MONARCH 2 is a global, randomized, double-blind, phase 3 study of abemaciclib/placebo + fulvestrant in patients with hormone receptor positive, human epidermal growth factor receptor 2-negative advanced breast cancer. The East Asian population comprised 212 (31.7%) of the 669 intent-to-treat population in the MONARCH 2 trial. Consistent with the primary analysis, this subpopulation analysis of East Asian patients indicated progression-free survival benefit in the abemaciclib arm. The median overall survival was not reached in the abemaciclib arm and was 48.9 months in the placebo arm (hazard ratio 0.80; 95% confidence interval 0.52–1.24; p = 0.377). In addition, other efficacy endpoints, including time to chemotherapy, chemotherapy free survival, and time to second disease progression, indicated benefit in the abemaciclib arm. This analysis found no new safety concerns with longer follow-up. These findings support the positive benefit–risk balance of the MONARCH 2 regimen in East Asian patients with hormone receptor positive, human epidermal growth factor receptor 2-negative advanced breast cancer.

中文翻译：

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Abemaciclib 联合氟维司群治疗 HR+、HER2− 晚期乳腺癌的东亚女性：MONARCH 2 的总生存期

MONARCH 2 是一项针对激素受体阳性、人表皮生长因子受体 2 阴性晚期乳腺癌患者的 abemaciclib/安慰剂 + 氟维司群的全球性、随机、双盲、3 期研究。在 MONARCH 2 试验中，东亚人群占 669 名意向治疗人群中的 212 名 (31.7%)。与主要分析一致，东亚患者的这项亚群分析表明 abemaciclib 组的无进展生存获益。abemaciclib 组未达到中位总生存期，安慰剂组为 48.9 个月（风险比 0.80；95% 置信区间 0.52–1.24；p = 0.377）。此外，其他疗效终点，包括化疗时间、无化疗生存期和二次疾病进展时间，表明 abemaciclib 组的益处。该分析未发现新的安全问题，且随访时间更长。这些发现支持 MONARCH 2 方案在东亚激素受体阳性、人表皮生长因子受体 2 阴性晚期乳腺癌患者中的正效益-风险平衡。