What's Happening?
Merck has announced positive results from its Phase 3 KEYNOTE-B15 trial, which evaluated the combination of KEYTRUDA (pembrolizumab) and Padcev (enfortumab vedotin-ejfv) in patients with muscle-invasive bladder cancer (MIBC) eligible for cisplatin-based chemotherapy. The trial demonstrated significant improvements in event-free survival, overall survival, and pathologic complete response rates when the combination was used both before and after surgery. This study, conducted in collaboration with Pfizer and Astellas, builds on previous successes of this drug combination in treating locally advanced or metastatic urothelial cancer. The safety profile of the combination was consistent with known profiles of each drug, and no new safety signals
were identified.
Why It's Important?
The findings from the KEYNOTE-B15 trial are significant as they offer a new potential treatment option for patients with muscle-invasive bladder cancer, a condition where treatment decisions are critical early on. The combination of KEYTRUDA and Padcev could change the standard of care by improving survival outcomes for patients who are eligible for cisplatin-based chemotherapy. This development is particularly important given the high recurrence rate of bladder cancer following standard treatments. The results could lead to regulatory filings worldwide, potentially expanding the availability of this treatment combination and improving patient outcomes.
What's Next?
Merck plans to share the trial results with regulatory authorities globally, which could lead to new regulatory approvals for the combination therapy. Additionally, the data will be presented at an upcoming medical meeting, which may further influence clinical practices and guidelines. The company is also conducting additional Phase 3 studies to evaluate KEYTRUDA across all stages of bladder cancer, which could further expand its use in oncology.
