Clinical Trials
MM BCG Plus Mitomycin: A Practical Alternative Amid Global BCG Shortage
ANZUP 1301, BCG plus mitomycin matched BCG alone for efficacy while using fewer BCG doses in high-risk NMIBC.
With ongoing Bacillus Calmette-Guérin (BCG) shortages impacting bladder cancer care worldwide, the phase 3 ANZUP 1301 trial offers valuable insights into the potential of BCG combined with mitomycin (MM) as a pragmatic alternative for BCG-naïve patients with high-risk, non–muscle-invasive bladder cancer (NMIBC).
The trial enrolled 501 patients following transurethral resection of bladder tumors, randomizing them to either BCG plus MM or BCG alone. Both regimens demonstrated similar efficacy, with no significant difference in 2-year disease-free survival (75% for BCG + MM vs 71% for BCG alone; hazard ratio, 0.87; P=0.3). Secondary outcomes, including recurrence rates and complete response at 3 months, showed comparable results between the 2 groups.
However, a key advantage of the BCG plus MM regimen is its reduced reliance on BCG doses—requiring 39% fewer doses while maintaining effectiveness. Patients in the combination group also had fewer treatment discontinuations, with 78% completing planned doses versus 68% in the BCG-alone arm. While grade 3 to 5 adverse events (AEs) were slightly more frequent in the BCG plus MM group (43 vs 37 AEs), the safety profile remained manageable.
For oncology teams navigating the challenges of BCG shortages, these findings suggest that BCG plus MM is a practical alternative. Although it does not improve survival outcomes compared to BCG alone, its reduced BCG demand and improved adherence rates make it a viable option for ensuring uninterrupted care during supply constraints.
By considering BCG plus MM as a treatment option, oncology practices can help address the global shortage while maintaining effective care for patients with NMIBC.
Reference
- Hayne D, Zhang AY, Thomas H, et al. Bacillus Calmette-Guérin plus mitomycin versus Bacillus Calmette-Guérin alone for Bacillus Calmette-Guérin-naïve non-muscle-invasive bladder cancer: a randomised phase 3 trial (ANZUP 1301). Eur Urol. 2026;89:446-453. Online ahead of print.
With ongoing Bacillus Calmette-Guérin (BCG) shortages impacting bladder cancer care worldwide, the phase 3 ANZUP 1301 trial offers valuable insights into the potential of BCG combined with mitomycin (MM) as a pragmatic alternative for BCG-naïve patients with high-risk, non–muscle-invasive bladder cancer (NMIBC).
The trial enrolled 501 patients following transurethral resection of bladder tumors, randomizing them to either BCG plus MM or BCG alone. Both regimens demonstrated similar efficacy, with no significant difference in 2-year disease-free survival (75% for BCG + MM vs 71% for BCG alone; hazard ratio, 0.87; P=0.3). Secondary outcomes, including recurrence rates and complete response at 3 months, showed comparable results between the 2 groups.
However, a key advantage of the BCG plus MM regimen is its reduced reliance on BCG doses—requiring 39% fewer doses while maintaining effectiveness. Patients in the combination group also had fewer treatment discontinuations, with 78% completing planned doses versus 68% in the BCG-alone arm. While grade 3 to 5 adverse events (AEs) were slightly more frequent in the BCG plus MM group (43 vs 37 AEs), the safety profile remained manageable.
For oncology teams navigating the challenges of BCG shortages, these findings suggest that BCG plus MM is a practical alternative. Although it does not improve survival outcomes compared to BCG alone, its reduced BCG demand and improved adherence rates make it a viable option for ensuring uninterrupted care during supply constraints.
By considering BCG plus MM as a treatment option, oncology practices can help address the global shortage while maintaining effective care for patients with NMIBC.
Reference
- Hayne D, Zhang AY, Thomas H, et al. Bacillus Calmette-Guérin plus mitomycin versus Bacillus Calmette-Guérin alone for Bacillus Calmette-Guérin-naïve non-muscle-invasive bladder cancer: a randomised phase 3 trial (ANZUP 1301). Eur Urol. 2026;89:446-453. Online ahead of print.
