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<p>Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) are heterogeneous tumors with limited treatment options. This phase 2 Bayesian study evaluated the combination of regorafenib, a multikinase inhibitor, and avelumab, a programmed death 1 (PD1) ligand 1 inhibitor, in advanced grade 2–grade 3 well-differentiated GEP neuroendocrine tumors or grade 3 GEP neuroendocrine carcinomas after progression on prior therapies. A total of 47 participants were enrolled and 42 were evaluable for efficacy. Participants received regorafenib (160 mg per day) and avelumab (10 mg kg<sup>−1</sup> biweekly) in 28-day cycles. The primary endpoint, 6-month objective response rate per the response evaluation criteria in solid tumors version 1.1, was 18% (95% confidence interval (CI): 8–31%), with a median progression-free survival of 5.5 months (95% CI: 3.6–8). Durable responses were noted (16.6 months; 95% CI: 3.7–no response). Treatment-related adverse events were manageable, with fatigue, diarrhea and palmar-plantar erythrodysesthesia being most common. Exploratory biomarker analysis identified PD1 and indoleamine 2,3-dioxygenase 1 expression and activity as potential resistance markers. These findings highlight the clinical potential of regorafenib and avelumab in GEP-NENs, emphasizing the need for predictive biomarkers and validation in future randomized trials. Clinical Trial registration<b>:</b> <a href="https://clinicaltrials.gov/ct2/show/NCT03475953">NCT03475953</a>.</p>

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Regorafenib plus avelumab in advanced gastroenteropancreatic neuroendocrine neoplasms: a phase 2 trial and correlative analysis

  • 期刊论文

  • 发表日期：

    2025年4月9日

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  • Sophie Cousin,
  • Jean-Philippe Guégan,
  • Lola Jade Palmieri,
  • Jean Philippe Metges,
  • Simon Pernot,
  • Carine A. Bellera,
  • Eric Assenat,
  • Iphigenie Korakis,
  • Philippe Alexandre Cassier,
  • Antoine Hollebecque,
  • Coralie Cantarel,
  • Michèle Kind,
  • Isabelle Soubeyran,
  • Harry Sokol,
  • Lucile Vanhersecke,
  • Alban Bessede,
  • Antoine Italiano

摘要

Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) are heterogeneous tumors with limited treatment options. This phase 2 Bayesian study evaluated the combination of regorafenib, a multikinase inhibitor, and avelumab, a programmed death 1 (PD1) ligand 1 inhibitor, in advanced grade 2–grade 3 well-differentiated GEP neuroendocrine tumors or grade 3 GEP neuroendocrine carcinomas after progression on prior therapies. A total of 47 participants were enrolled and 42 were evaluable for efficacy. Participants received regorafenib (160 mg per day) and avelumab (10 mg kg−1 biweekly) in 28-day cycles. The primary endpoint, 6-month objective response rate per the response evaluation criteria in solid tumors version 1.1, was 18% (95% confidence interval (CI): 8–31%), with a median progression-free survival of 5.5 months (95% CI: 3.6–8). Durable responses were noted (16.6 months; 95% CI: 3.7–no response). Treatment-related adverse events were manageable, with fatigue, diarrhea and palmar-plantar erythrodysesthesia being most common. Exploratory biomarker analysis identified PD1 and indoleamine 2,3-dioxygenase 1 expression and activity as potential resistance markers. These findings highlight the clinical potential of regorafenib and avelumab in GEP-NENs, emphasizing the need for predictive biomarkers and validation in future randomized trials. Clinical Trial registration: NCT03475953.