GU Cancers 2026 | KEYMAKER-U04 substudy 04B: EV and pembrolizumab-based strategies in UC
Michiel Van Der Heijden, MD, PhD, Netherlands Cancer Institute, Amsterdam, Netherlands, comments on results from the Phase I/II KEYMAKER-U04 substudy 04B (NCT05845814) of first-line enfortumab vedotin plus pembrolizumab with or without coformulated LAG3 or TIGIT-targeted immune checkpoint inhibitors in locally advanced or metastatic urothelial cancer. The addition of these novel checkpoint inhibitors did not demonstrate clinically meaningful efficacy improvements compared to the standard combination. This interview took place at the 2026 ASCO GU Cancers Symposium in San Francisco, CA.
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Transcript
So this is a trial that was actually presented by my colleague, but I was involved as the first author as well. So in this trial, we looked at whether additional checkpoint inhibitors, so LAG3 antigen, could actually improve the response of EV plus pembrolizumab. It was a reasonably sized trial to get a first efficacy signal. Unfortunately, in this trial, we did not find an increased efficacy of the combination with different checkpoint inhibitors added to EV plus pembrolizumab...
So this is a trial that was actually presented by my colleague, but I was involved as the first author as well. So in this trial, we looked at whether additional checkpoint inhibitors, so LAG3 antigen, could actually improve the response of EV plus pembrolizumab. It was a reasonably sized trial to get a first efficacy signal. Unfortunately, in this trial, we did not find an increased efficacy of the combination with different checkpoint inhibitors added to EV plus pembrolizumab. So that’s one thing we really were hoping for, that we can still improve upon this regimen and in this case unfortunately we didn’t see that signal.
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