Gilead Sciences, Inc. (NASDAQ:GILD) announced positive results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer.
TROPiCS-02 is an event driven study with planned analyses based on a pre-specified number of events and this interim analysis was executed based on the pre-specified criteria.
Merdad Parsey, Chief Medical Officer, said, “These survival results from the TROPiCS-02 study are important for the breast cancer community and we are encouraged by the potential this may have in helping patients who otherwise have limited alternatives.”
The detailed overall survival (OS) results will be presented at an upcoming medical conference.
Gilead has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA).
The company is planning to share these study results with health authorities outside the United States.
Price Action : Gilead shares are trading around 3 percent at $65.09 on Monday at the time of publication.
