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Background <p><i>FGFR2</i> has garnered attention as a promising therapeutic target for gastric cancer (GC) because of its role in GC progression. Infigratinib, an FGFR1–3 selective tyrosine kinase inhibitor, has shown potential in preclinical GC models.</p> Methods <p>Infigratinib was evaluated in a phase 2 trial for patients with <i>FGFR2</i>-amplified GC or gastroesophageal junction (GEJ) adenocarcinoma who had failed two or more lines of systemic treatment for locally advanced or metastatic disease. A total of 21 patients received 125 mg of infigratinib orally once daily on a “3 weeks on, 1 week off” schedule.</p> Results <p>Infigratinib showed preliminary antitumor activity in this molecularly selected population, as reflected by a confirmed objective response rate of 23.8% (95% CI, 8.2–47.2) with median progression-free survival of 3.4 months and median overall survival of 6.7 months. The most common grade 3–4 adverse events were elevated aspartate aminotransferase, decreased white blood cell count, and neutropenia. No treatment-related deaths occurred. Exploratory genomic analyses identified alterations in individual patients with disease progression that may be associated with resistance; however, these findings were based on a limited number of cases and should be interpreted as hypothesis-generating.</p> Conclusions <p>The findings support continued investigation of FGFR-targeted strategies in <i>FGFR2</i>-amplified GC/GEJ adenocarcinoma, while underscoring the need for larger studies, refined biomarker selection, and deeper characterization of resistance mechanisms.</p> Trial registration <p>NCT05019794, Registered 28 July 2021, <a href="https://clinicaltrials.gov/study/NCT05019794">https://clinicaltrials.gov/study/NCT05019794</a>.</p>

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Efficacy and safety of infigratinib in patients with refractory advanced gastric or gastroesophageal junction adenocarcinoma harboring FGFR2 gene amplification: a single-arm, multicenter phase 2 trial

  • 期刊论文

  • 发表日期：

    2026年6月23日

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  • Jiajia Yuan,
  • Jifang Gong,
  • Zhi Peng,
  • Tian Shu Liu,
  • HuiTing Xu,
  • Jianwei Yang,
  • Jia Wei,
  • Haiping Jiang,
  • Yanhong Deng,
  • Yusheng Wang,
  • Changsong Qi,
  • Cheng Lyu,
  • Qiao Sun,
  • Lei Mu,
  • Lin Song,
  • Xiaotian Zhang,
  • Lin Shen

摘要

Background

FGFR2 has garnered attention as a promising therapeutic target for gastric cancer (GC) because of its role in GC progression. Infigratinib, an FGFR1–3 selective tyrosine kinase inhibitor, has shown potential in preclinical GC models.

Methods

Infigratinib was evaluated in a phase 2 trial for patients with FGFR2-amplified GC or gastroesophageal junction (GEJ) adenocarcinoma who had failed two or more lines of systemic treatment for locally advanced or metastatic disease. A total of 21 patients received 125 mg of infigratinib orally once daily on a “3 weeks on, 1 week off” schedule.

Results

Infigratinib showed preliminary antitumor activity in this molecularly selected population, as reflected by a confirmed objective response rate of 23.8% (95% CI, 8.2–47.2) with median progression-free survival of 3.4 months and median overall survival of 6.7 months. The most common grade 3–4 adverse events were elevated aspartate aminotransferase, decreased white blood cell count, and neutropenia. No treatment-related deaths occurred. Exploratory genomic analyses identified alterations in individual patients with disease progression that may be associated with resistance; however, these findings were based on a limited number of cases and should be interpreted as hypothesis-generating.

Conclusions

The findings support continued investigation of FGFR-targeted strategies in FGFR2-amplified GC/GEJ adenocarcinoma, while underscoring the need for larger studies, refined biomarker selection, and deeper characterization of resistance mechanisms.

Trial registration

NCT05019794, Registered 28 July 2021, https://clinicaltrials.gov/study/NCT05019794.