An experimental oncolytic virus therapy developed by CG Oncology helped clear tumors in 75% of bladder cancer patients in a Phase 3 study.
The therapy, known as cretostimogene grenadenorepvec, or creto for short, is a virus designed to infect and destroy tumor cells. It’s a form of immunotherapy — as the virus spreads through tumor cells and kills them, the ruptured cells release tiny cancer markers that alert immune cells, which join the attack.
In a Phase 3 study called BOND-003, CG Oncology enrolled 112 patients with high-risk non-muscle invasive bladder cancer — a form of bladder cancer where the tumor cells are only in the bladder’s inner lining and haven’t grown deeper into the muscle.
While 79 of 105 patients experienced a complete response, 52 had a duration of response greater than six months. And 29 out of 35 patients remained in remission for at least one year.
The vast majority of the patients in the trial haven’t had surgery to remove all or part of their bladder.
The most common adverse events related to treatment were bladder spasms, as well as frequent, urgent or painful urination, and blood in the urine, CG Oncology reported. Two patients in the study experienced serious treatment-related adverse events that were grade 2, and no patients experienced grade 3 or higher adverse events related to treatment.
Arthur KuanThe interim data with an April 1 cutoff were shared at the American Urological Association annual meeting Friday. The new cut of data comes after CG Oncology reported earlier results from the study last year. “As we went from 66 patients to 105 patients, the fact that [complete response] rate maintained at 75% — that really stood out to me,” CG CEO Arthur Kuan told Endpoints News.
CG’s study included patients who already received treatment with a vaccine called Bacillus Calmette-Guérin (BCG), but didn’t respond to it. Last week, the FDA approved ImmunityBio’s Anktiva in combination with BCG for a similar group of patients to the one CG is studying. J&J is also testing a drug-device it calls the “pretzel” in this group of patients.
CG is currently aiming to submit an application for FDA approval in the second half of 2025, Kuan said, and the company plans to provide an update on its timing following another readout later this year.
The company went public earlier this year, and its stock has risen by 25% since. Ahead of the readout Friday morning, CG’s shares $CGON were up 13%.