Astellas Pharma Inc., led by President and CEO Naoki Okamura, and Pfizer Inc. have announced encouraging topline results from an interim analysis of the Phase 3 EV-304 trial, also known as KEYNOTE-B15, evaluating PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab). This pivotal study assessed the combination as neoadjuvant and adjuvant therapy compared with standard cisplatin-based chemotherapy in patients with muscle-invasive bladder cancer who are eligible for cisplatin. The trial successfully met its primary endpoint by showing significant improvements in event-free survival and also demonstrated meaningful gains in overall survival, a key secondary endpoint. The study further met a secondary endpoint by showing a higher pathologic complete response rate with PADCEV plus pembrolizumab compared to chemotherapy, and the combination’s safety profile aligned with expectations from previous studies.
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Christopher Hoimes, DO, Director of the Bladder Cancer Program and Center for Cancer Immunotherapy at Duke Cancer Institute and EV-304 Principal Investigator, emphasized that nearly half of patients with muscle-invasive bladder cancer progress to metastatic disease within three years. He stated that these EV-304 results mark an important milestone for urothelial cancer treatment, showing that perioperative enfortumab vedotin plus pembrolizumab can deliver substantial survival benefits to both cisplatin-eligible and cisplatin-ineligible patients, potentially shifting treatment away from traditional platinum-based chemotherapy.
Moitreyee Chatterjee-Kishore, PhD, MBA, Head of Oncology Development at Astellas, highlighted that the positive EV-304 findings, combined with recent EV-303 data, reinforce the potential of PADCEV plus pembrolizumab to improve survival for a broad population of patients with muscle-invasive bladder cancer. She noted that Astellas remains committed to advancing treatment options and bringing these improvements to patients in need.
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Jeff Legos, PhD, MBA, Chief Oncology Officer at Pfizer, stated that for the first time patients in the perioperative setting can experience significant survival benefits from a combination therapy without relying on platinum-based chemotherapy. He described the EV-304 results, alongside EV-303 findings, as a demonstration of the promising role this combination could play as a cornerstone therapy for bladder cancer regardless of cisplatin eligibility.
Bladder cancer is the ninth most common cancer worldwide, with over 614,000 new cases annually, including an estimated 85,000 in the United States. Muscle-invasive bladder cancer represents roughly 30 percent of all cases, and even after standard neoadjuvant cisplatin chemotherapy followed by surgery, approximately half of patients experience recurrence.
Currently, PADCEV plus pembrolizumab is approved in the U.S. for cisplatin-ineligible patients with muscle-invasive bladder cancer as neoadjuvant therapy followed by continued adjuvant treatment after cystectomy, based on results from the Phase 3 EV-303 trial. The new EV-304 results in cisplatin-eligible patients will be submitted for presentation at upcoming medical conferences and discussed with global regulatory authorities to explore potential approvals for broader patient populations.
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Source- PR Newswire
