Cretostimogene Effective for BCG-Unresponsive Bladder Cancer: Phase 3 Data
Mark Tyson, MD, MPH, discusses practice-changing data from the phase 3 BOND-003 study.
Data from the phase 3 BOND-003 trial (NCT04452591), presented at the 2025 American Urological Association Annual Meeting, demonstrated that intravesical cretostimogene grenadenorepvec (CG0070) is a highly effective and well-tolerated treatment for patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).
In an interview with Targeted OncologyTM, Mark D. Tyson, MD, MPH, urologic oncologist at Mayo Clinic, discusses findings from BOND-003.
The study revealed a complete response (CR) rate of 75.5% in the overall patient population (n=83) at the data cutoff. Landmark CR rates at 12 and 24 months were 46.4% (n=110) and 33.7% (n=101), respectively, with Kaplan-Meier estimates of 50.7% and 42.3%. Notably, all CRs were centrally confirmed.
Urologic oncologist Mark D. Tyson, MD, highlighted the durable nature of the treatment and its potential for integration into routine urology practice. The study also showed promising duration of response, with an estimated probability of 58.3% at 24 months. Furthermore, most patients remained free from progression to muscle-invasive bladder cancer and avoided radical cystectomy at 24 months. Cretostimogene demonstrated consistent efficacy across various patient subgroups, including those with prior chemotherapy.
The safety profile was favorable, with most treatment-related adverse events being low-grade and resolving quickly. The most common side effects included bladder spasm, increased urinary frequency, and urgency. No grade 3 or higher treatment-related adverse events or discontinuations were reported. These findings support the FDA's prior fast track and breakthrough therapy designations for cretostimogene in this challenging patient population.
