AstraZeneca’s Truqap fails in Phase III trial

AstraZeneca has discontinued the Phase III CAPItello-280 study (NCT05348577) investigating Truqap (capivasertib) in metastatic castration-resistant prostate cancer (mCRPC) after an Independent Data Monitoring Committee (IDMC) concluded that it was unlikely to meet its primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS). The trial had combined Truqap with docetaxel and androgen-deprivation therapy (ADT) compared to the same regimen with placebo.

Despite this setback, Truqap has shown promise in other studies. In November 2023, the drug was FDA-approved for advanced HR-positive breast cancer in combination with Faslodex. It was also recently shown to be effective in the CAPItello-281 study, meeting the rPFS endpoint in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer.

Truqap is an ATP-competitive AKT inhibitor and is forecasted to reach blockbuster status by 2027, with sales expected to hit $1.78bn by 2030.

05-05-2025