AstraZeneca (AZ) has announced positive high-level results from a late-stage study of its AKT inhibitor Truqap (capivasertib) in a subset of prostate cancer patients.
The phase 3 CAPItello-281 trial has been comparing the efficacy and safety of the drug in combination with abiraterone and androgen deprivation therapy (ADT) against abiraterone and ADT plus placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).
Prostate cancer is the second most common cancer in men globally, with more than 52,000 cases of the disease diagnosed in the UK every year. Metastatic prostate cancer is associated with a significant mortality rate, with only one third of patients surviving five years after diagnosis, and those with a tumour biomarker of PTEN deficiency have a particularly poor prognosis.
AZ’s Truqap combination demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival versus abiraterone and ADT with placebo.
Additionally, while overall survival (OS) data was immature at the time of the analysis, AZ said its combination showed an “early trend” towards an OS improvement and that the trial will continue to further assess OS as a key secondary endpoint.
The safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 was also shown to be broadly consistent with the known profile of each drug.
Already approved to treat specific cases of breast cancer, AZ’s Truqap works by blocking the effects of proteins called ATK kinases, which allow cancer cells to grow and multiply.
According to Susan Galbraith, executive vice president, oncology research and development at AZ, the results from CAPItello-281 show for the first time that adding an AKT inhibitor to a standard-of-care therapy can provide benefit to patients with a biomarker of PTEN-deficient mHSPC.
“By targeting a key driver of the disease, we have been able to improve upon current therapies and demonstrate the potential role of this combination in an area of critical unmet need. It will be important to see greater maturity in key secondary endpoints including OS,” she said.
Data from the study will now be presented at an upcoming medical meeting and shared with global regulatory authorities, the company said.