CG Oncology (CGON) Conference presentation summary

Study design and population

• BOND-003 Cohort P evaluated intravesical cretostimogene in high-risk, BCG-unresponsive high-grade Ta/T1 NMIBC without CIS; 56 patients enrolled, with tumors completely resected before treatment.

• Median age was 74 years; 78.6% were male, 33.9% had high-grade T1 disease, and median prior BCG instillations were 9.

• Primary endpoint was high-grade event-free survival (HG-EFS); secondary endpoints included recurrence-free, progression-free, cystectomy-free, and cancer-specific survival.

Efficacy results

• Median follow-up was 6.0 months; Kaplan-Meier estimated HG-EFS was 95.7% at 3 months (95% CI 83.8–98.9), 84.6% at 6 months (68.6–92.9), and 80.4% at 9 months (62.3–90.4).

• Eight patients underwent re-induction at 3 months; no patients underwent radical cystectomy and no progression to muscle-invasive bladder cancer was observed.

• HG-EFS remained favorable across subgroups: HG Ta 92.8%, 75.9%, and 75.9% at 3, 6, and 9 months; HG T1 100%, 100%, and 87.5%, respectively.

Safety and tolerability

• Treatment-related adverse events occurred in 40/56 patients (71.4%); none were Grade 3 or higher, serious, or fatal.

• Common treatment-related events were bladder spasm (46.4%), dysuria (39.3%), pollakiuria (25.0%), and urgency (19.6%); all were Grade 1–2.

• No treatment-related dose delays, missed doses, or discontinuations; 98.2% received all protocol-defined treatments.