DALLAS, July 27, 2026
CG Oncology, Inc. announced the publication of results from its pivotal Phase 3 BOND-003 Cohort C clinical 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. The published findings reinforce the investigational therapy’s durable complete responses, long-term bladder preservation, low disease progression rates, and favorable safety profile in a heavily pretreated patient population. The study met its primary endpoint with statistical significance, exceeding historical and contemporary clinical benchmarks and supporting the potential of cretostimogene to become a new bladder-sparing treatment option for patients who have limited alternatives after failing BCG therapy.
Clinical Data Demonstrate Durable Efficacy and Low Disease Progression
The publication reported that 75.5% of patients achieved a complete response (CR) at any point during treatment with cretostimogene monotherapy. Among responding patients, 64.2% maintained their response at 12 months, while 60.1% remained in response at 24 months, with a median duration of response of at least 27.9 months that continues to mature. Approximately 90% of patients who remained in response at 12 months maintained those responses through 24 months, and one participant has remained disease-free for more than 51 months. The study also demonstrated 96.6% progression-free survival from progression to muscle-invasive bladder cancer at both 48 and 96 weeks, highlighting the therapy’s potential to preserve the bladder while delaying or preventing disease progression. Investigators also observed meaningful responses in patients previously treated with therapies including intravesical gemcitabine-docetaxel and systemic pembrolizumab, demonstrating activity across a challenging real-world patient population.
Safety Profile Supports Office-Based Treatment Approach
The BOND-003 Cohort C study further demonstrated a favorable safety and tolerability profile, with no Grade 3 or higher treatment-related adverse events, no treatment-related discontinuations, and no treatment-related deaths reported during the trial. The most commonly observed treatment-related adverse events included bladder spasms, urinary frequency, urinary urgency, painful urination, and blood in the urine, with a median resolution time of just one day. The investigational therapy is administered through a practical office-based intravesical procedure and does not require general anesthesia, operating room time, additional cystoscopy, or prophylactic medications, allowing integration into existing American Urological Association (AUA) and Society of Urologic Nurses and Associates (SUNA) treatment workflows. According to lead investigator Dr. Mark D. Tyson II, these characteristics, combined with durable efficacy, could significantly change treatment options for patients seeking bladder preservation instead of radical cystectomy.
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Publication Strengthens Cretostimogene Development Program
The publication in The Lancet Oncology represents an important milestone for CG Oncology as it continues advancing cretostimogene grenadenorepvec across multiple stages of non-muscle invasive bladder cancer. Chief Medical Officer Dr. Vijay Kasturi stated that the findings validate the strength of the clinical evidence supporting the investigational therapy and reinforce its potential to become a foundational monotherapy for BCG-unresponsive NMIBC. Beyond the completed Phase 3 BOND-003 study, the company is also conducting the Phase 3 PIVOT-006 trial in intermediate-risk NMIBC and the Phase 2 CORE-008 study while expanding patient access through its Expanded Access Program in North America. Having already received both FDA Fast Track and Breakthrough Therapy Designations, cretostimogene continues to advance as a promising oncolytic immunotherapy designed to deliver durable responses while preserving the bladder and improving quality of life for patients with difficult-to-treat bladder cancer.
Source: CG Oncology press release
