DALLAS, May 15, 2026
CG Oncology announced positive initial Phase 2 data from the CORE-008 Cohort CX trial, evaluating cretostimogene grenadenorepvec combined with gemcitabine in patients with high-risk non-muscle invasive bladder cancer (HR NMIBC) who were either BCG-exposed or BCG-unresponsive. The study demonstrated high complete response (CR) rates, strong high-grade event-free survival (HG-EFS), and a favorable safety profile, supporting the growing potential of bladder-sparing intravesical combination therapies in difficult-to-treat bladder cancer populations.
The trial showed high complete response rates in patients with carcinoma in situ (CIS)-containing disease, reaching 85.7% in the intention-to-treat population and 92.3% in the efficacy evaluable population. In addition, overall high-grade event-free survival was 96.0% at three months and 89.5% at six months, with consistent efficacy observed across both concurrent and sequential treatment schedules. Importantly, no statistically significant efficacy differences were observed between treatment approaches, suggesting flexibility in clinical administration strategies.
Combination Therapy Shows Strong Safety and Clinical Activity
Investigators reported that the combination therapy maintained a well-tolerated safety profile, with no Grade 3 or higher treatment-related adverse events and no deaths reported during the study period. The majority of patients were over age 65 and more than 80% were treated in community practice settings, reinforcing the real-world applicability of the regimen.
Researchers also noted that efficacy remained consistent across both BCG-exposed and BCG-unresponsive populations, an important finding given the limited treatment options available for patients who fail or recur after Bacillus Calmette-Guérin (BCG) therapy. The study evaluated intravesical administration only, avoiding systemic chemotherapy exposure while preserving bladder function.
Cretostimogene Expands Potential as Bladder-Sparing Therapy
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According to CG Oncology, cretostimogene grenadenorepvec is an investigational intravesical oncolytic immunotherapy designed to stimulate anti-tumor immune responses directly within the bladder. The therapy has now been studied in more than 400 NMIBC patients across multiple clinical programs, including the ongoing Phase 3 BOND-003 and PIVOT-006 studies.
Clinical experts presenting the data emphasized that the combination of intravesical immunotherapy and chemotherapy could provide an important new bladder-sparing treatment strategy for patients with recurrent or treatment-resistant disease. The encouraging durability, safety, and feasibility data from CORE-008 Cohort CX may help expand the intravesical treatment landscape at a time when urologists continue to face therapeutic limitations and BCG supply challenges.
Source: CG Oncology press release
