Dr Bardia provides his opinion on the current state of the ER+/HER2- treatment landscape and where elacestrant belongs in the current treatment paradigm.
Dr. Aditya Bardia: Based on the results of the EMERALD trial, Elacestrant potentially could be used in the second-line setting for patients with ER-positive HER2-negative metastatic breast cancer. EMERALD trial was as a single agent. There's also interest in combination therapy combining endocrine agents with other targeted agents such as PI3 kinase inhibitors as well as everolimus so that would be of interest as well.
Aromatase inhibitors are currently used in the adjuvant setting for patients with postmenopausal early breast cancer and they're also used in the metastatic setting as first-line therapy in combination with a CDK4/6 inhibitor. In terms of second, third-line setting, we sometimes do use aromatase inhibitors in combination with everolimus so if Elacestrant is FDA approved in the second, third-line setting, some physicians would consider using it as a single agent but there are others who would be interested in combination therapy in combination with a PI3 kinase mTOR or other targeted agents.
In terms of unmet need for patients with ER-positive, HER2-negative breast cancer, I can highlight three. The first is we need better endocrine agents. For example, fulvestrant is a selective estrogen receptor degrader but is given as an intramuscular shot, which can be inconvenient for patients so we need oral options for patients with ER-positive HER2-negative metastatic breast cancer. The second unmet need is once patients have endocrine-resistant disease, the mainstay of management right now is chemotherapy. Their interest in antibody-drug conjugates, trastuzumab deruxtecan, sacituzumab govitecan, but we need better agents that can help prolong survival for patients with ER-positive metastatic breast cancer and also improve quality of life in this setting. Then finally, the unmet need is to prevent metastatic ER-positive breast cancer. If we have good therapies in early breast cancer, if we can diagnose early breast cancer early, potentially we can prevent the emergence of metastatic disease, which would be wonderful for our patients.