Therapeutic efficacy of Capivasertib

CAPItello-291 is a Phase III, double-blind, randomized controlled trial designed to evaluate the efficacy of Truqap in combination with Faslodex, compared with placebo plus Faslodex, for the treatment of patients with locally advanced (unresectable) or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-low or negative (immunohistochemistry [IHC] score 0 or 1+, or IHC 2+ with negative in-situ hybridization [ISH] results) breast cancer.

This global trial enrolled a total of 708 adult patients with histologically confirmed hormone receptor-positive, HER2-low or negative breast cancer. These patients had experienced disease recurrence or progression during or after aromatase inhibitor therapy, regardless of prior treatment with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, and had received no more than one line of chemotherapy for advanced disease. The trial was designed with dual primary endpoints: progression-free survival (PFS) in the overall patient population, and PFS in the subset of patients whose tumors harbored qualifying alterations in the phosphatidylinositol 3-kinase/protein kinase B (PI3K/AKT) signaling pathway (involving the PIK3CA, AKT1 or PTEN genes). Trial results showed that approximately 40% of the tumors had the aforementioned genetic alterations, and around 70% of the patients had previously received a CDK4/6 inhibitor.

from FDA，2024.09