An updated analysis from the Phase III NATALEE trial reveals that the addition of Kisqali (ribociclib) to endocrine therapy (ET) provides a sustained and deepening benefit for patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer. The investigational treatment demonstrated a 28.5% reduction in the risk of recurrence compared to ET alone. This data, presented at the European Society for Medical Oncology (ESMO) Congress 2024, highlights the potential of Kisqali to significantly improve outcomes in this patient population.
The invasive disease-free survival (iDFS) benefit observed with Kisqali was consistent across all pre-specified patient subgroups, including those with node-negative disease. This finding is particularly relevant as it suggests that Kisqali can provide benefit to a broader range of patients with early breast cancer, regardless of nodal involvement.
This four-year post-hoc analysis also showed consistent results across secondary efficacy endpoints, including distant disease-free survival (DDFS), with a trend for improvement in overall survival (OS). While the OS data is still maturing, the trend suggests a potential long-term survival advantage with the addition of Kisqali to endocrine therapy.
The NATALEE trial is a Phase III, randomized, open-label study evaluating the efficacy and safety of Kisqali in combination with endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer. The primary endpoint of the trial is iDFS. Secondary endpoints include DDFS and OS. The trial enrolled a diverse patient population with stage II and III disease.
