Abstract 165P
Background
Third-generation EGFR-TKIs have demonstrated significant efficacy as adjuvant therapy in patients with EGFR-mutated NSCLC. Aumolertinib, a novel third-generation EGFR TKI, has shown outstanding effectiveness in NSCLC patients with EGFR mutation, including those with brain metastasis. The study aimed to evaluate the long-term efficacy and safety of adjuvant aumolertinib in postoperative patients.
Methods
Patients who underwent radical surgery for EGFR-mutated (19Del/L858R) NSCLC (stage IA2-IIIA) were enrolled from four medical centers. They received aumolertinib at a daily dose of 110 mg for durations ranging from 1 to 3 years, depending on the pathological stage and individual physical conditions. The study assessed disease-free survival (DFS), safety, and tolerability.
Results
A total of 288 patients were enrolled. The median follow-up period was 28.3 months. At the data cutoff (December, 2024), disease recurrence was reported in 22 patients. The 4-year DFS rate was 74.1% in the overall population and 82.7% for stage I patients. Among stage I patients, 44% presented with high-risk pathological factors, with 22.6% having at least one such factor. The most common high-risk factors included visceral pleural invasion (21.7%), micropapillary patterns (12.7%), and solid components (7%). Patients with high-risk recurrence factors had a significantly higher risk of recurrence compared to those without such factors (p=0.0001), suggesting that prolonged adjuvant therapy may be beneficial for these patients. No grade ≥3 adverse events were reported during aumolertinib treatment. Adverse reactions occurred in 103 patients (35.9%), with the most common being rash (50/288, 17.4%), abnormal liver function (18/288, 6.2%), oral ulcers (17/288, 5.9%), and diarrhea (15/288, 5.2%).
Conclusions
These updated results reinforce the robust efficacy of aumolertinib as an adjuvant therapy for NSCLC, following surgery, with an excellent safety profile. Long term follow-up is ongoing to investigate additional survival outcomes.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.