NICE(UK) recommends Truqap (capivasertib) with fulvestrant for treating hormone receptor-positive HER2-negative advanced breast cancer after endocrine treatment - AstraZeneca

NICE(UK): Capivasertib plus fulvestrant is recommended as an option for treating hormone receptor (HR)‑positive HER2‑negative (defined as immunohistochemistry [IHC]0 or IHC1 positive, or IHC2 positive and in situ hybridisation [ISH]1 negative) locally advanced or metastatic breast cancer in adults that has: i) 1 or more PIK3CA, AKT1 or PTEN gene alterations; ii) recurred or progressed after a cyclin-dependent kinase (CDK) 4 and 6 inhibitor plus an aromatase inhibitor. Capivasertib plus fulvestrant is only recommended if the company provides it according to the commercial arrangement. This recommendation is not intended to affect treatment with capivasertib plus fulvestrant that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop. Why the committee made these recommendations: Usual treatment for HR‑positive HER2‑negative locally advanced or metastatic breast cancer with 1 or more PIK3CA, AKT1 or PTEN gene alterations that has recurred (come back) after or progressed (got worse) on endocrine treatment is: i) alpelisib plus fulvestrant (for cancer with a PIK3CA alteration), or ii) exemestane plus everolimus. For this evaluation, the company asked for capivasertib to be considered only for people whose cancer has recurred or progressed after a CDK 4 and 6 inhibitor plus an aromatase inhibitor (a type of endocrine treatment). This does not include everyone who it is licensed for. Capivasertib plus fulvestrant has not been directly compared in a clinical trial with alpelisib plus fulvestrant or everolimus plus exemestane, but indirect comparisons suggest that it is likely to work as well as these. When considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, capivasertib plus fulvestrant is recommended.