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Light microscopy of the internal lining of the urinary bladder; haematoxylin and eosin stain
Managing High-Risk NMIBC

Transcript: Neal Shore on the POTOMAC trial

Last updated: 30th Oct 2025
Published: 30th Oct 2025

Neal Shore, MD, FACS

Interview recorded October 2025. All transcripts are created from interview footage and directly reflect the content of the interview at the time. The content is that of the speaker and is not adjusted by Medthority.

- Well, several, but I'm gonna talk about two that I had, well, I'll talk about three that I had a very significant role in. And they were all oral presentations, podium. One was a presidential and two were, you know, large podium presentations. So I'm very happy to be attending ESMO 2025.

I was the Co-PI on the POTOMAC study and my Co-PI, Maria De Santis, presented it. And this was a phase three trial for patients who had high-risk non-muscle invasive bladder cancer. There were three arms to the study. The control arm was traditional induction maintenance, BCG for two years. And the other two therapeutic arms, the first was a one-year course of durvalumab given intravenously. And then the second arm was durvalumab given intravenously once a month, with only an induction course of BCG.

There's been other preclinical work demonstrating that BCG can upregulate PD receptor expression, so that was the basis for the study. And the primary endpoint was event-free survival. It was a successful trial. The hazard ratio was 0.68. This is in high-risk NMIBC patients who have TA grade three carcinoma in situ and lamin appropriate T1. So prior to this study, there was another successful phase three trial looking at a PD blocker with a very similar construct.

So now, here's a second and very important study that demonstrates that for patients who have high-risk non-muscle invasive bladder cancer, by adding a checkpoint inhibitor, in the case of POTOMAC, this was durvalumab given intravenously once a month for a year's time.

We published simultaneously in The Lancet. Very proud of that accomplishment.

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