Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that the multi-center, randomized, open-label Phase III NATALEE study has achieved its primary endpoint of invasive disease-free survival (iDFS). The study assessed the efficacy of Kisqali (ribociclib) in combination with endocrine therapy (ET) for hormone receptor-positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (EBC) patients at risk of recurrence. Secondary endpoints included safety, quality of life, and overall survival.
Significant Reduction in Recurrence Risk for Stage II and III EBC Patients
The NATALEE study’s results indicated that for patients with stage II and III EBC, regardless of lymph node metastasis status, the combination of ribociclib with ET significantly reduced the risk of recurrence and provided sustained benefits compared to standard ET adjuvant therapy. This finding is particularly significant as it pertains to a patient population with a high risk of recurrence.
Recommendation for Early Termination Based on Interim Analysis
Based on the interim analysis showing the significant benefits of Kisqali in combination with ET, the Independent Data Monitoring Committee recommended the early termination of the NATALEE study. This recommendation underscores the robustness of the study’s findings and the potential impact of Kisqali on the treatment landscape for early breast cancer.
Ribociclib’s Approval History and Current Indications
Ribociclib, a selective cyclin-dependent kinase (CDK) 4/6 inhibitor, was first approved in the US for the first-line treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer in March 2017, followed by approval in the EU five months later. Novartis secured market approval for the drug in China in January 2023 for use as initial endocrine therapy for premenopausal or perimenopausal female patients with HR-positive, HER2-negative, locally advanced, or metastatic breast cancer in combination with an aromatase inhibitor.-Fineline Info & Tech
