Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (Nasdaq: AZN) on Monday reported promising results from the CAPItello-281 Phase III trial, where its Truqap (capivasertib) combination demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) for patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC). This marks the first AKT inhibitor combination to show such benefits in this specific prostate cancer subtype.

Results indicated that Truqap, when combined with abiraterone and androgen deprivation therapy (ADT), outperformed the abiraterone and ADT regimen with placebo regarding the primary endpoint of rPFS. Although overall survival (OS) data remains immature at this stage, early trends suggest potential OS improvements with the Truqap combination. The trial will continue to further evaluate OS as a key secondary endpoint.

Prostate cancer ranks as the second most prevalent cancer among men and is the fifth leading cause of cancer-related deaths, with over 1.4 million cases and approximately 397,000 deaths reported in 2022. Of the 200,000 patients diagnosed annually with mHSPC, about 25% have PTEN-deficient tumours, which are associated with poorer prognoses.

The safety profile of Truqap combined with abiraterone and ADT was consistent with the known safety profiles of the individual drugs. Data from the trial will be presented at an upcoming medical conference and shared with regulatory authorities worldwide.

Truqap, a first-in-class ATP-competitive inhibitor of all three AKT isoforms, is currently also being evaluated in other Phase III trials for breast cancer and prostate cancer. AstraZeneca continues to lead advancements in oncology, aiming to transform cancer treatment through innovative therapies and a robust pipeline.