A randomized phase 3 trial designed to evaluate elacestrant for patients with ER-positive, HER2-negative advanced or metastatic breast cancer met both of its primary endpoints, according to the agent’s manufacturer.
Results showed the agent extended PFS compared with investigator’s choice of hormonal agent in the overall study population and the subgroup of those with estrogen receptor 1 (ESR1) mutations.
Elacestrant (Menarini Group/Radius Health) is a selective estrogen receptor degrader.
The open-label EMERALD trial assessed the agent as second- or third-line monotherapy for patients with ER-positive, HER2-negative advanced or metastatic breast cancer.
The trial included 466 patients who had received one or two lines of endocrine therapy, including a cyclin-dependent kinase 4/6 inhibitor. Nearly half (47%) of patients had ESR1 mutations, which are key drivers of endocrine therapy resistance in this population.
Researchers assigned patients to elacestrant once daily or investigator’s choice of approved hormonal agent.
PFS in the entire study population and in the subgroup of patients with ESR1 mutations served as the primary endpoints. Secondary endpoints included OS, objective response rate and duration of response.
“Advanced /metastatic ER-positive, HER2-negative breast cancer pretreated with endocrine therapy remains an area of high unmet medical need. Additional therapeutic options for this patient population are urgently needed,” investigator Aditya Bardia, MD, MPH, medical oncologist at Massachusetts General Hospital and associate professor at Harvard Medical School, said in a Radius-issued press release. “The results provide a significant advancement for patients suffering from this devastating disease. It was also important to see the positive data for those patients with ESR1 mutations, known to confer additional resistance to standard endocrine therapy.”
Complete results of the EMERALD trial will be presented at this year’s San Antonio Breast Cancer Symposium.
Based on EMERALD trial results, Menarini and Radius intend to proceed with regulatory submissions in the United States and European Union in 2022.
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