Ribociclib Maintains Long-Term Disease Control in HR+ HER2 Metastatic Breast Cancer

One in four patients with HR+ HER2- metastatic breast cancer remained progression free for at least four years with Kisqali plus endocrine therapy, according to MONALEESA data presented at SABCS 2025. Median progression free survival reached 6.8 years. Five year NATALEE results also showed sustained reductions in distant recurrence in early breast cancer, reinforcing Kisqali’s broad clinical benefit.

New data presented by Novartis at the 2025 San Antonio Breast Cancer Symposium highlight the durability of response achieved with ribociclib, positioning the CDK4/6 inhibitor as a cornerstone therapy across metastatic and early HR positive HER2 negative breast cancer. A pooled post hoc exploratory analysis from the MONALEESA program showed that one in four patients with HR positive HER2 negative advanced breast cancer remained progression free for at least four years when treated with Kisqali plus endocrine therapy.

The findings, drawn from first line populations in MONALEESA 2, 3 and 7, underscore the clinical relevance of long-term progression control in metastatic disease, where durable benefit has historically been difficult to achieve.

The benefit was consistent across menopausal status, age, body mass index, and extended to a proportion of patients with traditionally unfavorable prognostic features, including liver metastases and involvement of three or more metastatic sites. Median progression free survival reached 6.8 years, and median overall survival was not estimable within the available follow up period.

Kisqali remains the only CDK4/6 inhibitor to show statistically significant overall survival benefit across all three Phase III metastatic breast cancer trials in the class. This consistency in both disease control and survival outcomes continues to shape treatment decisions in first line HR positive HER2 negative metastatic breast cancer.

Commenting on the new analysis, Dr. Pedram Razavi noted, ''The latest MONALEESA analysis shows that 1 in 4 patients with metastatic disease remained progression free for four years or more. Our biomarker analyses demonstrate clinical and genomic factors potentially associated with these outstanding responses, highlighting the importance of precision medicine in identifying which patients may derive the greatest benefit from CDK4/6 inhibitors.''

NATALEE Five-Year Sub Analysis Strengthens Evidence in Early Disease

Novartis also presented new findings from a five year sub analysis of the NATALEE trial. Kisqali combined with a nonsteroidal aromatase inhibitor continued to improve distant disease free survival compared with aromatase inhibition alone. The effect was consistent across node negative and node positive subgroups, reinforcing the value of ribociclib based adjuvant therapy for the broadest population of HR positive HER2 negative early breast cancer.

These data follow earlier evidence that Kisqali is the only CDK4/6 inhibitor recommended as Category 1 preferred by NCCN Guidelines for all node positive early breast cancer and for select node negative high risk disease. Regulatory approvals for the early breast cancer indication continue to expand globally, including recent authorization from China’s National Medical Products Administration.

A CDK4/6 Inhibitor With Broad Clinical Validation

Ribociclib selectively inhibits CDK4 and CDK6, key regulators of cell cycle progression that become overactivated in HR positive breast cancer. The drug has secured approvals in more than 100 countries and has achieved high clinical benefit ratings from both NCCN and the European Society for Medical Oncology. In early disease and in metastatic settings, Kisqali’s overall survival advantage, durability of disease control, and consistent benefit in premenopausal and postmenopausal populations distinguish it from other agents in its class.

Together, the MONALEESA pooled analysis and the long-term NATALEE findings provide a reinforced evidence base for ribociclib in both metastatic and early breast cancer, emphasizing its role in extending disease control and reducing recurrence risk across clinically diverse patient populations.