ANZUP 1301 is a Phase III randomized controlled trial comparing BCG plus mitomycin to BCG alone in patients with high-risk non-muscle invasive bladder cancer. The data was presented at ASCO last year and this is the quality of life data as well which hasn’t been yet seen. So we found in our study that in terms of the primary outcome measure, which was disease-free survival, BCG plus mitomycin had higher DFS and other important outcome measures...
ANZUP 1301 is a Phase III randomized controlled trial comparing BCG plus mitomycin to BCG alone in patients with high-risk non-muscle invasive bladder cancer. The data was presented at ASCO last year and this is the quality of life data as well which hasn’t been yet seen. So we found in our study that in terms of the primary outcome measure, which was disease-free survival, BCG plus mitomycin had higher DFS and other important outcome measures. But unfortunately, none of those improvements were beyond the play of chance. However, a combination of BCG mitomycin was better tolerated with higher completion rates than BCG alone. Importantly, the BCG mitomycin regimen uses 39% less BCG even with the higher completion rates. So those are the main findings of the study. In terms of the quality of life data, we did see that there were less deterioration in people’s symptom scores on the AUA symptom index who were on the BCG plus mitomycin compared to BCG alone. In terms of other efficacy measures that we looked at we did look at some subgroup analyses which suggested that in the higher risk patients BCG mitomycin is more effective and we also did a Bayesian statistical analysis which suggested there is an 83% probability that the BCG mitomycin is favorable for DFS and a 94% chance it’s non-inferior. The rest of the quality of life measures were very similar between the two arms without showing a great deal of difference. But what we’re left with is a new regimen for high risk non-muscle invasive bladder cancer that uses 39% less BCG and there is a global shortage of BCG currently with similar efficacy possibly greater efficacy in higher risk disease and in addition to that higher completion rates and evidence that it’s better tolerated. We looked at the serious adverse events in the study, and the serious adverse events that occurred related to treatment, so the ones the investigators had said, this is probably related to the treatment, were actually much higher in BCG alone than in BCG mitomycin. So I think this is potentially a very useful regimen which really could be adopted widely and that would potentially resolve the global BCG shortage.
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