Ribociclib and Endocrine Therapy Improves DFS in Early Breast Cancer

Gabriel Hortabagyi, MD, professor of Medicine at The University of Texas MD Anderson Cancer Center, provides an update on data from the phase 3 NATALEE trial (NCT03701334) for patients with early breast cancer.

In the multicenter, randomized, open-label, phase 3 study, investigators evaluated the combination of ribociclib (Kisqali) with endocrine therapy as adjuvant treatment in patients with hormone receptor (HR)-positive/HER2-negative early breast cancer.

These updated follow-up data were presented at the San Antonio Breast Cancer Symposium (SABCS) 2023. Findings revealed that there was improved disease-free survival among patients with stage II or III ER-positive/HER2-negative breast cancer.

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0:09 | There were roughly 509 events at the time of this analysis in the ribociclib plus nonsteroidal aromatase inhibitor arm. At the time of the analysis, we had 75% of patients on that arm [were] still taking the aromatase inhibitor, and 21% [who were] still taking ribociclib. So, 78% had stopped taking ribociclib either because they completed 3 years or because they had early discontinuation, either because of the development of recurrent invasive disease or because of adverse events.

1:01 | In the other arm, there were 68 and a half percent of patients still taking the aromatase inhibitor, whereas 27% changed and had discontinued the nonsteroidal aromatase inhibitor. The median follow-up at this time of this analysis was 33.3 months with a maximum follow-up of about 51 months. The absolute invasive disease-free survival benefit with ribociclib was 3.1% at 3 years, which was double what we had reported for 2 years, which was about 1 and a half percent. The benefit there continues to expand, continues to persist, and the separation of the curve continues to expand. The hazard ratio was point .749, which is highly statistically significant and it corresponded to about a 25% reduction in invasive disease.