Immunotherapy Achieves High Complete Response Rate in Bladder Cancer

CG Oncology recently announced interim findings from its Phase III BOND-003 clinical trial, highlighting the efficacy of its experimental oncolytic immunotherapy, cretostimogene, in treating non-muscle invasive bladder cancer (NMIBC). The study revealed that a significant percentage of patients experienced a complete response to the treatment, with many maintaining this response for over a year. Notably, none of these patients required radical surgery or showed signs of cancer progression.

The data, presented at the 2024 American Urological Association annual meeting, indicated that 75.2% of the subjects responded completely to cretostimogene as a monotherapy. Among them, 29 patients sustained their response for at least 12 months. The median duration of response was still undetermined at the time of the interim analysis, with a cystectomy-free survival rate of 92.4%.

CG Oncology’s president and COO, Ambaw Bellete, emphasized in a statement the potential of cretostimogene as a bladder preservation therapy that could significantly enhance patient outcomes and their quality of life. The company anticipates final data from the BOND-003 study by the end of 2024 and plans to proceed with regulatory submissions.

Cretostimogene functions as a targeted therapy, entering and replicating within tumor cells to trigger their death. The therapy mimics a virus, spreading to and destroying neighboring cancer cells. The cellular debris released in the process attracts the body's immune cells, further combating the tumor.

In December 2023, the FDA recognized the potential of cretostimogene by granting it Fast Track and Breakthrough Therapy designations for the treatment of high-risk NMIBC. The Phase III BOND-003 study is an open-label, single-arm trial that includes 190 NMIBC patients who have not responded to previous Bacillus Calmette Guerin (BCG) treatments. The study is not only assessing response rates and response duration but also examining the therapy's impact on recurrence-free and progression-free survival.

Safety is a key aspect of the trial, and as per the interim results, 70 patients reported treatment-related adverse events, with bladder spasms, pain during urination, and blood in urine being the most common. However, there were no severe grade 3 or higher treatment-related adverse events, nor were there any deaths or treatment discontinuations due to the therapy.

The announcement of the interim data follows CG Oncology's successful initial public offering (IPO) in January 2024, which provided the company with a substantial financial boost of $380 million. The proceeds from the IPO are intended to support the advancement of cretostimogene through additional clinical trials, including another Phase III study for intermediate-risk NMIBC and a Phase II trial in combination with Merck’s Keytruda (pembrolizumab) for high-risk, BCG-unresponsive NMIBC.