AstraZeneca: Capivasertib Phase III Trial Meets Primary Goals

British drug major AstraZeneca PLC (AZN.L) Wednesday announced positive high-level results from the CAPItello-291 Phase III trial of capivasertib in combination with Faslodex (fulvestrant) in advanced HR-positive breast cancer. The trial met both primary endpoints.

Capivasertib is an investigational oral treatment currently in Phase III trials for the treatment of multiple subtypes of breast cancer, prostate cancer and a Phase II trial for haematologic malignancies.

CAPItello-291 is a Phase III, double-blind, randomised trial that is part of a larger clinical programme focused on capivasertib, an investigational AKT (serine/threonine kinase) inhibitor.

The trial showed a statistically significant and clinically meaningful improvement in progression-free survival or PFS versus placebo plusFaslodexin 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.

In the trial, PFS was improved in the overall patient population and in a prespecified biomarker subgroup of patients whose tumours had qualifying alterations in the PIK3CA, AKT1 or PTEN genes.

The company noted that the overall survival or OS data were immature at the time of the analysis, but early data are encouraging. The trial will continue to assess OS as a key secondary endpoint.

In the trial, the safety profile of capivasertib plus Faslodex was similar to that observed in previous trials evaluating this combination .

AstraZeneca will present the trial data at a forthcoming medical meeting and will be shared with global health authorities.

Capivasertib was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics.

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