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Durable 24-Month Outcomes From BOND-003 Cohort C: Phase 3 Study of Intravesical Cretostimogene Grenadenorepvecfor High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ
Mark A. Preston, MD, MPH1, Roger Li, MD2, Shreyas S. Joshi, MD3, Trinity J. Bivalacqua, MD, PhD4, Gary D. Steinberg, MD5, Mark D. Tyson, MD, MPH6.
1Dana Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, USA, 2H. Lee Moffitt Cancer Center, Tampa, FL, USA, 3Emory University School of Medicine, Atlanta, GA, USA, 4University of Pennsylvania, Philadelphia, PA, USA, 5Rush University Medical Center, Chicago, IL, USA, 6Mayo Clinic, Phoenix, AZ, USA.
Background: There are limited efficacious, well-tolerated bladder-sparing options for patients with HR BCG-UR NMIBC. Cretostimogene, 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 phase-3 study evaluating the efficacy and safety of cretostimogene in patients with HR BCG-UR NMIBC with CIS +/- HG Ta/T1.
Methods: A total of 112 adults with confirmed HR BCG-UR NMIBC with CIS were enrolled. Participants had previously received adequate BCG and were considered BCG-UR by US FDA guidelines. Cretostimogene treatment comprised six weekly induction doses, then three weekly maintenance cycles for up to three years. Participants were eligible for re-induction for biopsy-proven HG Ta or CIS at Month 3. Response assessments included serial cystoscopy, urine cytology, and mandatory mapping biopsy, with centralized pathology review. The primary endpoint was Complete Response (CR) at any time.
Results: As of the June 23, 2025 data cutoff, efficacy data were available for 110 patients. With a median follow-up time of 25.8 months, the CR rate at any time was 75.5% (83/110) (95%CI 66.3-83.2%). The 12-month CR rate was 46.4% (51/110) (95%CI 36.8-56.1%). Updated results include landmark and Kaplan-Meier estimated 24-month CR rates of 41.8% (46/110) (95%CI 32.5-51.6%) and 42.4% (95%CI: 32.7-51.7%), respectively. CRs were consistent across all patient subgroups. At Month 24, 97.3% (107/110) were free from ≥T2 progression during the treatment phase and 83.6.% (92/110) avoided RC; 83.3% (15/18) of patients who underwent RC were T0 or NMIBC. There were no grade ≥3 treatment-related adverse events. Grade 1 and 2 adverse events were transient (median resolution time=1 day).
Conclusions: Cretostimogene demonstrates durable, well-tolerated bladder preservation in patients with HR BCG-UR NMIBC with CIS, with 42% achieving CR at 24 months and no grade ≥3 treatment-related toxicity.
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