Season 15 · Episode 21
S15 Ep21: FDA Approval of Enfortumab Vedotin/Pembrolizumab Redefines Perioperative Care for Cisplatin-Ineligible MIBC: With Christof Vulsteke, MD, PhD
OncLive® On Air · OncLive® On Air
December 31, 20258m 24s
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Show Notes
In today’s episode, the discussion features Christof Vulsteke, MD, PhD, head of the Integrated Cancer Center Ghent in Belgium, who provided clinical and regulatory insight into the KEYNOTE-905 study (NCT03924895) and the November 2025 FDA approval of enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) for patients with cisplatin-ineligible muscle-invasive bladder cancer (MIBC).
In this exclusive interview, Dr Vulsteke outlined the scientific rationale and study design of KEYNOTE-905, reviewed the key efficacy and safety findings observed with the enfortumab vedotin/pembrolizumab combination, and discussed how the safety profile of this combination aligns with prior experience in bladder cancer. He also contextualized the significance of this FDA approval in addressing a longstanding unmet need for cisplatin-ineligible patients and highlighted remaining gaps in care, including global access, patient selection, and future research directions aimed at improving outcomes in this challenging-to-treat population.
In this exclusive interview, Dr Vulsteke outlined the scientific rationale and study design of KEYNOTE-905, reviewed the key efficacy and safety findings observed with the enfortumab vedotin/pembrolizumab combination, and discussed how the safety profile of this combination aligns with prior experience in bladder cancer. He also contextualized the significance of this FDA approval in addressing a longstanding unmet need for cisplatin-ineligible patients and highlighted remaining gaps in care, including global access, patient selection, and future research directions aimed at improving outcomes in this challenging-to-treat population.