SABCS 2022 | CAPItello-291: capivasertib +fulvestrant for AI-resistant HR+/HER2- advanced breast cancer

Hope Rugo, MD, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, provides an overview of the Phase III CAPItello-291 (NCT04305496) trial investigating the efficacy and safety of the pan-AKT inhibitor capivasertib plus fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer that had progressed on or after aromatase inhibitor (AI) therapy with or without a CDK4/6 inhibitor. The dual primary endpoint was progression-free survival in the overall population and in patients with AKT pathway-altered tumors. The Phase II FAKTION (NCT01992952) trial had previously shown the addition of capivasertib to fulvestrant significantly improved progression-free survival (PFS) and overall-survival (OS) in postmenopausal women with AI-resistant HR-positive/HER2-negative advanced breast cancer. However, FAKTION used an assay which did not pickup most of the pathway alterations. Following use of an improved assay, capivasertib appeared to be primarily effective in patients with mutations in the PI3K pathway, including activating PIK3CA mutation, AKT mutation or loss of PTEN. CAPItello-291 was thereafter designed to assess PFS in AKT pathway-altered tumors, as well at the intent-to-treat population. The dual primary endpoint was PFS in the overall population and in patients with AKT pathway-altered tumors. Overall, the median PFS was 7.2 months with capivasertib plus fulvestrant and 3.6 months with fulvestrant monotherapy. In patients with AKT pathway-altered tumors, median PFS was 7.3 months with capivasertib plus fulvestrant and 3.1 months with fulvestrant monotherapy. Overall, capivasertib plus fulvestrant significantly improved PFS compared to fulvestrant alone in the overall population, and in patients with AKT pathway-altered tumors and demonstrated a mangeable safety profile. This interview took place at the San Antonio Breast Cancer Symposium (SABCS) 2022 in San Antonio, TX.

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