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Novartis Cancer Drug Shows Sustained Benefit In Five-Year Breast Cancer Trial

Author: Vandana Singh | October 17, 2025 01:02pm

On Friday, Novartis AG (NYSE:NVS) shared results from the five-year analysis of the Phase 3 NATALEE trial of Kisqali (ribociclib).

The data demonstrated a sustained benefit at a median of two years after a three-year treatment with Kisqali (median follow-up: 58.4 months).

Results showed a 28.4% reduction in risk of recurrence in patients with high-risk stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer treated with Kisqali plus endocrine therapy compared to ET alone.

Also Read: Novartis Strengthens Kidney Disease Pipeline With Promising Data

The five-year invasive disease-free survival (iDFS) rates were 85.5% in the Kisqali plus ET arm versus 81.0% in the ET alone arm, representing a clinically meaningful 4.5% improvement.

Overall survival (OS) continues to show an encouraging trend, with further improvement in the hazard ratio (HR) to 0.800 and a narrowing confidence interval compared to the final iDFS analysis (OS HR = 0.892), demonstrating a 20% reduction in the risk of death compared to ET.

The NATALEE trial will continue follow-up to ensure sufficient data is collected for OS and other long-term endpoints.

Price Action: NVS stock is up 0.78% at $131.79 at the last check on Friday.

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Posted In: NVS

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