FX.co ★ Novartis: Kisqali Reduces Recurrence Risk By 28.5% In Late-stage Early Breast Cancer Trial

**Novartis Pharma AG, a subsidiary of Swiss pharmaceutical giant Novartis AG (NVS), announced on Monday an updated analysis from the pivotal Phase III NATALEE trial. This study investigates Kisqali (ribociclib) in combination with endocrine therapy (ET) and has shown extended benefits in early breast cancer patients beyond the initial three-year treatment period.**

**In this trial, Kisqali demonstrated a 28.5% reduction in the risk of recurrence compared to ET alone for patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.**

**Novartis submitted the NATALEE trial data to both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2023, with FDA regulatory action anticipated in the third quarter.**

**Kisqali, developed by Novartis in collaboration with Astex Pharmaceuticals, is a selective cyclin-dependent kinase inhibitor. This class of drugs helps slow cancer progression by inhibiting two key proteins, cyclin-dependent kinase 4 and 6.**

**The NATALEE trial is a global Phase III multi-center, randomized, open-label study designed to evaluate the efficacy and safety of Kisqali with ET as an investigational adjuvant treatment compared to ET alone in patients with stage II and III HR+/HER2- early breast cancer. This trial is conducted in partnership with TRIO.**

**Notably, the invasive disease-free survival benefit continues to increase post the three-year treatment period across all patient subgroups, including those without nodal involvement.**

**Trial results are consistent across secondary endpoints, including distant disease-free survival, and show a trend towards improved overall survival. Safety profiles indicate generally low-grade symptomatic adverse events, reinforcing Kisqali's well-tolerated status.**

**Late-breaking data from this four-year post-hoc analysis will be presented at the European Society for Medical Oncology (ESMO) Congress 2024.**

**Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis, commented, "As we anticipate global regulatory approval, we are encouraged by the long-term results from NATALEE, which demonstrate deepening efficacy benefits for Kisqali. Many patients diagnosed with HR+/HER2- early breast cancer remain at risk of recurrence, and these findings enhance the growing body of evidence supporting Kisqali's potential to consistently reduce this risk across a broad patient population, including those with node-negative disease who have limited options beyond ET."**