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GU Cancers 2025 | Evaluating real-world toxicities of EV and pembrolizumab in UC

Dora Niedersüß-Beke, MD, MBA, Klinik Ottakring, Vienna, Austria, comments on the real-world outcomes of enfortumab vedotin plus pembrolizumab in Austrian patients with advanced urothelial carcinoma (UC). The observed toxicities were comparable to those reported in trials, notable the Phase III EV-302 trial (NCT04223856). The findings reaffirm the efficacy of first-line enfortumab vedotin plus pembrolizumab in the real-world setting. This interview took place at the ASCO GU Cancers Symposium 2025 in San Francisco, CA.

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Transcript

Concerning toxicities, we had all grade serious adverse events in 70% of our patients with 16% grade 3 or higher grade events. We had four fatal events in our patient population. This was one colitis, one rectal bleeding, one infection with multi-organ failure, and one pneumocystis pneumonia. These are very interesting data we should look at further. In general the data were very comparable to the EV-302 Phase III data...

Concerning toxicities, we had all grade serious adverse events in 70% of our patients with 16% grade 3 or higher grade events. We had four fatal events in our patient population. This was one colitis, one rectal bleeding, one infection with multi-organ failure, and one pneumocystis pneumonia. These are very interesting data we should look at further. In general the data were very comparable to the EV-302 Phase III data. So we in Austria have no additional new safety or outcome issues. So it is for us the new and it’s not even new the standard of care in first line and locally advanced metastatic urothelial cancer.

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