Merck (NYSE:MRK) announces positive results from a Phase 3 clinical trial, KEYNOTE-590, evaluating Keytruda (pembrolizumab), combined with chemo, for the treatment of locally advanced or metastatic esophageal cancer in a first-line setting.
An interim analysis by the independent Data Monitoring Committee showed that the study met the primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemo plus placebo.
A key secondary endpoint, objective response rate (ORR), was also met.
No new safety signals were reported.
The company plans to share the data with global regulatory authorities and submit the results for presentation at ESMO in late September.
Keytruda is currently approved in the U.S. and China for second-line squamous cell carcinoma of the esophagus whose tumors express PD-L1.
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