FDA Approval Insights: Elacestrant in ER+/HER2– ESR1-mutated Advanced or Metastatic Breast Cancer

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Stemline Therapeutics, we had the pleasure of speaking with Francois-Clement Bidard, MD, PhD, about the FDA approval of elacestrant (Orserdu) in patients with estrogen receptor (ER)–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. Dr Bidard is a professor of medicine at the Institut Curie and Université Paris-Saclay, head of the translational research group for circulating cancer biomarkers, and cocoordinator of Breast Cancer Research at the Institut Curie in France.

On January 27, 2023, the FDA approved elacestrant in postmenopausal women or adult men with ER-positive, HER2-negative, advanced or metastatic breast cancer harboring an ESR1 mutation who have progressed on at least 1 line of endocrine therapy. The regulatory decision was based on findings from the phase 3 EMERALD trial (NCT03778931), in which patients who received elacestrant had a median progression-free survival of 3.8 months (95% CI, 2.2-7.3) vs 1.9 months (95% CI, 1.9-2.1) with control endocrine therapy.

In our exclusive interview, Dr Bidard discussed the significance of this approval, key efficacy and safety data from the EMERALD trial, and the importance of testing for ESR1 mutations in patients with ER-positive, HER2-negative disease.

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Editor’s Note: Dr. Bidard has received research support from Pfizer, Prolynx, Menarini Silicon Biosystems, Merck KGaA, Rain Oncology, Roche, and Seagen; is a consultant for Astra-Zeneca, Caris, Daiichi-Sankyo, Exact Sciences, GE Healthcare, Gilead, GSK, Inatherys, Lilly, Menarini/Stemline, Novartis, Rain Oncology, Sanofi, and Seagen; is a speaker for Astra-Zeneca, Daiichi-Sankyo, Lilly, Menarini/Stemline, Pfizer, Rain Oncology, Sanofi, and Seagen; and is on the congresses for Astra-Zeneca, Pfizer, and Novartis.