NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Friday recommended that the National Health Service make AstraZeneca's AKT pathway inhibitor Truqap (capivasertib) with fulvestrant available to certain patients with hormone receptor (HR)-positive, HER2-negative breast cancer.
Under this recommendation, patients with metastatic or locally advanced breast cancer with one or more PIK3CA, AKT1, or PTEN alterations, who have progressed after an endocrine-based regimen, would be eligible for treatment with Truqap and fulvestrant. NICE estimated that about 1,100 patients in England could benefit from the combination therapy.
NICE based its decision on additional analyses provided by AstraZeneca from the Phase III CAPItello-291 trial, in which patients on Truqap and fulvestrant had improved progression-free survival, compared to patients on placebo and fulvestrant. In the Truqap group, patients with PI3K- and AKT-altered tumors lived a median 7.3 months without disease progression or death whereas those in the placebo group lived just 3.1 months before their disease progressed. The Truqap group also appeared to have better median overall survival, but the difference between Truqap-treated patients and those only on fulvestrant did not reach statistical significance.
In indirect comparisons with current standard treatments in this setting, including Novartis' PI3K inhibitor Piqray (alpelisib) plus fulvestrant and exemestane plus everolimus, an external assessment group found that the Truqap regimen was likely to be equally effective.
The list price of Truqap is £5,850 ($7,637.32) per 64-pack of 200-mg tablets and £77,088.12 for one year of treatment. AstraZeneca has a commercial arrangement with NHS to provide Truqap plus fulvestrant at a confidential discount.
To identify those eligible for Truqap-fulvestrant, doctors will need to test patients for PIK3CA, AKT1, or PTEN genetic alterations. PIK3CA alterations are routinely included in genomic testing panels for patients with breast cancer, but AKT1 and PTEN mutations are not. AstraZeneca estimated that additional costs for testing would be £281.02, and NICE's review committee agreed that this was a reasonable expenditure.
Truqap was approved in combination with fulvestrant in patients with HR-positive, HER2-negative advanced or metastatic breast cancers bearing PIK3CA, AKT1, and PTEN alterations in Europe in June 2024 and in the US in November 2023.