CG Oncology Announces Publication of Pivotal Phase 3 BOND-003 Cohort C Study Results in The Lancet Oncology

CG Oncology, Inc. (NASDAQ: CGON) today announced the publication of results from the pivotal Phase 3 BOND-003 Cohort C trial evaluating cretostimogene grenadenorepvec monotherapy in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 disease, in The Lancet Oncology.

Dr. Tyson continued, “These results are particularly encouraging given BOND-003 enrolled a heavily pretreated population representative of the patients that clinicians often encounter in real-world practice. Specifically, we observed meaningful responses in patients who had already received other therapies, including intravesical gemcitabine–docetaxel or systemic pembrolizumab, underscoring cretostimogene's activity across a clinically diverse and difficult-to-treat patient population. If approved by the FDA, cretostimogene may represent an important, bladder-sparing, advancement in the bladder cancer treatment paradigm, and meaningfully improve patient outcomes.”

BOND-003 Cohort C met its primary endpoint with statistical significance, exceeding historic and contemporary clinical benchmarks. Key findings and observations reported in the publication include:

Robust complete response (CR) rates and durable responses in patients with high-risk BCG-unresponsive NMIBC: 75.5% (95% CI 66.3–83.2) achieved a CR at any time, after receiving treatment with cretostimogene as monotherapy. 12- and 24-month duration of response (DOR) was 64.2% (95% CI 52.2–73.8) and 60.1% (95% CI 48.2–70.0), respectively. Median DOR is at least 27.9 months and is ongoing, with approximately 90% of patients in response at 12 months maintaining durable responses at 24 months, and one patient disease-free beyond 51 months.

Favorable safety and tolerability profile: No Grade 3 or greater treatment-related adverse events or treatment-related discontinuations or deaths reported. The median time to resolution of related adverse events was 1 day (IQR 0–7). The most common TRAEs (≥10%) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.

Clinically meaningful progression-free survival: 96.6% of patients were free from progression to muscle invasive bladder cancer at 48 weeks and 96 weeks.

Practical, office-based administration: Cretostimogene does not require prophylactic medication (e.g., anticholinergics), operating room time, additional cystoscopy, or anesthesia-dosing and aligns with existing AUA/SUNA intravesical administration policy, supporting ease of integration into both academic and community urology practice settings.