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Safety and Efficacy of Aumolertinib as First-Line Treatment in EGFR-Mutant Lung Adenosquamous Carcinoma: A
Longfeng Zhang1, Long Huang2, Dingzhi Huang3
1Department of Thoracic Oncology Clinical Oncology School of Fujian Medical University Fujian Cancer Hospital Fuzhou Fujian China.
Abstract:
Lung adenosquamous carcinoma (ASC) is a rare histological subtype of non-small cell lung cancer (NSCLC), and prospective data regarding the efficacy of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in this patient population remain scarce. This prospective, multicenter, single-arm phase II trial (NCT04354961) evaluated the safety and efficacy of aumolertinib as first-line treatment for treatment-naïve patients with stage IV EGFR-mutant ASC. Eligible patients received aumolertinib 110 mg orally once daily, with progression-free survival (PFS) as the primary endpoint and objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety as secondary endpoints. The study was terminated early due to slow accrual, with 12 patients enrolled (median age: 66 years; 58.3% male; 58.3% with EGFR exon 19 deletion). After a median follow-up of 29.0 months, the median PFS and OS were 11.1 months (95% CI, 4.27-NA) and 16.7 months (95% CI, 11.3-NA), respectively. Confirmed ORR and DCR were 58.3% and 83.3%. Treatment-related adverse events (TRAEs) occurred in 75% of patients, with 33.3% experiencing grade 3-4 TRAEs; no treatment-related deaths were observed. Aumolertinib exhibits clinical activity with a manageable safety profile in EGFR-mutant ASC patients. However, its reduced efficacy compared with EGFR-mutant adenocarcinoma highlights the need for histology-specific therapeutic strategies. Trial Registration: NCT04354961.
Insights
Aumolertinib showed clinical activity in lung adenosquamous carcinoma (ASC) patients with EGFR mutations. However, its efficacy was lower than in adenocarcinoma, suggesting a need for histology-specific treatments.
Area of Science:
- Oncology
- Clinical Trials
- Pharmacology
Background:
- Lung adenosquamous carcinoma (ASC) is a rare non-small cell lung cancer (NSCLC) subtype.
- Limited prospective data exist on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) efficacy in ASC.
- EGFR mutations are key drivers in NSCLC, but treatment response can vary by histology.
Purpose of the Study:
- To evaluate the safety and efficacy of aumolertinib as a first-line treatment for stage IV EGFR-mutant ASC.
- To determine progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
- To assess the potential of aumolertinib in a histology-specific context for NSCLC.
Main Methods:
- Prospective, multicenter, single-arm phase II trial (NCT04354961).
- 12 treatment-naïve patients with stage IV EGFR-mutant ASC received aumolertinib 110 mg daily.
- Primary endpoint: PFS. Secondary endpoints: ORR, DCR, OS, and safety.
Main Results:
- Median PFS was 11.1 months and median OS was 16.7 months.
- Confirmed ORR was 58.3% and DCR was 83.3%.
- Treatment-related adverse events (TRAEs) occurred in 75% of patients (33.3% grade 3-4); no treatment-related deaths.
Conclusions:
- Aumolertinib demonstrated clinical activity and a manageable safety profile in EGFR-mutant ASC.
- Efficacy appears reduced compared to EGFR-mutant adenocarcinoma.
- Highlights the necessity for histology-specific therapeutic strategies in NSCLC treatment.
