SABCS 2021 | EMERALD: elacestrant vs. SOC for patients with ER+ HER2- metastatic breast cancer
Aditya Bardia, MD, MPH, Massachusetts General Hospital, Boston, MA, discusses results from the Phase III randomised EMERALD trial (NCT03778931), investigating the novel oral selective estrogen receptor (ER) degrader, elacestrant, compared to standard of care (SOC) endocrine therapy for patients with ER+ HER2- metastatic breast cancer. Primary endpoints were progression-free survival (PFS) in the overall patient population and in patients with ESR1 mutation. The trial reported a 30% reduction in risk of progression or death in the overall progression, which rose to 45% in patients with ESR1 mutation, compared to SOC. The main side effect was nausea, which was more severe for patients receiving elacestrant than those receiving SOC. This interview took place at the San Antonio Breast Cancer Symposium 2021 in San Antonio.
Transcript (edited for clarity)
Clinically, there’s an unmet need for better endocrine therapies for patients with ER-positive, HER2-negative metastatic breast cancer. EMERALD was a phase 3 global clinical trial looking at a novel oral selective estrogen receptor degrader, elacestrant versus standard of care endocrine therapy, fulvestrant or AIs.
Patients were randomized to receive elacestrant versus standard endocrine therapy...
Clinically, there’s an unmet need for better endocrine therapies for patients with ER-positive, HER2-negative metastatic breast cancer. EMERALD was a phase 3 global clinical trial looking at a novel oral selective estrogen receptor degrader, elacestrant versus standard of care endocrine therapy, fulvestrant or AIs.
Patients were randomized to receive elacestrant versus standard endocrine therapy. The study had co-primary endpoints of progression-free survival in the overall population, and progression-free survival in patients who have mutant ESR1.
Overall, the trial was positive. It showed that patients who received elacestrant did much better as compared to those who received standard endocrine therapy. There was a 30% reduction in risk of progression or death in patients who received elacestrant versus standard of care. 45% reduction in risk of progression or death in the ESR1 mutant subgroup, again, in favor of elacestrant.
And finally, there was a trend towards improvement in overall survival with elacestrant as compared to standard of care endocrine therapy. So, multiple endpoints demonstrated that elacestrant was better than standard endocrine therapy.
In terms of side effects, the number one side effects seen with elacestrant was nausea. And the incidence of nausea, this being an oral pill, was higher as compared to standard of care endocrine therapy, including fulvestrant. Besides that, the other adverse events are pretty much similar between elacestrant and standard endocrine therapy.
So, in conclusion, this is the first Phase III clinical trial that has demonstrated that an oral selective estrogen receptor degrader is better as compared to standard endocrine therapy, and potentially could be a new treatment option for our patients with ER-positive, HER2-negative metastatic breast cancer.
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