2023-06-02 08:43:17 ET
Announcing data from its pivotal study NATALEE, Novartis ( NYSE: NVS ) announced Friday that its oral breast cancer therapy Kisqali as a combination regimen lowered the risk of cancer recurrence by 25% in certain patients with early breast cancer.
The global study was designed to evaluate Kisqali with endocrine therapy (ET) against ET alone in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.
More than 90% of breast cancer cases are in the early stage. About a third of HR+/HER2 early breast cancer patients with stage II and more than half with stage III experience cancer recurrence.
According to an interim readout, the CDK4/6 inhibitor with ET cut the risk of cancer recurrence by 25.2% compared to ET alone in a broad set of patients with HR+/HER2- early breast cancer.
As for secondary efficacy endpoints, Kisqali and ET led to 26% and 28% risk reduction in distant disease-free survival and recurrence-free survival, respectively.
Low levels of white blood cells, known as neutrophils, and liver-related adverse events were among the most frequently cited and noteworthy adverse events.
Kisqali is approved in the U.S. as a combination therapy for adults with HR+/HER2- advanced or metastatic breast cancer.
Novartis ( NVS ) expects to use these data to file regulatory submissions in the U.S. and Europe before the year-end.
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Novartis says breast cancer pill Kisqali cut risk of recurrence by 25%