CHICAGO -- Progression-free survival (PFS) in metastatic hormone receptor (HR)-positive breast cancer more than doubled with the AKT inhibitor ipatasertib added to fulvestrant after first-line CDK4/6 inhibition, a randomized trial showed.

Median PFS increased from 1.94 months with single-agent fulvestrant to 5.32 months with the addition of ipatasertib. Patients with AKT pathway alterations obtained a similar PFS benefit. PFS assessment by blinded independent review yielded an even larger difference in the overall population (9.07 vs 3.71 months) and in the AKT -altered cohort (12.88 vs 3.68 months). Overall survival (OS) did not differ between treatment arms in a preliminary analysis.

Adverse events were more common but manageable with the combination, reported Stephen Chia, MD, of

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