other material
confidence high
sentiment positive
materiality 0.85
CG Oncology reports 54% CR at 24 months for cretostimogene combo in NMIBC
CG Oncology, Inc.
- Phase 2 CORE-001 final results: 54% (19/35) complete response rate at 24 months in BCG-unresponsive HR-NMIBC with CIS.
- Median duration of response exceeds 21 months; 95% of 12-month CR patients maintained CR for another 12 months.
- Progression-free survival at 24 months was 100%; cystectomy-free survival at 24 months was 80% (100% for CR patients).
- No synergistic toxicity observed; combination with pembrolizumab well tolerated.
- FDA Breakthrough Therapy Designation granted in May 2023; company plans to incorporate findings into planned CORE-008 trial.