- KEYTRUDA plus Padcev reduced event-free survival risk by 47% and death risk by 35% in muscle-invasive bladder cancer.
- The Phase 3 KEYNOTE-B15 trial results will be presented at the 2026 ASCO Genitourinary Cancers Symposium.
- Median follow-up was 33.6 months, with 79.4% of patients alive without disease progression at two years.
- Pathologic complete response rate increased to 55.8% with KEYTRUDA plus Padcev.
Study Overview
The Phase 3 KEYNOTE-B15 trial evaluated the efficacy of KEYTRUDA (pembrolizumab) combined with Padcev (enfortumab vedotin-ejfv) in treating muscle-invasive bladder cancer (MIBC) in cisplatin-eligible patients. The study demonstrated significant improvements in event-free survival (EFS) and overall survival (OS) when compared to traditional neoadjuvant chemotherapy and surgery.
Key Findings
Results showed a 47% reduction in the risk of EFS events and a 35% reduction in the risk of death. After a median follow-up of 33.6 months, 79.4% of patients treated with the combination were alive without disease progression or recurrence, compared to 66.2% with standard treatment. The pathologic complete response (pCR) rate increased from 32.5% to 55.8% with the new regimen.
Clinical Implications
The findings suggest that the combination of KEYTRUDA and Padcev could become a new standard of care for cisplatin-eligible MIBC patients, offering a significant survival benefit over existing treatments. The trial's results will be presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, highlighting its potential impact on future treatment protocols.
