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CG Oncology Continues to Demonstrate Best-in-Disease Durability and Tolerability in BOND-003 Cohort C; Additional 12 Patients in Complete Response at 24 Months

  • Robust 24-month complete response (CR) rate of 41.8% observed for cretostimogene monotherapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) treatment
  • 90% of 12-month responders remained disease free at 24 Months
  • Safety profile remains consistent
Reno, Nevada (UroToday.com) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced updated data on BOND-003 Cohort C showing 12 additional patients with high risk non-muscle invasive bladder cancer (HR NMIBC) were in complete response (CR) at 24 months. The robust 24-month complete response landmark rate of 41.8% (CR rate observed in 46 out of 110 patients) for cretostimogene monotherapy reaffirms the best-in-disease durability that the Company announced at the American Urological Association Annual Meeting in April 2025. Cretostimogene’s safety profile also remains consistent with no grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported. Trinity J. Bivalacqua, MD, PhD, Urologic Oncology at Penn Medicine, and Co-Director, Genitourinary Cancer Service Line, Abramson Cancer Center, will present these updated data tomorrow, September 6, 2025, at the New England Section of the American Urological Association’s 94th annual meeting in Boston, Massachusetts.

“Based on the latest data cut, I remain very encouraged that if approved, cretostimogene will represent an important, bladder-sparing advancement in the management of high risk non-muscle invasive bladder cancer in patients who have disease that is unresponsive to BCG,” said Trinity J. Bivalacqua, MD, PhD. “In my clinical experience, bladder cancer patients are seeking treatment options that offer durable and sustained results. The latest data from the BOND-003 Cohort C study demonstrates that if a patient is a responder at 12 months, there is a 90 percent chance they will remain in response at 24 months. This is unprecedented in the high-risk, heavily pretreated NMIBC patient population and very meaningful for those battling this difficult disease.”
“The data from our Phase 3 BOND-003 Cohort C registrational trial underscores cretostimogene’s potential to become a breakthrough backbone treatment for bladder cancer patients,” said Ambaw Bellete, President & Chief Operating Officer at CG Oncology. “We are eager to bring this innovative treatment to a broad range of NMIBC patients, and we are making great strides towards that goal as we prepare to initiate our BLA submission for cretostimogene in our initial indication for the treatment of patients with HR NMIBC unresponsive to BCG in the fourth quarter of this year.”

The Phase 3 BOND-003 Cohort C study is in patients with high-risk NMIBC unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease. The study reported 75.5% CR at any time and 41.8% 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 are 64.1% and 58.3%, respectively. Median DOR is 28 months and is ongoing. Notably, 96.6% of patients were free from progression to muscle invasive disease at 24 months.

A total of 110 highly pretreated patients are efficacy evaluable in the BOND-003 Cohort C study, which makes it the largest study in this patient population to date. These patients received a median of 12 prior BCG doses, some as high as 66. Prior intervening therapy also included intravesical chemotherapy (41.1%) and systemic immunotherapy (6.3%). Despite their highly pretreated conditions, patients tolerated cretostimogene treatment well. There were no Grade 3 or greater TRAEs or deaths reported. Patients who experienced TRAEs of any grade had a median resolution time of one day. No treatment-related discontinuation of cretostimogene was observed, and 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance. The most common TRAEs (≥10%) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.

Source: CG Oncology. (2025). CG Oncology Continues to Demonstrate Best-in-Disease Durability and Tolerability in BOND-003 Cohort C; Additional 12 Patients in Complete Response at 24 Months [Press release]. https://ir.cgoncology.com/news-releases/news-release-details/cg-oncology-continues-demonstrate-best-disease-durability-and.