Professor Dickon Hayne shares data on mitomycin plus BCG in high-risk NMIBC

The combination of mitomycin plus BCG demonstrated comparable efficacy and safety to BCG alone, but led to fewer treatment discontinuations in patients with high-risk non–muscle invasive bladder cancer (NMIBC). The mitomycin regimen also includes fewer doses of BCG vs BCG alone, which has important implications in light of the ongoing BCG shortage.

In a recent interview with Urology Times®, lead author Prof Dickon Hayne discussed the background and key findings of this study in-depth. The data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

Hayne is a professor of urology at the University of Western Australia as well as the head of urology at Fiona Stanley Hospital in Perth, Australia.

In total, the study enrolled 501 patients who were randomly assigned to receive mitomycin plus BCG (n = 248) or BCG alone (n = 252).

Data showed comparable efficacy outcomes between the 2 arms. A complete response at the 3 month time point was achieved in 90% of patients in the mitomycin plus BCG arm vs 86% of patients in the BCG alone arm (HR, 1.05; 95% CI, 0.98 to 1.12; P = .22).

Additionally, at 2 years, disease-free survival was 76% in the mitomycin plus BCG arm vs 71% in the BCG alone arm (HR, 0.86; 95% CI, 0.64 to 1.14; P = .30). Similarly, the recurrence-free rate at 2 years was 81% and 75%, respectively (HR, 0.84; 95% CI, 0.81 to 1.18; P = 31).

At 5 years, progression-free survival was 87% in the combination arm vs 81% in the BCG alone arm (HR, 0.74; 95% CI, 0.45 to 1.21; P = .23). Five-year overall survival was 87% in both arms (HR, 1.07; 95% CI, 0.61 to 1.88; P = .81).

On the potential implications of these data, Hayne noted, “Widespread adoption of the BCG plus mitomycin regimen would actually help to resolve that BCG shortage.”

REFERENCE

1. Hayne D, Zhang A, Thomas H, et al. Mitomycin plus BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: A randomized phase 3 trial (ANZUP 1301). J Clin Oncol. 2025;43 (suppl 17; abstr LBA4504). doi: 10.1200/JCO.2025.43.17_suppl.LBA4504