Cretostimogene Monotherapy Demonstrated 75.2% Complete Response Rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
IRVINE, Calif., May 03, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. today announced that data from the Phase 3 BOND-003 study evaluating the efficacy and safety of cretostimogene monotherapy in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG), showed that 75.2% of patients (79 out of 105 [95% confidence interval (CI), 65-83]) achieved a complete response (CR) at any time, as of the cutoff date of April 1, 2024. These data were featured today at the Paradigm-Shifting, Practice-Changing Clinical Trials in Urology Plenary Session as an oral presentation (Abstract #24-11358) by Dr. Mark D. Tyson, Urologic Oncologist at Mayo Clinic, at the 2024 American Urological Association (AUA) Annual Meeting, in San Antonio, TX. In addition, cretostimogene has shown durable responses over time with twenty-nine patients maintaining a complete response for 12 months or more, pending evaluation and assessment of ongoing responses in twenty-two patients as of the data cutoff. Median duration of response (DOR) was not reached. 92.4% cystectomy-free survival was observed and none of the patients with a complete response had undergone radical cystectomy or showed nodal or metastatic progression.
- 92.4% cystectomy-free survival was observed and none of the patients with a complete response had undergone radical cystectomy or showed nodal or metastatic progression.
- “The positive 12-month BOND-003 data presented at AUA 2024, with a notable duration of response, reinforces cretostimogene monotherapy as a potential backbone therapy in the NMIBC treatment landscape for BCG-unresponsive patients.
- “Cretostimogene reported remarkable interim efficacy results, with over half of the patients experiencing complete responses upon repeat induction.
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