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

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.
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