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<p>To investigate the efficacy and safety of osimertinib plus savolitinib for patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations and de novo MET aberrations, we conducted a randomized, multicenter, open-label, phase 2 study (ClinicalTrials.gov identifier: NCT05163249). Treatment-naïve patients with locally advanced or metastatic NSCLC harboring de novo MET amplification or overexpression and EGFR mutations were randomized to receive osimertinib monotherapy (cohort 1, 80 mg orally once daily) or combination therapy (cohort 2, osimertinib 80 mg orally once daily and savolitinib 300 mg orally twice daily). The primary endpoint was the confirmed objective response rate (ORR). A total of 44 patients were randomized to either cohort 1 (<i>n</i> = 23) or cohort 2 (n = 21). The pre-specified study endpoint was achieved. The confirmed ORR was 60.9% (95% confidence interval [CI]: 38.5–80.3) in cohort 1 and 90.5% (95% CI: 69.6–98.8) in cohort 2, with disease control rates of 87% (95% CI: 66.4–97.2) and 95.2% (95% CI: 76.2–99.9). Treatment-related adverse events of grade 3 or higher occurred in 2 patients (8.7%) in cohort 1 and 12 patients (57.1%) in cohort 2. Osimertinib plus savolitinib showed promising antitumor activity and manageable safety.</p>

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Osimertinib with or without savolitinib as first-line treatment for MET-aberrant, EGFR-mutant NSCLC: randomized phase 2 trial (FLOWERS)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月13日

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  • Anna Li,
  • Wei-Neng Feng,
  • Juan Li,
  • Bing-Fei Xu,
  • Jun Zhao,
  • Yun Jia,
  • Ke-Jing Tang,
  • Yong-Sheng Li,
  • Cheng-Zhi Zhou,
  • Yun Fan,
  • Chong-Rui Xu,
  • Yue-Li Sun,
  • Hua-Jun Chen,
  • Hong-Hong Yan,
  • Zong-Kun Shi,
  • Jin-Ji Yang

摘要

To investigate the efficacy and safety of osimertinib plus savolitinib for patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations and de novo MET aberrations, we conducted a randomized, multicenter, open-label, phase 2 study (ClinicalTrials.gov identifier: NCT05163249). Treatment-naïve patients with locally advanced or metastatic NSCLC harboring de novo MET amplification or overexpression and EGFR mutations were randomized to receive osimertinib monotherapy (cohort 1, 80 mg orally once daily) or combination therapy (cohort 2, osimertinib 80 mg orally once daily and savolitinib 300 mg orally twice daily). The primary endpoint was the confirmed objective response rate (ORR). A total of 44 patients were randomized to either cohort 1 (n = 23) or cohort 2 (n = 21). The pre-specified study endpoint was achieved. The confirmed ORR was 60.9% (95% confidence interval [CI]: 38.5–80.3) in cohort 1 and 90.5% (95% CI: 69.6–98.8) in cohort 2, with disease control rates of 87% (95% CI: 66.4–97.2) and 95.2% (95% CI: 76.2–99.9). Treatment-related adverse events of grade 3 or higher occurred in 2 patients (8.7%) in cohort 1 and 12 patients (57.1%) in cohort 2. Osimertinib plus savolitinib showed promising antitumor activity and manageable safety.