Capivasertib Plus Fulvestrant Gains EU Approval for Advanced Breast Cancer

The European Commission’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is based on findings from the CAPItello-291 Phase III trial. This pivotal study, published in The New England Journal of Medicine, demonstrated that the combination of capivasertib and fulvestrant reduces the risk of disease progression or death by 50% compared to fulvestrant and placebo.

A total of 708 patients participated in the study, with 289 patients (40.8%) exhibiting alterations in the AKT pathway and 489 patients (69.1%) having previously received a CDK4/6 inhibitor for advanced breast cancer. Across the entire study population, the median progression-free survival was 7.2 months in the capivasertib–fulvestrant group, compared to 3.6 months in the placebo–fulvestrant group (hazard ratio for progression or death: 0.60; 95% confidence interval [CI]: 0.51 to 0.71; P<0.001). Among patients with AKT pathway alterations, the median progression-free survival was 7.3 months with capivasertib–fulvestrant, versus 3.1 months with placebo–fulvestrant (hazard ratio: 0.50; 95% CI: 0.38 to 0.65; P<0.001). The most common grade 3 or higher adverse events in the capivasertib–fulvestrant group were rash (12.1% vs. 0.3% in the placebo group) and diarrhea (9.3% vs. 0.3%). Discontinuation due to adverse events was reported in 13.0% of patients on capivasertib compared to 2.3% of those on placebo.

The approval of capivasertib in combination with fulvestrant represents growth in the treatment landscape for patients with advanced breast cancer, offering new hope and improved outcomes for those with these specific genetic alterations.

References:

1. https://www.astrazeneca.com/media-centre/press-releases/2024/truqap-plus-faslodex-approved-in-the-eu-for-patients-with-advanced-er-positive-breast-cancer.html