Interim NATALEE Data Support Ribociclib Plus Endocrine Therapy for Stage II/III HR-Positive / HER2-Negative Early Breast Cancer

  • 2023 ASCO ANNUAL MEETING – Key Points:
    • NATALEE was designed to evaluate the combination of ribociclib plus endocrine therapy in patients with early breast cancer
    • There was a trend toward improved OS with ribociclib plus endocrine therapy, and a 3-year treatment duration of ribociclib 400 mg showed a predictable safety profile that was more favorable than the 600 mg dose of ribociclib used in the metastatic setting
    • Follow-up data is still being collected, and further quality-of-life results will be provided later in the year
    • The combination of CDK 4 / 6 inhibitor ribociclib plus endocrine therapy significantly improved invasive disease-free survival (iDFS) compared with endocrine therapy alone in a broad population of patients with stage II or III HR-positive /HER2-negative early breast cancer:
      • According to results of the second interim efficacy analysis of the phase 3 NATALEE study
    • With a median follow-up for iDFS of 27.7 months:
      • The risk for invasive disease was reduced by 25.2% with ribociclib plus endocrine therapy compared with endocrine therapy alone (HR 0.748, 95% CI [0.618, 0.906]; P = .0014)
    • The 3-year iDFS rate was 90.4% for the combination therapy compared with 87.1% for endocrine therapy alone:
      • Which is an absolute difference of 3.3%
    • These results support ribociclib plus endocrine therapy as a new and effective treatment of choice for a broad population of at-risk patients with stage II or III HR-positive / HER2-negative early breast cancer, which is easy to identify in clinical practice
#Arrangoiz #BreastSurgeon #MountSinaiMedicalCenter #MSMC #BreastCancer #SurgicalOncologist #CancerSurgeon

Leave a comment