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Transcript: ​Neal Shore on KEYNOTE-905

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

Neal Shore, MD, FACS

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- The KEYNOTE-905, which I was a member of the steering advisory committee, where it's part of the original design of the study. This was really looking at patients with T2 to T4 muscle-invasive bladder cancer who were randomised to receiving no neoadjuvant-adjuvant therapy, just cystectomy.

They're deemed to be platinum ineligible and some are refusing platinum based chemotherapy. In the treatment arm, they received neoadjuvant enfortumab vedotin and pembrolizumab, went to radical cystectomy, and then an adjuvant course of enfortumab vedotin and pembrolizumab. Looking at the event-free survival, the hazard ratio was 0.5, and then ultimately as a secondary endpoint, the overall survival was 0.4. I think this is a remarkably important study. It piggybacks on the 301 trial, which demonstrated that EV pembro in first line metastatic was clearly superior to adjuvant chemotherapy platinum based. So this is a remarkably and important accomplishment.

There were about 350 patients in the study. The adverse event profile was consistent with what we know about pembrolizumab as well as enfortumab vedotin and so I think this is gonna be really important for our healthcare colleagues, whether they're medical oncologists or uro oncologists, to really be fully aware of this and how to optimise their multidisciplinary team.

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