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Elacestrant

(Orserdu®)

Orserdu®

Drug updated on 10/21/2024

Dosage FormTablet (oral; 345 mg, 86 mg)
Drug ClassEstrogen receptor antagonists
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for treatment of postmenopausal women or adult men, with ERpositive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

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Summary
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  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Elacestrant significantly improved progression-free survival (PFS) compared to standard-of-care (SOC) endocrine monotherapy, with a hazard ratio (HR) of 0.70 (95% CI, 0.55 to 0.88; P = .002) in the overall population of patients with ER-positive/HER2-negative advanced breast cancer who had been pretreated with one or two lines of endocrine therapy.
  • In patients with detectable ESR1 mutations, elacestrant showed a more pronounced benefit for PFS, with a hazard ratio of 0.55 (95% CI, 0.39 to 0.77; P = .0005), indicating superior effectiveness in this subgroup.
  • A notable 43.4% of patients had received two prior endocrine therapies, and 47.8% had detectable ESR1 mutations, highlighting the specific population characteristics relevant to elacestrant's effectiveness.
  • Elacestrant was associated with treatment-related grade 3/4 adverse events in 7.2% of patients, compared to 3.1% in the standard-of-care (SOC) group. Treatment discontinuations due to adverse events occurred in 3.4% of elacestrant patients versus 0.9% in the SOC group, indicating a higher incidence of severe adverse effects with elacestrant.
  • Nausea was reported in 35.0% of patients receiving elacestrant, with 2.5% experiencing grade 3/4 nausea, compared to 18.8% and 0.9%, respectively, in the SOC group, highlighting a significant safety concern.
  • The study focused on patients with ER-positive/HER2-negative advanced breast cancer, including those who had been pretreated with one or two lines of endocrine therapy and required pretreatment with a cyclin-dependent kinase 4/6 inhibitor, with ≤ 1 chemotherapy. Among these patients, 47.8% had detectable ESR1 mutations, and 43.4% had received two prior endocrine therapies, indicating a substantial proportion of patients may benefit from elacestrant's improved progression-free survival, particularly those with ESR1 mutations.