High-Dose Aumolertinib Demonstrates Promising Efficacy in Untreated EGFR-Mutant NSCLC with Brain Metastases: Insights from the ACHIEVE Phase 2 Trial

Highlight

• High-dose aumolertinib (165 mg) achieved a 12-month progression-free survival (PFS) rate of 62.1% in untreated EGFR-variant NSCLC patients with brain metastases.
• The intracranial PFS rate at 12 months reached 76.8%, indicating robust CNS activity of the drug on measurable brain lesions.
• Systemic and intracranial objective response rates (ORR) were remarkably high, exceeding 80% in both the full analysis and CNS evaluable-for-response populations.
• The safety profile was manageable; the main grade 3/4 toxicity was elevated creatine phosphokinase without any treatment-related deaths.

Study Background and Disease Burden