New Cretostimogene Grenadenorepvec Data Highlight its Potential to Become the Backbone Therapy for High-Risk Non-Muscle Invasive Bladder Cancer

Core Insights - CG Oncology, Inc. announced promising topline data from BOND-003 Cohort P and CORE-008 Cohort A, indicating efficacy, safety, and tolerability of cretostimogene for bladder cancer treatment [1][2][3] BOND-003 Cohort P Results - The BOND-003 trial demonstrated High-Grade Event-Free Survival (HG-EFS) rates of 95.7% at 3 months, 84.6% at 6 months, and 80.4% at 9 months among 51 evaluable patients [4][9] - No Grade 3 or greater treatment-related adverse events (TRAEs) were reported, and no patients progressed to muscle-invasive bladder cancer (MIBC) [5][9] - The study included 56 patients across 35 clinical sites in the U.S. and Japan [6] CORE-008 Cohort A Results - CORE-008 Cohort A showed an overall Complete Response (CR) rate of 83.7% in evaluable patients, with an 88.0% CR rate for optimized administration compared to 79.2% for original administration [7][10] - The safety profile was consistent with previous trials, with no serious adverse events or treatment-related discontinuations reported [8][10] Cretostimogene Overview - Cretostimogene is an investigational oncolytic immunotherapy for Non-Muscle Invasive Bladder Cancer (NMIBC), with over 400 patients involved in its clinical development [11] - The company is conducting two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC [11] Company Background - CG Oncology focuses on developing and commercializing bladder-sparing therapies for bladder cancer patients, aiming to improve their quality of life [12]