Aumolertinib as first-line therapy for locally advanced or metastatic <i>EGFR</i> -mutant non–small cell lung cancer: A single-arm meta-analysis.

Abstract

e20715 Background: Patients with EGFR-mutated non-small-cell lung cancer (NSCLC) have a high risk of recurrence and post-surgical mortality. Aumolertinib, a third-generation EGFR tyrosine-kinase inhibitor, is approved in China for adjuvant treatment in patients with EGFR-mutated NSCLC either with an exon 19 deletion (ex19del) or exon 21 substitution (Leu858Arg) mutation. We aimed to perform a single-arm meta-analysis to evaluate the efficacy of Aumolertinib in EGFR-mutated NSCLC patients. Methods: We conducted a systematic search on PubMed, Scopus, Web of Science (WOS), and Cochrane Central from inception until January 15th 2026. All studies assess the effect of aumolertinib in patients with EGFR-mutated NSCLC. Our primary outcome was the progression free survival (PFS), while secondary outcomes were objective response rate (ORR) and disease control rate (DCR). Results: A total of 18 studies with 1,488 patients were included. The pooled PFS rate was 41% (95% CI: 31%–51%), with substantial heterogeneity (I² = 93.1%). The pooled ORR was 70% (95% CI: 62%–77%; I² = 85.8%), while the pooled DCR reached 97% (95% CI: 94%–99%; I² = 71.4%). All pooled outcomes were statistically significant (p &lt; 0.001). Conclusions: This single-arm meta-analysis demonstrates that aumolertinib is associated with favorable efficacy outcomes in patients with EGFR-mutated NSCLC, achieving high ORR and DCR with a moderate PFS benefit. Despite notable heterogeneity across studies, these findings support the clinical effectiveness of Aumolertinib as a therapeutic option for this population. Further randomized controlled trials are needed to confirm these results and define its comparative efficacy.