Capivasertib regimen extends PFS in advanced breast cancer
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The addition of capivasertib to fulvestrant significantly extended PFS among patients with advanced hormone receptor-positive breast cancer, according to topline data released by the agent’s manufacturer.
Capivasertib (AZD5363, AstraZeneca) is an investigational AKT inhibitor in development for breast cancer, prostate cancer and hematologic malignancies.
The randomized phase 3 CAPItello-291 trial included 708 adults with histologically confirmed hormone receptor-positive, HER2-low or HER2-negative locally advanced or metastatic breast cancer whose disease had recurred or progressed during or after aromatase inhibitor therapy, with or without a cyclin-dependent kinase 4/6 inhibitor.
Study participants had received up to one line of chemotherapy for advanced disease.
Researchers assigned patients to fulvestrant plus either capivasertib or placebo.
The study met both of its primary endpoints, showing improved PFS with the capivasertib regimen 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.
The safety profile of capivasertib plus fulvestrant appeared similar to that observed in prior trials evaluating the combination.
Data from CAPItello-291 will be presented at a medical meeting and shared with global health authorities, according to an AstraZeneca-issued press release.
“These exciting data in an all-comers population indicate that capivasertib could become a new first-in-class treatment option for patients with [hormone receptor]-positive breast cancer,” Susan Galbraith, MD, PhD, executive vice president of oncology research and development with AstraZeneca, said in the release. “These patients often experience tumor progression on or resistance to available endocrine therapies for advanced disease and urgently need new therapies that extend the effectiveness of endocrine-based treatment approaches.”
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