Abstract 371P
Background
Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) are now the standard first-line therapy for patients(pts) with EGFR+ non-small cell lung cancer (NSCLC). Elderly pts account for approximately 60% of all NSCLC pts. They do not always benefit from standard treatments due to impaired organ function and multiple diseases. Aumolertinib is a third-generation EGFR-TKI, and current data on third-generation EGFR-TKIs in elderly pts are very limited.
Methods
This study enrolled pts with stage IIA-IVB EGFR+ NSCLC who received aumolertinib alone as first-line therapy, stratified according to gender and disease stage, and the efficacy and safety were compared between pts ≥65 and <65 years (yr) in different subgroups using the chi-square test. The primary endpoint was objective response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety.
Results
A total of 66 pts (39% were male) were included. Overall, ORR and DCR were 74.2% and 97.0%, respectively (Efficacy; Table). ORR was 71.4% and 77.4% for pts ≥65 and <65 yr, respectively, and DCR was 97.1% and 96.8%, respectively. There were no statistical differences in ORR and DCR between pts ≥65 and <65 yr in all subgroups. Median PFS and OS had not been reached. The overall adverse event (AE) rate was 51.5%. The incidence of grade ≥3 AEs was 4.5%. In pts ≥65 and <65 yr, the incidence of AEs was 45.7% and 58.1%, respectively (p=0.32). All AEs were not statistically different between the two groups. Table: 371P
ORR | DCR | ||||||
Overall | ≥65 yr71.4% | <65 yr77.4% | P value0.58 | ≥65 yr97.1% | <65 yr96.8% | P value0.94 | |
Gender | Male | 64.7% | 77.8% | 0.49 | 94.1% | 100% | 0.46 |
Female | 77.8% | 77.3% | 0.97 | 100% | 95.5% | 0.36 | |
Stage | IIA | 100% | 100% | 0.38 | 100% | 100% | 0.38 |
IIB | 100% | 100% | 0.38 | 100% | 100% | 0.38 | |
IIIA | 80% | 80% | 1 | 100% | 100% | 1 | |
IIIB | - | 100% | - | - | 100% | - | |
IVA | 65.2% | 75% | 0.52 | 95.7% | 100% | 0.40 | |
IVB | 66.7% | 71.4% | 0.88 | 100% | 85.7% | 0.49 |
Conclusions
This was the first report of aumolertinib in elderly pts. In the real world, the efficacy and safety profile of aumolertinib as first-line treatment in elderly EGFR+ NSCLC pts were similar to that seen in the younger subgroup.
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
364P - Tepotinib with an EGFR-tyrosine kinase inhibitor (TKI) in patients with EGFR-mutant MET-amplified NSCLC: A case series
Presenter: Azura Ahmad
Session: Poster viewing 05.
365P - Patterns of progression on first-line osimertinib in patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC): A Swiss cohort study
Presenter: Alexandra Schuler
Session: Poster viewing 05.
366P - EGFR amplification is a putative resistance mechanism for NSCLC-LM patients with TKI therapy and is associated with poor outcome
Presenter: Hainan Yang
Session: Poster viewing 05.
367P - High-dose aumolertinib in EGFR-mutant NSCLC patients with brain metastases: Primary data from ACHIEVE
Presenter: Yun Fan
Session: Poster viewing 05.
368P - A special Imaging pattern of bilateral diffuse metastases in advanced lung adenocarcinoma harboring EGFR mutations was associated with a favorable prognosis to EGFR-TKIs
Presenter: Zhen-Bang Gu
Session: Poster viewing 05.
370P - Outcomes in patients with EGFR-mutant locally advanced or metastatic NSCLC co-mutations receiving aumolertinib as first-line treatment: A retrospective study
Presenter: Fang Cun
Session: Poster viewing 05.
373P - Safety and efficacy of aumolertinib treatment in patients with advanced NSCLC harboring uncommon EGFR mutations: Cohort 2
Presenter: WenFeng Fang
Session: Poster viewing 05.