pivotal Phase 3 BOND-003 Cohort C trial of cretostimogene grenadenorepvec monotherapy in patients with high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without Ta/T1 disease. The single-arm study met its primary endpoint with statistical significance, with 75.5% of patients achieving a complete response at any time. Duration of response was 64.2% at 12 months and 60.1% at 24 months, while median duration of response was at least 27.9 months and remained ongoing. CG Oncology said 96.6% of patients were free from progression to muscle-invasive bladder cancer at both 48 and 96 weeks, and approximately 89% of patients maintained their bladders at 12 months and 81% at 24 months. The company also reported no Grade 3 or greater treatment-related adverse events, no treatment-related discontinuations or deaths, and a median 1 day to resolution for related adverse events. The publication adds peer-reviewed detail to a late-stage bladder cancer program that has FDA Fast Track and Breakthrough Therapy designations, though cretostimogene remains investigational.