Cretostimogene Grenadenorepvec Receives FDA Fast Track and Breakthrough Designations for Bladder Cancer Treatment
CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) has been granted Fast Track and Breakthrough Therapy designations by the FDA for the treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients. This novel oncolytic immunotherapy is currently being evaluated in clinical trials.
The Phase III BOND-003 and Phase II CORE-001 clinical trials are assessing CG0070 in combination with pembrolizumab for the treatment of NMIBC with carcinoma in situ with or without Ta or T1 tumors. Additionally, a separate investigator-sponsored clinical trial is examining the combination of CG0070 and nivolumab for the treatment of muscle invasive bladder cancer.
The FDA’s decision was based on data from ongoing clinical trials, including the BOND-003 trial (NCT04452591). Preliminary results showed that the intravesically delivered CG0070 provided clinical benefit in terms of complete responses with acceptable tolerability.
Ambaw Bellete, President and COO of CG Oncology, expressed gratitude for the FDA’s Fast Track and Breakthrough Therapy Designations, emphasizing the importance for patients in need of effective bladder cancer treatments. Bellete also thanked the patients, caregivers, investigators, and staff involved in the clinical trials, highlighting their contributions to the development of CG0070.
The BOND-003 trial enrolled 116 patients with high-risk NMIBC who exhibited BCG unresponsiveness and persistent or recurrent disease within one year of BCG therapy completion. Eligible patients had an ECOG performance status of 0 to 2 and acceptable organ function, while those who were not suitable candidates for radical cystectomy or who refused the procedure were included. Exclusion criteria encompassed upper tract or prostatic urethra malignancy, previous adenovirus-based cancer therapy, as well as muscle-invasive or locally advanced metastatic bladder cancer.
The fast-tracked status of CG0070 holds significant promise for patients with high-risk NMIBC, providing hope for improved outcomes and new therapeutic options. With further advancements and collaboration between CG Oncology and the FDA, CG0070 may prove to be a cornerstone in the treatment of bladder cancer.
Bladder cancer affects millions of people worldwide and has a significant impact on patients and their families. The urgent need for effective treatments underscores the importance of innovations like CG0070. As clinical trials progress, the potential for a breakthrough in bladder cancer treatment becomes increasingly tangible, bringing hope to those affected by the disease.
