CG Oncology Completes Enrollment in PIVOT-006 Phase 3 Bladder Cancer Study

CG Oncology has completed enrollment in its Phase 3 PIVOT-006 study, comparing adjuvant intravesical cretostimogene grenadenorepvec to surveillance following bladder tumor removal in patients with intermediate-risk non-muscle invasive bladder cancer. The study aims to address the high unmet need in this patient population and will encompass a broad range of patient types per AUA/SUO Guidelines.

CG Oncology, Inc. (NASDAQ: CGON) has achieved a significant milestone in its clinical development efforts by completing enrollment in its Phase 3 PIVOT-006 study. The study, which aims to compare the efficacy of adjuvant intravesical cretostimogene grenadenorepvec to standard surveillance following bladder tumor removal, is designed to address the high unmet need in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC).

The PIVOT-006 trial, which enrolled over 360 patients across 90 sites, is one of the largest randomized phase 3 studies in this patient population. The study's rapid enrollment underscores the high demand for effective treatment options in IR NMIBC, where recurrence rates can reach up to 70% and durable treatment options are limited [2].

The trial compares cretostimogene, an investigational intravesically delivered oncolytic immunotherapy, to standard surveillance. Participants undergo standard tumor removal and are then randomized to either receive cretostimogene instillations or surveillance. The study aims to evaluate the therapeutic benefits of cretostimogene in reducing recurrence rates and improving patient outcomes.

The completion of enrollment in PIVOT-006 marks a significant step forward for CG Oncology in its mission to transform the treatment landscape for bladder cancer patients. The company's commitment to addressing high unmet needs and its ability to rapidly enroll patients in clinical trials demonstrate its dedication to innovation and patient-centric research.

For investors, the successful enrollment in PIVOT-006 indicates the strong interest and demand for cretostimogene in the IR NMIBC population. The trial's design and rapid enrollment suggest a promising pipeline for the company's innovative immunotherapies.

In conclusion, the completion of enrollment in PIVOT-006 highlights CG Oncology's progress in developing novel treatment options for IR NMIBC. The study's design and rapid enrollment underscore the high unmet need in this patient population and the potential of cretostimogene to address this need.

References:
[1] CG Oncology Completes Enrollment in Phase 3 PIVOT-006 Study [https://www.stocktitan.net/news/CGON/cg-oncology-completes-enrollment-in-pivot-e57xu41v3nfz.html]
[2] CG Oncology, Inc. Press Release [https://www.globenewswire.com/news-release/2025/09/03/2309485/EN.html]