Kaklamani's Insights on the EMERALD Trial and Elacestrant in Advanced Breast Cancer
In this episode of Targeted Talks, Virginia Kaklamani, MD, DSc, discusses the background, findings, and implications of the phase 3 EMERALD trial.
In this episode of Targeted Talks, Virginia Kaklamani, MD, DSc, professor of medicine in the Division of Hematology-Medical Oncology at The University of Texas Health Science Center San Antonio and the leader of the breast cancer program at the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center, discusses the background, findings, and implications of the phase 3 EMERALD trial (NCT03778931).
The study enrolled patients with estrogen receptor (ER)-positive/HER2-negative advanced breast cancer who had received 1 to 2 lines of endocrine therapy. These patients were required to have pretreatment with a CDK4/6 inhibitor and 1 or more lines of chemotherapy. Once enrolled, patients were randomized to receive elacestrant (Orserdu), the first oral selective estrogen receptor degrader (SERD) approved in breast cancer, at a dose of 400 mg orally once daily or standard-of-care endocrine monotherapy.
The primary end points were progression-free survival (PFS) by blinded independent central review in all patients and patients with detectable ESR1 mutations.
The trial showed significant improvements in PFS for both the overall and mutated patient populations, with the most benefit seen in those with ESR1 mutations and a prior duration of CDK4/6 inhibitor treatment of more than 12 months. Additionally, elacestrant was effective regardless of metastatic site or other mutations. The trial also highlighted the agent’s favorable safety profile and the importance of liquid biopsy testing for detecting ESR1 mutations.
“What we found was that in patients that had tumors with ESR1 mutations, there was an improvement in progression-free survival with elacestrant compared [with] standard-of-care endocrine therapy. The median PFS in the elacestrant arm was 3.8 months vs the standard-of-care endocrine therapy, which was around 1.9 months. This was statistically significant,” explains Kaklamani.
Here, she delves deeper into what these data mean for patients with and oncologists treating ER-positive/HER2-negative advanced breast cancer.
