As reported in The Lancet Oncology by Zhang et al, the Chinese phase III ARTS trial showed superior disease-free survival with the third-generation EGFR tyrosine kinase inhibitor aumolertinib as adjuvant therapy vs placebo in patients with completely resected stage II to IIIB EGFR-mutated non–small cell lung cancer (NSCLC).
Study Details
In the multicenter double-blind trial, 210 patients (modified intention-to-treat population for primary analysis) who had received standard adjuvant chemotherapy were randomly assigned between April 2021 and May 2022 to receive aumolertinib at 110 mg (n = 106) or placebo (n = 104) once daily for up to 3 years or until disease recurrence or other discontinuation criteria were met. The primary endpoint was disease-free survival on blinded independent central review.
Key Findings
As of the data cutoff date (in April 2024), the median duration of follow-up was 27.56 months (interquartile range [IQR] = 22.18–27.70 months) in the aumolertinib group and 27.63 months (IQR = 22.18–27.79 months) in the placebo group.
Median disease-free survival was not reached (95% confidence interval [CI] = 29.14 months to not reached) in the aumolertinib group vs 19.42 months (95% CI = 11.24–26.22 months) in the placebo group (hazard ratio = 0.17, 95% CI = 0.09–0.29, P < .0001). Rates at 24 months were 81% vs 44%.
Overall survival data were not mature at time of analysis. Death had occurred in three patients in the aumolertinib group and four patients in the placebo group.
Among 213 patients in the safety population, grade 3 to 4 adverse events occurred in 29 patients (27%) in the aumolertinib group vs 23 (22%) in the placebo group; the most common in the aumolertinib group were increased blood creatine phosphokinase (7% vs 0% in placebo group), prolonged QT interval (3% vs 3%), and pneumonia (2% vs 3%). Serious adverse events occurred in 13% vs 12% of patients. No treatment-related deaths were observed.
The investigators concluded: “Aumolertinib showed substantial clinical benefits as adjuvant therapy in Chinese patients with stage II–IIIB EGFR-mutated NSCLC. The manageable safety profile of aumolertinib supports its suitability in the adjuvant setting.”
Ying Cheng, MD, of the Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China, is the corresponding author for The Lancet Oncology article.
DISCLOSURE: The study was funded by Hansoh Pharmaceutical Group. For full disclosures of the study authors, visit thelancet.com.
