Novartis has reported a nearly 20% reduction in the risk of death among patients with high-risk, hormone receptor-positive (HR+)/HER2-negative early breast cancer treated with Kisqali (ribociclib) plus endocrine therapy (ET), compared with endocrine therapy alone.

 

This, in a six-year follow-up analysis of the Phase III NATALEE trial.

 

The findings demonstrate a sustained overall survival (OS) benefit in a broad population of patients with stage II and III early breast cancer, including those with high-risk node-negative disease and all patients with node-positive disease.

 

The combination reduced the risk of death by 19.1% compared with endocrine therapy alone, with consistent survival benefits across all key patient subgroups.

 

The results also point to lasting benefits beyond the treatment period. Patients had been off Kisqali for a median of 38 months and had completed the five-year protocol-specified duration of endocrine therapy. Meanwhile, the absolute invasive disease-free survival (iDFS) benefit increased from 4.1% at five years to 5.3% at six years, suggesting that the benefits of treatment continued to emerge years after therapy ended.

 

The six-year analysis showed fewer metastatic recurrences among patients receiving Kisqali plus endocrine therapy than among those receiving endocrine therapy alone. The absolute overall survival difference also widened, increasing from 1.2% at five years to 2.1% at six years.

 

Breast cancer-specific survival (BCSS) further supported the overall survival findings, with Kisqali plus endocrine therapy associated with an approximately 30% reduction in the risk of breast cancer-specific death compared with endocrine therapy alone.

 

“The NATALEE six-year data clearly demonstrate a clinically meaningful improvement in overall survival with ribociclib plus endocrine therapy," said Dennis J. Slamon, MD, Chief of the Division of Hematology/Oncology, UCLA Department of Medicine. 

 

"These findings have very important implications for patients as well as health care providers worldwide and further strengthen the role of ribociclib in treating patients with HR+/HER2- early breast cancer at high risk of recurrence.”

 

Andrea Myers, Global Head, Oncology Development, Novartis, Ad Interim, said the findings reinforce Kisqali’s role in treating eligible patients with early breast cancer at high risk of recurrence.

 

“The clinically meaningful overall survival benefit observed in NATALEE underscores Kisqali as a standard of care for eligible patients and its foundational role in early breast cancer treatment,” said Andrea Myers, Global Head, Oncology Development, Novartis, Ad Interim. 

 

“These findings demonstrate the value of combining CDK4/6i with endocrine therapy in the broadest population of patients at high risk of recurrence, including those with high-risk node-negative disease and all node-positive patients.”