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. The phase III study reported a 75.2% complete response rate, with 83% maintaining a response beyond 12 months, demonstrating significant durability and tolerability with no major adverse events. Notably, patients not responding to initial treatment showed improvement upon subsequent doses, underscoring the adaptive immune response triggered by Cretostimogene. Based on these data, the FDA granted Fast Track & Breakthrough Therapy designation. Dr. Tyson highlights ongoing expansions in clinical trials and introduces an Expanded Access Program, emphasizing Cretostimogene’s promising role in enhancing bladder cancer management.

Biographies:

Mark Tyson II, MD, MPH, Urologic Oncologist, Mayo Clinic Arizona, Scottsdale, AZ

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AUA 2024: 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


POSTER: BOND-003 | Cohort P | A Phase 3, Single-Arm Study of Cretostimogene Grenadenorepvec for the Treatment of Papillary NMIBC without Carcinoma in Situ, Unresponsive to BCG

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BOND-003 Phase 3 Results: Revolutionizing Bladder Cancer Treatment with Intravesical Cretostimogene Grenadenorepvec Monotherapy for High-Risk BCG-Unresponsive NMIBC - Mark Tyson

SUO 2023: First Results from BOND-003, a Phase 3 Study of Intravesical Cretostimogene Grenadenorepvec Monotherapy for Patients with High-Risk BCG Unresponsive NMIBC