Abstract 145P
Background
Pathological subtypes are prognostic indicators independent of TNM stage. Patients (pts) with high-risk factors (solid, micropapillary, or complex gland) had poorer prognosis. APPOINT (NCT04922138) is the first two-arm study to explore the efficacy and safety of the third-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) aumolertinib as adjuvant therapy in stage I A EGFR-mutated NSCLC pts with high risk factors.
Methods
This prospective, multi-center, two-arm study aimed to enroll 102 stage I A EGFR-mutated NSCLC pts with solid, micropapillary, and/or complex gland components ≥10%. After radical lung cancer surgery, they will receive oral aumolertinib 110 mg qd as adjuvant therapy (arm A) or observation (arm B) for 3 years. The primary endpoint is 2-year disease-free survival (DFS) rate, and secondary endpoints include 3-, 4-, and 5-year DFS rate, 5-year overall survival rate and safety.
Results
A total of 95 stage I A EGFR-mutated (19Del, L858R and uncommon mutations) NSCLC pts were enrolled with at least one high-risk factor, including solid, micropapillary, and/or complex gland components. 46 in arm A and 49 in arm B. The median age was 57 and 66 years, 62.2%and 65.3%were female, respectively. At data cut-off (December 2024), the median follow-up time was 16.5 months, all pts in arm A had no symptoms of tumor recurrence and 2 pts in arm B had recurrence, the 1-year DFS was 100% vs 87%. 1-year risk of tumor recurrence was 0% vs 12.8%, respectively. 34 pts in arm A were experienced adverse events (AE), there were no grade ≥3 AE occurred during aumolertinib treatment, the common treatment emergent adverse events were creatine kinase increase (34.8%), lactate dehydrogenase increase (15.2%), liver function injury (10.9%) and mouth ulceration (10.9%).
Conclusions
The early data of this study showed the promising efficacy and safety aumolertinib in patients with completely resected stage I A EGFR mutated NSCLC with high-risk factors.
Clinical trial identification
NCT04922138.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.