AstraZeneca (NASDAQ: AZN), a leading UK-based pharmaceutical company, has encountered a setback in the Phase III clinical trial for its first-in-class adenosine triphosphate (ATP)-competitive AKT inhibitor, Truqap (capivasertib). The trial, known as CAPItelo-290, failed to meet its dual primary endpoints of improved overall survival (OS) in both the overall trial population and a subgroup of patients with specific gene-expressing tumors.
The double-blind, randomized CAPItelo-290 study evaluated the efficacy and safety of Truqap in combination with paclitaxel versus placebo plus paclitaxel as a first-line treatment for locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC), enrolling 923 patients. The study particularly focused on a subgroup population with tumors exhibiting alterations in the PI3K/AKT pathway, including genes PIK3CA, AKT1, or PTEN.
Truqap is currently under investigation in ongoing Phase III trials for breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281), in combination with established treatments. The drug received its first approval in the US in 2023 and has since been approved in Japan, Australia, and other markets for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with specific biomarker alterations (PIK3CA, AKT1, or PTEN) as a second-line therapy. Truqap is currently under review for approval in the China market.- Flcube.com
