CG Oncology’s late-stage bladder cancer treatment notched a complete response in roughly three-quarters of treated patients, fueling optimism that the company’s Wall Street success story is no fluke.
The oncolytic-virus-based therapeutic company reported Friday that cretostimogene elicited a 75.2% complete response rate in a late-stage trial among 105 evaluable patients with non-muscle invasive bladder cancer (NMIBC).
The data reported at the American Urological Association annual meeting found that none of the patients reporting a complete response had to get their bladder removed and that 29 patients maintained a complete response for at least a year, with 22 more patients pending evaluation. The median duration of response has not yet been reached as of the April 1 data cutoff, with more durability data expected at the end of the year. There were no grade 3 or higher adverse events reported among patients.
CG CEO Arthur Kuan called the data “highly encouraging,” particularly given the size of the data set and the 94.5% compliance rate.
“Ultimately, for patients, we want to give them something that they can adhere to, and come back for the necessary treatments,” Kuan said in an interview ahead of the company’s presentation.
CG is among a handful of biotechs and pharmas that are looking to advance the bladder cancer market with a diversity of approaches. Cretostimogene is an oncolytic-virus-based monotherapy that infects cancer cells which in turn shed cytokines that draw in the immune system. Aside from the clinical response rate, the therapy is differentiated by working without Bacillus Calmette-Guerin, a vaccine used to treat bladder cancer that’s had supply issues.
Confident in the drug's potential, investors showered CG with a $380 million IPO in late January, the strongest so far in 2024.
ImmunityBio’s IL-15 agonist was approved to treat NMIBC in late April based on a 62% complete response rate among 77 evaluable patients. Johnson & Johnson’s drug-device combo treatment TAR-200 is also in the mix and in the middle of a phase 3 study after a 77% complete response rate was reported among 30 evaluable patients in phase 2.
Kuan emphasized that CG’s response rate places it at or close to the top of the food chain and that the company is more than capable of competing in the market without selling off commercial rights to a larger pharma.
“We are going all in,” he said. “We believe this is an area where the bigger players may not have an edge over the ‘smaller players.’” He credits his confidence to the relationship CG has built with urologists around the country and the fact that he doesn’t expect to need a massive sales force to get the drug to patients. CG plans to submit a new drug application to the FDA in the second half of 2025.
One potential boost to cretostimogene’s durability could be adding Keytruda, with a taste of data expected at this year’s American Society of Clinical Oncology annual conference. Keytruda was approved to treat NMIBC in 2020 based off a 41% complete response rate.
“The way I-O combos have worked in other indications is we've seen this super long tail,” Kuan said. “We are hoping that that [mechanism of action] and outcome that [pembrolizomab] can do in other indications could translate over here.”
Editor's note: This story was updated to correct that CG Oncology plans to file a BLA in the second half of 2025, not the second quarter.