CG Oncology, Inc. (NASDAQ: CGON) has released updated data on the Bond-003 cohort C, demonstrating continued success in treating high-risk non-muscle invasive bladder cancer (HR NMIBC) with their investigational oncolytic immunotherapy, Cretostimogene. The latest data reveals that an additional 12 patients achieved complete response (CR) at 24 months, resulting in a robust 24-month CR rate of 41.8% for Cretostimogene monotherapy in patients unresponsive to Bacillus Calmette Guerin (BCG) treatment.
Moreover, the safety profile of Cretostimogene remains consistent, with no grade 3 or greater treatment-related adverse events (TRAES) or deaths reported. Importantly, 90% of the patients who responded at 12 months remained disease-free at 24 months, indicating the therapy's durability and effectiveness.
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 CRs as of the cutoff date of June 23, 2025. The estimated 12* and 24-month duration of response (DOR) rates stand at 64.1% and 58.3%, respectively, with a median DOR of 28 months, which is ongoing. Notably, 96.6% of patients were free from progression to muscle invasive disease at 24 months.
In this largest study of this patient population to date, 110 highly pretreated patients were efficacy evaluable in the Bond-003 cohort C study. These patients had received a median of 12 prior BCG doses, with some having received as high as 66 doses. Despite their highly pretreated conditions, patients tolerated Cretostimogene treatment well, with no grade 3 or greater TRAES or deaths reported.
The most common TRAES (≥10%) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria. The positive data from the Phase 3 trial underlines Cretostimogene's potential 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.
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program involving more than 400 patients with non-muscle invasive bladder cancer. The program also includes two Phase 3 clinical trials: Bond-003 for high-risk BCG-unresponsive NMIBC and Pivot-006 for intermediate-risk NMIBC.
CG Oncology is positioning Cretostimogene as a potential bladder-sparing therapeutic for patients afflicted with bladder cancer, with the goal of providing innovative immunotherapies to improve the quality of life for urologic cancer patients. The market has reacted to these announcements by moving the company's shares 5.46% to a price of $32.63. Check out the company's full 8-K submission here.
