Merck’s KEYTRUDA and KEYTRUDA QLEX in combination with Padcev receive FDA priority review for cisplatin-eligible muscle-invasive bladder cancer based on Phase 3 KEYNOTE-B15 data.
Written By: Mennatullah Mansour, PharmD
Reviewed By: Pharmacally Editorial Team
Merck announced that the U.S. Food and Drug Administration has granted priority review to two supplemental Biologics License Applications (sBLAs) for KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The FDA has set a target action date of August 17, 2026 under priority review.
The applications are supported by data from the Phase 3 KEYNOTE-B15 (EV-304) trial (NCT04700124), conducted in collaboration with Pfizer and Astellas and presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium.
The study evaluated perioperative pembrolizumab plus enfortumab vedotin followed by surgery versus standard neoadjuvant cisplatin-based chemotherapy followed by surgery in 808 cisplatin-eligible patients, with event-free survival (EFS) as the primary endpoint and overall survival (OS) and pathologic complete response (pCR) as key secondary endpoints. KEYNOTE-B15 demonstrated an overall survival benefit for the pembrolizumab-based regimen and a higher pathologic complete response rate compared with standard chemotherapy.
The trial outcome positions pembrolizumab plus enfortumab vedotin among Phase 3 regimens demonstrating survival benefit in bladder cancer and, if approved, the combination could expand perioperative pembrolizumab-based treatment options for cisplatin-eligible patients with MIBC, building on existing approvals in cisplatin-ineligible MIBC and in locally advanced or metastatic urothelial cancer across several regions.
The combination has also shown overall survival benefit in multiple Phase 3 trials, including KEYNOTE-B15, KEYNOTE-905, and KEYNOTE-A39, and is approved in several markets for advanced urothelial cancer as well as in the U.S. for cisplatin-ineligible MIBC.
Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, stated that findings from KEYNOTE-B15 challenge existing treatment expectations in MIBC, noting that many patients continue to experience disease progression despite surgery and chemotherapy and that the combination may help improve outcomes.
Globally, bladder cancer affected more than 600,000 people in 2022, with about one-quarter of cases classified as muscle-invasive; current standard treatment involves cisplatin-based chemotherapy followed by surgery, yet recurrence occurs in nearly half of patients, underscoring the need for improved perioperative strategies.
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About the Writer
Mennatullah Mansour is pursuing a PharmD and is based in Alexandria, Egypt. She is driven by a strong passion for continuous learning and professional development, with a focus on pharmaceutical care, patient health, and medication safety. Her interests include prescription processing, patient counseling, and interpreting clinical information. She brings a detail-oriented approach and a strong ability to translate medical knowledge into clear, accurate, and reliable content for healthcare audiences.