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A pilot study of neoadjuvant combination of anti-PD-1 camrelizumab and VEGFR2 inhibitor apatinib for locally advanced resectable oral squamous cell carcinoma

Author

Listed:
  • Wu-tong Ju

    (Shanghai Jiao Tong University School of Medicine)

  • Rong-hui Xia

    (Shanghai Jiao Tong University School of Medicine)

  • Dong-wang Zhu

    (Shanghai Jiao Tong University School of Medicine)

  • Sheng-jin Dou

    (Shanghai Jiao Tong University School of Medicine)

  • Guo-pei Zhu

    (Shanghai Jiao Tong University School of Medicine)

  • Min-jun Dong

    (Shanghai Jiao Tong University School of Medicine)

  • Li-zhen Wang

    (Shanghai Jiao Tong University School of Medicine)

  • Qi Sun

    (Shanghai Jiao Tong University School of Medicine)

  • Tong-chao Zhao

    (Shanghai Jiao Tong University School of Medicine)

  • Zhi-hang Zhou

    (Shanghai Jiao Tong University School of Medicine)

  • Si-yuan Liang

    (Shanghai Jiao Tong University School of Medicine)

  • Ying-ying Huang

    (Shanghai Jiao Tong University School of Medicine)

  • Yong Tang

    (Shanghai Jiao Tong University School of Medicine)

  • Si-cheng Wu

    (Shanghai Jiao Tong University School of Medicine)

  • Jing Xia

    (The Medical Department, 3D Medicines Inc.)

  • Shi-qing Chen

    (The Medical Department, 3D Medicines Inc.)

  • Yue-zong Bai

    (The Medical Department, 3D Medicines Inc.)

  • Jiang Li

    (Shanghai Jiao Tong University School of Medicine)

  • Qi Zhu

    (Shanghai Jiao Tong University School of Medicine)

  • Lai-ping Zhong

    (Shanghai Jiao Tong University School of Medicine
    National Center for Stomatology
    National Clinical Research Center for Oral Diseases
    Shanghai Key Laboratory of Stomatology)

Abstract

Novel neoadjuvant therapy regimens are warranted for oral squamous cell carcinoma (OSCC). In this phase I trial (NCT04393506), 20 patients with locally advanced resectable OSCC receive three cycles of camrelizumab (200 mg, q2w) and apatinib (250 mg, once daily) before surgery. The primary endpoints are safety and major pathological response (MPR, defined as ≤10% residual viable tumour cells). Secondary endpoints include 2-year survival rate and local recurrence rate (not reported due to inadequate follow-up). Exploratory endpoints are the relationships between PD-L1 combined positive score (CPS, defined as the number of PD-L1-stained cells divided by the total number of viable tumour cells, multiplied by 100) and other immunological and genomic biomarkers and response. Neoadjuvant treatment is well-tolerated, and the MPR rate is 40% (8/20), meeting the primary endpoint. All five patients with CPS ˃10 achieve MPR. Post-hoc analysis show 18-month locoregional recurrence and survival rates of 10.5% (95% CI: 0%–24.3%) and 95% (95% CI: 85.4%–100.0%), respectively. Patients achieving MPR show more CD4+ T-cell infiltration than those without MPR (P = 0.02), and decreased CD31 and ɑ-SMA expression levels are observed after neoadjuvant therapy. In conclusion, neoadjuvant camrelizumab and apatinib is safe and yields a promising MPR rate for OSCC.

Suggested Citation

  • Wu-tong Ju & Rong-hui Xia & Dong-wang Zhu & Sheng-jin Dou & Guo-pei Zhu & Min-jun Dong & Li-zhen Wang & Qi Sun & Tong-chao Zhao & Zhi-hang Zhou & Si-yuan Liang & Ying-ying Huang & Yong Tang & Si-cheng, 2022. "A pilot study of neoadjuvant combination of anti-PD-1 camrelizumab and VEGFR2 inhibitor apatinib for locally advanced resectable oral squamous cell carcinoma," Nature Communications, Nature, vol. 13(1), pages 1-11, December.
  • Handle: RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-022-33080-8
    DOI: 10.1038/s41467-022-33080-8
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    1. Joris L. Vos & Joris B. W. Elbers & Oscar Krijgsman & Joleen J. H. Traets & Xiaohang Qiao & Anne M. Leun & Yoni Lubeck & Iris M. Seignette & Laura A. Smit & Stefan M. Willems & Michiel W. M. Brekel & , 2021. "Neoadjuvant immunotherapy with nivolumab and ipilimumab induces major pathological responses in patients with head and neck squamous cell carcinoma," Nature Communications, Nature, vol. 12(1), pages 1-13, December.
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    3. Rebekka Duhen & Carmen Ballesteros-Merino & Alexandra K. Frye & Eric Tran & Venkatesh Rajamanickam & Shu-Ching Chang & Yoshinobu Koguchi & Carlo B. Bifulco & Brady Bernard & Rom S. Leidner & Brendan D, 2021. "Neoadjuvant anti-OX40 (MEDI6469) therapy in patients with head and neck squamous cell carcinoma activates and expands antigen-specific tumor-infiltrating T cells," Nature Communications, Nature, vol. 12(1), pages 1-14, December.
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    1. Li Yuan & Guo-Dong Jia & Xiao-Fei Lv & Si-Yi Xie & Shan-Shan Guo & Da-Feng Lin & Li-Ting Liu & Dong-Hua Luo & Yi-Fu Li & Shen-Wen Deng & Ling Guo & Mu-Sheng Zeng & Xiu-Yu Cai & Sai-Lan Liu & Xue-Song , 2023. "Camrelizumab combined with apatinib in patients with first-line platinum-resistant or PD-1 inhibitor resistant recurrent/metastatic nasopharyngeal carcinoma: a single-arm, phase 2 trial," Nature Communications, Nature, vol. 14(1), pages 1-17, December.

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