- High CR rates at any time observed in the CIS-containing population with 85.7% and 92.3% in the ITT population and Efficacy Evaluable population, respectively
- High-Grade - EFS in the overall intention-to-treat population was 96.0% at 3 months and 89.5% at 6 months
- Efficacy was comparable across concurrent and sequential treatment arms and across both BCG-exposed and BCG-Unresponsive populations
“Cohort CX was designed to assess whether combining cretostimogene with gemcitabine can further extend the strong clinical profile we have established with cretostimogene monotherapy,” said Vijay Kasturi, Chief Medical Officer of CG Oncology. “As the first prospective intravesical-only combination study of its kind, these early data demonstrate robust clinical activity across both treatment schedules, a favorable safety profile, and comparable efficacy. Importantly, the results reinforce the strategic potential of scalable intravesical-only combination regimens in high-risk NMIBC. We look forward to sharing durability data later this year.”Efficacy and Safety Analysis: As of the March 13, 2026, data cut off, the overall HG-EFS was 96.0% at 3 months and 89.5% at 6 months, with a median follow-up of 6.6 months, in the overall intent-to-treat (ITT) population. There were no statistically significant differences in HG-EFS across concurrent and sequential treatment arms. High complete response (CR) rates at any time were observed in the CIS-containing population with 85.7% (95% CI, 67.3% – 96.0%) and 92.3% (95% CI, 74.9% - 99.1%) in the ITT population with 85.7% (24/28) (95% CI, 67.3%-96.0%) and Efficacy Evaluable population with 92.3% (24/26) (95% CI, 74.9%-99.1%), 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 (TRAEs) and no deaths reported. The majority of patients were male (78.2%), white (92.7%), and over 65 years of age (81.8%), 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.
“In Cohort CX, we observed consistent responses to the combination of cretostimogene and gemcitabine across both BCG-exposed and BCG-unresponsive populations,” said Trinity Bivalacqua, M.D., Ph.D., Professor of Urology at the University of Pennsylvania and lead investigator of CORE-008 Cohort CX. “These findings highlight the feasibility and encouraging clinical profile of this intravesical oncolytic immunotherapy combined with chemotherapy as a bladder-sparing approach that can be readily adopted in everyday practice. At a time when urologists face ongoing therapeutic constraints and supply challenges, expanding the intravesical treatment armamentarium has the potential to meaningfully improve care for patients across a wide range of NMIBC disease states.”
Source: CG Oncology, Inc. (2026). 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 [Press release]. https://ir.cgoncology.com/news-releases/news-release-details/cg-oncology-reports-positive-first-results-core-008-cohort-cx.