Commentary|Videos|April 29, 2025
Cretostimogene Effective for BCG-Unresponsive Bladder Cancer: Phase 3 Data
Author(s)Mark D. Tyson, II, MD, MPH
Mark Tyson, MD, MPH, discusses practice-changing data from the phase 3 BOND-003 study.
Data from the
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.
REFERENCE:
Tyson M. BOND-003 cohort C- a phase-3, single-arm study of intravesical cretostimogene grenadenorepvec for high-risk BCG-unresponsive NMIBC with CIS. Presented at: American Urological Association Annual Congress; April 26-29, 2025; Las Vegas, NV. P2s.
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