ASCO 2025 | The rapidly eolving landscape for high-risk non-muscle invasive bladder cancer treatment
Dickon Hayne, MBBS, MD, FRCS, FRACS, UWA Medical School, Perth, Australia, comments on the rapidly evolving landscape of high-risk, non-muscle invasive bladder cancer treatment, highlighting the need for new and safer therapies, particularly in the context of BCG shortages and the increasing use of systemic checkpoint inhibitors. Prof. Hayne notes that BCG plus mitomycin is a widely available and effective first-line treatment, but acknowledges the drawbacks of systemic checkpoint inhibition and the potential for new intravesical and systemic therapies to improve outcomes. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
So this is a big space now. So we had decades with almost nothing other than BCG or chemotherapy for non-muscle invasive bladder cancer. And there has been an explosion in new therapies, both new immune therapies, drugs like nadofaragin, Vicineum, and agents like N-803, which are actually being utilized mainly in the BCG unresponsive setting. And we’ve got new intravesical treatments with gemcitabine and docetaxel, which are gaining traction...
So this is a big space now. So we had decades with almost nothing other than BCG or chemotherapy for non-muscle invasive bladder cancer. And there has been an explosion in new therapies, both new immune therapies, drugs like nadofaragin, Vicineum, and agents like N-803, which are actually being utilized mainly in the BCG unresponsive setting. And we’ve got new intravesical treatments with gemcitabine and docetaxel, which are gaining traction. Some of this has occurred as a result of the BCG shortage because these agents have had to be used because there’s not been enough BCG to go around. And there’s also been an explosion in the use of systemic checkpoint inhibitors in addition to BCG for high-risk non-muscle invasive bladder cancer. By definition, it’s a localized condition. So to upfront subject patients to the risks of systemic checkpoint inhibition does have some drawbacks for sure, not to mention the costs of these agents. So BCG plus mitomycin are both very widely available, inexpensive drugs, which are very effective in the first line management. So there is a rapidly evolving space and we will be, as we do develop new biomarkers and also other ways of delivering checkpoint inhibitor therapy perhaps in addition to intravesical drugs and perhaps we can do that more safely. Our group was responsible for the SUTD trials, it’s another ANZUP study where we’re exploring the role of suburothelial durvalumab, so giving checkpoint inhibitors but actually putting them directly into the bladder by injection in the hope that you’ll reduce the systemic side effects whilst also getting the benefits of the immune effects on the immune system. These are also phase one studies and further studies are planned but there’s a whole evolving area in high-risk non-muscle invasive bladder cancer at the moment for sure. So much going on.
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