The data for IDFS in cohort 2 remained immature. In addition, the 3-year IDFS rates in the control arm suggested that patients with Ki-67-high tumors had a higher risk of developing an IDFS event than those with Ki-67-low tumors (79.0% versus 87.2%, respectively), thus indicating the prognostic value of Ki-67 in this patient population. Numerical benefit was also observed in the cohort 1 Ki-67-low population (IDFS HR = 0.70, 95% CI 0.51-0.98 nominal P = 0.036), suggesting that abemaciclib + ET resulted in an IDFS benefit regardless of the Ki-67 index in cohort 1 ( Figure 3). The clinically meaningful benefit in IDFS and DRFS in the cohort 1 Ki-67-high population was maintained ( Figure 2B IDFS HR = 0.63, 95% CI 0.49-0.80 nominal P = 0.0002 and Supplementary Table S3, available at DRFS HR = 0.60, 95% CI 0.46-0.79 nominal P = 0.0002), with an absolute improvement of 7.1% and 5.2% in 3-year IDFS and DRFS rates, respectively. OS data remained immature as the required number of events was not reached at the time of this analysis.Īt AFU1, analyses of Ki-67 subpopulations in cohort 1 showed consistent results with PO. Bone and liver were the most common sites of distant recurrence with fewer recurrences in the abemaciclib arm ( Supplementary Table S2, available at ). Treatment benefit in IDFS and DRFS was generally consistent across prespecified subgroups ( Figure 1B, Supplementary Figure S4B, available at ). With more patients at risk for recurrence at 3 years, the data demonstrated an absolute improvement of 5.4% for 3-year IDFS rates (abemaciclib + ET: 88.8% versus ET alone: 83.4%) and 4.2% for 3-year DRFS rates (abemaciclib + ET: 90.3% versus ET alone: 86.1%). The Kaplan–Meier (KM) curves ( Figure 1A, Supplementary Figure S4A, available at ) continued to show the benefit of abemaciclib, even beyond the 2-year study treatment period. With 8 months of additional median follow-up, the benefit of abemaciclib + ET was maintained for IDFS ( Table 2 HR = 0.70, 95% CI 0.59-0.82 nominal P < 0.0001) and DRFS ( Table 2 HR = 0.69, 95% CI 0.57-0.83 nominal P < 0.0001).
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