CG Oncology, Inc. recently announced it has completed enrollment in its Phase 3, randomized, open-label PIVOT-006 study comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance following bladder tumor removal in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC).

“Intermediate-risk NMIBC presents a significant clinical challenge, with recurrence rates reaching up to 70% and few durable treatment options available to patients,” said Robert Svatek, MD, MSCI, urologic oncologist at the Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center and global Principal Investigator for PIVOT-006. “Although it carries a lower risk of progression than high-risk disease, the relentless cycle of procedures and surveillance can diminish patients’ quality of life. There is growing enthusiasm within the urology community about the potential of cretostimogene in both intermediate- and high-risk NMIBC, underscored by the rapid enrollment of over 360 patients into the PIVOT-006 study across 90 plus sites. This unique therapy introduces a novel treatment paradigm—selectively lysing tumor cells while simultaneously activating a robust anti-cancer immune response.”

“At CG Oncology, we remain steadfast in our mission to transform the treatment landscape for individuals living with bladder cancer,” said Vijay Kasturi, MD, Chief Medical Officer at CG Oncology. “Our clinical trial program is purposefully designed to address the full spectrum of disease stages and tumor types, with a particular focus on areas of high unmet need. We are especially encouraged by the strong interest and rapid enrollment, nearly a year ahead of schedule, in PIVOT-006 which highlights the urgent need for new treatment options in the intermediate-risk NMIBC population. This momentum reinforces our path toward a potential indication in adjuvant IR NMIBC, for which there are no U.S. FDA approved options. We are deeply grateful to the SUO-CTC for their support, to all participating trial sites for their dedication, and most importantly, to the patients who make this research possible.”

PIVOT-006 is a Phase 3, randomized, open-label trial in intermediate-risk NMIBC comparing adjuvant intravesical cretostimogene grenadenorepvec to surveillance after bladder tumor removal. All participants undergo standard tumor removal, then are randomized to either receive cretostimogene instillations (weekly for 6 weeks, then weekly for 3 weeks every 3 months for one year) or surveillance. Control patients may switch to treatment if they relapse. To learn more about the study including eligibility requirements please visit: https://pivot006.com/.

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 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. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer