Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Safety analyses from the phase III EMBER-3 trial.

作者：Joyce O’Shaughnessy, François‐Clément Bidard, Patrick Neven, M.L. Casalnuovo, Philippe Aftimos, C. Saura Manich, Nadia Harbeck, Lisa A. Carey, Giuseppe Curigliano, José Á. García-Sáenz, María Fernández-Abad, Larissa Carvalho Lopes de Paula, Yeon Hee Park, Özgür Özyılkan, María del Mar Muñoz, S. Formentini, Emily Barrett, Shanshan Cao, Aarti Chawla, Komal Jhaveri · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.1060 · 被引用次数：4 · 研究领域：Advanced Breast Cancer Therapies、Neuroendocrine Tumor Research Advances

1060 Background: Imlunestrant is a next-generation, brain-penetrant, oral SERD. The EMBER-3 trial (NCT04975308) in patients with ER+, HER2- ABC and disease progression on/after aromatase inhibitor therapy showed significant progression-free survival improvement with imlunestrant (imlu; 400 mg once daily [QD]) over standard therapy (SOC, fulvestrant or exemestane) among patients with ESR1 mutations, as well as with imlunestrant+abemaciclib (imlu [400 mg QD] + abema [150 mg twice daily]) over imlu in all patients regardless of ESR1 mutation status. Detailed safety analyses are presented. Methods: The safety population included all patients who received at least one dose of study treatment. Analyses included incidence, severity (CTCAE v 5.0), management, and outcomes of common treatment-emergent adverse events (TEAEs). Results: Safety analyses included 859 patients: imlu (n=327), SOC (n=324), and imlu+abema (n=208). Incidence of any (imlu: 83%; SOC: 84%; imlu+abema: 98%), ≥ grade 3 TEAEs (imlu: 17%; SOC: 21%; imlu+abema: 49%), and serious AEs (SAEs; imlu: 10%; SOC 12%; imlu+abema: 17%) were similar between imlu and SOC arms and higher in the combination arm. Most common any-grade AEs with imlu were diarrhea (21%), nausea (17%), and fatigue (23%) and with imlu+abema were diarrhea (86%), nausea (49%), and neutropenia (48%); majority were grade 1 AEs. Incidence of elevated transaminases (any%/≥G3%: 16/1 and 20/5), VTE (1/0 and 3/1), ILD (1/0 and 2/0), bradycardia (2/0 and 1/0), and...