CG Oncology Continues to Demonstrate Best-in-Disease Durability and Tolerability in BOND-003 Cohort C; Additional 12 Patients in Complete Response at 24 Months

Core Insights - CG Oncology, Inc. announced a robust 24-month complete response (CR) rate of 41.8% for cretostimogene monotherapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment [1][2] - The study showed that 90% of 12-month responders remained disease-free at 24 months, indicating strong durability of response [2] - The safety profile of cretostimogene remains consistent, with no grade 3 or greater treatment-related adverse events (TRAEs) reported [1][3] Study Details - The Phase 3 BOND-003 Cohort C study involved 110 highly pretreated patients, making it the largest study in this patient population to date [3] - The study reported a complete response rate of 75.5% at any time and a 24-month CR rate of 41.8%, with 46 confirmed CRs as of June 23, 2025 [2][3] - The estimated duration of response (DOR) rates at 12 and 24 months were 64.1% and 58.3%, respectively, with a median DOR of 28 months [2] Patient Tolerance and Compliance - Patients tolerated cretostimogene treatment well, with a median resolution time of one day for any grade TRAEs [3] - No treatment-related discontinuation was observed, and 97.3% of patients completed all expected treatments, indicating favorable patient adherence [3] Cretostimogene Overview - Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy studied in over 400 patients with NMIBC [4] - The clinical development program includes two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC [4] Company Vision - CG Oncology aims to develop and commercialize innovative immunotherapies for bladder cancer patients, enhancing their quality of life [6]