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Third-generation EGFR-TKI have demonstrated remarkable efficacy as adjuvant therapy in patients with EGFR-mutated NSCLC. Aumolertinib, a novel third-generation EGFR tyrosine kinase inhibitor (TKI), has shown outstanding effectiveness in NSCLC patients with EGFR mutation, including those with brain metastasis. The objective of this study was to assess the long-term efficacy and safety of adjuvant aumolertinib in postoperative patients. Patients who underwent radical surgery for EGFR-mutated NSCLC with stage IA2-ⅢA were enrolled from four different medical centers. They received aumolertinib 110 mg once daily for 6 months to 3 years, depending on the pathological stage and individual physical conditions. The disease-free survival (DFS), safety and tolerability were evaluated. Patterns of recurrence and CNS DFS were prespecified exploratory end points. The retrospective analysis included 290 patients who underwent radical surgery, and were pathologically diagnosed with adenocarcinoma, EGFR mutation-positive, and stage IA2-ⅢA NSCLC. At the data cutoff (December 11, 2023), the median follow-up was 19.2 months. The 3-year DFS rate was 92.4% in the overall population. For stage I (IA and IB) and II-IIIA disease, the 3-year DFS rate was 91.7% (91.7% and 100%) and 91.2%, respectively. CNS recurrence occurred in only one patient in the overall population, and 3-year CNS DFS rate was 99%. The estimated probability of observing CNS recurrence at 36 months was 1% in the overall population and 2.5% in stage IB-IIIA disease, respectively. During aumolertinib treatment, no adverse events of grade≥3 were reported. Among the 290 patients, 104 patients (35.9%) experienced drug-related adverse reactions, with rash (50/290, 17.2%), diarrhea (16/290, 5.5%), abnormal liver function (18/290, 6.2%), and oral ulcer (17/290, 5.8%) being the most common. These updated data further underscore the pronounced efficacy of aumolertinib in the postoperative adjuvant treatment of NSCLC, accompanied by an excellent safety profile. Long term follow-up for our study is ongoing to explore additional survival outcomes.
Zhang et al. (Fri,) studied this question.