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No Truqap déjà vu in triple-negative breast cancer

Endocrine receptor-positive breast cancer carrying PIK3CA/AKT1/PTEN alterations provided a way into the market for AstraZeneca’s Truqap last November, but the trick won’t be repeated in triple-negative disease. Astra today said the AKT inhibitor’s chemo combo CAPItello-290 trial, in front-line triple-negative breast cancer patients, failed to show an overall survival benefit versus chemo alone. There was no signal either in the overall population or in a subgroup of patients with tumours harbouring PIK3CA/AKT1/PTEN alterations. That mirrors the earlier failure of Roche’s now discontinued AKT inhibitor ipatasertib in the Ipatunity-170 trial. Ipatasertib also failed in the ER-positive breast cancer population in which Truqap got approved, as well as in castration-sensitive prostate cancer, where Truqap’s CAPItello-280 study is due to end in 2026. Before then Truqap could see another clinical catalyst: CAPItello-281, in first-line PTEN-altered hormone-sensitive prostate cancer, is due to complete this October, six months earlier than prior estimates.


Selected Truqap studies

SettingTrialOutcome
HR+/HER2- breast cancerCAPItello-291 (2nd-line, +Faslodex)+ve for PFS in all-comers & in PIK3CA/AKT1/PTEN-altered subgroup; US approved for PIK3CA/AKT1/PTEN-altered in Nov 2023
CAPItello-292 (2nd-line, +CDK4/6 inhibition +Faslodex)Ends Nov 2027 (delayed from Oct 2025, then Aug 2026)
1st-line TNBCCAPItello-290Failed for OS in all-comers and in PIK3CA/AKT1/PTEN-altered subgroup in Jun 2024
Castration-resistant prostate cancerCAPItello-280 (2nd-line)Ends Oct 2026 (delayed from Jul 2026)
1st-line hormone-sensitive prostate cancerCAPItello-281 (PTEN-altered, Zytiga combo)Ends Oct 2024 (advanced from Apr 2025)

Source: OncologyPipeline.

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