NATALEE Clinical Trial: Ribociclib (Kisquali) reduces recurrence risk in early stage breast cancer

The NATALEE Clinical Trial recently released new data regarding the effectiveness of the CDK4/6 inhibitor Ribociclib (Kisquali) in the treatment of hormone receptor positive (ER/PR+), early stage, high recurrence risk, lymph node negative (N0) breast cancer.

This trial included over 5,000 early stage, node negative, high risk women with breast cancer. The study was split into two groups:

One group was administered Ribociclib (a CDK4/6 inhibitor) in combination with endocrine therapy (an aromatase inhibitor).

The control group in the study was administered only the aromatase inhibitor, which was the current standard of treatment at the time of the study.

The results of the trial found that the addition of Ribociclib to an aromatase inhibitor reduced the cancer recurrence risk by 25%. This means that the women who were administered the aromatase inhibitor and Ribociclib had a 25% lower risk of their invasive cancer coming back (recurring), when compared to the women who were given only Ribociclib.

Furthermore, the study also observed a 3 year invasive (stages I-III) disease free survival benefit of 28% with Ribociclib + the aromatase inhibitor in comparison to an aromatase inhibitor alone.

Finally, the study observed a distant (stage 4) disease free survival risk reduction of 25% with Ribociclib combined with the aromatase inhibitor. This means that the women with metastatic breast cancer who were administered Ribociclib along with the aromatase inhibitor had a 25% lower mortality (death) risk compared to the women administered the aromatase inhibitor alone.

Because of this clinical trial and others like it, the new standard of treatment for both premenopausal and postmenopausal women with hormone receptor positive breast cancers is an aromatase inhibitor combined with a CDK4/6 inhibitor, showing the leaps and bounds that clinical trials are making in the realm of breast cancer treatment efficacy.

References: Breast Cancer Research Foundation. (2023). ASCO 2023: Updates from Major Breast Cancer Clinical Trials. https://www.bcrf.org/blog/bcrf-asco-2023-clinical-trials-news-updates/

ASCO Publications. (2023). Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer: Primary results from the phase III NATALEE trial. https://ascopubs.org/doi/10.1200/JCO.2023.41.17_suppl.LBA500

Novartis. (2024). Latest analysis of Novartis NATALEE study shows Kisqali® reduces risk of cancer recurrence for early breast cancer patients with high-risk node-negative disease. https://www.novartis.com/news/media-releases/latest-analysis-novartis-natalee-study-shows-kisqali-reduces-risk-cancer-recurrence-early-breast-cancer-patients-high-risk-node-negative-disease