Novartis Announces Positive Phase III NATALEE Trial Results: Kisqali Reduces Recurrence Risk by 25% in Early Breast Cancer

On May 2, Novartis announced positive primary endpoint data from the pivotal Phase III NATALEE trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The data showed that Kisqali (ribociclib) in combination with endocrine therapy (ET) reduced the risk of cancer recurrence by 25.2% (HR=0.748; 95% CI: 0.618, 0.906; p=0.0014) in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer compared to endocrine therapy (ET) alone.

Consistent and clinically meaningful invasive disease-free survival (iDFS) benefits were observed across key pre-specified subgroups.

All secondary efficacy endpoints of Kisqali also achieved positive results, including distant disease-free survival (DDFS) (26% risk reduction) and relapse-free survival (RFS) (28% risk reduction), with a trend toward improvement in overall survival (OS) (HR=0.759; 95% CI: 0.539, 1.068).

Kisqali 400mg demonstrated a favorable safety profile, with a low incidence of symptomatic adverse events (AEs) and minimal need for dose adjustments over three years of treatment. The most frequently reported specific adverse events (Grade 3 or higher) were neutropenia (43.8%) and liver-related AEs (e.g., elevated transaminases) (8.3%). The incidence rates of Grade 3 or higher QT interval prolongation and diarrhea in the Kisqali group were low, at 1.0% and 0.6%, respectively.

NATALEE Study is the world's first and only Phase III CDK4/6 inhibitor adjuvant study to achieve positive results in a broad population of Stage II and III EBC. Novartis plans to submit these Phase III data to regulatory authorities in the United States and Europe by the end of the year.

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