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Purpose <p>Epidermal growth factor receptor (<i>EGFR</i>) amplification remains a controversial therapeutic biomarker. We report outcomes of erlotinib plus bevacizumab (E + B) in patients with <i>EGFR</i>-amplified metastatic solid tumors.</p> Methods <p>Patients with metastatic solid cancer who had progressed after standard therapies and were treated with E + B based on central molecular tumor board recommendations in the KOSMOS trial were included. Only those with an <i>EGFR</i> copy number ≥ 3 were selected. The primary endpoint was the clinical benefit rate (CBR), while secondary endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.</p> Results <p>Between February 2021 and April 2024, 25 patients were treated with E + B (median EGFR copy 8.9; range, 3–76). Six tumor types were included, with colorectal cancer being the most prevalent (N = 14), followed by glioblastoma (N = 5), and other types (N = 6). Overall, four partial responses (PR) and seven cases of stable disease (SD) lasting over 16&#xa0;weeks were observed, resulting in a CBR of 44.0% and ORR of 16%. The median PFS was 3.7&#xa0;months (95% confidence interval [CI]: 1.7–4.6), whereas the median OS was 7.9&#xa0;months (95% CI: 6.5 to not estimable). Six patients experienced one or more grade 3 adverse events related to E + B, including hypertension and mucositis.</p> Conclusion <p>The E + B combination showed modest anti-tumor activity in patients with heavily pretreated <i>EGFR</i>-amplified solid cancers. While NGS may help identify new applications for existing drugs, additional investigations are warranted to validate the efficacy and benefit of E + B in this population.</p>

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Erlotinib plus bevacizumab in EGFR-amplified metastatic solid tumors: results from the KOSMOS I, II study of molecular profiling–guided therapy in advanced cancers

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月15日

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  • Jiwon Lee,
  • Jongmin Sim,
  • Yun-Gyoo Lee,
  • Gyeong-Won Lee,
  • Hyun Ae Jung,
  • Kyu-Pyo Kim,
  • Tae-Yong Kim,
  • Hyewon Ryu,
  • Min-Hee Ryu,
  • Mi-Sun Ahn,
  • Minsuk Kwon,
  • Bhumsuk Keam,
  • Jeong Mo Bae,
  • Sheehyun Kim,
  • Harim Koo,
  • Sun Young Kim,
  • Jee Hyun Kim,
  • Soohyeon Lee

摘要

Purpose

Epidermal growth factor receptor (EGFR) amplification remains a controversial therapeutic biomarker. We report outcomes of erlotinib plus bevacizumab (E + B) in patients with EGFR-amplified metastatic solid tumors.

Methods

Patients with metastatic solid cancer who had progressed after standard therapies and were treated with E + B based on central molecular tumor board recommendations in the KOSMOS trial were included. Only those with an EGFR copy number ≥ 3 were selected. The primary endpoint was the clinical benefit rate (CBR), while secondary endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.

Results

Between February 2021 and April 2024, 25 patients were treated with E + B (median EGFR copy 8.9; range, 3–76). Six tumor types were included, with colorectal cancer being the most prevalent (N = 14), followed by glioblastoma (N = 5), and other types (N = 6). Overall, four partial responses (PR) and seven cases of stable disease (SD) lasting over 16 weeks were observed, resulting in a CBR of 44.0% and ORR of 16%. The median PFS was 3.7 months (95% confidence interval [CI]: 1.7–4.6), whereas the median OS was 7.9 months (95% CI: 6.5 to not estimable). Six patients experienced one or more grade 3 adverse events related to E + B, including hypertension and mucositis.

Conclusion

The E + B combination showed modest anti-tumor activity in patients with heavily pretreated EGFR-amplified solid cancers. While NGS may help identify new applications for existing drugs, additional investigations are warranted to validate the efficacy and benefit of E + B in this population.