Dr Jhaveri on the FDA Approval of Imlunestrant Plus Abemaciclib for ESR1-Mutated Breast Cancer

Komal Jhaveri, MD, joins Targeted Talks to discuss the FDA approval of imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio) for patients with ESR1-mutated, estrogen receptor–positive, HER2-negative metastatic breast cancer. She explains the unmet need, noting that existing endocrine monotherapies leave many patients without a durable benefit. She then reviews the design of the phase 3 EMBER-3 trial (n = 874) and the updated analysis with 28.5 months of follow-up. In ESR1-mutated disease, progression-free survival with imlunestrant monotherapy was 5.5 vs 3.8 months (HR, 0.62), with a numerical overall survival gain of 34.5 vs 23 months. The combination showed a benefit over imlunestrant alone, including in patients previously treated with a CDK4/6 inhibitor. Dr Jhaveri also covers the safety profile, the broader NCCN-endorsed population, potential use in the first-line setting for patients with brain metastases or a known baseline ESR1 mutation, and the ongoing phase 3 EMBER-4 adjuvant trial.