Home Alzheimer’s Disease Phase III KEYNOTE-361 Trial Fails to Meet Primary End Points

Phase III KEYNOTE-361 Trial Fails to Meet Primary End Points

An update from the phase III KEYNOTE-361 trial, evaluating pembrolizumab (Keytruda) in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic urothelial carcinoma, indicated that the study did not meet its pre-specified dual primary endpoints of overall survival (OS) or progression-free survival (PFS), compared with standard of care chemotherapy (cisplatin or carboplatin plus gemcitabine), according to Merck, the agent’s developer. 

Though in the final analysis of the study there was an improvement in OS and PFS for patients treated with the anti-PD-1 therapy in combination with chemotherapy alone, these results did not meet statistical significance per the pre-specified statistical plan.

“In this study, (pembrolizumab) in combination with chemotherapy in previously untreated patients with advanced or metastatic bladder cancer was…

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