WCLC 2025 - Posters & ePosters-P3.12.11 Aumolertinib Plus Chemotherapy as First - Line for Ps 2 - 3 Advanced NSCLC With EGFR Mutations: A Phase 2 Subgroup Analysis

P3.12.11 Aumolertinib Plus Chemotherapy as First - Line for Ps 2 - 3 Advanced NSCLC With EGFR Mutations: A Phase 2 Subgroup Analysis

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This phase 2 study (NCT04646824) evaluated the efficacy and safety of aumolertinib combined with chemotherapy (pemetrexed and carboplatin) as first-line treatment in advanced non-small cell lung cancer (NSCLC) patients with EGFR mutations and poor performance status (PS 2-3), a group often excluded from clinical trials. <br /><br />Between November 2020 and October 2021, 34 patients with EGFR-mutant NSCLC (Ex19del, L858R, and rare mutations) were enrolled, with 17 patients having ECOG PS scores of 2 or 3. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.<br /><br />Results in the PS 2-3 subgroup (n=17) showed a median PFS of 24.0 months (95% CI, 17.0 to 26.0), an ORR of 94.1%, and a DCR of 100%. Median OS was not reached at the time of analysis. Among 17 patients who underwent circulating tumor DNA (ctDNA) testing, 88.2% (15/17) demonstrated clearance of EGFR mutations after 2-4 treatment cycles, indicating a potential biomarker of response. Two patients who retained EGFR mutation positivity experienced early disease progression.<br /><br />The most common grade 3 adverse event was decreased neutrophil count, indicating manageable safety concerns.<br /><br />In conclusion, aumolertinib plus chemotherapy as first-line treatment demonstrated meaningful clinical benefits in EGFR-mutant NSCLC patients with poor performance status (PS 2-3), reflected by high response rates, durable PFS, and high rates of ctDNA clearance. These findings suggest this regimen could be an effective option for advanced NSCLC patients traditionally excluded from clinical trials due to poor functional status.

Asset Subtitle

Yan Wei Li

Meta Tag

Speaker Yan Wei Li

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

aumolertinib

chemotherapy

non-small cell lung cancer

NSCLC

EGFR mutations

poor performance status

progression-free survival

objective response rate

circulating tumor DNA

first-line treatment