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CG Oncology Completes Enrollment in PIVOT-006

  • Rapid enrollment underscores high unmet need in intermediate-risk non-muscle invasive bladder cancer (NMIBC)
  • One of the largest randomized phase 3 studies in this patient population will encompass the broadest range of patient types per AUA/SUO Guidelines
Reno, Nevada (UroToday.com) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that 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, M.D., 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.”

Source: CG Oncology, Inc. (2025). CG Oncology Completes Enrollment in PIVOT-006 [Press release]. https://ir.cgoncology.com/news-releases/news-release-details/cg-oncology-completes-enrollment-pivot-006.