Apatinib combined with camrelizumab in the treatment of recurrent/metastatic nasopharyngeal carcinoma: a prospective multicenter phase II study

Front Immunol. 2024 Jan 3:14:1298418. doi: 10.3389/fimmu.2023.1298418. eCollection 2023.

Abstract

Background: Preclinical studies demonstrated that immune checkpoint inhibitors combined with antiangiogenic drugs have a synergistic anti-tumor effect. This present phase II trial aimed to evaluate the efficacy and safety of apatinib combined with camrelizumab in patients with recurrent/metastatic nasopharyngeal carcinoma (RM-NPC).

Methods: Patients with RM-NPC were administered with apatinib at 250 mg orally once every day and with camrelizumab at 200 mg via intravenous infusion every 2 weeks until the disease progressed or toxicity became unacceptable. The objective response rate (ORR) was the primary endpoint, assessed using RECIST version 1.1. Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety were the key secondary endpoints. This study was registered with ClinicalTrials.gov, NCT04350190.

Results: This study enrolled 26 patients with RM-NPC between January 14, 2021 and September 15, 2021. At data cutoff (March 31, 2023), the median duration of follow-up was 16 months (ranging from 1 to 26 months). The ORR was 38.5% (10/26), the disease control rate (DCR) was 61.5% (16/26), and the median PFS was 6 months (IQR 3.0-20.0). The median OS was 14 months (IQR 6.0-21.25). Treatment-related grade 3 or 4 adverse events occurred in seven (26.9%) patients, and comprised anemia (7.7%), stomatitis (3.8%), headache (3.8%), pneumonia (7.7%), and myocarditis (3.8%). There were no serious treatment-related adverse events or treatment-related deaths.

Conclusion: In patients with RM-NPC, apatinib plus camrelizumab showed promising antitumor activity and manageable toxicities.

Keywords: apatinib; camrelizumab; clinical trial; immunotherapy; nasopharyngeal carcinoma; targeted therapy.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Antibodies, Monoclonal, Humanized*
  • Humans
  • Nasopharyngeal Carcinoma / drug therapy
  • Nasopharyngeal Neoplasms* / drug therapy
  • Prospective Studies
  • Pyridines*

Substances

  • apatinib
  • camrelizumab
  • Pyridines
  • Antibodies, Monoclonal, Humanized

Associated data

  • ClinicalTrials.gov/NCT04350190

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was supported by the Natural Science Foundation Key Projects of Guangxi (No. 2018GXNSFDA050021); Guangxi Medical and health key discipline construction project; The “139” Talent Cultivation Plan Program of Guangxi Medical High-level Backbone, the National Natural Science Foundation of China (No. 82160479); the CSCO Youth Innovative Oncology Research Fund (No. Y-Young2020-0520); the Scientific Research Program of the Health Commission of Guangxi Zhuang Autonomous Region (Nos. Z20201200, Z20170816, Z20170207); Self-funded scientific research project of Guangxi Zhuang Autonomous region Health and Family Planning Commission (Z20180415).