ESMO Asia 2025 | KEYNOTE-905: perioperative enfortumab vedotin and pembrolizumab in MIBC
Christof Vulsteke, MD, PhD, AZ Maria Middelares, Ghent, Belgium, discusses results from the Phase III KEYNOTE-905 study (NCT03924895) evaluating perioperative enfortumab vedotin plus pembrolizumab in patients with muscle-invasive bladder cancer (MIBC) who were ineligible for cisplatin. Clinically meaningful improvements in event-free survival, overall survival, and pathological complete response rates were observed. Safety was manageable and consistent with known profiles. This interview took place at 2025 European Society for Medical Oncology (ESMO) Asia Congress in Singapore, Singapore.
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Transcript
Yeah, it all started in the metastatic space. We have flabbergast results in the first-line metastatic space. We published that in New England in 2024. It doubled progression-free survival. It doubled overall survival. There was a 30% complete response rate. And these complete responders, after two years, 75% of them are still in a complete response. So that was the background of the Kino 905, a very powerful regimen in the metastatic space...
Yeah, it all started in the metastatic space. We have flabbergast results in the first-line metastatic space. We published that in New England in 2024. It doubled progression-free survival. It doubled overall survival. There was a 30% complete response rate. And these complete responders, after two years, 75% of them are still in a complete response. So that was the background of the Kino 905, a very powerful regimen in the metastatic space. And we shifted it to the early space. And we chose for the very bad ones. This is an ineligible population. This is an older, frailer, more comorbid population. There are no systemic options for them. We go for upfront surgery in this population. And this is a very high chance of relapse in this population. We see that also in the control arm of the Kino 905 that after two years, 60% of them already do have a relapse. And there were no overall survival data in this population. So this was the population we chose, the CIS-ineligible, muscle-invasive bladder cancer patient population. And the reason to bring in that EVP regimen was metastatic.
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