Astrazeneca (AZN.US) announced positive results from the CAPItello-281 Phase 3 clinical trial today.
According to Zhito Finance APP, Astrazeneca (AZN.US) announced positive results from the CAPItello-281 Phase 3 clinical trial today. Analysis shows that for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), Astrazeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of radiographic progression-free survival (rPFS) compared to the combination of abiraterone and ADT with a placebo. It has been reported that the Truqap combination is the first AKT inhibitor combination proven beneficial for this specific subtype of prostate cancer.
At the time of this analysis, overall survival (OS) data is not yet mature; however, Truqap combination therapy shows early trends of OS improvement compared to the placebo group. The trial will continue as planned to further evaluate the results of the key secondary endpoint OS. The safety of Truqap used in combination with abiraterone and ADT in the CAPItello-281 trial is generally consistent with the known safety profiles of each of the drugs.
Truqap is a selective, ATP-competitive inhibitor targeting three AKT kinase isoforms (AKT1/2/3). This oral pharmaceutical has been tested in numerous clinical projects for tumors with alterations in the PI3K/AKT/PTEN signaling pathway. Last November, this therapy was approved by the FDA 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 adult patients.