Therapeutic Response

ER positive, HER2-negative, and PTEN frameshift variants status confers therapeutic sensitivity to Capivasertib in combination with Fulvestrant in patients with Invasive Breast Carcinoma.

Statements

Source and description
Truqap (capivasertib) [product information]. EMA. The European Medicines Agency (EMA) has authorized capivasertib in combination with fulvestrant for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. Capivasertib's product information further states that in pre- or perimenopausal women, capivasertib plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. The product information further states that, for men, administration of LHRH agonist according to current clinical practices should be considered. This indication is based on CAPItello-291, a randomized, double-blind, placebo-controlled trial, where HER2-negative status was defined as either IHC 0 or 1+, or IHC 2+/ISH-, and qualifying alterations were activating mutations in PIK3CA and AKT1 and inactivating mutations in PTEN.
Truqap (capivasertib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to capivasertib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. The efficacy of capivasertib in combination with fulvestrant was evaluated in CAPItello-291 (NCT04305496), which described biomarker eligibility as PIK3CA/AKT1 activating mutations or PTEN loss of function alterations.