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Journal of Thoracic Oncology
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Efficacy, Safety, and Biomarker Analysis of Neoadjuvant Camrelizumab and Apatinib in Patients with Resectable Non-Small-Cell Lung Cancer: A Phase 2 Clinical Trial

  • Author Footnotes
    # contributing equally
    Jun Zhao
    Footnotes
    # contributing equally
    Affiliations
    Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China

    Key Laboratory of Minimally Invasive Therapy Research for Lung Cancer, Chinese Academy of Medical Sciences, Beijing, China
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  • Author Footnotes
    # contributing equally
    Liang Zhao
    Footnotes
    # contributing equally
    Affiliations
    Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
    Search for articles by this author
  • Wei Guo
    Affiliations
    Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China

    Key Laboratory of Minimally Invasive Therapy Research for Lung Cancer, Chinese Academy of Medical Sciences, Beijing, China
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  • Shuhang Wang
    Affiliations
    GCP center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
    Search for articles by this author
  • Xiuli Tao
    Affiliations
    PET-CT center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
    Search for articles by this author
  • Lin Li
    Affiliations
    Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
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  • Yousheng Mao
    Affiliations
    Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China

    Key Laboratory of Minimally Invasive Therapy Research for Lung Cancer, Chinese Academy of Medical Sciences, Beijing, China
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  • Fengwei Tan
    Affiliations
    Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China

    Key Laboratory of Minimally Invasive Therapy Research for Lung Cancer, Chinese Academy of Medical Sciences, Beijing, China
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  • Yushun Gao
    Affiliations
    Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
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  • Ning Wu
    Affiliations
    PET-CT center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
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  • Jianming Ying
    Affiliations
    Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
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  • Qi Xue
    Affiliations
    Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China

    Key Laboratory of Minimally Invasive Therapy Research for Lung Cancer, Chinese Academy of Medical Sciences, Beijing, China
    Search for articles by this author
  • Ning Li
    Affiliations
    GCP center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
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  • Shugeng Gao
    Correspondence
    Corresponding to: Prof. Shugeng Gao, Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.17 Panjiayuan Street South, Chaoyang District, Beijing 100021, People's Republic of China.
    Affiliations
    Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China

    Key Laboratory of Minimally Invasive Therapy Research for Lung Cancer, Chinese Academy of Medical Sciences, Beijing, China
    Search for articles by this author
  • Jie He
    Affiliations
    Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
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  • Author Footnotes
    # contributing equally
Published:March 01, 2023DOI:https://doi.org/10.1016/j.jtho.2023.02.019
Efficacy, Safety, and Biomarker Analysis of Neoadjuvant Camrelizumab and Apatinib in Patients with Resectable Non-Small-Cell Lung Cancer: A Phase 2 Clinical Trial
Previous ArticleInstitution-Level Evolution of Lung Cancer Resection Quality with Implementation of a Lymph Node Specimen Collection Kit.
Next ArticleMRTX-500 Phase 2 Trial: Sitravatinib With Nivolumab in Patients With Non-Squamous Non-Small Cell Lung Cancer Progressing On/After Checkpoint Inhibitor Therapy or Chemotherapy
      This paper is only available as a PDF. To read, Please Download here.

      Abstract

      Background

      Camrelizumab (an anti-PD-1 antibody) combined with apatinib (an antiangiogenic agent) have conferred benefits for advanced non-small-cell lung cancer (NSCLC). We aimed to assess the activity and safety of neoadjuvant camrelizumab plus apatinib in resectable NSCLC patients.

      Methods

      In this phase 2 trial, patients with histologically confirmed resectable stage IIA-IIIB NSCLC (stage IIIB, T3N2 only) received intravenous camrelizumab (200 mg) every 2 weeks for three cycles and oral apatinib (250 mg) once daily for 5 days followed by 2 days off for 6 weeks. Surgery was planned 3-4 weeks after apatinib discontinuation. The primary endpoint was major pathologic response (MPR) rate, assessed in patients who received at least one dose of neoadjuvant treatment and underwent surgery.

      Results

      Between November 9, 2020 and February 16, 2022, 78 patients were treated and 65 (83%) underwent surgery. All 65 patients achieved an R0 surgical resection. Among 65 patients, 37 (57%, 95% CI 44%-69%) patients had an MPR, of whom 15 (23%, 95% CI 14%-35%) had a pathologic complete response (pCR). Pathologic responses observed in squamous-cell NSCLC were superior to adenocarcinoma (MPR: 64% vs. 25%; pCR: 23% vs. 0%). The radiographic objective response rate was 52% (95% CI 40%-65%). Among all the 78 enrolled patients, 37 (47%, 95% CI 36%-59%) patients had an MPR, of whom 15 (19%, 95% CI 11%-30%) had a pCR. Four (5%) of 78 patients had grade 3 neoadjuvant treatment-related adverse events (TRAEs). No grade 4 or 5 TRAEs occurred. Receiver operating characteristic analysis showed a significant correlation between the maximum reduction of standard uptake values and pathologic response (R = 0.619, P < 0.0001). Additionally, baseline PD-L1 expression, HOXA9 and SEPT9 methylation levels, and ctDNA status before surgery were associated with pathologic responses.

      Conclusion

      Neoadjuvant camrelizumab plus apatinib showed promising activity and manageable toxicity in patients with resectable stage IIA-IIIB NSCLC, which might be a potential therapeutic option in neoadjuvant setting.

      Keywords

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      Article info

      Publication history

      Accepted: February 26, 2023
      Received in revised form: February 20, 2023
      Received: December 11, 2022

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      CRediT Authorship Contribution Statement

      Jun Zhao: Investigation, Resources, Writing - original draft, Writing - review & editing

      Liang Zhao: Investigation, Resources, Project administration, Writing - original draft, Writing - review & editing

      Wei Guo: Investigation, Project administration, Writing - original draft, Writing - review & editing

      Shuhang Wang: Formal analysis, Data curation, Writing - review & editing

      Xiuli Tao: Investigation, Resources, Writing - review & editing

      Lin Li: Investigation, Resources, Writing - review & editing

      Yousheng Mao: Investigation, Resources, Writing - review & editing

      Fengwei Tan: Investigation, Resources, Writing - review & editing

      Yushun Gao: Investigation, Resources, Writing - review & editing

      Ning Wu: Investigation, Formal analysis, Writing - review & editing

      Jianming Ying: Investigation, Methodology, Writing - review & editing

      Qi Xue: Investigation, Validation, Writing - review & editing

      Ning Li: Formal analysis, Software, Writing - review & editing

      Shugeng Gao: Conceptualization, Data curation, Methodology, Writing - review & editing, Funding acquisition, Project administration, Resources, Supervision

      Jie He: Project administration, Resources, Supervision

      Funding

      This work was supported by the National Key Research and Development Program of China (2021YFC2500900), the National Natural Science Foundation of China (82002451, 82273129), the CAMS Initiative for Innovative Medicine (2021-I2M-1-015), and the Jiangsu Hengrui Pharmaceuticals Co., Ltd (no grant number).

      Conflict of Interest Statement

      The authors declare that they have no competing interests.

      Identification

      DOI: https://doi.org/10.1016/j.jtho.2023.02.019

      Copyright

      © 2023 Published by Elsevier Inc. on behalf of International Association for the Study of Lung Cancer.

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