AstraZeneca reports positive phase 3 results for Truqap in prostate cancer study

AstraZeneca (AZ) has reported promising results from a late-phase study of its AKT inhibitor, Truqap (capivasertib), targeting a specific group of prostate cancer patients. The phase 3 CAPItello-281 trial has been assessing the drug's effectiveness and safety when combined with abiraterone and androgen deprivation therapy (ADT). This was compared against the combination of abiraterone and ADT with a placebo in patients suffering from PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).

Globally, prostate cancer is the second most frequently diagnosed cancer among men, with over 52,000 new cases identified annually in the UK alone. Metastatic prostate cancer has a high mortality rate, with merely a third of patients surviving five years post-diagnosis. Furthermore, men with PTEN deficiency biomarkers in their tumors particularly face a dire prognosis.

In this trial, the Truqap combination exhibited a notable and meaningful enhancement in the primary endpoint, which is radiographic progression-free survival, compared to the placebo group. Although the overall survival (OS) data were still maturing at the time of the analysis, AZ highlighted an "early trend" indicating OS improvement. The trial will continue to evaluate OS as a critical secondary endpoint.

The safety profile of the Truqap combination in the CAPItello-281 study was found to be generally consistent with the established safety profiles of each individual drug. Truqap, already approved for treating certain breast cancer cases, functions by inhibiting the activity of proteins known as ATK kinases, which are instrumental in the growth and multiplication of cancer cells.

Susan Galbraith, AZ’s executive vice president of oncology research and development, emphasized that the CAPItello-281 results are groundbreaking. They suggest for the first time that integrating an AKT inhibitor with standard-of-care therapy can benefit patients with 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 stated.

AZ has announced plans to present the data from this study at a forthcoming medical conference and will also share the findings with global regulatory authorities.