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Background <p>Highly vascularised neuroendocrine tumours (NETs) are attractive targets for foslinanib (CVM-1118), which disrupts vasculogenic mimicry and induces apoptosis via tumour necrosis factor receptor-associated protein 1. We evaluated the efficacy and safety of CVM-1118 in advanced NETs.</p> Methods <p>Patients with grades 1–2, well-differentiated lung, gastrointestinal, or pancreatic NETs, refractory or intolerant to one or more standard therapies and progressing within 6 months, received CVM-1118 (200–300 mg orally twice daily) in 28-day cycles. Primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.</p> Results <p>Of 43 enroled participants, 35 were efficacy-evaluable; most had grade 2 pancreatic (63%) or gastrointestinal (34%) NETs with two prior therapies. Median PFS was 10.5 months (95% CI, 5.6–22.3). ORR was 3%, DCR was 77%, and median OS was not reached (95% CI, 23.8–NR). Sensitivity analysis in the full analysis set (<i>N</i> = 43) showed a PFS estimate broadly aligned with the primary analysis (median, 8.4 months); patients with prior everolimus, sunitinib, or peptide receptor radionuclide therapy (<i>N</i> = 22; median, 8.3 months) showed similar findings. Treatment-related adverse events occurred in 44%, mostly grades 1–2, with no serious events.</p> Conclusions <p>CVM-1118 demonstrates favourable efficacy and safety in advanced NETs.</p> Clinical Trial Registration <p>ClinicalTrials.gov identifier, NCT03600233.</p>

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Efficacy and safety of a novel oral anti-vasculogenic mimicry agent, CVM-1118, in advanced well-differentiated neuroendocrine tumors: a Phase IIa trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月2日

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  • Chia-Jui Yen,
  • Ming-Huang Chen,
  • Yen-Yang Chen,
  • Li-Yuan Bai,
  • Jen-Shi Chen,
  • Jason Chia-Hsun Hsieh,
  • Yu-Hsuan Shih,
  • I-Chen Wu,
  • Yen-Ling Chen,
  • Chun-Man Chen,
  • Ting-Yu Chao,
  • Yi-Wen Chu,
  • Du-Shieng Chien

摘要

Background

Highly vascularised neuroendocrine tumours (NETs) are attractive targets for foslinanib (CVM-1118), which disrupts vasculogenic mimicry and induces apoptosis via tumour necrosis factor receptor-associated protein 1. We evaluated the efficacy and safety of CVM-1118 in advanced NETs.

Methods

Patients with grades 1–2, well-differentiated lung, gastrointestinal, or pancreatic NETs, refractory or intolerant to one or more standard therapies and progressing within 6 months, received CVM-1118 (200–300 mg orally twice daily) in 28-day cycles. Primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.

Results

Of 43 enroled participants, 35 were efficacy-evaluable; most had grade 2 pancreatic (63%) or gastrointestinal (34%) NETs with two prior therapies. Median PFS was 10.5 months (95% CI, 5.6–22.3). ORR was 3%, DCR was 77%, and median OS was not reached (95% CI, 23.8–NR). Sensitivity analysis in the full analysis set (N = 43) showed a PFS estimate broadly aligned with the primary analysis (median, 8.4 months); patients with prior everolimus, sunitinib, or peptide receptor radionuclide therapy (N = 22; median, 8.3 months) showed similar findings. Treatment-related adverse events occurred in 44%, mostly grades 1–2, with no serious events.

Conclusions

CVM-1118 demonstrates favourable efficacy and safety in advanced NETs.

Clinical Trial Registration

ClinicalTrials.gov identifier, NCT03600233.