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

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.

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Publication Details

Journal
npj Breast Cancer
Published
2026-04-27
DOI
https://doi.org/10.1038/s41523-026-00950-z
Primary Topic
Advanced Breast Cancer Therapies
Type
article
Field-Weighted Citation Impact
0.00

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article

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

François‐Clément Bidard, Larissa de Paula, Aarti Chawla, Emily Barrett et al.
npj Breast Cancer
Advanced Breast Cancer Therapies
article

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

François‐Clément Bidard, Larissa de Paula, Aarti Chawla, Emily Barrett, Shanshan Cao, Cristina Saura, M.L. Casalnuovo, María Fernández Abad, Y H Park, Ozgur Ozyilkan, Komal L. Jhaveri, Patrick Neven, Jose A. Garcia-Saenz, Lisa A. Carey, Giuseppe Curigliano, Maria Munoz, Joyce O’Shaughnessy, Nadia Harbeck, Philippe Aftimos
article en

Abstract

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.

npj Breast Cancer
University of North Carolina at Chapel Hill (US), Memorial Sloan Kettering Cancer Center (US), Eli Lilly (United States) (US), Başkent University (TR), University of Milan (IT), Cornell University (US), Universitair Ziekenhuis Leuven (BE), Institut Jules Bordet (BE), Samsung Medical Center (KR), Baylor University Medical Center (US), Hospital Clínico San Carlos (ES), Vall d'Hebron Hospital Universitari (ES), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Hospital Universitario Ramón y Cajal (ES), Instituto Brasileiro de Controle do Câncer (BR), Vall d'Hebron Institute of Oncology (ES), European Institute of Oncology (IT), Institut Curie (FR), Ludwig-Maximilians-Universität München (DE), Sungkyunkwan University (KR)
Eli Lilly and Company, National Institutes of Health, National Cancer Institute
Good health and well-being
Openalex Percentile: Top 16%
Advanced Breast Cancer Therapies
DOIOpen Access PDFOpenAlex
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