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<p>Progression-free survival (PFS) with first-line third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors remains suboptimal in EGFR L858R-mutated advanced non-small-cell lung cancer (NSCLC), highlighting a need for strategies to delay resistance. This single-arm, phase II study (FIRM; ChiCTR2200060897) evaluates first-line double-dose firmonertinib (160 mg/day) in adults with L858R-mutated locally advanced or metastatic NSCLC. With a median follow-up of 27.5 months in 33 patients, primary endpoint was a median PFS of 21.1 months. Secondary endpoints include an unreached median overall survival, an objective response rate of 75.8%, a disease control rate of 90.9%, and an 18-month PFS rate of 63.1%. Grade ≥3 treatment-emergent adverse events occur in 6.1% of patients. Baseline circulating tumor DNA (ctDNA) variant allele frequency predicts ctDNA clearance at cycle 3 day 1, which correlates with longer PFS. Double-dose firmonertinib shows promising efficacy and tolerability, supporting its preliminary potential as first-line treatment for EGFR L858R-mutated advanced NSCLC.</p>

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Double-dose firmonertinib as first-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer harboring EGFR L858R mutation: a prospective, multicenter, phase II study (FIRM)

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月19日

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  • Bo Shen,
  • Chun Wang,
  • Liqin Zhang,
  • Yingying Zhu,
  • Xing Zhang,
  • Xiaoxuan Wang,
  • Zhen Guo,
  • Li Wang,
  • Xiaohua Wang,
  • Liqun Zhu,
  • Yun Zhou,
  • Danting Liao,
  • Meiqi Shi

摘要

Progression-free survival (PFS) with first-line third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors remains suboptimal in EGFR L858R-mutated advanced non-small-cell lung cancer (NSCLC), highlighting a need for strategies to delay resistance. This single-arm, phase II study (FIRM; ChiCTR2200060897) evaluates first-line double-dose firmonertinib (160 mg/day) in adults with L858R-mutated locally advanced or metastatic NSCLC. With a median follow-up of 27.5 months in 33 patients, primary endpoint was a median PFS of 21.1 months. Secondary endpoints include an unreached median overall survival, an objective response rate of 75.8%, a disease control rate of 90.9%, and an 18-month PFS rate of 63.1%. Grade ≥3 treatment-emergent adverse events occur in 6.1% of patients. Baseline circulating tumor DNA (ctDNA) variant allele frequency predicts ctDNA clearance at cycle 3 day 1, which correlates with longer PFS. Double-dose firmonertinib shows promising efficacy and tolerability, supporting its preliminary potential as first-line treatment for EGFR L858R-mutated advanced NSCLC.