What's Happening?
Merck has announced positive results from the Phase 3 KEYNOTE-905 trial, which evaluated the combination of KEYTRUDA (pembrolizumab) and Padcev (enfortumab vedotin-ejfv) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. The study demonstrated significant improvements in event-free survival, overall survival, and pathologic complete response rates when the combination was administered before and after surgery, compared to surgery alone. This marks the first time a systemic treatment has shown such benefits in this patient population, addressing a critical unmet need. The trial was conducted in collaboration with Pfizer and Astellas, and the results will be shared with regulatory authorities worldwide.
Why It's Important?
The findings from the KEYNOTE-905 trial represent a significant advancement in the treatment of muscle-invasive bladder cancer, particularly for patients who cannot undergo cisplatin-based chemotherapy. This population has historically faced limited treatment options and poor prognoses. The success of the KEYTRUDA and Padcev combination could lead to new standard-of-care practices, potentially improving survival rates and quality of life for these patients. The study's results also reinforce the potential of combining immunotherapy with antibody-drug conjugates to address unmet needs in oncology, which could influence future cancer treatment strategies and research.
What's Next?
Merck plans to present the trial data at an upcoming medical meeting and will engage with regulatory authorities to discuss potential approvals. The ongoing evaluation of secondary endpoints in the trial may provide further insights into the efficacy of the treatment combination. Additionally, Merck is conducting several other Phase 3 studies to explore the use of KEYTRUDA across different stages of bladder cancer, which could expand its application and benefit more patients in the future.
