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Topline Results From BOND-003 Cohort P- A Multi-National, Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for Treatment of High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with HG Ta/T1 (Without CIS)
Timothy N. Clinton, MD1, Siamak Daneshmand, MD2, Timothy D. Lyon, MD3, Ankeet M. Shah, MD4, Trinity J. Bivalacqua, MD, PhD5, Amy N. Luckenbaugh, MD6, Colin P.N. Dinney, MD7, Mark Tyson, MD8.
1Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, USA, 2University of Southern California/Norris Comprehensive Cancer Center, Los Angeles, CA, USA, 3Mayo Clinic, Jacksonville, FL, USA, 4Duke University Medical Center, Durham, NC, USA, 5University of Pennsylvania, Philadelphia, PA, USA, 6Vanderbilt University, Nashville, TN, USA, 7University of Rochester, Rochester, NY, USA, 8Mayo Clinic, Phoenix, AZ, USA.
Background: US FDA-approved treatments for BCG-UR patients with CIS exist, but additional bladder-sparing therapies are needed, especially for the BCG-UR HG Ta/T1 population. Cretostimogene grenadenorepvec, an oncolytic immunotherapy, selectively targets and lyses cancer cells with Retinoblastoma (Rb)-E2F pathway alterations, triggering anti-tumor immune activation which is further amplified by the GM-CSF transgene. BOND-003 (NCT04452591) is a single-arm clinical trial assessing the efficacy and safety of intravesical cretostimogene for patients with HR BCG-UR HG Ta/T1 NMIBC.
Methods: Fifty-six adults with histologically confirmed HR BCG-UR NMIBC with HG Ta/T1 (without CIS) were enrolled on Cohort P. Intravesical cretostimogene was instilled for six weekly doses during the induction phase, followed by three weekly maintenance cycles quarterly through Month 12, then every six months through Month 36. Re-induction at three months was permitted for HG Ta and CIS at Month 3. Response assessments included cystoscopy, urine cytology, imaging, and mandatory mapping biopsy at Month 12 with centralized pathology review. The primary endpoint was High-Grade Event-Free Survival (HG-EFS).
Results: A total of 56 patients who received treatment with cretostimogene were evaluated based on data from September 1, 2025 cut off. At baseline, 78.6% of patients were 65 years or older, 21.4% were female, 58.9% had HG Ta, and 41.1% had HG T1 papillary NMIBC. Kaplan-Meier estimates of HG-EFS at 6- and 9-months were 84.6% (95% CI 68.6 - 92.9%) and 80.4% (95% CI 62.3-90.4%), respectively. No patients underwent a radical cystectomy. No patients progressed to muscle-invasive bladder cancer. Most adverse events were localized to low-grade bladder symptoms. There were no grade ≥3 treatment-related adverse events (TRAEs), serious TRAEs, or discontinuations of treatment related to cretostimogene.
Conclusions: These results demonstrate intravesical cretostimogene's consistent efficacy and a well-tolerated safety profile. Mature data with longer-term follow-up will build upon these promising findings and inform future treatment approaches with cretostimogene.
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