Adjuvant Aumolertinib Improves Disease-Free Survival in Resected EGFR-Mutated Non–Small Cell Lung Cancer

Clinical Summary: 

• Design/Population: This randomized, double-blind, phase 3 trial evaluated adjuvant aumolertinib versus placebo in patients with completely resected stage II to IIIB EGFR-mutated non–small cell lung cancer (NSCLC) who had completed standard adjuvant therapy.
• Key Outcomes: Aumolertinib significantly prolonged disease-free survival compared with placebo, reducing the risk of disease recurrence or death by 83%. Median disease-free survival was not reached, and the treatment demonstrated a manageable safety profile with no new safety signals.
• Clinical Relevance: These findings support adjuvant aumolertinib as an effective treatment option for patients with resected EGFR-mutated NSCLC and reinforce the role of third-generation EGFR tyrosine kinase inhibitors in reducing postoperative disease recurrence.

Results from the phase 3 ARTS trial demonstrated that adjuvant aumolertinib significantly improved disease-free survival (DFS) compared with placebo in patients with completely resected EGFR-mutated non-small cell lung cancer (NSCLC), supporting its use as an effective postoperative treatment strategy.

“Patients with resectable [NSCLC], particularly those with EGFR mutations, face a high risk of recurrence and mortality post-surgery,” stated Liang Zhang, MD, Jilin Cancer Hospital in Changchun, China, and coauthors. “Aumolertinib, a third-generation EGFR tyrosine kinase inhibitor, is approved in China for adjuvant treatment in patients with NSCLC harboring an EGFR exon 19 deletion or exon 21 L858R mutation.”

In this double-blind, placebo-controlled trial, 214 patients with completely resected stage II to IIIB EGFR-mutated NSCLC who had completed standard adjuvant therapy were randomized 1:1 to receive either 110 mg of once-daily aumolertinib (n = 107) or placebo (n = 107) for up to 3 years or until disease recurrence or unacceptable toxicity. The primary end point was DFS. A key secondary end point was safety. 

At analysis, median DFS had not been reached in the aumolertinib arm compared with 19.4 months in the placebo arm, representing an 83% reduction in the risk of disease recurrence or death (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.09 to 0.29; P < .0001).

The most common grade 3/4 adverse events reported with aumolertinib were increased blood creatine phosphokinase (7%), prolonged QT interval (3%), pneumonia (2%), and hypertension (1%). Treatment-related serious adverse events occurred in one patient receiving aumolertinib and three patients receiving placebo. No treatment-related deaths or new safety signals were reported.

“Aumolertinib showed substantial clinical benefits as adjuvant therapy in Chinese patients with stage II to IIIB EGFR-mutated NSCLC,” concluded Dr Zhang and colleagues. “The manageable safety profile of aumolertinib supports its suitability in the adjuvant setting.”

Source: 

Zhang L, Zhang X, Wu L, et al. Aumolertinib as adjuvant therapy in resected EGFR-mutated non-small-cell lung cancer (ARTS): a double-blind, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. Published online: January 12, 2026. doi:10.1016/S1470-2045(25)00643-6