Capivasertib Phase III trial met primary endpoints, says AstraZeneca

Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) shares were up as much as 3% this morning, after it announced new clinical data indicating that its capivasertib, a potential first-in-class AKT inhibitor, could become a new option for patients in early and 1L metastatic HR+/ET-sensitive breast cancer, regardless of biomarker status.

Positive high-level results from the CAPItello-291 Phase III trial showed that AstraZeneca’s capivasertib (formerly AZD5363) 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).

AstraZeneca says 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.