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Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis

  • Authors:
    • Shaoqing Fan
    • Chunyue Gai
    • Baokun Li
    • Guiying Wang
  • View Affiliations / Copyright

    Affiliations: Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, P.R. China, Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, P.R. China, Department of General Surgery, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, P.R. China
    Copyright: © Fan et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
  • Article Number: 351
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    Published online on: June 30, 2023
       https://doi.org/10.3892/ol.2023.13937
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Abstract

In November 2021, the National Medical Products Administration (China) approved the marketing of envafolimab injection for the treatment of advanced defective mismatch repair (dMMR)/high microsatellite instability (MSI‑H) solid tumors. Envafolimab became the first domestic PD‑L1 inhibitor approved in China and the first worldwide approved subcutaneously injectable PD‑L1 inhibitor. To the best of our knowledge, there are no reports of systematic analyses regarding the use of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors. The present study was a single‑arm meta‑analysis performed on data systematically searched and retrieved from literature published on PubMed, Web of Science, Cochrane Library, China National Knowledge Infra‑structure and Wan Fang databases on 1 October 2022. Quality assessment using the 20 items developed by the Canadian Institute of Health Economics. Data heterogenicity was evaluated using the I2 statistics. For datasets with I2>50%, the cumulative incidence and 95% CI for the outcomes of interests were calculated using the random effects model, whereas for I2<50% the fixed effects model was used. The current meta‑analysis included four studies enrolling 181 patients with advanced dMMR/MSI‑H solid tumors. The pooled objective remission rate was 29.53% (95% CI, 8.61‑50.45%). The pooled disease control rate was 60.58% (95% CI, 31.79‑89.38%). The pooled median progression‑free survival was 4.89 months (95% CI, 1.86‑7.93 months). The pooled overall survival (OS) rate was 73.38% (95% CI, 65.76‑80.99%). The pooled 6‑month and 12‑month OS rates were 75.80% (95% CI, 57.02‑94.58%) and 69.32% (95% CI, 51.92‑86.72%), respectively. The combined data on the incidence of treatment‑emergent adverse events (TEAEs) of any grade from all the studies was 77.19% (95% CI, 63.15‑91.23%). Most of the adverse reactions were mild and the rate of 3/4 grade TEAE was 10.37% (95% CI, 6.14‑14.60%). Gevokizumab was effective and safe in the treatment of patients with advanced dMMR/MSI‑H solid tumors and its convenience could significantly improve patient compliance; therefore, the clinical application of envafolimab is promising.
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1 

Das S and Johnson DB: Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors. J Immunother Cancer. 7:3062019. View Article : Google Scholar : PubMed/NCBI

2 

Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, et al: Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 357:409–413. 2017. View Article : Google Scholar : PubMed/NCBI

3 

Papadopoulos KP, Harb W, Peer CJ, Hua Q, Xu S, Lu H, Lu N, He Y, Xu T, Dong R, et al: First-in-human phase I study of envafolimab, a novel subcutaneous single-domain anti-PD-L1 antibody, in patients with advanced solid tumors. Oncologist. 26:e1514–e1525. 2021. View Article : Google Scholar : PubMed/NCBI

4 

Markham A: Envafolimab: First approval. Drugs. 82:235–240. 2022. View Article : Google Scholar : PubMed/NCBI

5 

Machiels JP, Tao Y, Burtness B, Tahara M, Licitra L, Rischin D, Waldron J, Simon C, Gregoire V, Harrington K, et al: Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncol. 16:1235–1243. 2020. View Article : Google Scholar : PubMed/NCBI

6 

Galsky MD, Mortazavi A, Milowsky MI, George S, Gupta S, Fleming MT, Dang LH, Geynisman DM, Walling R, Alter RS, et al: Randomized double-blind phase II study of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer. J Clin Oncol. 38:1797–1806. 2020. View Article : Google Scholar : PubMed/NCBI

7 

Ömeroğlu Şimşek G: Lung cancer management in COVID-19 pandemic. Turk Thorac J. 21:340–344. 2020. View Article : Google Scholar : PubMed/NCBI

8 

National Medical Products Administration (NMPA), . Envafolimab Injection. Full prescribing information. NMPA; Beijing: 2021

9 

Liu R, Yin X, Deng Y, Xu N, Xiang S, Zhang Y, Gong Y, Liu D and Xu J: Safety and efficacy of envafolimab combined with FOLFOX as first-line treatment in patients with locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma in a phase II clinical trial. Chin J New Drugs. 031:1502–1508. 2022.(In Chinese).

10 

Li J, Deng Y, Zhang W, Zhou AP, Guo W, Yang J, Yuan Y, Zhu L, Qin S, Xiang S, et al: Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors. J Hematol Oncol. 14:952021. View Article : Google Scholar : PubMed/NCBI

11 

Moga C, Guo B, Schopflocher D and Harstall C: Development of a quality appraisal tool for case series studies using a modified delphi technique. 2012.

12 

Shimizu T, Nakajima TE, Yamamoto N, Yonemori K, Koyama T, Kondo S, Sunakawa Y, Izawa N, Horie Y, Xiang S, et al: Phase I study of envafolimab (KN035), a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody, in Japanese patients with advanced solid tumors. Invest New Drugs. 40:1021–1031. 2022. View Article : Google Scholar : PubMed/NCBI

13 

Diaz LA Jr, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, et al: Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): Final analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 23:659–670. 2022. View Article : Google Scholar : PubMed/NCBI

14 

Marabelle A, Le DT, Ascierto PA, Di Giacomo AM, De Jesus-Acosta A, Delord JP, Geva R, Gottfried M, Penel N, Hansen AR, et al: Efficacy of pembrolizumab in patients with noncolorectal high microsatellite instability/mismatch repair-deficient cancer: Results from the phase II KEYNOTE-158 study. J Clin Oncol. 38:1–10. 2020. View Article : Google Scholar : PubMed/NCBI

15 

Overman MJ, McDermott R, Leach JL, Lonardi S, Lenz HJ, Morse MA, Desai J, Hill A, Axelson M, Moss RA, et al: Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): An open-label, multicentre, phase 2 study. Lancet Oncol. 18:1182–1191. 2017. View Article : Google Scholar : PubMed/NCBI

16 

Chongqing T, Sini L, Xiaohui Z, Liubao P, Ye P, Shuxia Q, Liting W, Meiyu W and Xiaomin W: Cost-effectiveness of first-line versus second-line pembrolizumab or chemotherapy in patients with microsatellite-instability-high/mismatch repair-deficient advanced colorectal cancer. Front Pharmacol. 12:8029422021. View Article : Google Scholar : PubMed/NCBI

17 

Liu T, Liu S, Guan S, Tai Y, Jin Y and Dong M: Cost-effectiveness analysis of pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. J Chemother. Jan 2–2023.(Epub ahead of print). View Article : Google Scholar

18 

Shu Y, Ding Y and Zhang Q: Cost-effectiveness of nivolumab plus chemotherapy vs chemotherapy as first-line treatment for advanced gastric cancer/gastroesophageal junction cancer/esophagel adenocarcinoma in China. Front Oncol. 12:8515222022. View Article : Google Scholar : PubMed/NCBI

19 

Salem ME, Bodor JN, Puccini A, Xiu J, Goldberg RM, Grothey A, Korn WM, Shields AF, Worrilow WM, Kim ES, et al: Relationship between MLH1, PMS2, MSH2 and MSH6 gene-specific alterations and tumor mutational burden in 1057 microsatellite instability-high solid tumors. Int J Cancer. 147:2948–2956. 2020. View Article : Google Scholar : PubMed/NCBI

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Copy and paste a formatted citation
Spandidos Publications style
Fan S, Gai C, Li B and Wang G: Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis. Oncol Lett 26: 351, 2023.
APA
Fan, S., Gai, C., Li, B., & Wang, G. (2023). Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis. Oncology Letters, 26, 351. https://doi.org/10.3892/ol.2023.13937
MLA
Fan, S., Gai, C., Li, B., Wang, G."Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis". Oncology Letters 26.2 (2023): 351.
Chicago
Fan, S., Gai, C., Li, B., Wang, G."Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis". Oncology Letters 26, no. 2 (2023): 351. https://doi.org/10.3892/ol.2023.13937
Copy and paste a formatted citation
x
Spandidos Publications style
Fan S, Gai C, Li B and Wang G: Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis. Oncol Lett 26: 351, 2023.
APA
Fan, S., Gai, C., Li, B., & Wang, G. (2023). Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis. Oncology Letters, 26, 351. https://doi.org/10.3892/ol.2023.13937
MLA
Fan, S., Gai, C., Li, B., Wang, G."Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis". Oncology Letters 26.2 (2023): 351.
Chicago
Fan, S., Gai, C., Li, B., Wang, G."Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis". Oncology Letters 26, no. 2 (2023): 351. https://doi.org/10.3892/ol.2023.13937
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