CG Oncology's Investigational Bladder Cancer Drug Shows Promising Response

CG Oncology's investigational bladder cancer drug, cretostimogene, has shown a "robust" response in clinical trials. The company's lead candidate, BOND-003, is a targeted oncolytic immunotherapy agent in Phase II for treating non-muscle invasive bladder cancer. CORE-001 is a Phase II trial of cretostimogene with BCG-unresponsive NMIBC, and PIVOT-006 is a Phase III trial assessing the safety and efficacy of adjuvant cretostimogene as a monotherapy for intermediate-risk NMIBC.

CG Oncology, Inc. has announced the completion of enrollment in its Phase 3, randomized, open-label PIVOT-006 study, which compares adjuvant intravesical cretostimogene grenadenorepvec versus surveillance following bladder tumor removal in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) [1].

The PIVOT-006 study, led by Robert Svatek, M.D., MSCI, a urologic oncologist at the Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center, enrolled over 360 patients across 90 plus sites. The rapid enrollment underscores the high unmet need in intermediate-risk NMIBC, where recurrence rates can reach up to 70% and few durable treatment options are available [2].

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program including over 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC [1].

The PIVOT-006 trial aims to evaluate the safety and efficacy of cretostimogene as a monotherapy for intermediate-risk NMIBC. Participants undergo standard tumor removal and are then randomized to either receive cretostimogene instillations or surveillance. Control patients may switch to treatment if they relapse [2].

CG Oncology, a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, remains committed to transforming the treatment landscape for bladder cancer patients. The company's clinical trial program is designed to address the full spectrum of disease stages and tumor types, with a particular focus on areas of high unmet need [2].

The completion of PIVOT-006 enrollment highlights the urgent need for new treatment options in the intermediate-risk NMIBC population and reinforces CG Oncology's path towards a potential indication in adjuvant IR NMIBC, for which there are no U.S. FDA approved options [2].

References:
[1] https://www.marketscreener.com/news/cg-oncology-completes-enrollment-in-pivot-006-ce7d59dbd98ef023
[2] https://ir.cgoncology.com/news-releases/news-release-details/cg-oncology-completes-enrollment-pivot-006