CG Oncology, a late-stage clinical biopharmaceutical company focused on developing and commercialising a potential backbone bladder-sparing therapeutic for patients with bladder cancer, announced topline data from BOND-003 Cohort P and first results from CORE-008 Cohort A, which demonstrated promising efficacy, safety and tolerability. These data will be presented today as Late-Breaking Abstracts at the Society of Urologic Oncology (SUO) 26th Annual Meeting. 

“For people living with bladder cancer, the need for primary treatment of newly diagnosed NMIBC and a durable, bladder-sparing option for those with BCG unresponsive disease is urgent. New data from BOND-003 Cohort P and CORE-008 Cohort A add to a growing body of evidence demonstrating cretostimogene’s potential to become a backbone treatment across the NMIBC spectrum, if approved. The topline efficacy, safety, and tolerability announced today are consistent with what we previously observed with the pivotal Phase 3 monotherapy data, but in an even more prevalent NMIBC population, notably BCG-UR papillary-only,” said Trinity J. Bivalacqua, M.D., PhD, Urologic Oncologist at University of Pennsylvania.

“We are delighted to share new and more mature data in different sub-groups, underscoring our commitment to address the broadest range of NMIBC patients. This sets us up for the future expansion and long-term success of cretostimogene. With its best-in-disease profile and dual MOA, we are confident that cretostimogene will continue to demonstrate differentiated data from current and investigational NMIBC therapies,” said Ambaw Bellete, President & Chief Operating Officer at CG Oncology.

TOPLINE BOND-003 COHORT P RESULTS
Results from the BOND-003 Cohort P clinical trial of cretostimogene monotherapy in patients with BCG-UR papillary-only NMIBC demonstrate encouraging HG-EFS and a consistent, well-tolerated safety profile. The study’s primary endpoint is High-Grade Event-Free Survival (HG-EFS). As of the September 1, 2025, data cut-off, in 51 efficacy evaluable patients, Kaplan-Meier estimates of HG-EFS at 3- 6- and 9-months are 95.7 per cent (95 per cent CI 83.8 – 98.9), 84.6 per cent (95 per cent CI 68.6 – 92.9 per cent) and 80.4 per cent (95 per cent CI 62.3-90.4 per cent), respectively.

A favourable safety and tolerability profile was observed with no Grade 3 or greater treatment-related adverse events (TRAEs) and no deaths reported. To date, no patients have undergone a radical cystectomy or progressed to MIBC. No treatment-related discontinuation of cretostimogene was observed. There were no missed doses, or dose delays due to TRAE. The most common TRAEs (≥10 per cent) were bladder spasms, dysuria, pollakiuria, and hematuria.

The study has completed enrollment with 56 patients receiving cretostimogene across 35 clinical sites in the United States and Japan.

CORE-008 Cohort A Results
The first results from CORE-008 Cohort A demonstrate that cretostimogene monotherapy has promising clinical efficacy, tolerability, and safety in patients with high-risk, BCG-naïve NMIBC with CIS, compared with outcomes observed in historical BCG-naive trials. The primary endpoint is Complete Response (CR) at any time. As of the September 1, 2025, data cut off, the overall CR rate at any time in evaluable patients is 83.7 per cent (41/49) (95 per cent CI 70.3-92.7 per cent) with the original administration achieving a 79.2 per cent CR rate (57.8, 92.9) in 19 out of 24 patients as compared with the optimized administration which resulted in an 88.0 per cent CR rate (68.8, 97.5) in 22 out of 25 patients.

The safety and tolerability profile is consistent with prior clinical trials of cretostimogene. The most common adverse events are low-grade and localised to the bladder. There are no related serious adverse events (SAEs), Grade 3+ adverse events or treatment-related discontinuations. No patients progressed to MIBC or metastatic disease.