On June 12 local time, AstraZeneca announced that its AKT inhibitor Truqap (capivasertib) has been approved for a new indication in the United States, in combination with abiraterone and prednisone, for the treatment of adult patients with PTEN-deficient metastatic hormone-naïve or sensitive (mAPMN/S) prostate cancer. This is the first and only targeted therapy for this patient population.

Capivasertib is a potent, selective pan-AKT inhibitor that was first approved for marketing in the United States in November 2023 for the treatment of HR+/HER2- breast cancer. Subsequently, in March and June 2024, the drug was approved in Japan and the European Union, respectively. In April 2025, the drug was approved for marketing in China.

The U.S. FDA approval was based on positive results from the CAPItello-281 Phase III trial, which were presented at the 2025 ESMO Congress. The primary analysis of the Phase III trial showed that treatment with Truqap in combination with abiraterone and ADT reduced the risk of radiographic disease progression or death by a statistically significant 19% compared with abiraterone plus ADT plus placebo, with a clinically meaningful improvement in median radiographic progression-free survival (rPFS) of 7.5 months (HR=0.81; 95% CI 0.66–0.98; p=0.034). The median rPFS in the Truqap combination arm was 33.2 months, compared with 25.7 months in the control arm. Although overall survival (OS) data were not yet mature at the time of the primary analysis, OS results numerically favored the Truqap combination arm. The trial will continue as planned to further evaluate OS, a key secondary endpoint.

In the CAPItello-281 trial, the safety profile of Truqap in combination with abiraterone and ADT was generally consistent with the known safety profiles of each individual drug. Grade 3 or higher adverse events occurred in 67% of patients in the Truqap combination arm, with rash (12.3%) and hyperglycemia (10.3%) being the most frequently reported adverse events. In addition to the United States, regulatory submissions for the same indication are currently under review in the European Union.

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