The European Medicines Agency (EMA) has recommended approval of Merck’s KEYTRUDA and Padcev combination for the first-line treatment of unresectable or metastatic urothelial carcinoma. This recommendation follows positive results from the Phase 3 KEYNOTE-A39 trial.
The combination therapy significantly improved overall survival (OS) and progression-free survival (PFS) compared to platinum-based chemotherapy. The risk of death was reduced by 53% with KEYTRUDA and Padcev. The combination also reduced the risk of disease progression or death by 55%.
This positive opinion brings KEYTRUDA closer to becoming the preferred first-line treatment for advanced or metastatic urothelial carcinoma in Europe. It would be the third bladder cancer indication for KEYTRUDA in the EU if approved.
Merck, Pfizer, and Astellas continue to study combination therapy in an extensive clinical program for various stages of urothelial cancer. This includes two Phase 3 clinical trials for muscle-invasive bladder cancer in KEYNOTE-B15 and KEYNOTE-B71.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.