Core Insights - CG Oncology announced positive topline data from the Phase 3 BOND-003 trial for cretostimogene in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC), showing a 74.5% complete response rate among patients [1][2][3] - The median duration of response exceeds 27 months, with 63.5% of patients remaining in response at 12 months and 56.6% at 24 months [2][3] - The treatment demonstrated favorable safety, with no Grade 3 or greater treatment-related adverse events reported [2][3] Company Overview - CG Oncology is focused on developing and commercializing innovative therapies for bladder cancer, aiming to improve patient outcomes and quality of life [9] - The company has received FDA Fast Track and Breakthrough Therapy Designations for cretostimogene in December 2023 [5] - Cretostimogene is an investigational oncolytic immunotherapy that has been studied in over 250 patients with NMIBC [8] Clinical Trial Details - The BOND-003 trial is a single-arm, Phase 3 study involving 112 patients with high-risk BCG-unresponsive NMIBC [4] - The primary endpoint is the complete response rate, while the duration of response is a secondary endpoint [4] - The trial population includes patients with prior treatments, indicating a highly pre-treated cohort [4] Market Context - Bladder cancer is a significant health concern, with over 83,000 estimated diagnoses in 2024, and NMIBC accounts for approximately 75% of these cases [7] - There is a critical need for new treatment options in bladder cancer, highlighting the potential impact of cretostimogene if approved [2][3]
Groundbreaking Cretostimogene Grenadenorepvec Monotherapy Data Demonstrates Sustained, Durable Complete Responses in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer