Adjuvant Aumolertinib in Resected EGFR-Mutated Non-Small Cell Lung Cancer

Key Clinical Takeaways: 

• Design/Population: This randomized, double-blind, phase 3 trial evaluated adjuvant aumolertinib vs placebo in patients with completely resected stage II to IIIB NSCLC harboring EGFR exon 19 deletion or exon 21 L858R mutations who had received standard adjuvant therapy.
• Key Outcomes: Aumolertinib significantly improved disease-free survival compared with placebo, reducing the risk of recurrence or death by 83%, with median DFS not reached at a median follow-up of approximately 28 months.
• Clinical Relevance: These results support aumolertinib as an effective adjuvant treatment option in EGFR-mutated NSCLC, offering durable disease control with a manageable safety profile in the postresection setting.

According to results from the phase 3 ARTS trial, adjuvant aumolertinib demonstrated clinical promise with a manageable safety profile among patients with EGFR-mutated non-small cell lung cancer (NSCLC).

“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, Changchun, China, and coauthors. “Aumolertinib, a third-generation EGFR tyrosine-kinase inhibitor, is approved in China for adjuvant treatment in patients with NSCLC harboring EGFR with an exon 19 deletion or exon 21 substitution mutation.”

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

At analysis, median DFS was not reached in the aumolertinib arm and was 19.42 months in the placebo arm (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 in the aumolertinib arm included increased blood creatine phosphokinase (7%), prolonged electrocardiogram QT interval (3%), hypertension (1%), and pneumonia (2%). Treatment-related serious adverse events occurred in 1 patient in the aumolertinib arm and 3 patients in the placebo arm. No treatment-related deaths occurred, and no new safety signals were identified.

“Aumolertinib showed substantial clinical benefits as adjuvant therapy in Chinese patients with stage I to IIIB EGFR-mutated NSCLC,” concluded Dr Zhang et al. “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