ESMO Asia 2025 | Asian perspectives on the KEYNOTE-905 of EV and pembrolizumab in MIBC
Yao Zhu, MD, PhD, Fudan University, Shanghai, China, discusses the Phase III KEYNOTE-905 trial (NCT03924895) of perioperative enfortumab vedotin (EV) and pembrolizumab in patients with muscle-invasive bladder cancer (MIBC). A significant improvement in event-free survival and overall survival were reported. Overall, the trial raises important clinical questions about sparing the bladder for patients with a strong response to treatment and tailoring adjuvant treatment based on patient response. This interview took place at 2025 European Society for Medical Oncology (ESMO) Asia Congress in Singapore, Singapore.
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Transcript
Okay, thank you. So it’s my honor to discuss the KEYNOTE-905 study. And this study is a randomized phase three clinical trial. And the patients with muscle-invasive bladder cancer, clinical stage T2 or T4 disease, N0, M0 disease were recruited and these patients should have cisplatin-ineligible disease or deny receipt of new adjuvant cisplatin-based chemotherapy...
Okay, thank you. So it’s my honor to discuss the KEYNOTE-905 study. And this study is a randomized phase three clinical trial. And the patients with muscle-invasive bladder cancer, clinical stage T2 or T4 disease, N0, M0 disease were recruited and these patients should have cisplatin-ineligible disease or deny receipt of new adjuvant cisplatin-based chemotherapy. And the patients were randomized to two arms. So one arm is the radical cystectomy and lymph node dissection, then observation, and the clinical outcome comes and the other arm is patients who are treated with new adjuvant EV and pembro. Then after three cycles, the patients will undergo radical cystectomy and lymph node dissection. Then there is another adjuvant treatment phase, including six cycles of EV and 14 cycles of pembrolizumab. So this is a randomized phase three clinical trial. And the key clinical primary endpoint is event-free survival. And the key secondary endpoint is overall survival. And the results of the KEYNOTE-905 are very, very important and very profound because the hazard ratio of EFS is 0.4 and the hazard ratio for overall survival is 0.5, which sets a new benchmark for the new adjuvant chemo and immune therapy in muscle-invasive bladder cancer. And we are glad to see nearly 40% of patients were recruited outside the United States and the European Union. And in the Asian region, we have patients recruited from East Asia and also from Southeast Asia. And in this study, I think the most intriguing result is the high pCR, pathological complete response rate. More than 50% of the patients get the pCR after new adjuvant EV and pembrolizumab treatment. So this study opens another important clinical question in the future. So can we spare the bladder for those patients with a super response to the EV and pembrolizumab? And also in this study, we also see a significant improvement in the overall survival for these kinds of patients. So the next question is how to precisely give the length and the intensity of adjuvant treatment in patients with different responses to the new adjuvant EV and pembro.
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