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Kisqali Cuts Recurrence in 5-Year NATALEE Results for High-Risk Early HR+/HER2- Breast Cancer

Follow-up continues to confirm overall survival after a three-year course showed durable benefit.

Overview

  • Novartis reported a 28.4% relative reduction in recurrence with ribociclib plus endocrine therapy versus endocrine therapy alone in the five-year analysis.
  • Five-year invasive disease-free survival was 85.5% with ribociclib plus endocrine therapy compared with 81.0% with endocrine therapy alone, a 4.5 percentage-point absolute gain.
  • Overall survival showed an improved hazard ratio of 0.800, with five-year rates of 94.1% versus 92.5%, indicating an encouraging but still developing signal.
  • Benefits persisted roughly two years after completion of the three-year ribociclib course, with no new safety signals reported at approximately five years of follow-up.
  • Investigators also observed significant improvements in distant endpoints (DDFS HR 0.709; DRFS HR 0.699), and the trial will keep collecting data to solidify long-term outcomes.