Therapeutic Response

HER2-negative, PIK3CA oncogenic variants, and PR positive status confers therapeutic sensitivity to Alpelisib in combination with Fulvestrant in patients with Invasive Breast Carcinoma.

Statements

Source and description
Piqray (alpelisib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to alpelisib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test, following progression on or after an endocrine-based regimen.
Piqray (alpelisib) [product information]. EMA. The European Medicines Agency (EMA) has authorized alpelisib in combination with fulvestrant for the treatment of patients who are either postmenopausal women or men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as a monotherapy. This indication is based on C2301, a phase 3, randomized, double-blind, and placebo-controlled study that evaluated alpelisib in combination with fulvestrant based on the presence or absence of a PIK3CA. No survival benefit was shown in the group without PIK3CA variants and PIK3CA variants observed were: p.C420R, p.E542K, p.E545A, p.E545D (1635G>T), p.E545G, p.E545K, p.Q546E, p.Q546R, p.H1047L, p.H1047R, and p.H1047Y.