Therapeutic Response

PTEN-deficient status confers therapeutic sensitivity to Abiraterone acetate in combination with Capivasertib and Prednisone in patients with Prostate Adenocarcinoma.

Statements

Source and description

Truqap (capivasertib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to capivasertib in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naive or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test. The package insert notes that mAPMN/S prostate cancer was previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC). This indication is supported by CAPItello-281 (NCT04493853), a randomized, double-blind, placebo-controlled, multicenter trial in which PTEN deficiency status was defined as >= 90% of viable malignant cells with no specific cytoplasmic staining, as determined by central testing with the immunohistochemistry-based VENTANA PTEN (SP218) RxDx Assay.