Roche and AstraZeneca’s fortunes in AKT inhibition diverged some time ago, and today Astra completed its rout. The UK company’s US approval for capivasertib, trademarked Truqap, has come a year after Roche pulled the plug on its rival, ipatasertib. Even so the victory hasn’t been as comprehensive as might have been expected: the FDA has restricted Truqap’s label, in second-line ER-positive HER2-negative breast cancer, to patients with PIK3CA/AKT1/PTEN alterations, effectively cutting the addressable population in half. This is despite Truqap plus Faslodex meeting both primary PFS endpoints of the CAPItello-291 study, cutting risk of progression or death versus Faslodex alone by 40% in all-comers and by 50% in the PIK3CA/AKT1/PTEN-altered subgroup. In ER-positive HER2-negative breast cancer Roche’s ipatasertib was tested in front-line settings, and failed Ipatunity-130, a study in PIK3CA/AKT1/PTEN-altered disease. Ipatunity-150, an Ibrance/Faslodex combo study, was completed without data being reported, and Roche finally discontinued ipatasertib after its failure in prostate cancer. Truqap’s next test comes in first-line triple-negative breast cancer, with data due next year from CAPItello-290; scoring in this trial could be tougher than in CAPItello-291, since it tests overall survival, doesn’t preselect for PIK3CA/AKT1/PTEN, and doesn’t include immunotherapy, an emerging treatment standard. A comparison of two AKT inhibitors Ipatasertib (Roche)Capivasertib (AstraZeneca)ER+/HER2- breast cancerIpatunity-130 (1st-line, PIK3CA/AKT1/PTEN-altered*)CAPItello-291 (2nd-line, +Faslodex)Failed+ve for PFS in all-comers & in PIK3CA/AKT1/PTEN-altered subgroupIpatunity-150 (1st-line, +Ibrance +Faslodex)CAPItello-292 (2nd-line, +CDK4/6 inhibition +Faslodex)Completed, presumed failedEnds Aug 2026 (delayed from Oct 2025)1st-line TNBCIpatunity-170 (+/-Tecentriq)CAPItello-290FailedEnded Oct 2023, data H1 2024Castration-resistant prostate cancerIpatential-150 (1st-line, Zytiga combo)CAPItello-280 (2nd-line)Failed in all-comers; +ve for PFS in PTEN-alteredEnds Jul 20261st-line hormone-sensitive prostate cancer(None)CAPItello-281 (PTEN-altered, Zytiga combo)Ends Apr 2025Note: *also had TNBC cohort. Source: OncologyPipeline.This story has been amended to correct the hazard ratio in CAPItello-291.
Roche and AstraZeneca’s fortunes in AKT inhibition diverged some time ago, and today Astra completed its rout. The UK company’s US approval for capivasertib, trademarked Truqap, has come a year after Roche pulled the plug on its rival, ipatasertib. Even so the victory hasn’t been as comprehensive as might have been expected: the FDA has restricted Truqap’s label, in second-line ER-positive HER2-negative breast cancer, to patients with PIK3CA/AKT1/PTEN alterations, effectively cutting the addressable population in half. This is despite Truqap plus Faslodex meeting both primary PFS endpoints of the CAPItello-291 study, cutting risk of progression or death versus Faslodex alone by 40% in all-comers and by 50% in the PIK3CA/AKT1/PTEN-altered subgroup. In ER-positive HER2-negative breast cancer Roche’s ipatasertib was tested in front-line settings, and failed Ipatunity-130, a study in PIK3CA/AKT1/PTEN-altered disease. Ipatunity-150, an Ibrance/Faslodex combo study, was completed without data being reported, and Roche finally discontinued ipatasertib after its failure in prostate cancer. Truqap’s next test comes in first-line triple-negative breast cancer, with data due next year from CAPItello-290; scoring in this trial could be tougher than in CAPItello-291, since it tests overall survival, doesn’t preselect for PIK3CA/AKT1/PTEN, and doesn’t include immunotherapy, an emerging treatment standard.
A comparison of two AKT inhibitors
This story has been amended to correct the hazard ratio in CAPItello-291.
