AstraZeneca (AZN, Financial) has announced positive results from its Phase 3 CAPItello-281 clinical trial. The study evaluated the efficacy of Truqap (capivasertib) combined with abiraterone and androgen deprivation therapy (ADT) in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). The combination demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to a placebo combined with abiraterone and ADT.
This marks the first AKT inhibitor combination proven beneficial for this specific subtype of prostate cancer. While overall survival (OS) data remains immature, there is an early trend indicating OS improvement with the Truqap combination over the placebo group. The trial will continue as planned to further assess the key secondary endpoint of OS.
The safety profile of Truqap, when used with abiraterone and ADT in the CAPItello-281 trial, aligns with the known safety profiles of each individual drug. Truqap is an oral, selective, ATP-competitive inhibitor targeting the AKT kinase isoforms (AKT1/2/3). It is being tested in various clinical programs to treat tumors with alterations in the PI3K/AKT/PTEN signaling pathway.
Last November, the therapy received FDA approval for use in combination with fulvestrant to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in adults.
