480P - Aumolertinib as adjuvant therapy for resectable stage I-III EGFR-mutant NSCLC: Also effective in EGFR co-mutation

Background

EGFR-mutant NSCLC patients(pts) have various types of co-mutation, such as TP53. Co-mutations contribute to high tumor heterogeneity in early NSCLC, potentially resulting in different clinical outcomes of resectable NSCLC. However, the impact of clinical benefit in pts with EGFR co-mutation in the ADAURA study remains unclear. Our study aimed to investigate the efficacy of the third-generation EGFR-TKI aumolertinib as adjuvant therapy for stage I-III EGFR-mutant NSCLC underwent R0 resection, and the impact of co-mutations on the clinical benefit.

Methods

We enrolled EGFR-mutant NSCLC pts who underwent radical surgery and received a daily dose of aumolertinib 110 mg. The duration of adjuvant therapy depended on the pts’pathologic stage and physical conditions. We evaluated the disease-free survival (DFS) and safety ,including the efficacy of aumolertinib in pts with co-mutation.

Results

This study retrospectively analyzed 91 cases of pathologically confirmed adenocarcinoma, EGFR positive mutation (19Del or L858R), and stage I-III NSCLC pts from August 2021 to August 2023. At the data cut-off, all pts have no symptoms of tumor recurrence. 62 pts (68.1%) have been followed up for ≥ 6 months, 27 pts (29.7%) have been followed up for ≥ 12 months. The 1-year DFS rate is 100%.

Among them, 35 pts had EGFR co-mutation and 48.5% was with TP53 co-mutation. Median age was 59 years and 74.3% were female. 17 pts (48.6%) have been followed up for ≥ 6 months, 7 pts (20%) have been followed up for ≥ 12 months. At 12 months, 100% pts were alive and disease-free, consistent with the overall population. There was no difference in postoperative recurrence between the co-mutation and the overall population currently. No grade≥3 adverse events occurred. The common adverse events were mild rash and diarrhea. No pts withdrew from therapy due to adverse drug reactions.

Conclusions

This study demonstrated the significant efficacy of aumolertinib as adjuvant therapy for completely resected stage I-III EGFR-mutated NSCLC, and reported the consistent efficacy of aumolertinib in pts with co-mutation for the first time. Our study is still ongoing to expand the cohort of pts with co-mutation and extend the follow-up period to determine longer-term outcomes.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.