CG Oncology, Inc. (NASDAQ: CGON) has announced significant developments regarding its investigational oncolytic immunotherapy, cretostimogene grenadenorepvec, at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.
In the phase 3 study, named bond-003 cohort C, which targets 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, the complete response (CR) rate at any time was reported at 75.5%. At 24 months, the CR rate was estimated at 42.3% by Kaplan-Meier (K-M) estimation, with a median duration of response (DOR) of 28 months. Notably, 97.3% of patients were free from progression to muscle-invasive disease at 24 months.
In addition, cohort P, which is in 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.
The safety profile of cretostimogene was reported to be well-tolerated, 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.
Gary D. Steinberg, M.D., Professor at the Department of Urology at Rush University Medical Center, commented on the findings, stating, "We continue to see strong safety and efficacy, as well as best-in-disease durability and tolerability, with cretostimogene at the 24-month mark, in a high-risk, heavily pretreated NMIBC patient population."
Ambaw Bellete, President & Chief Operating Officer of CG Oncology, also emphasized the potential of cretostimogene, stating, "The compelling efficacy, durability, freedom from progression to muscle-invasive disease, and tolerability of cretostimogene offer potential, distinct advantages over existing therapies for the treatment of high-risk BCG-unresponsive NMIBC."
The company will host a conference call and webcast on Monday, April 28, 2025, to discuss these developments further.
Cretostimogene grenadenorepvec is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with NMIBC. It is currently being evaluated in two phase 3 clinical trials: bond-003 for high-risk BCG-unresponsive NMIBC and pivot-006 for intermediate-risk NMIBC. Additionally, the company has initiated an expanded access program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Today the company's shares have moved 25.3% to a price of $28.03. For the full picture, make sure to review CG Oncology's 8-K report.
