EMERALD Trial Results: What Prior CDK4/6i Duration Means for Treatment Success

Clinical Brief: Elacestrant Subgroup Benefits and Safety Profile

Main Discussion Topics:

• Efficacy across different disease sites (bone-only versus visceral)
• Impact of tumor burden (multiple sites of metastasis)
• Co-mutation status (PIK3CA, p53) and treatment efficacy
• Safety profile focusing on gastrointestinal (GI) tolerability and lipid monitoring
• FDA recommendation for lipid profile monitoring requirements

Key Points for Physicians:

• Elacestrant efficacy maintained in visceral disease and high tumor burden
• Unexpected positive results even in p53-mutant tumors
• Less antiemetic use required compared with aromatase inhibitors
• New requirement: lipid profile before treatment and as needed thereafter
• Overall well-tolerated side effect profile with manageable GI symptoms

The comprehensive subset analyses support broad applicability of elacestrant in ESR1-mutant patients who demonstrate endocrine sensitivity, regardless of traditional adverse prognostic factors.