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New Cretostimogene Grenadenorepvec Data Highlight its Potential to Become the Backbone Therapy for High-Risk Non-Muscle Invasive Bladder Cancer
Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 Disease in BOND-003 Cohort PCORE-008
About this update from Cg Oncology, Inc.
[{"type":"text","content":"Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 Disease in BOND-003 Cohort PCORE-008 Cohort A Data in HR BCG-Naïve NMIBC demonstrates 88% CR and favorable safety with optimized administration Robust clinical pipeline that spans multiple late-stage studies across intermediate- and high-risk NMIBC IRVINE, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- 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 topline data from BOND-003 Cohort P and first results from CORE-008 Cohort A which demonstrated promising efficacy, safety and tolerability. These data will be presented today as Late-Breaking Abstracts at the Society of Urologic Oncology (SUO) 26th Annual Meeting. “For people living with bladder cancer, the need for primary treatment of newly diagnosed NMIBC and a durable, bladder-sparing option for those with BCG unresponsive disease is urgent. New data from BOND-003 Cohort P and CORE-008 Cohort A add to a growing body of evidence demonstrating cretostimogene’s potential to become a backbone treatment across the NMIBC spectrum, if approved. The topline efficacy, safety, and tolerability announced today are consistent with what we previously observed with the pivotal Phase 3 monotherapy data, but in an even more prevalent NMIBC population, notably BCG-UR papillary-only,” said Trinity J. Bivalacqua, M.D., Ph.D., Urologic Oncologist at University of Pennsylvania. “We are delighted to share new and more mature data in different sub-groups, underscoring our commitment to address the broadest range of NMIBC patients. This sets us up for the future expansion and long-term success of cretostimogene. With its best-in-disease profile and dual MOA, we are confident that cretostimogene will continue to demonstrate differentiated data from current and investigational NMIBC therapies,” said Ambaw Bellete, President & Chief Operating Officer at CG Oncology. TOPLINE BOND-003 COHORT P RESULTSResults from the BOND-003 Cohort P clinical trial of cretostimogene monotherapy in patients with BCG-UR papillary-only NMIBC demonstrate encouraging HG-EFS and a consistent, well-tolerated safety profile. The study’s primary endp...