CG Oncology, Inc. (NASDAQ: CGON) has recently announced promising results for cretostimogene grenadenorepvec monotherapy at the 2025 American Urological Association (AUA) Annual Meeting. The phase 3 BOND-003 cohort C study, which focused on patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) treatment with carcinoma in situ (CIS) with or without TA or T1 disease, reported a robust 24-month complete response rate of 42.3% by Kaplan-Meier estimation. Furthermore, a striking 97.3% of all treated patients remained free from progression to muscle-invasive bladder cancer (MIBC) at 24 months.
In addition to these impressive findings, the study revealed that 91.6% of responders remained cystectomy-free at 24 months, and no grade 3 or greater treatment-related adverse events or deaths were reported. The cohort P data, which involved patients with BCG-unresponsive TA/T1 disease without CIS, showed an estimated 90.5% high-grade recurrence-free survival at 3 and 9 months in 24 treated patients. These results demonstrate the potential of cretostimogene's unique dual mechanism of action in treating different tumor types across high-risk NMIBC, positioning it as a potential breakthrough backbone therapy in bladder cancer treatment.
The BOND-003 cohort C study, which is the largest study in this patient population to date, included 110 highly pretreated patients who received a median of 12 prior BCG doses, with some patients receiving as many as 66. Despite their highly pretreated conditions, patients tolerated cretostimogene treatment well, with no grade 3 or greater treatment-related adverse events or deaths reported. Furthermore, 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance.
Following these compelling results, CG Oncology plans to host a conference call and webcast to discuss the findings on Monday, April 28, 2025, at 8 a.m. EDT. The company's investigational, intravesically delivered oncolytic immunotherapy, cretostimogene, has been studied in a clinical development program involving more than 400 patients with NMIBC. This program includes two phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. Additionally, CG Oncology has initiated an expanded access program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements.
These promising results suggest that, if approved, cretostimogene could represent a significant advancement for people suffering from bladder cancer, addressing a considerable unmet need in this patient population. The market has reacted to these announcements by moving the company's shares 32.2% to a price of $29.57. If you want to know more, read the company's complete 8-K report here.
