CG Oncology Highlights Bladder Cancer Response to Immunotherapy

CG Oncology recently shared interim results from the Phase III BOND-003 study, showcasing the effectiveness of their investigational oncolytic immunotherapy, cretostimogene, in treating non-muscle invasive bladder cancer (NMIBC). The findings revealed that the therapy achieved a durable complete response in a significant portion of patients.

The data, presented at the 2024 American Urological Association annual meeting, indicated that 75.2% of patients experienced a complete response when treated with cretostimogene monotherapy. Notably, 29 of these patients sustained their complete response for a minimum of 12 months. The median duration of response has yet to be determined, according to the interim analysis.

Importantly, none of the patients who achieved a complete response required a radical cystectomy, nor did they show any evidence of nodal or metastatic progression. The overall cystectomy-free survival rate was reported at 92.4%.

Ambaw Bellete, President and COO of CG Oncology, commented on the interim results, emphasizing that the data supports cretostimogene’s potential as a bladder-sparing treatment that could significantly enhance patient outcomes and quality of life for those with NMIBC. The company aims to have topline data from the BOND-003 study by the end of 2024 and plans to move forward with a regulatory submission.

Cretostimogene operates as a targeted oncolytic immunotherapy. It infiltrates tumors and replicates within them, leading to cell death. Similar to viruses, the new cretostimogene molecules then spread to other cancer cells, causing their destruction. Additionally, the cellular debris from the dying cancer cells draws the body's immune cells to the site, further aiding in the fight against the tumor.

In December 2023, the FDA granted Fast Track and Breakthrough Therapy designations to cretostimogene for high-risk NMIBC. The Phase III BOND-003 study, an open-label, single-arm trial, is evaluating cretostimogene monotherapy in 190 patients with NMIBC who did not respond to prior Bacillus Calmette Guerin (BCG) treatment. Besides response rates and duration of response, the study is also assessing the therapy’s impact on recurrence-free and progression-free survival in certain patient cohorts.

The trial is monitoring cretostimogene’s safety profile as well. As of the interim analysis, 70 patients experienced treatment-related adverse events, the most frequent being bladder spasms, painful urination, and blood in the urine. No grade 3 or higher treatment-related adverse events were reported, and there were no deaths or treatment-related discontinuations.

The release of this interim data follows CG Oncology’s enhanced initial public offering (IPO) in January 2024, which provided the company with $380 million. CG Oncology plans to use these funds to further develop cretostimogene, including another Phase III trial in intermediate-risk NMIBC and a Phase II study in collaboration with Merck’s Keytruda (pembrolizumab) for high-risk, BGC-unresponsive NMIBC.