WCLC 2025 - Posters & ePosters-EP.12.38 Firmonertinib(160Mg) Combined With Chemotherapy as First-Line Treatment for Advanced NSCLC Patients With EGFR Mutations and Cns Metastases

EP.12.38 Firmonertinib(160Mg) Combined With Chemotherapy as First-Line Treatment for Advanced NSCLC Patients With EGFR Mutations and Cns Metastases

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This phase II, single-arm clinical study evaluated the efficacy and safety of firmoneitinib (AST2818) combined with pemetrexed and platinum-based chemotherapy as first-line treatment for 12 advanced non-small cell lung cancer (NSCLC) patients harboring EGFR classic mutations (19Del or L858R) and central nervous system (CNS) metastases. Conducted in Anhui Province between January 2024 and March 2025, all patients received firmoneitinib 160mg plus chemotherapy.<br /><br />Key efficacy outcomes showed an objective response rate (ORR) of 75% systemically and 83.3% in CNS lesions, with disease control rates (DCR) of 100% and 91.7%, respectively. At a median follow-up of approximately 5 months, only one patient experienced disease progression; progression-free survival data remain immature.<br /><br />The study population had a median age of 61 years, with a slight female predominance (58.4%). Half had EGFR exon 19 deletions, the other half L858R mutations, and one-third carried TP53 co-mutations. All had performance status ECOG 1, with most exhibiting multiple CNS metastatic sites.<br /><br />The combination treatment demonstrated a manageable safety profile. Treatment-related adverse events (TRAEs) occurred in 66.7% of patients, with 33.3% experiencing grade 3 TRAEs, but no grade 4 events, treatment discontinuations, or deaths were reported. Common adverse events included anemia (50%) and leukopenia (41.6%), primarily attributable to chemotherapy. Four patients required dose reductions due to TRAEs.<br /><br />In conclusion, firmoneitinib 160mg plus pemetrexed and platinum-based chemotherapy showed promising clinical efficacy with acceptable toxicity in EGFR-mutated NSCLC patients with CNS metastases. These findings support its potential as a viable first-line therapeutic option, addressing the unmet need for effective CNS-penetrant treatments in this patient population. Further follow-up and larger studies are warranted to confirm long-term outcomes.

Asset Subtitle

Lailing Li

Meta Tag

Speaker Lailing Li

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

firmoneitinib

AST2818

pemetrexed

platinum-based chemotherapy

non-small cell lung cancer

NSCLC

EGFR mutations

central nervous system metastases

clinical trial phase II

treatment efficacy and safety