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ESMO Asia 2025 | Defining patient groups in the KEYNOTE-905 trial of EV & pembrolizumab

Yao Zhu, MD, PhD, Fudan University, Shanghai, China, highlights the importance of defining patient characteristics in the KEYNOTE-905 trial (NCT03924895), which includes both cisplatin-ineligible and cisplatin-declining patients. The high pathological complete response rate of enfortumab vedotin (EV) and pembrolizumab also justifies its use in patients with different cisplatin eligibility criteria. The results need to be verified in real-world settings to assess the impact of renal function status and comorbidities on treatment outcomes in different patient populations, but the tolerability of the combination therapy in Asian patients is promising based on data from the trial. This interview took place at 2025 European Society for Medical Oncology (ESMO) Asia Congress in Singapore, Singapore.

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Transcript

Yes, I think it’s a very important question to define the characteristics of recruited patients for the KEYNOTE-905, because it includes not only patients with cisplatin ineligible, but also cisplatin declining patients. So it’s somehow two different patient cohorts in this study. Generally speaking, I think the high pathological complete response rate of EV pembro as a new adjuvant treatment justifies its use in patients with different cisplatin eligible criteria...

Yes, I think it’s a very important question to define the characteristics of recruited patients for the KEYNOTE-905, because it includes not only patients with cisplatin ineligible, but also cisplatin declining patients. So it’s somehow two different patient cohorts in this study. Generally speaking, I think the high pathological complete response rate of EV pembro as a new adjuvant treatment justifies its use in patients with different cisplatin eligible criteria. But we should test the results in the real world to see whether the renal function status will impact the pathological complete response in different patient populations. And another thing that should be considered is the comorbidities of different patients in different geographic areas. And we both know EV and pembro, they have different adverse events profiles. So in Asian patients, we have the data from the EV302 trial which tests EV and pembrolizumab in locally advanced and metastatic urothelial cancer and we can see in Asian patients there are a low proportion of patients who discontinued the treatment due to adverse events and a slightly longer treatment duration so we think the trial is quite tolerable in Asian patients, but we still need more real-world data to validate these observations.

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