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CAPItello-281 delivered the first AKT inhibitor success in prostate cancer, for the ~25% of men whose tumours have lost PTEN on the trial's own immunohistochemistry cut-off.
CAPItello-281, trial NCT04493853 sponsored by AstraZeneca and reported in 2025, delivered the first AKT inhibitor success in prostate cancer, for the roughly quarter of men whose tumours have lost PTEN on its own immunohistochemistry cut-off, 1,519 of 6,003 tested. It randomised 1,012 men with de novo metastatic hormone-sensitive, PTEN-deficient prostate cancer to abiraterone with capivasertib or placebo, met its primary radiographic progression-free survival endpoint with topline results in November 2024 presented in 2025, and led to FDA approval in the second quarter of 2026, with diarrhoea, rash and raised blood sugar as the class effects. OnCo links it to AKT as a target, to the PI3K, AKT and mTOR pathway, and to capivasertib and abiraterone acetate. It is a single pivotal trial with immature overall survival, and whether the modest progression benefit justifies the added toxicity is the open question. Capivasertib has its own page.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,012 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survival, PTEN-deficient mHSPCprimary | Capivasertib + abiraterone + ADT | - | 40 months | 0.81 (0.68 to 0.96) | 0.017 | link |
| Placebo + abiraterone + ADT | - | 31.7 months |
Shares AKT, PI3K, AKT and mTOR inhibitors, Capivasertib, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test.
Shares PI3K, AKT and mTOR inhibitors, Capivasertib, AstraZeneca, Small-molecule kinase inhibitors.
Shares Prescribe a quarter dose of abiraterone with breakfast, Abiraterone acetate, AstraZeneca, Prostate cancer.
Shares PI3K, AKT and mTOR inhibitors, Capivasertib, AstraZeneca, Small-molecule kinase inhibitors.
Shares PI3K, AKT and mTOR inhibitors, Capivasertib, AstraZeneca, Small-molecule kinase inhibitors.
Shares AKT, PI3K, AKT and mTOR inhibitors, Capivasertib, PI3K / AKT / mTOR.
Shares Prescribe a quarter dose of abiraterone with breakfast, Abiraterone acetate, Prostate cancer.
Shares Prescribe a quarter dose of abiraterone with breakfast, Abiraterone acetate, Prostate cancer.