Merck announced that the Phase 3 KEYNOTE-361 trial evaluating Keytruda in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic urothelial carcinoma (bladder cancer) did not meet its pre-specified dual primary endpoints of overall survival (OS) or progression-free survival (PFS), compared with standard of care chemotherapy.
The trial enrolled 1,010 patients. In the final analysis of the study, there was an improvement in OS and PFS for patients treated with Keytruda in combination with chemotherapy (cisplatin or carboplatin plus gemcitabine) compared to chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. The monotherapy arm of the study was not formally tested since superiority was not reached for OS or PFS in the Keytruda combination arm. No new safety signals were identified.
Results from KEYNOTE-361 will be presented at an upcoming medical meeting and will be discussed with regulatory authorities.
About Keytruda (pembrolizumab)
Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Keytruda has three FDA-approved bladder cancer indications across multiple types and stages of bladder cancer.
About Bladder Cancer
Bladder cancer begins when cells in the urinary bladder start to grow uncontrollably. As more cancer cells develop, they can form a tumor and spread to other areas of the body. Urothelial carcinoma, the most common type of bladder cancer, starts in the urothelial cells that line the inside of the bladder. It is estimated there were more than 549,000 new cases of bladder cancer and nearly 200,000 deaths from the disease globally in 2018. In the United States, it is estimated there will be more than 81,000 new cases of bladder cancer and nearly 18,000 deaths from the disease in 2020. The five-year survival rate for advanced or metastatic bladder cancer (stage IV) is estimated to be approximately 5%.