{
  "abstract": "Background: Treatment options for refractory gastric cancer are limited. Preclinical data suggest interplay between angiogenesis and immune regulation, with vascular endothelial growth factor impairing antitumor immunity through decreasing antigen presentation, effector function, and immune cell trafficking. This phase II study evaluated lenvatinib plus pembrolizumab in the refractory setting. Patients and methods: Eligible patients had advanced gastric or gastroesophageal junction adenocarcinoma with measurable disease, Eastern Cooperative Oncology Group ≤ 1, and progression after ≥1 prior therapy, without prior immune checkpoint inhibitor exposure. Patients received pembrolizumab 200 mg i.v. every 21 days and lenvatinib 20 mg orally daily, with a 7-day lead-in. Primary endpoint was objective response rate. Using Simon optimal two-stage design, 29 patients were planned; the study would be considered positive if ≥6 responses were observed. Secondary endpoints included safety, progression-free survival (PFS), and overall survival (OS). Results: Enrollment was prematurely suspended at 24 patients due to evolving practice patterns. Median age was 63 years; 75% were male; 63% were White. Seven patients (29%) received ≥2 lines of therapy. Among 20 assessable patients, 5 (25%) achieved partial responses, including 2 with combined positive score (CPS) <1 tumors. Median duration of response was 31.6 weeks. Median PFS and OS were 12.9 and 21.4 weeks, respectively. Treatment was well tolerated with no new safety signals. Conclusions: Lenvatinib plus pembrolizumab did not meet the predefined efficacy threshold in the overall cohort. However, treatment was well tolerated and encouraging responses were seen in patients with CPS <1 tumors. Although the sample size was limited, these findings suggest that further investigation of this treatment strategy in patients with CPS < 1 disease may be warranted.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Medical Oncology, Stanford University School of Medicine, Stanford, USA",
    "Division of Medical Oncology, NYU Laura and Isaac Pearlmutter Cancer Center, New York, USA",
    "Division of Biostatistics, Department of Population Health, NYU Grossman School of Medicine and Biostatistics Shared Resource, Pearlmutter Cancer Center, New York, USA",
    "Department of Biostatistics, NYU College of Global Public Health, New York, USA",
    "New York-Presbyterian Weill Cornell Medical Center, New York, USA",
    "Division of Hematology and Oncology, Mount Sinai Tisch Cancer Center, New York, USA"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 12,
  "authors": [
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      "name": "J.W. Lee"
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    {
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        1
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      "name": "P.E. Oberstein"
    },
    {
      "affs": [
        2
      ],
      "name": "J.D. Goldberg"
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    {
      "affs": [
        3
      ],
      "name": "M. Jia"
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    {
      "affs": [
        1
      ],
      "name": "D. Becker"
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    {
      "affs": [
        4
      ],
      "name": "D. Siolas"
    },
    {
      "affs": [
        1
      ],
      "name": "N. Beri"
    },
    {
      "affs": [
        1
      ],
      "name": "T. Ryan"
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    {
      "affs": [
        4
      ],
      "name": "P. Kozuch"
    },
    {
      "affs": [
        2
      ],
      "name": "B. Levinson"
    },
    {
      "affs": [
        1
      ],
      "name": "L.P. Leichman"
    },
    {
      "affs": [
        5
      ],
      "name": "D.J. Cohen"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/3k6kdgmsdw877.bib",
  "cited_by": 0,
  "doi": "10.1016/j.esmogo.2026.100420",
  "fulltext_url": "http://www.sciencedirect.com/science/article/pii/S2949819826001202",
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  "landing_url": "https://doi.org/10.1016/j.esmogo.2026.100420",
  "language": "en",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
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  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
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      "lcc",
      "RC254-282"
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    [
      "openalex",
      "2740|Gastric Cancer Management and Outcomes"
    ]
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  "openalex": "W7223097972",
  "pdf_url": "https://www.esmogastro.org/article/S2949-8198(26)00120-2/pdf",
  "pmcid": "PMC13718771",
  "pmid": "42959918",
  "published": "2026-10-21",
  "publisher": "Elsevier",
  "ris": "https://research.draconitic.com/paper/3k6kdgmsdw877.ris",
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  "subjects": [
    {
      "field": "medicine",
      "origin": "lcc:RC254-282",
      "subfield": "oncology"
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  ],
  "title": "Phase II study of lenvatinib plus pembrolizumab for patients with immunotherapy-naive advanced gastric cancer following first-line therapy",
  "title_text": "Phase II study of lenvatinib plus pembrolizumab for patients with immunotherapy-naive advanced gastric cancer following first-line therapy",
  "type": "peer-reviewed",
  "updated_at": "2026-11-02T12:22:44Z",
  "url": "https://research.draconitic.com/paper/3k6kdgmsdw877",
  "venue": "ESMO Gastrointestinal Oncology",
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