Elacestrant in ESR1-mutant, endocrine-responsive metastatic breast cancer: should health authorities consider post hoc data to inform priority access?

For patients with hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-) metastatic breast cancer (mBC) progressed on first-line endocrine therapy plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i), fulvestrant, a selective estrogen receptor degrader (SERD) administered intramuscularly, represented the only monotherapy option until the approval of elacestrant. This oral SERD has been approved for patients with ESR1-mutant HR+/HER2- mBC by the European Medicines Agency, the Food and Drug Administration, and the UK Medicines and Healthcare products Regulatory Agency, according to the results of the randomized phase III EMERALD trial, which demonstrated elacestrant superiority over standard endocrine monotherapy. Consequently, elacestrant has been incorporated in the European Society for Medical Oncology and American Society of Clinical Oncology guidelines. However, in Europe, the access to this recommended drug depends on the decision of the National Health Authorities of each state. In this communication, we describe the main results and implications of the EMERALD trial, in the context of the biomarker-driven algorithm for patients with HR+/HER2- mBC progressed on CDK4/6i, and conclude that a subgroup of patients with ESR1-mutant tumors and specific clinical features can really derive a clinically meaningful benefit from elacestrant, sparing access to more toxic combination approaches and preserving the quality of life.

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Publication Details

Journal
ESMO Open
Published
2024-09-01
DOI
https://doi.org/10.1016/j.esmoop.2024.103701
Citations
6
Primary Topic
Advanced Breast Cancer Therapies
Type
article
Field-Weighted Citation Impact
2.51

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article

Elacestrant in ESR1-mutant, endocrine-responsive metastatic breast cancer: should health authorities consider post hoc data to inform priority access?

Giuseppe Curigliano, François‐Clément Bidard, Barbara Pistilli, Cristian Villanueva et al.
6 citations
ESMO Open
Advanced Breast Cancer Therapies
2.51
article

Elacestrant in ESR1-mutant, endocrine-responsive metastatic breast cancer: should health authorities consider post hoc data to inform priority access?

Giuseppe Curigliano, François‐Clément Bidard, Barbara Pistilli, Cristian Villanueva, Dario Trapani, J. Gligorov, F. Dalenc, Javier Cortés, Nicholas C. Turner, Frédérique Penault‐Llorca, Carmine Valenza, Gilles Freyer, Mónica Arnedos, Sibylle Loibl
article en
6 citations

Abstract

For patients with hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-) metastatic breast cancer (mBC) progressed on first-line endocrine therapy plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i), fulvestrant, a selective estrogen receptor degrader (SERD) administered intramuscularly, represented the only monotherapy option until the approval of elacestrant. This oral SERD has been approved for patients with ESR1-mutant HR+/HER2- mBC by the European Medicines Agency, the Food and Drug Administration, and the UK Medicines and Healthcare products Regulatory Agency, according to the results of the randomized phase III EMERALD trial, which demonstrated elacestrant superiority over standard endocrine monotherapy. Consequently, elacestrant has been incorporated in the European Society for Medical Oncology and American Society of Clinical Oncology guidelines. However, in Europe, the access to this recommended drug depends on the decision of the National Health Authorities of each state. In this communication, we describe the main results and implications of the EMERALD trial, in the context of the biomarker-driven algorithm for patients with HR+/HER2- mBC progressed on CDK4/6i, and conclude that a subgroup of patients with ESR1-mutant tumors and specific clinical features can really derive a clinically meaningful benefit from elacestrant, sparing access to more toxic combination approaches and preserving the quality of life.

ESMO OpenVol. 9(9)
Université Claude Bernard Lyon 1 (FR), Inserm (FR), Lyon College (US), University of Milan (IT), BioClinica (United States) (US), Université de Versailles Saint-Quentin-en-Yvelines (FR), Université Clermont Auvergne (FR), Université Paris-Saclay (FR), Breast Cancer Now (GB), Cancer Institute (WIA) (IN), Institut Gustave Roussy (FR), Sorbonne Université (FR), Cardiovascular Center Bethanien (DE), Assistance Publique – Hôpitaux de Paris (FR), Hospices Civils de Lyon (FR), MedSIR (Spain) (ES), Royal Marsden Hospital (GB), Centre de Recherche en Cancérologie de Lyon (FR), Institut Claudius Regaud (FR), Institut Bergonié (FR), Clinique Clémentville (FR), International Breast Cancer Study Group (CH), Hôpital Tenon (FR), Imagerie Moléculaire et Stratégies Théranostiques, European Institute of Oncology (IT), Institut Curie (FR), Universidad Europea de Madrid (ES), HCL Technologies (India) (IN)
Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Fondazione Beretta, Veracyte, Relay Therapeutics, Astellas Pharma, European Society for Medical Oncology, Daiichi Sankyo Europe
Openalex Percentile: Top 10%
Advanced Breast Cancer Therapies
2.51
DOIOpen Access PDFOpenAlex
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