GU Cancers 2026 | EV-PRIME: enfortumab vedotin, pembrolizumab and radiotherapy in MIBC

Yes, absolutely. So my name is Vadim Koshkin. I’m an associate professor and GU medical oncologist at the University of California, San Francisco. One of the posters we actually presented at the ASCO GU meeting that just happened in February in San Francisco was our trial in progress called EV Prime. This is a truly multidisciplinary effort for our group here at UCSF among medical oncology, radiation oncology, and of course, urology. This is a trial for patients with muscle-invasive bladder cancer who want to avoid a radical cystectomy. And instead of sort of taking these patients down the radical cystectomy path where, you know, we give them neoadjuvant treatment, then, you know, followed by surgery, we use the bladder-sparing approach with radiation and systemic therapy. The novelty of this trial is using Enfortumab, Vedotin, and Pembrolizumab, the really potent systemic therapy that now will be our really neoadjuvant standard of care for muscle-invasive bladder cancer patients, even based on some of the other data presented at this meeting, namely the KEYNOTE B15 study and an earlier study, EV-303, that was presented at ESMO. So we know that Enfortumab-Vedotin and Pembrolizumab is a really effective systemic therapy for these patients. And the question then becomes, can we maybe avoid radical cystectomy for many of these folks? And so instead of doing Enfortumab, Vedotin, and Pembrolizumab followed by radical cystectomy, we’re doing Enfortumab, Vedotin, and Pembrolizumab concurrent with bladder-focused radiation. So patients get radiation to the bladder for six weeks or a little over six weeks. That’s a standard fractionation regimen. Concurrently with that, they’re getting Enfortumab-Vedotin and Pembrolizumab. And Enfortumab-Vedotin and Pembrolizumab is given in three-week cycles. So they get two cycles, so six weeks total concurrent with radiation. After that, they get three more cycles of Enfortumab-Vedotin and Pembrolizumab. And after that, they get Pembrolizumab only to complete a total of a year of treatment. So this trial is using a dose escalation strategy. So it’s a standard 3 plus 3 design in phase 1, phase 1B, I should say, and then a dose expansion in phase 2. So in phase 1B portion of this trial, we are gradually increasing the dose of Enfortumab-Vedotin in each cohort because, well, at the time of this trial design and still the safety data of this approach, so combining Enfortumab-Vedotin, Pembrolizumab, and radiation is limited. So we want to make sure, first of all, that it’s safe to do this and which dose of Enfortumab it is safe to do this at. And then after completing this dose escalation and, again, a 3 plus 3 fashion, then we, with the recommended phase 2 dose, we will then proceed with the phase 2 dose expansion with, again, the recommended phase 2 dose of Enfortumab-Vedotin.

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