Breaking Paradigms in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
June 23, 2026
Breaking Paradigms: BOND-003 Cretostimogene Monotherapy for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Mark Tyson II, MD, MPH
Mark Tyson presents results from the BOND-003 study, evaluating the efficacy of cretostimogene grenadenorepvec monotherapy in treating BCG-unresponsive non-muscle-invasive bladder cancer. Cretostimogene, an oncolytic adenovirus, selectively targets and destroys cancer cells while sparing normal tissue and boosting antitumor immunity. Based on these data, the FDA granted Fast Track & Breakthrough Therapy designation.
Paradigm-shifting, Practice-changing Clinical Trials in Urology
Pivotal Results from BOND-003: A Phase 3, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Mark Tyson II, MD, MPH
Mark Tyson presents pivotal results from BOND-003, a phase 3 study on intravesical cretostimogene grenadenorepvec for high-risk, BCG-unresponsive non-muscle invasive bladder cancer. The study demonstrated a 75.2% complete response rate at any time, with durable responses observed over time and high cystectomy-free survival and progression-free survival rates. The treatment was generally well-tolerated, with most adverse events being grade 1-2, and the FDA has granted fast-track designation for cretostimogene monotherapy in BCG-unresponsive CIS.
