Abstract 480P
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.
Resources from the same session
62P - Combination of chemotherapy with endocrinal therapy as upfront treatment of metastatic breast cancer in hormone receptor- positive, HER2 -negative disease: A phase II randomised clinical trial
Presenter: Mariam Saleh
Session: Poster Display
Resources:
Abstract
63P - Efficacy and safety of eribulin plus carboplatin combination for HER2-negative metastatic breast cancer
Presenter: Mengqian Ni
Session: Poster Display
Resources:
Abstract
64P - Unmet needs following metastatic breast cancer in a middle-income Asian country
Presenter: Nirmala Bhoo-Pathy
Session: Poster Display
Resources:
Abstract
66P - Utidelone-based therapy in metastatic solid tumors after failure of standard therapies: A prospective, multicenter, single-arm trial
Presenter: Jianjun Zhang
Session: Poster Display
Resources:
Abstract
67P - Efficacy and safety of trastuzumab biosimilar in HER2+ve metastatic breast cancer: A multicenter phase III study
Presenter: krishna Mohan
Session: Poster Display
Resources:
Abstract
68P - Neratinib in combination with fulvestrant and or palbociclib can overcome endocrine resistance in HER2-low/ ER+ breast cancer
Presenter: Maryam Arshad
Session: Poster Display
Resources:
Abstract
69P - A multicenter, retrospective, real-world study of inetetamab combined with pyrotinib and vinorelbine as treatment for HER2-positive metastatic breast cancer
Presenter: Nan Jin
Session: Poster Display
Resources:
Abstract
70P - Overall survival of eribulin, trastuzumab, and pertuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer: A phase II, single-arm clinical trial
Presenter: Kenichi Inoue
Session: Poster Display
Resources:
Abstract
71P - Efficacy and safety of disitamab vedotin after trastuzumab for HER2 -positive breast cancer: A real-world data of retrospective study
Presenter: Chao Li
Session: Poster Display
Resources:
Abstract
72P - Real-world data on the efficacy of T-DM1 biosimilar for the treatment of HER2-positive metastatic breast cancer patients: Outcomes from a single center retrospective study in India
Presenter: Kaushal Patel
Session: Poster Display
Resources:
Abstract