Following an upsized IPO earlier this year, CG Oncology on Friday posted promising Phase III data for cretostimogene, which elicited a 75% complete response rate in high-risk non-muscle invasive bladder cancer patients.
CG Oncology on Friday unveiled interim data from the Phase III BOND-003 study, demonstrating that its investigational oncolytic immunotherapy cretostimogene can induce durable complete response in the vast majority of treated non-muscle invasive bladder cancer patients.
The results, presented over the weekend at the 2024 American Urological Association annual meeting, showed that 75.2% of patients achieved complete response to cretostimogene monotherapy. Twenty-nine of these patients maintained their complete response for at least 12 months. At the time of the interim analysis, median duration of response had not yet been reached.
None of the patients with complete response needed radical cystectomy or showed signs of nodal or metastatic progression. The overall cystectomy-free survival was 92.4%.
Ambaw Bellete, CG Oncology’s president and COO, in a statement said that these interim findings from BOND-003 reinforce cretostimogene’s “potential as a bladder-sparing therapeutic that could materially improve both patient outcomes and quality of life” in patients with non-muscle invasive bladder cancer (NMIBC).
CG Oncology is expecting topline data from BOND-003 by the end of 2024 and will work toward a regulatory submission.
Cretostimogene is a targeted oncolytic immunotherapy that works by entering tumors and replicating inside them, triggering cell death. Like viruses, the newly formed cretostimogene molecules spread and infiltrate and kill other cancer cells, according to the biotech’s website. At the same time, cellular debris released by the dying cancer cells attract the body’s immune cells, which also helps fight tumors.
In December 2023, the FDA granted cretostimogene its Fast Track and Breakthrough Therapy designations for high-risk NMIBC.
In the Phase III BOND-003 study, an open-label, single-arm trial, CG Oncology is evaluating cretostimogene as a monotherapy in 190 NMIBC patients who failed prior Bacillus Calmette Guerin (BCG) treatment. Aside from response rates and duration of response, certain cohorts within BOND-003 are also evaluating the therapy’s effect on recurrence-free and progression-free survival.
BOND-003 is also looking at cretostimogene’s safety. As of the interim readout, 70 patients experienced treatment-related adverse events, the most common of which included bladder spasms, dysuria and hematuria. The trial detected no grade 3 or higher treatment-related adverse events. There were also no deaths or treatment-related dropouts.
Friday’s data drop follows CG Oncology’s upsized initial public offering (IPO) in January 2024, which gave the company a $380 million boost.
CG Oncology at the time noted that it would use the IPO proceeds to support the development of cretostimogene, which involves another Phase III study in intermediate-risk NMIBC and a Phase II trial, with Merck’s Keytruda (pembrolizumab), in high-risk, BGC-unresponsive NMIBC.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
