CG Oncology, Inc. (NASDAQ: CGON) has released updated data on its bond-003 cohort C study, showcasing the effectiveness of its investigational oncolytic immunotherapy, Cretostimogene, in treating high-risk non-muscle invasive bladder cancer (HR NMIBC) patients unresponsive to Bacillus Calmette-Guerin (BCG) treatment.
The updated data revealed a robust 24-month complete response (CR) rate of 41.8% for Cretostimogene monotherapy, with 12 additional patients achieving complete response at 24 months. Notably, 90% of the 12-month responders remained disease-free at the 24-month mark.
The phase 3 bond-003 cohort C study reported a 75.5% CR at any time and a 41.8% CR at 24 months, with 46 confirmed complete responses as of the cutoff date of June 23, 2025. The estimated 12* and 24-month duration of response (DOR) rates were 64.1% and 58.3%, respectively, with a median DOR of 28 months, which is ongoing.
Furthermore, 96.6% of patients were free from progression to muscle-invasive disease at 24 months. The study, which is the largest in this patient population to date, included 110 highly pretreated patients, with some having received as many as 66 prior BCG doses. Despite their highly pretreated conditions, patients tolerated Cretostimogene treatment well, with no grade 3 or greater treatment-related adverse events or deaths reported. Additionally, 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance.
Dr. Trinity J. Bivalacqua, MD, PhD, expressed encouragement, stating that if approved, Cretostimogene would represent an important, bladder-sparing advancement in the management of HR NMIBC in patients unresponsive to BCG treatment. The data from the bond-003 cohort C study demonstrates an unprecedented 90% chance of responders at 12 months remaining in response at 24 months, which is considered very meaningful for patients battling this difficult disease.
Ambaw Bellete, President & Chief Operating Officer at CG Oncology, highlighted the potential of Cretostimogene to become a breakthrough backbone treatment for bladder cancer patients. The company aims to initiate its Biologics License Application (BLA) submission for Cretostimogene in the fourth quarter of 2025 for the treatment of patients with HR NMIBC unresponsive to BCG.
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program involving more than 400 patients with NMIBC. The program includes two phase 3 clinical trials and a phase 2 trial, along with an expanded access program for eligible patients.
CG Oncology is focused on developing and commercializing potential bladder-sparing therapeutics for patients afflicted with bladder cancer.
The company will present the updated data at the New England Section of the American Urological Association’s 94th Annual Meeting in Boston, Massachusetts, on September 6, 2025. Today the company's shares have moved 7.92% to a price of $30.94. For more information, read the company's full 8-K submission here.
