The AKT inhibitor capivasertib combined with fulvestrant improved progression-free survival among patients with HR-positive, HER2-low, or -negative, locally advanced breast cancer compared to fulvestrant and placebo, based on an announcement from capivasertib’s manufacturer.

The data comes from the global phase 3 CAPItello-291 study: a double blind, randomized controlled trial of 708 adults with HR-positive, HER2-low, or -negative breast cancer that have not responded to aromatase inhibitor therapy.

If approved by regulatory agencies, capivasertib has the potential to become a first-in-class drug inhibiting the AKT protein. The trial met both of its primary endpoints, improving PFS in both a subgroup of patients with alterations to the PIK3CA, AKT1, or PTEN genes, as well as in the overall patient population.

These trial results demonstrate that capivasertib offers a clinically meaningful improvement in PFS for patients with HR-positive breast cancer. Although data on overall survival were immature at the time of the announcement, early numbers are quoted as being “promising.” The manufacturer also said it would present the findings at an upcoming scientific meeting.

“These exciting data in an all-comers population indicate that capivasertib could become a new first-in-class treatment option for patients with HR-positive breast cancer,” Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, said. “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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Disclosures: Galbraith is an employee of AstraZeneca. CAPItello-291 is being supported by AstraZeneca.