ASCO 2025 | ANZUP 1301: BCG + mitomycin a promising alternative to BCG alone for high-risk bladder cancer
Dickon Hayne, MBBS, MD, FRCS, FRACS, UWA Medical School, Perth, Australia, comments on the efficacy and completion rates of the randomized Phase III ANZUP 1301 trial (NCT02948543) comparing BCG plus mitomycin to BCG alone in high-risk, non–muscle-invasive bladder cancer. Prof. Hayne notes that the BCG plus mitomycin regimen showed similar efficacy and adverse events to BCG alone, but with improved completion rates and reduced BCG doses required. This regimen, particularly in higher-risk patients, may offer a promising alternative to BCG alone, especially in light of the global BCG shortage, which could be alleviated by widespread adoption of the BCG plus mitomycin regimen. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
We saw a comparison of BCG plus mitomycin to BCG, and BCG plus mitomycin had very similar efficacy and adverse events to BCG alone, but with much higher completion rates and also 40% fewer BCG doses required in the BCG plus mitomycin arm compared to the BCG alone. We also did a subgroup analysis of the higher-risk patients, and they seem to benefit more from the addition of mitomycin than the lower-risk patients...
We saw a comparison of BCG plus mitomycin to BCG, and BCG plus mitomycin had very similar efficacy and adverse events to BCG alone, but with much higher completion rates and also 40% fewer BCG doses required in the BCG plus mitomycin arm compared to the BCG alone. We also did a subgroup analysis of the higher-risk patients, and they seem to benefit more from the addition of mitomycin than the lower-risk patients. So overall, BCG plus mitomycin seems to be a good alternative to BCG alone. And of course, we’re currently faced with a global BCG shortage, with best estimates that we’re somewhere between 30 to 50% short of BCG for the supply where required. So, a widespread adoption of the BCG plus mitomycin regimen could actually go a long way to resolving the global BCG shortage.
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