FDA approves elacestrant for advanced breast cancer
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The FDA approved elacestrant for certain patients with advanced or metastatic breast cancer.
The approval applies to use of the agent by postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated breast cancer whose disease progressed after at least one line of endocrine therapy.
Elacestrant (Orserdu, Stemline Therapeutics) is an orally administered selective estrogen receptor degrader.
The FDA also approved the Guardant 360 CDx assay (Guardant Health) as a companion diagnostic to identify patients who are appropriate for elacestrant treatment.
The agency approved elacestrant based on results of the randomized phase 3 EMERALD trial.
The multicenter, open-label trial included 477 postmenopausal patients with ER-positive, HER2-negative metastatic breast cancer who received one or two prior lines of endocrine therapy without chemotherapy in the metastatic setting. All patients had progressed on prior cyclin-dependent kinase 4/6 inhibitor treatment.
Researchers randomly assigned 239 patients to 400 mg elacestrant daily. The other 238 received standard of care, which consisted of investigator’s choice of fulvestrant or an aromatase inhibitor.
PFS by blinded independent review committee assessment among patients with ESR1 mutations, as well as PFS among all patients regardless of ESR1 mutation status, served as primary endpoints. OS, safety, tolerability and quality of life served as secondary endpoints.
As Healio previously reported, results presented at San Antonio Breast Cancer Symposium showed the study met both primary endpoints.
Results showed reduced risk for disease progression or death with elacestrant among all patients (HR = 0.69; 95% CI, 0.55-0.88) and among those with ESR1 mutations (HR = 0.54; 95% CI, 0.38-0.76).
Researchers reported higher 12-month PFS rates with elacestrant among all patients (22.3% vs. 9.4%) and among those with ESR1 mutations (26.7% vs. 8.1%).
A prespecified interim OS analysis revealed a trend in favor of elacestrant among all patients (HR = 0.75; 95% CI, 0.54-1) and in the ESR1 mutation-positive group (HR = 0.59; 95% CI, 0.36-0.95). Final OS results are anticipated in 2022.
Treatment-related adverse events that occurred more frequently in the elacestrant group than standard care group included nausea (25.3% vs. 8.7%), vomiting (11% vs 2.6%) and fatigue (11% vs 7.9%). Most of these events were grade 1 or grade 2, according to researchers.
Approximately twice as many patients assigned elacestrant experienced grade 3 or higher treatment-related adverse events (7.2% vs. 3.1%), a result primarily driven by nausea (2.1% vs. 0.9%).
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