- The New England Journal of Medicine (NEJM) published data from Phase 3 MONALEESA-2 trial of Novartis AG's (NYSE: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.
