Bladder Cancer Breakthrough: Understanding Cretostimogene

Cretostimogene grenadenorepvec is an investigational oncolytic immunotherapy that is being studied for the treatment of bladder cancer, particularly non-muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guérin (BCG) therapy.

In an interview with Targeted Oncology^TM, Mark D. Tyson, MD, MPH, urologic oncologist at Mayo Clinic, discusses what sets cretostimogene apart from other therapies in the field.

Studies, such as the phase 3 BOND-003 trial (NCT04452591), have shown a high complete response (CR) rate in patients with high-risk BCG-unresponsive NMIBC. The "any time" CR rate has been reported as high as 75.5%. A significant number of patients who achieve a complete response maintain it over time. At 12 months, the CR rate was reported at 46%, and at 24 months, approximately 42.3% by Kaplan-Meier estimation. The median duration of response has been reported to exceed 28 months and is ongoing.¹

Cretostimogene is being investigated as a bladder-sparing therapeutic, offering an alternative to radical cystectomy, which is the current standard recommendation for high-risk BCG-unresponsive NMIBC. Additionally, a high percentage of patients treated with cretostimogene have remained free from progression to muscle-invasive bladder cancer. 

The FDA has granted fast track and breakthrough therapy designations to cretostimogene for the treatment of high-risk BCG-unresponsive NMIBC, which may expedite its development and review.²

REFERENCES:

1. Tyson M. BOND-003 cohort C- a phase-3, single-arm study of intravesical cretostimogene grenadenorepvec for high-risk BCG-unresponsive NMIBC with CIS. Presented at: American Urological Association Annual Congress; April 26-29, 2025; Las Vegas, NV. P2s.

2. CG Oncology receives both FDA fast track and breakthrough therapy designation for cretostimogene grenadenorepvec in high-risk BCG-unresponsive non-muscle invasive bladder cancer. News release. CG Oncology, Inc. December 5, 2023. Accessed April 26, 2025. https://tinyurl.com/3v4hvakh