Novartis reports 19.1% lower death risk with Kisqali in six‑year NATALEE trial

Novartis announced six‑year follow‑up results from the Phase III NATALEE trial in high‑risk HR+/HER2‑ early breast cancer. Kisqali (ribociclib) plus endocrine therapy cut overall mortality risk by 19.1% versus endocrine therapy alone (HR = 0.809, 95 % CI 0.661‑0.989). The absolute overall‑survival benefit grew to 2.1 % at six years, and invasive disease‑free survival improved by 5.3 % versus 4.1 % at five years. No new safety signals were observed.

The company says the data support broader adoption of Kisqali and could extend its market share in adjuvant breast‑cancer therapy. Investors may see future revenue growth if guidelines incorporate the six‑year survival benefit.

  • 1Kisqali plus endocrine therapy reduced the risk of death by 19.1 % compared with endocrine therapy alone (HR = 0.809; 95 % CI 0.661‑0.989).
  • 2The absolute overall‑survival benefit increased from 1.2 % at five years to 2.1 % at six years.
  • 3Invasive disease‑free survival benefit rose from 4.1 % at five years to 5.3 % at six years.
  • 4The trial enrolled 5,101 adult patients across 20 countries.
  • 5Patients had been off Kisqali for a median of three years (38 months) at the time of the six‑year analysis.
  • 6No new safety signals were observed; secondary‑primary malignancy rates were 3.0 % with Kisqali plus ET and 3.3 % with ET alone.

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