A novel immunotherapy may offer a new option for patients with bladder cancer who no longer respond to bacillus Calmette-Guérin (BCG), according to a study presented on December 5 at the 2024 Society of Urologic Oncology Annual Meeting in Dallas.
The therapy, cretostimogene grenadenorepvec, is an investigational intravesically delivered oncolytic immunotherapy, meaning that is a virus designed to selectively replicate in and break down cancer cells while simultaneously amplifying the immune response against tumors.
Study Details
The phase III, single-arm BOND-003 trial evaluated the use of cretostimogene grenadenorepvec in 112 patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer and carcinoma in situ, with or without Ta or T1 papillary tumors. This highly pretreated study population included patients who had received prior intravesical chemotherapy and systemic immunotherapy. The primary endpoint of the study was complete response at any time, with duration of response measured as a secondary endpoint.
Efficacy data from 110 participants in the study showed that 74.5% experienced complete cancer remission after receiving cretostimogene grenadenorepvec as a single agent, with many remaining cancer-free beyond 2 years. The median duration of response has not been reached but exceeds 27 months as of the data cutoff. Notably, most participants did not require bladder removal surgery, and the treatment was well tolerated with minimal serious side effects. Ongoing research will look to determine the long-term efficacy and whether combining this therapy with other treatments will enhance its effectiveness.
“These findings address a significant unmet need for bladder cancer patients and could improve their quality of life,” said Mark Tyson, MD, MPH, urologic oncologist at Mayo Clinic Comprehensive Cancer Center and lead investigator of the study. “We now know this treatment can be both effective and safe, potentially reducing the need for bladder removal surgery and providing a much-needed alternative for patients with limited options.”
