CG Oncology, Inc. (NASDAQ: CGON) is set to unveil the results from its Phase 3 BOND-003 trial, evaluating cretostimogene monotherapy for patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). The company will host a conference call and live webcast on December 5, 2024, to discuss the data.
The BOND-003 trial's findings will be presented by Dr. Mark Tyson, II, a urologic oncologist at Mayo Clinic and the lead investigator of the study, at the Society of Urologic Oncology (SUO) 25th Annual Meeting in Dallas, TX.
Understanding the Significance of BOND-003
Bladder cancer is a significant health concern, with over 83,000 people estimated to be diagnosed in 2024 in the United States alone. NMIBC represents approximately 75% of newly diagnosed bladder cancer cases. High-risk BCG-unresponsive NMIBC poses a considerable challenge, as patients often face limited treatment options after BCG failure.
Cretostimogene grenadenorepvec is an investigational oncolytic immunotherapy delivered intravesically. It is currently being evaluated as a potential bladder-sparing therapeutic option. The BOND-003 trial is a pivotal study in this development program, specifically targeting high-risk BCG-unresponsive NMIBC.
CG Oncology's Clinical Development Program
CG Oncology's clinical program for cretostimogene includes multiple trials, involving over 250 patients with NMIBC. Besides BOND-003, the company is also conducting the Phase 3 PIVOT-006 trial for intermediate-risk NMIBC and the Phase 2 CORE-008 trial for high-risk NMIBC. An Expanded Access Program is also available in North America for patients unresponsive to BCG who meet specific eligibility criteria.
About Cretostimogene Grenadenorepvec
Cretostimogene grenadenorepvec is designed to selectively replicate within tumor cells, leading to their lysis and the release of tumor-associated antigens. This process stimulates a systemic anti-tumor immune response, potentially leading to durable remissions in patients with NMIBC. It's important to note that cretostimogene is an investigational agent, and its safety and efficacy have not been established by regulatory authorities.
