CG Oncology CORE-008 Study Shows 96% Survival Rate in High-Risk Bladder Cancer Patients

CG Oncology announced first results from CORE-008 Cohort CX, a Phase 2 study evaluating intravesical cretostimogene grenadenorepvec in combination with gemcitabine sequential versus concurrent treatment schedules in patients with high-risk non-muscle invasive bladder cancer. This trial includes HR NMIBC patients who are either BCG-exposed or BCG-unresponsive. The data, which demonstrate encouraging high-grade event-free survival, high complete response rates and a well-tolerated safety profile, will be presented tomorrow at the Society of Urologic Oncology Session at the 2026 American Urological Association annual meeting in Washington, D.C. As of the March 13, data cut off, the overall HG-EFS was 96% at 3 months and 89.5% at 6 months, with a median follow-up of 6.6 months, in the overall intent-to-treat population. There were no statistically significant differences in HG-EFS across concurrent and sequential treatment arms. High complete response rates at any time were observed in the CIS-containing population with 85.7% and 92.3% in the ITT population with 85.7% and Efficacy Evaluable population with 92.3%, respectively. Furthermore, complete response rates were maintained across the treatment arms. A favorable safety and tolerability profile was observed with no Grade 3 or greater treatment-related adverse events and no deaths reported. The majority of patients were male, white, and over 65 years of age, with the cohort well-balanced across concurrent and sequential treatment arms. Out of the overall population, 65.6% of patients were BCG-exposed and 34.5% were BCG-unresponsive. More than 80% of patients were treated in community practices.