CG Oncology (CGON) Conference presentation summary

Study background and design

• Phase 3 BOND-003 trial evaluated cretostimogene grenadenorepvec monotherapy in high-risk BCG-unresponsive NMIBC with CIS, enrolling 112 patients with mandatory 12-month biopsies and regular monitoring.

• Induction and maintenance regimens included weekly dosing, with a second induction for non-responders and maintenance over three years.

• Primary endpoint was complete response (CR) at any time, with additional endpoints including duration of response, recurrence-free survival, progression-free survival, cystectomy-free survival, and safety.

Patient demographics and baseline characteristics

• Majority were male (74%), white (62%), and over 65 years old (83%), with a mean age of 72.9 years.

• Highly pre-treated population: median of 12 prior BCG instillations, 41% had prior chemotherapy, and 6% had systemic immunotherapy.

• 80% had CIS alone, while 20% had CIS with high-grade Ta/T1 disease.

Efficacy outcomes

• Overall CR rate was 75.5% at any time (95% CI: 66.3%-83.2%), with 46.4% at 12 months and 41.8% at 24 months.

• Median duration of response was 27.9 months, with 96.4% free from progression to ≥T2 disease.

• All CRs were centrally confirmed, with high concordance between local and central assessments.