Novartis has reported a 28.5% reduced risk of breast cancer recurrence in an updated analysis from the Phase III NATALEE trial of Kisqali (ribociclib), when combined with endocrine therapy.
The trial showed to reduce the recurrence in patients with early-stage hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.
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Kisqali is a selective cyclin-dependent kinase inhibitor that targets proteins involved in the rapid division of cancer cells. It has already been approved in 99 countries for metastatic breast cancer.
NATALEE is a global, multi-centre study assessing the efficacy and safety of Kisqali with endocrine therapy versus endocrine therapy alone in patients with breast cancer. The trial enrolled 5,101 adult patients across 20 countries.
The new findings from the NATALEE trial, indicate a consistent invasive disease-free survival (iDFS) benefit across all patient subgroups. This includes those with node-negative disease, showcasing Kisqali’s potential as a post-treatment option to prevent recurrence.
Secondary efficacy endpoints also reflected positive outcomes, with distant disease-free survival mirroring the primary results.
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By GlobalDataThere was a notable trend towards improved overall survival, although this did not reach statistical significance.
Safety data from the trial remained consistent with past reports, with no new safety concerns identified.
The most common adverse events of Grade 3 or higher included neutropenia, liver-related events, and QT interval prolongation.
Regulatory submissions based on the NATALEE data have been made to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2023.
A decision from the FDA is anticipated in the third quarter of the year.
Novartis president, development and chief medical officer Shreeram Aradhye said: “As we anticipate regulatory action from health authorities worldwide, we are highly encouraged by these longer-term results from NATALEE showing a deepening efficacy benefit for Kisqali.”
