Positive high-level results from the CAPItello-291 Phase III trial showed that AstraZeneca’s capivasertib in combination with FASLODEX® (fulvestrant) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo plus FASLODEX in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low or negative locally advanced or metastatic breast cancer, following recurrence or progression on or after endocrine therapy (with or without a CDK4/6 inhibitor).
The trial met both primary endpoints, improving PFS in the overall patient population and in a prespecified biomarker subgroup of patients whose tumors had qualifying alterations in the PIK3CA, AKT1 or PTEN genes. Although the overall survival (OS) data were immature at the time of the analysis, early data are encouraging. The trial will continue to assess OS as a key secondary endpoint.
The safety profile of capivasertib plus FASLODEX was similar to that observed in previous trials evaluating this combination.
https://finance.yahoo.com/news/capivasertib-plus-faslodex-fulvestrant-significantly-110000919.html
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