NEW YORK – Menarini Group and Radius Health on Wednesday said they plan to proceed with regulatory filings in the US and Europe for their selective estrogen receptor degrader elacestrant based on the activity seen in the Phase III EMERALD study in estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer patients.
The trial, which compared elacestrant to standard of care hormone therapies in these patients, met both primary endpoints, and elacestrant improved progression-free survival in the entire study population and in patients with tumors harboring estrogen receptor 1, or ESR1, mutations.
The study enrolled 466 patients, with 47 percent harboring an ESR1 mutation in their tumors. Breast tumors with ESR1 mutations can become resistant to endocrine therapy.
A full analysis of the EMERALD study data is ongoing, and the companies plan to present detailed results at the San Antonio Breast Cancer Symposium in December. Menarini and Radius also plan to submit regulatory applications seeking approval for elacestrant as a treatment for ER-positive, HER2-negative advanced breast cancer in the US and EU in 2022.
Last year, Florence, Italy-based Menarini licensed elacestrant from Radius. Menarini took over global development and commercialization of the drug in a deal worth up to $350 million.
Also in 2020, Boston-headquartered Radius partnered with Guardant Health to develop Guardant360 CDx assay as companion diagnostic for elacestrant.