Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative, PIK3CA somatic variants, PR positive status confers therapeutic sensitivity to Alpelisib, Fulvestrant in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and 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 monotherapy.