A recent Phase 3 study conducted by Merck & Co., Seagen, and Astellas Pharma has achieved its primary goals in certain patients with the most common form of bladder cancer. This study combined Merck’s widely-used cancer drug Keytruda with Astellas’ and Seagen’s Padcev, comparing it to chemotherapy. The study successfully met its dual primary endpoints of overall survival and progression-free survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma.
Notably, the combination therapy also demonstrated a statistically significant improvement in the overall response rate, a key secondary endpoint of the study. It is important to highlight that the study enrolled patients who may or may not be eligible for treatment with cisplatin-based chemotherapy, irrespective of their PD-L1 status.
Locally advanced or metastatic urothelial carcinoma refers to bladder cancer that has spread to nearby organs or muscles, as well as other parts of the body.
Merck, Seagen, and Astellas have stated that this study will serve as the foundation for global submissions of the Keytruda/Padcev combination and as the confirmatory trial for the accelerated approval granted by the U.S. Food and Drug Administration in April. The companies, which initiated their collaboration in late 2019 to investigate Padcev in combination with Keytruda for urothelial cancer, are continuing their comprehensive clinical development program across various stages of the disease.