Overview

• The phase 3 KEYNOTE-905/EV-303 trial randomized about 600 non-metastatic muscle-invasive bladder cancer patients who were ineligible for or declined cisplatin into three arms: perioperative Padcev plus pembrolizumab, pembrolizumab alone, or surgery alone.
• Interim analysis showed the Padcev plus pembrolizumab arm achieved statistically significant and clinically meaningful improvements in event-free survival and overall survival versus surgery alone.
• The combination also yielded higher pathologic complete response rates without introducing new safety signals beyond known profiles for the individual agents.
• Full numerical data have not yet been disclosed but will be presented at an upcoming medical conference as the trial continues to mature and safety follow-up is completed.
• Padcev generated $1.59 billion in sales last year, and positive perioperative data could support label expansion into neoadjuvant and adjuvant settings.