GlobeNewswire·May 15, 2026, 8:00 AM ET

CG Oncology Reports Positive First Results from CORE‑008 Cohort CX Phase 2 Trial Evaluating Intravesical Combination Therapy in High-Risk BCG-Exposed and BCG-Unresponsive Patients

CG Oncology announced positive first results from the Phase 2 CORE-008 Cohort CX study evaluating cretostimogene grenadenorepvec combined with gemcitabine for high-risk non-muscle invasive bladder cancer.
High-grade event-free survival was 96.0% at 3 months & 89.5% at 6 months in the overall intention-to-treat population with a median follow-up of 6.6 months.
Complete response rates in the CIS-containing population were 85.7% in the intention-to-treat population & 92.3% in the efficacy evaluable population.
Efficacy was comparable across concurrent & sequential treatment arms as well as across BCG-exposed & BCG-unresponsive patient populations.
The safety profile was favorable with no Grade 3 or greater treatment-related adverse events & no deaths reported.
Data will be presented at the Society of Urologic Oncology Session during the 2026 American Urological Association Annual Meeting in Washington, D.C.
The trial included patients who were 78.2% male, 92.7% white, 81.8% over 65 years of age, with 65.6% BCG-exposed & 34.5% BCG-unresponsive.
More than 80% of patients were treated in community practices.
Cretostimogene is an investigational intravesical oncolytic immunotherapy currently in a development program including Phase 3 trials BOND-003 & PIVOT-006.