NEJM Publication Shows Novartis' Kisqali With Longest Median Overall Survival In Breast Cancer Setting

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  • The New England Journal of Medicine (NEJM) published data from Phase 3 MONALEESA-2 trial of Novartis AG's NVS Kisqali (ribociclib) plus letrozole demonstrating a statistically significant improvement in overall survival.
  • MONALEESA-2 overall survival data were first presented at the European Society for Medical Oncology Congress in September 2021. 
  • The NEJM publication includes additional analyses substantiating the longest median overall survival benefit ever reported for HR+/HER2- advanced breast cancer patients, supporting the use of Kisqali combination therapy as a first-line treatment.
  • Patients who received Kisqali plus letrozole as first-line therapy saw a 24% reduction in risk of death compared to those receiving letrozole alone.
  • The overall survival benefit with Kisqali plus letrozole continued to increase over time​, with the survival rate of patients receiving Kisqali plus letrozole at 44.2% at six years (12.2% higher than letrozole alone).
  • Fewer patients in the Kisqali combo group received subsequent treatment with any-line CDK4/6 inhibitor therapy (34.4% for letrozole alone compared to 21.7%).
  • The study has the longest reported follow-up for any CDK4/6 inhibitor trial to date with a median of 80 months, with no new safety signals emerging.
  • Price Action: NVS shares are up 0.85% at $82.85 during the premarket session on the last check Thursday.
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Posted In: BiotechNewsHealth CareGeneralbreast cancerBriefs
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