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<p>In EMBER-3 (NCT04975308), among patients with ER + , HER2- advanced breast cancer (ABC) with recurrence/progression on/after endocrine therapy (ET), imlunestrant significantly prolonged PFS versus standard ET in patients with <i>ESR1</i> mutations, and imlunestrant + abemaciclib prolonged PFS versus imlunestrant in the overall population. We report the incidence, severity, timing, and management of common treatment-emergent adverse events (TEAEs), including safety profiles of select subgroups. In both imlunestrant-containing arms, the most common TEAEs were reversible, low grade, single occurrences; occurred early in treatment; and resulted in few treatment discontinuations (imlunestrant, 5%; imlunestrant + abemaciclib, 6%). TEAEs in imlunestrant+abemaciclib arm were managed with dose adjustments (61%) and supportive medication. Imlunestrant monotherapy had a similar safety profile between patients aged &lt;65 and ≥65 years, while imlunestrant + abemaciclib had a similar safety profile to other abemaciclib+ET combinations in both age groups. Imlunestrant and imlunestrant + abemaciclib provide effective, convenient oral therapy with a favorable and manageable safety profile for patients with ER+, HER2- ABC with recurrence/progression on/after ET.</p>

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Imlunestrant with or without abemaciclib in advanced breast cancer: safety analyses from the EMBER-3 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月27日

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  • Joyce O’Shaughnessy,
  • Francois-Clement Bidard,
  • Patrick Neven,
  • Monica Lis Casalnuovo,
  • Philippe Aftimos,
  • Cristina Saura,
  • Nadia Harbeck,
  • Lisa A. Carey,
  • Giuseppe Curigliano,
  • Jose A. Garcia-Saenz,
  • Maria Fernandez Abad,
  • Larissa de Paula,
  • Yeon Hee Park,
  • Ozgur Ozyilkan,
  • Maria Munoz,
  • Emily Barrett,
  • Shanshan Cao,
  • Aarti Chawla,
  • Komal L. Jhaveri

摘要

In EMBER-3 (NCT04975308), among patients with ER + , HER2- advanced breast cancer (ABC) with recurrence/progression on/after endocrine therapy (ET), imlunestrant significantly prolonged PFS versus standard ET in patients with ESR1 mutations, and imlunestrant + abemaciclib prolonged PFS versus imlunestrant in the overall population. We report the incidence, severity, timing, and management of common treatment-emergent adverse events (TEAEs), including safety profiles of select subgroups. In both imlunestrant-containing arms, the most common TEAEs were reversible, low grade, single occurrences; occurred early in treatment; and resulted in few treatment discontinuations (imlunestrant, 5%; imlunestrant + abemaciclib, 6%). TEAEs in imlunestrant+abemaciclib arm were managed with dose adjustments (61%) and supportive medication. Imlunestrant monotherapy had a similar safety profile between patients aged <65 and ≥65 years, while imlunestrant + abemaciclib had a similar safety profile to other abemaciclib+ET combinations in both age groups. Imlunestrant and imlunestrant + abemaciclib provide effective, convenient oral therapy with a favorable and manageable safety profile for patients with ER+, HER2- ABC with recurrence/progression on/after ET.