AstraZeneca announced on June 12, 2023 that the U.S. FDA has agreed to prioritize the review of the new drug application for Capivasertib combined with Fulvestrant for the treatment of adult patients with locally advanced or metastatic breast cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative.
New treatment option! Capivasertib combined with Fulvestrant
The FDA priority review qualification was mainly based on a randomized, double-blind, placebo-controlled Phase III clinical trial, which aims to evaluate the efficacy of AKT pathway inhibitor Capivasertib combined with Fulvestrant in patients with HR+/HER2- advanced breast cancer who have experienced recurrence or disease progression during or after treatment with aromatase inhibitors.
A total of 708 patients were recruited in the trial and randomly assigned to the Capivasertib+Fulvestrant group and the placebo+Fulvestrant group in a 1:1 ratio for treatment. Among these patients, 289 patients had AKT pathway changes and 489 patients had previously received CDK4/6 inhibitors for advanced breast cancer.
The results of the trial showed that in the whole population, the combination of capivasertib + Fulvestrant reduced the risk of disease progression or death by 40% compared with placebo + Fulvestrant. The median progression-free survival of the capivasertib + Fulvestrant group was 7.2 months, while that of the placebo + Fulvestrant group was 3.6 months, which improved the survival by nearly 4 months.
In the population with AKT pathway changes, compared with placebo + Fulvestrant, capivasertib combined with Fulvestrant reduced the risk of disease progression or death by 50%, and the median progression-free survival of the capivasertib + Fulvestrant group was 7.3 months, while that of the placebo + Fulvestrant group was 3.1 months, which also improved the survival by nearly 4 months.
The above test data show that for patients with hormone receptor-positive advanced breast cancer, Capivasertib + Fulvestrant treatment has a longer progression-free survival period than Fulvestrant alone, which also indirectly confirms the efficacy of Capivasertib + Fulvestrant. This may become another new treatment option for breast cancer patients!
