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Brief Report: Aumolertinib as a Switch Therapy in Osimertinib-Intolerant NSCLC: The ACTIVE Trial - PubMed

3 hours ago
  • #Clinical Trial
  • #Non-Small Cell Lung Cancer
  • #EGFR-TKI Therapy
  • The ACTIVE trial is a prospective, multicenter, single-arm phase II study investigating aumolertinib as a switch therapy for EGFR-mutant advanced NSCLC patients intolerant to osimertinib.
  • Patients with grade ≥2 hematologic toxicities or ALT/AST increase, or grade ≥3 non-hematologic AEs on osimertinib switched to aumolertinib 110 mg daily after recovery.
  • The 3-month conversion success rate was 70.6% overall, with subgroups showing 78.9% for non-hematologic and 60.0% for hematologic toxicities.
  • Median post-switch progression-free survival was 11.6 months, and the 3-year overall survival rate was 52.4%, indicating sustained efficacy.
  • Treatment-related AEs occurred in 69.2% of patients (grade ≥3: 15.4%), with no discontinuations or deaths, supporting manageable safety.
  • The trial concludes that switching to aumolertinib is a feasible clinical strategy for osimertinib-intolerant patients, offering efficacy and safety.