A new study presents promising results for cretostimogene grenadenorepvec, an investigational non–muscle invasive bladder cancer (NMIBC) agent. According to Mark D. Tyson II, MD, MPH, a urologic oncologist at the Mayo Clinic, treatment with cretostimogene in patients with high-risk, BCG-unresponsive NMIBC yielded a complete response rate of 75.5%. The study’s primary end point was complete response at any time, and additional end points included recurrence-free survival, progression-free survival, and safety.
The study’s population consisted of 112 patients with pathologically confirmed, high-risk BCG-unresponsive NMIBC with CIS plus or minus high-grade Ta/T1 disease. Treatment consisted of an induction course of 6 weekly treatments, followed by “3 weekly instillations for maintenance every 3 months during the first year, and then every 6 months in years 2 and 3.” The study’s primary end point was complete response at any time.
The study showed that 97% of patients remained progression-free, and 84.5% avoided cystectomy, highlighting cretostimogene’s bladder-sparing potential. The estimated duration of response probability at 12 months was 64.1%, and at 24 months was 58.3%. The median duration of response is 27.9 months.
Cretostimogene was found to be exceptionally well-tolerated, with mostly grade 1 and grade 2 adverse events. No treatment-related grade 3 or higher adverse events were reported, and no deaths occurred. The study’s results suggest that cretostimogene offers a highly effective, well-tolerated, and durable treatment option for patients with non–muscle invasive bladder cancer that’s unresponsive to BCG.
Source: https://www.urologytimes.com/view/cretostimogene-yields-high-cr-rate-in-bcg-unresponsive-nmibc