Mark Tyson, MD shares promising BOND-003 results in papillary NMIBC

Topline results from cohort P of the BOND-003 trial were recently presented at the 2025 Society of Urology Oncology Annual Meeting in Phoenix, Arizona.^1,2 In an interview with Urology Times®, presenting author Mark D. Tyson, II, MD, MPH, recapped the trial’s key findings, in which cretostimogene grenadenorepvec demonstrated encouraging high-grade event-free survival (HG-EFS) at 3, 6, and 9 months in patients with high-risk papillary only BCG-unresponsive non–muscle invasive bladder cancer (NMIBC).

Tyson is a urologic oncologist at Mayo Clinic in Phoenix, Arizona.

In total, the study included 56 patients across 35 clinical trial sites in the US and Japan. Among the efficacy-evaluable patients (n = 51), data showed HG-EFS rates of 95.7% (95% CI, 83.8 to 98.9), 84.6% (95% CI, 68.6 to 92.9%) and 80.4% (95% CI, 62.3 to 90.4%) at 3, 6, and 9 months, respectively.

The agent also showed a favorable safety profile, with no grade 3 or greater treatment-related adverse events (TRAEs), treatment-related discontinuations, nor deaths were reported. The most common (≥10%) TRAEs included bladder spasms, dysuria, pollakiuria, and hematuria. At the time of data report, no patients had undergone a radical cystectomy or progressed to muscle-invasive disease.

“It's nice to see the consistency of cretostimogene’s efficacy and safety across multiple disease states and multiple trials,” Tyson concluded. “It gives us more confidence that the signals that we're seeing are reflective of the effect of the drug.”

REFERENCES

1. Tyson M. Late Breaking Abstract: Topline results from BOND-003 cohort P- a multi-national, single-arm study of intravesical cretostimogene grenadenorepvec for treatment of high-risk, papillary only, BCG-unresponsive non-muscle invasive bladder cancer. Presented at: Society of Urologic Oncology Annual Meeting; December 2-5, 2025; Phoenix, Arizona

2. New cretostimogene grenadenorepvec data highlight its potential to become the backbone therapy for high-risk non-muscle invasive bladder cancer. News release. CG Oncology. December 5, 2025. Accessed December 6, 2025. https://ir.cgoncology.com/news-releases/news-release-details/new-cretostimogene-grenadenorepvec-data-highlight-its-potential