A recent Phase III clinical trial, CAPItello-281, has shown promising results for the treatment of men with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).

The trial investigated the efficacy and safety of Truqap (capivasertib), an AKT inhibitor, in combination with abiraterone and androgen deprivation therapy (ADT) compared to abiraterone and ADT with a placebo.

The study found that the Truqap combination demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to the placebo group.
While overall survival (OS) data were not yet mature at the time of analysis, an early trend towards improvement was observed in the Truqap group. The trial will continue to assess OS as a key secondary endpoint.

Approximately 25% of mHSPC patients have PTEN-deficient tumors, which carry a worse prognosis.
The results of the CAPItello-281 trial are significant because they represent the first instance where the addition of an AKT inhibitor to standard treatment has shown benefit in patients with PTEN-deficient mHSPC. By targeting a key driver of the disease, this combination therapy offers hope for improved outcomes in an area of critical unmet need.
The safety profile of Truqap in combination with abiraterone and ADT was generally consistent with the known profiles of the individual medications. The complete data from the trial will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.

Truqap is already approved in the US, EU, Japan, and other countries for treating HR-positive, HER2-negative locally advanced or metastatic breast cancer with certain biomarker alterations (PIK3CA, AKT1, or PTEN) after recurrence or progression on or after endocrine-based treatment. This approval is based on the results of the CAPItello-291 trial.
In addition to the CAPItello-281 trial, Truqap is being evaluated in other Phase III trials for breast and prostate cancer treatment.

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