Abstract 166P
Background
Several retrospective analyses have demonstrated the efficacy and safety of aumolertinib as adjuvant therapy for completely resected NSCLC patients with EGFR mutations. However, prospective data supporting the use of aumolertinib as adjuvant therapy for completely resected stage I NSCLC are lacking. Here we firstly report the efficacy and safety of aumolertinib as adjuvant therapy for completely resected stage I NSCLC patients with EGFR mutation in a multi-center, single-arm study.
Methods
Patients with EGFR-mutant Stage IB and stage IA2–3 NSCLC who underwent R0 resection were eligible. Participants received aumolertinib 110 mg once daily within 10 weeks post-surgery for up to two years or until disease recurrence or withdrawal criteria were met. The primary endpoint was the 3-year disease-free survival (DFS) rate, with secondary endpoints included 2-year, 4-year, and 5-year DFS rates, overall survival (OS), and safety. Exploratory endpoints included changes in molecular residual disease (MRD) and the relationship between MRD status and therapeutic efficacy.
Results
A total of 67 patients were enrolled, of whom 46were evaluable for efficacy. The median age was 60 years (range: 44–70), with 78.3% being female, and 67.4% presenting with stage IA disease (IA2: 34.8%, IA3: 32.6%). High-risk pathological factors were identified in 8 cases. The median follow-up duration was 10.3 months. At the data cut-off, no disease recurrence was observed. The 2-year DFS rate was 100%, while the 3-year DFS rate (the primary endpoint) remains under observation. MRD data were available for 41 patients at least once postoperatively. Among them,2 cases initially tested initially positive but became negative following aumolertinib treatment. The overall incidence of adverse events (AEs) was 63 %, with most being grade 1–2. Grade 3 or higher TRAEs were reported in 2 patients (4.3%). No new safety signals were identified.
Conclusions
This prospective study provides preliminary evidence supporting the efficacy of aumolertinib as an adjuvant therapy for stage IA2–3 and IB NSCLC. Long-term follow-up is ongoing to further investigate the relationship between MRD and therapeutic efficacy.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.