The risk of recurrence or postoperative mortality remains a key challenge for patients with stage II–III non-small lung cancer (NSCLC), especially for those with tumors harboring EGFR mutations. Although the postoperative treatment landscape has improved due to the introduction of EGFR tyrosine kinase inhibitors (TKIs), there remains an urgent need for effective treatment options in this high-risk population.
New data suggest aumolertinib, a third-generation TKI, may deliver strong clinical benefits in the adjuvant setting as an EGFR-targeted treatment. Already approved in China as an adjuvant therapy for NSCLC harboring EGFR mutations, aumolertinib has demonstrated impressive disease-free survival (DFS) benefits along with a favorable safety profile in the phase III ARTS study.
Study Design
The double-blind, randomized, phase III trial enrolled patients with stage II–IIIB NSCLC from 48 hospitals across mainland China.1 Eligible patients had previously undergone complete resection followed by standard adjuvant therapy, harbored an EGFR mutation (Ex19del or L858R), and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.1
Of the 399 individuals screened for eligibility, 214 patients were randomly assigned to receive either aumolertinib (110 mg) or a placebo orally once daily for 3 years or until disease recurrence or discontinuation criteria were met.1 All patients were Chinese, with just over half being female (56%) and the remainder being male (44%).1 Nearly all patients (95%) had previously received adjuvant chemotherapy.1
The primary endpoint was DFS in the modified intention-to-treat (mITT) population. Safety was assessed in all patients who had previously received at least one dose of treatment.1
Results and Takeaways
The findings revealed a substantial improvement in DFS for the aumolertinib group, as assessed by blinded independent central review (BICR). Median DFS was not reached in the aumolertinib cohort, compared with 19.4 months in the placebo group.1 The hazard ratio (HR) for DFS was 0.17 (95% CI 0.09–0.29; p < 0.0001), representing an 83% relative reduction in the risk of recurrence or death.2
The 2-year DFS rate was significantly higher with aumolertinib than with placebo (88.2% vs. 40.6%). This benefit was consistent across various subgroups, including disease stage, EGFR mutation subtype, age, sex, smoking status, and ECOG performance status.2
Notably, the rate of disease recurrence was 14% in the aumolertinib group compared to 60% with placebo, and distant metastasis was less frequent with aumolertinib than with placebo (9% vs. 39%).1
Safety and Tolerability
Overall survival (OS) data were immature at the time of data cutoff; however, no treatment-related deaths were reported. Treatment-related adverse events (TRAEs) occurred in most patients (98% aumolertinib; 94% placebo).1
The most common grade 3 or 4 adverse events (AEs) in the aumolertinib group were increased blood creatine phosphokinase (7% vs. 0% in the placebo group), prolonged electrocardiogram QT interval (3% vs. 3%), hypertension (1% vs. 5%), and pneumonia (2% vs. 3%).1 Serious TRAEs were reported in only 1% of the aumolertinib cohort and 3% of those in the placebo group.1
With its favorable safety profile and notable DFS improvement, the ARTS trial supports adjuvant aumolertinib as an effective targeted option for patients with resected, EGFR-mutated NSCLC. Additional follow-up is needed to confirm OS data and long-term recurrence patterns.2
References
- 1. Aumolertinib as adjuvant therapy in resected EGFR-mutated non-small-cell lung cancer (ARTS): a double-blind, multicentre, randomised, controlled, phase 3 trial. Zhang, Liang et al. The Lancet Oncology, Volume 27, Issue 2, 159 – 168
- 2. ARTS Trial: Adjuvant Aumolertinib in Resected EGFR-Mutated NSCLC. OncoDaily. bit.ly/4kJUXC0
