Monarch E Trial In High Risk Early Breast Cancer

  • The addition of abemaciclib to adjuvant endocrine therapy:
    • Was evaluated in the phase 3 monarchE trial:
      • That enrolled patients with high-risk, early-stage breast cancer:
        • With high risk defined as:
          • ≥ 4 axillary nodes or
          • 1 to 3 axillary nodes with:
            • Grade 3 histology
            • A large primary tumor (equal or greater than 5 cm)
            • High Ki67 score:
              • Defined as ≥ 20%
      • At a median 27 months of follow up:
        • The addition of abemaciclib led to statistically significant improvements in:
          • Invasive disease-free survival (IDFS) (HR, 0.70; 95% CI, 0.59-0.82; nominal P < 0.0001)
          • Distant relapse-free survival (DRFS) (HR, 0.69; 95% CI, 0.57-0.83; nominal P < 0.0001)
        • These findings were consistent with those from earlier data analyses
        • A low Ki-67 level was prognostic of better outcome:
          • However, it was not predictive of benefit from abemaciclib in this study
      • Results from a prespecified overall survival (OS) interim analysis were presented at the 2022 San Antonio Breast Cancer Symposium:
        • All patients were no longer receiving abemaciclib at a median follow-up of 42 months
        • Invasive DFS and DRFS benefits were sustained beyond the treatment period
        • OS data remained immature at time of analysis (Table 1.1)

Table 1.1. Efficacy Results From the monarchE Study Presented at SABCS 2022

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