AstraZeneca (AZN.US) Combination Therapy Truqap Combination Phase 3 Trial Results Positive

The Zhitong Finance App learned that AstraZeneca (AZN.US) today announced the positive results of the Capitello-281 phase 3 clinical trial. The analysis showed that for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (MHSPC), AstraZeneca's Truqap (capivasertib) combined with abiraterone (abiraterone) and androgen deprivation therapy (ADT) showed statistically significant and clinically significant improvements in the main endpoints of radiologically-progressive survival (RPFs) compared with abiraterone and ADT combined placebo. According to reports, the TruQap combination is the first AKT inhibitor combination proven to be beneficial for this specific subtype of prostate cancer.

At the time of this analysis, overall survival (OS) data were not yet mature; however, the Truqap combination therapy showed an early trend of OS improvement compared to the placebo group. Trials will continue as planned to further evaluate the results of key secondary endpoint OS. The safety of TruQAP in combination with abiraterone and ADT in the Capitello-281 trial was broadly consistent with the known safety of each drug.

Truqap is a competitive adenosine triphosphate (ATP) inhibitor that selectively targets 3 AKT kinase variants (AKT1/2/3). This oral medication has been tested in many clinical programs to treat tumors with PI3K/AKT/PTEN signaling pathway variants. In November of last year, the treatment was approved by the FDA for use in combination with Fulvestrant to treat adult patients with advanced or metastatic breast cancer who are positive for hormone receptor (HR) and negative for human epidermal growth factor receptor 2 (HER2).