Real-World Experience: The Efficacy and Tolerability of Oral Elacestrant for Patients with ESR1 Mutations

Clinical Brief: Real-World Evidence Supporting Elacestrant Use

Main Discussion Topics:

• Real-world outcomes exceeding clinical trial results (unusual finding)
• GUARDIAN database analysis: 6.4 months median time to treatment failure
• Komoda database: 6.8 months progression-free survival (9.4 months if fulvestrant-naive)
• Expert clinical experience aligning with real-world data
• Importance of appropriate patient selection for optimal outcomes

Key Points for Physicians:

• Real-world PFS (6.4-6.8 months) exceeds EMERALD trial results (3.8 months)
• Fulvestrant-naive patients show particularly strong outcomes (9.4 months)
• Early adopters report better results with refined patient selection
• Confirms benefit of using elacestrant in second-line for appropriate patients
• Real-world data validates subgroup findings from EMERALD

The real-world evidence conclusively demonstrates that proper patient selection based on EMERALD subgroup analyses results in significantly improved clinical outcomes compared with the overall trial population.