Aumolertinib vs Gefitinib in Patients With Advanced NSCLC and EGFR Exon 19 Deletion or L858R Mutation

Get Permission

In a Chinese phase III trial (AENEAS) reported in the Journal of Clinical Oncology, Lu et al found that aumolertinib, a third-generation EGFR tyrosine kinase inhibitor approved in China, significantly improved progression-free survival vs gefitinib in the first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or L858R mutation.

Study Details

In the double-blind, multicenter trial, 429 patients were randomly assigned between November 2018 and September 2019 to receive aumolertinib at 110 mg once daily (n = 214) or gefitinib at 250 mg once daily (n = 215). The primary endpoint was investigator-assessed progression-free survival.

Progression-Free Survival

Median follow-up was 20.5 months in the aumolertinib group and 20.7 months in the gefitinib group. Median progression-free survival was 19.3 months (95% confidence interval [CI] = 17.8–20.8 months) in the aumolertinib group vs 9.9 months (95% CI = 8.3–12.6 months) in the gefitinib group (hazard ratio [HR] = 0.46, 95% CI = 0.36–0.60, P < .0001). Rates at 1 and 2 years were 69.5% vs 46.3% and 32.5% vs 12.9%.

Objective response was achieved in 73.8% vs 72.1% of patients (P = .6939; complete response in 1 patient in each group), with median response durations of 18.1 months vs 8.3 months (HR = 0.38, P < .0001). Disease control rates were 93.0% vs 96.7% (P = .0884). Overall survival data at the time of analysis showed that death had occurred in 54 vs 69 patients; 12-month rates were 86.2% vs 85.3%.


  • Aumolertinib significantly improved progression-free survival vs gefitinib.
  • Median progression-free survival was 19.3 vs 9.9 months.

Adverse Events

The most common adverse events of any grade in the aumolertinib and gefitinib groups were blood creatine phosphokinase increase (35.5% vs 9.3%), aspartate transaminase increase (29.9% vs 54.0%), alanine transaminase increase (29.4% vs 55.8%), rash (23.4% vs 41.4%), and diarrhea (16.4% vs 35.8%). Grade ≥ 3 adverse events occurred in 36.4% vs 35.8% of patients. Serious adverse events occurred in 22.0% vs 21.4%. Adverse events led to treatment discontinuation in 3.7% vs 5.1%. Adverse events led to death in five patients in the aumolertinib group and three patients in the gefitinib group; relationship to treatment could not be determined in one patient in each group, with all other deaths considered unrelated to treatment.

The investigators concluded, “Aumolertinib is a well-tolerated third-generation EGFR tyrosine kinase inhibitor that could serve as a treatment option for EGFR-mutant NSCLC in the first-line setting.”

Shun Lu, MD, of the Department of Medical Oncology, Shanghai Chest Hospital, Shanghai JiaoTong University, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by Hansoh Pharmaceutical Group Co, Ltd. For full disclosures of the study authors, visit

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.