Updated Analysis of Kisqali in NATALEE Trial Demonstrates Lasting Reduction in Distant Recurrence for Early Breast Cancer Patients
New data from the NATALEE trial for Kisqali (ribociclib) show a sustained reduction in the risk of distant recurrence for patients with early-stage breast cancer. The benefit continues to deepen beyond the 3-year treatment period, impacting both node-positive and high-risk node-negative patients, as well as different anatomical stages of the disease.
Real-World Insights Highlight Importance of CDK4/6 Inhibitors
Five-year real-world data in high-risk patients with hormone receptor-positive, HER2-negative early breast cancer underscore the value of combining CDK4/6 inhibitors with endocrine therapy. These findings suggest the addition of a CDK4/6 inhibitor can significantly benefit eligible patients, regardless of nodal involvement.
Key Results from NATALEE Phase III Trial
Novartis announced an updated analysis of the Phase III NATALEE trial showing Kisqali's effectiveness when combined with endocrine therapy. The trial demonstrated a 28.5% decrease in distant recurrence compared to endocrine therapy alone in patients with stage II and III HR+/HER2- early breast cancer.
Real-World Risk of Recurrence
Additional real-world data presented at the conference highlight that high-risk patients face a considerable chance of distant recurrence within five years, even with endocrine therapy alone. This emphasizes the need for more comprehensive treatment strategies involving CDK4/6 inhibitors.
Overview of the NATALEE Trial
The NATALEE trial is a global, Phase III, randomized study designed to evaluate the safety and effectiveness of Kisqali combined with endocrine therapy compared to endocrine therapy alone in patients with stage II and III HR+/HER2- early breast cancer. Conducted in collaboration with TRIO, the study included 5,101 patients from 20 countries. Treatment involved non-steroidal aromatase inhibitors (either anastrozole or letrozole) and goserelin where applicable. The primary goal of the study was to measure invasive disease-free survival (iDFS) based on standardized endpoint definitions.
The results provide strong evidence supporting Kisqali as a valuable addition to standard endocrine therapy for reducing the risk of distant recurrence in early breast cancer patients.
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