Imlunestrant with or without abemaciclib in advanced breast cancer: updated efficacy results from the phase III EMBER-3 trial.

In this article, we report updated efficacy from a prespecified interim overall survival(OS) analysis.

在这篇文章中，我们报告了预先设定的中期总生存（OS）分析的最新疗效数据。

patients_and_methods

Patients with ER-positive, HER2-negative ABC previously treated with aromatase inhibitors ± cyclin-dependent kinase 4 and 6 inhibitors were randomly assigned (1 : 1 : 1) to receive imlunestrant, SOC, and imlunestrant-abemaciclib.

先前接受芳香酶抑制剂±细胞周期依赖性激酶4和6抑制剂治疗的ER阳性、HER2阴性晚期乳腺癌患者被随机分配（1:1:1）接受imlunestrant、标准治疗（SOC）和imlunestrant-abemaciclib治疗。

Primary endpoints were PFS in imlunestrant versus SOC in patients with ESR1m and all patients, and versus imlunestrant-abemaciclib in all concurrently randomized patients.

主要终点是imlunestrant与SOC在携带ESR1突变患者和所有患者中的无进展生存期（PFS），以及与imlunestrant-abemaciclib在所有同时随机分配的患者中的比较。

OS was a key secondary endpoint (tested if the corresponding PFS was statistically significant).

总生存期（OS）是一个关键的次要终点（在相应的无进展生存期（PFS）统计显著时进行测试）。

Due to only two of three PFS endpoints being met, a limited significance level was passed to the OS comparisons.

由于仅满足了三个无进展生存期（PFS）终点中的两个，因此传递给总生存期（OS）比较的显著性水平有限。

Exploratory endpoints included time to chemotherapy, chemotherapy-free survival, and PFS2.

探索性终点包括化疗时间、无化疗生存期和PFS2。

Results

A total of 874 patients were randomized (imlunestrant, n = 331; SOC, n = 330; imlunestrant-abemaciclib, n = 213).

共有874名患者被随机分配（imlunestrant组，n=331；标准治疗组，n=330；imlunestrant-abemaciclib组，n=213）。

Median follow-up was 28.5 months; 10.1% of patients remained on treatment (data cut-off: 18 August 2025).In patients with ESR1m, median OS (mOS) was 34.5 months for imlunestrant versus 23.1 months for SOC [hazard ratio(HR) 0.60, 95% confidence interval(CI) 0.43-0.86, P = 0.0043, boundary for significance not reached].

中位随访时间为28.5个月；10.1%的患者仍在接受治疗（数据截止日期：2025年8月18日）。在携带ESR1m突变的患者中，imlunestrant的中位总生存期（mOS）为34.5个月，而标准治疗（SOC）为23.1个月[风险比（HR）0.60，95%置信区间（CI）0.43-0.86，P = 0.0043，显著性边界未达到]。

In all patients regardless of ESR1m, mOS was not reached with imlunestrant-abemaciclib versus 34.4 months with imlunestrant (HR 0.82, 95% CI 0.59-1.16, P = 0.2622).

在所有患者中，无论是否携带ESR1m突变，使用imlunestrant-abemaciclib的中位总生存期未达到，而使用imlunestrant的为34.4个月（HR 0.82，95% CI 0.59-1.16，P = 0.2622）。

Updated PFS demonstrated sustained benefit.

更新的无进展生存期（PFS）显示了持续的益处。

Notably, in all patients regardless of ESR1m, the median PFS of imlunestrant-abemaciclib versus imlunestrant was 10.9 versus 5.5 months (HR 0.59, 95% CI 0.47-0.74, nominal P < 0.0001).

值得注意的是，在所有患者中，无论ESR1m状态如何，imlunestrant-abemaciclib与imlunestrant相比，中位无进展生存期（PFS）分别为10.9个月和5.5个月（风险比HR 0.59，95%置信区间0.47-0.74，名义P值<0.0001）。

All prespecified exploratory endpoints favored imlunestrant-based regimens.

所有预先设定的探索性终点均倾向于支持基于imlunestrant的方案。

Safety remains consistent with prior reports.

安全性与以往报告保持一致。

Conclusions

These findings reinforce the clinical benefit of imlunestrant-based regimens as a potential all-oral, chemotherapy-free treatment option for endocrine-pretreated patients with ER-positive, HER2-negative ABC.

这些发现加强了基于imlunestrant方案的临床益处，作为一种潜在的全口服、无化疗治疗选择，适用于内分泌治疗过的ER阳性、HER2阴性晚期乳腺癌患者。