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ESMO 2026 | FINER: overall survival with ipatasertib & fulvestrant in ER+/HER2- breast cancer

Andrew Redfern, MD, Fiona Stanley Hospital, Perth, Australia, discusses overall survival results from the Phase III FINER (NCT04650581) trial of the pan-AKT inhibitor ipatasertib or placebo plus fulvestrant in patients with ER-positive, HER2-negative metastatic breast cancer progressing on a CDK4/6 inhibitor plus aromatase inhibitor. Despite previously reported meaningful progression-free survival improvements, adding ipatasertib did not improve overall survival in either the intention-to-treat population or the AKT pathway-altered cohort. This interview took place at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain.

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Transcript

The final rose as did other trials in its space from the observation that breast cancer can be driven by mutations along the AKT PI3 kinase mTOR pathway and it’s one of a number of agents that tries to exploit that to the good of patients. So the final trial looked at capivasertib which inhibits all of the three types of AKT all of which may be important in cancer in a similar way to capivasertib it’s sort of a sister drug I guess so the FINER trial took a backbone of fulvestrant in the second line for ER positive HER2-negative cancer, in patients that all had a CDK4-6 inhibitor and an aromatase inhibitor, and that’s where it differed slightly from Capitello-291, where 70% had had CDK4-6 inhibitor, 30% had not...

The final rose as did other trials in its space from the observation that breast cancer can be driven by mutations along the AKT PI3 kinase mTOR pathway and it’s one of a number of agents that tries to exploit that to the good of patients. So the final trial looked at capivasertib which inhibits all of the three types of AKT all of which may be important in cancer in a similar way to capivasertib it’s sort of a sister drug I guess so the FINER trial took a backbone of fulvestrant in the second line for ER positive HER2-negative cancer, in patients that all had a CDK4-6 inhibitor and an aromatase inhibitor, and that’s where it differed slightly from Capitello-291, where 70% had had CDK4-6 inhibitor, 30% had not. And so it was a randomization, really, capivasertib versus placebo, so it was blinded. Patients have 21 days on and seven days off in the usual schedule of fulvestrant and then monitored obviously to progression or intolerance. So our findings certainly at the progression-free survival basis, the initial assessment of 15 months, we saw a significant difference and that was updated at 35 months and it remains significant. The progression-free survival moves out from 1.9 up to 5.4 months, both in the overall cohort and a very similar increase in the AKT PI3K altered cohort also.

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