New data from the phase III ARTS trial published in The Lancet Oncology confirm that adjuvant aumolertinib significantly improves disease-free survival (DFS) compared with placebo in patients with completely resected stage II–IIIB EGFR-mutated non-small cell lung cancer (NSCLC). These findings add compelling evidence that continued targeted therapy after surgery can meaningfully delay recurrence in a disease subtype with high post-surgical risk.
The ARTS trial was a multicentre, double-blind, placebo-controlled phase III study that enrolled 214 patients with EGFR exon 19 deletion or L858R mutant NSCLC following complete tumour resection and standard adjuvant chemotherapy. Participants were randomised 1:1 to receive aumolertinib 110 mg daily or placebo for up to three years or until disease recurrence. Median follow-up was approximately 27.6 months in both arms.
CLINICAL SUMMARY
What was examined
The phase III ARTS trial evaluated adjuvant aumolertinib versus placebo in patients with completely resected stage II–IIIB EGFR-mutated NSCLC who had received standard postoperative chemotherapy.
Key findings
- Median disease-free survival was not reached with aumolertinib compared with 19.42 months with placebo.
- Aumolertinib reduced the risk of recurrence or death by 83 % (hazard ratio 0.17; 95 % CI 0.09–0.29; p < 0.0001).
- Two-year DFS rates were 88.2 % with aumolertinib versus 40.6 % with placebo. Benefits were consistent across subgroups.
Clinical implications
- Adjuvant aumolertinib offers a marked DFS advantage for patients with resected EGFR-mutant NSCLC and may shift postoperative management paradigms toward extended targeted therapy.
- Safety was manageable and consistent with known profiles of third-generation EGFR inhibitors.
The results showed a profound improvement in DFS with aumolertinib. Median DFS was not reached in the aumolertinib group compared with 19.42 months in the placebo arm. The hazard ratio for DFS was 0.17 (95 % CI 0.09–0.29; p < 0.0001), indicating an 83 % relative reduction in the risk of recurrence or death. At two years, DFS rates were 88.2 % with aumolertinib versus 40.6 % with placebo. These benefits were observed across predefined subgroups.
Aumolertinib’s safety profile was consistent with expectations for third-generation EGFR inhibitors. The most frequent grade 3–4 adverse events included elevated creatine phosphokinase and QT interval prolongation, with no treatment-related deaths reported.
Featured Event
These results align with and build on prior evidence that extended EGFR tyrosine kinase inhibitor therapy can substantially alter postoperative outcomes in patients with EGFR-driven NSCLC. The magnitude of the DFS benefit places aumolertinib among the most active adjuvant targeted therapies tested in this setting to date.
Paper: Liang Zhang 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, The Lancet Oncology 27(2) 2026. DOI: 10.1016/S1470-2045(25)00643-6. Access online here.
