CG Oncology has introduced a new treatment cretostimogene grenadenorepvec for high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) cases, particularly those with carcinoma in situ, with or without Ta or T1 (papillary) tumours.
This novel therapy is an investigational oncolytic immunotherapy delivered intravesically and is currently undergoing assessment in a phase 3 clinical trial named BOND-003. It targets patients with NMIBC who have not responded well to BCG treatment.
Additionally, cretostimogene grenadenorepvec is concurrently being assessed in a phase 2 trial (CORE-001) alongside pembrolizumab for the same condition. Furthermore, an investigator-sponsored trial is aimed to assess its effectiveness when paired with nivolumab specifically for the treatment of muscle invasive bladder cancer.
The therapy is actively undergoing clinical trials for bladder cancer treatment. Preliminary findings from the BOND-003 phase 3 trial showed promising results, with a 75.7 percent complete response rate at any point among patients receiving cretostimogene grenadenorepvec. Moreover, it demonstrated good tolerance, with no severe treatment-related adverse events observed.
Bladder cancer affects a substantial number of individuals, with estimates of over 82,000 new diagnoses in 2023. Non-muscle invasive bladder cancer (NMIBC) constitutes about 75 percent of these cases and is the most common type. It's the sixth most prevalent cancer in the US, with men accounting for three-quarters of newly diagnosed cases.
Cretostimogene Grenadenorepvec has gained both FDA fast track and breakthrough therapy designations for its potential in treating high-risk BCG-unresponsive non-muscle invasive bladder cancer.
