Mecapegfilgrastim in Chemotherapy-Induced Neutropenia: A Profile of Its Use in China

  • Zaina T. Al-SalamaEmail author
  • Susan J. Keam
Adis Drug Q&A


Mecapegfilgrastim (HHPG-19K) is a long-acting pegylated recombinant human granulocyte-colony stimulating factor (rhG-CSF) that is administered subcutaneously as prophylaxis once per chemotherapy cycle as a weight-adjusted dose of 100 µg/kg or as a 6 mg fixed dose. It is approved in China to reduce the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapy associated with a clinically significant incidence of febrile neutropenia. In phase III trials, once per cycle prophylaxis with mecapegfilgrastim was more effective than placebo in reducing the incidence of grade ≥ 3 neutropenia in cycle 1 in patients with advanced non-small cell lung cancer and was more effective than filgrastim at reducing the mean duration of grade ≥ 3 neutropenia in cycle 1 in patients with breast cancer. The tolerability and safety profiles of mecapegfilgrastim were similar to those of filgrastim, with no unexpected adverse events (AEs); most adverse reactions in cycle 1 were mild or moderate in severity. Thus, mecapegfilgrastim is an effective and generally well tolerated treatment option for patients with non-myeloid malignancies receiving myelosuppressive chemotherapy, and extends the options available for managing chemotherapy-induced neutropenia in China.



The manuscript was reviewed by: C. Cerchione, Hematology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola (FC), Italy; P. Gascón, Division of Medical Oncology, Hospital Clinic, University of Barcelona, Barcelona, Spain. During the peer review process, the manufacturer of mecapegfilgrastim was also offered an opportunity to review this article. Changes resulting from comments received will be made on the basis of scientific and editorial merit.

Compliance with Ethical Standards


The preparation of this review was not supported by any external funding.

Conflict of interest

Zaina T. Al-Salama and Susan J. Keam are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.


  1. 1.
    Kaushansky K. Lineage-specific hematopoietic growth factors. N Engl J Med. 2006;354(19):2034–45.CrossRefGoogle Scholar
  2. 2.
    National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: myeloid growth factors (version 2.2018). 2018. Accessed 23 Jul 2019.
  3. 3.
    Klastersky J, De Naurois J, Rolston K, et al. Management of febrile neutropaenia: ESMO clinical practice guidelines. Ann Oncol. 2016;27(Suppl 5):v111–8.CrossRefGoogle Scholar
  4. 4.
    Mitchell S, Li X, Woods M, et al. Comparative effectiveness of granulocyte colony-stimulating factors to prevent febrile neutropenia and related complications in cancer patients in clinical practice: a systematic review. J Oncol Pharm Pract. 2016;22(5):702–16.CrossRefGoogle Scholar
  5. 5.
    Morishita M, Leonard RC. Pegfilgrastim; a neutrophil mediated granulocyte colony stimulating factor-expanding uses in cancer chemotherapy. Expert Opin Biol Ther. 2008;8(7):993–1001.CrossRefGoogle Scholar
  6. 6.
    Jiangsu Hengrui Pharma Inc. Mecapegfilgrastim: prescribing information [English translation]. Lianyungang City: Jiangsu Hengrui Pharma Inc. 2018.Google Scholar
  7. 7.
    Xu F, Zhang Y, Miao Z, et al. Efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial. Ann Transl Med. 2019. Scholar
  8. 8.
    Zhou C, Huang Y, Wang D, et al. A randomized multicenter phase III study of single administration of mecapegfilgrastim (HHPG-19K), a pegfilgrastim biosimilar, for prophylaxis of chemotherapy-induced neutropenia in patients with advanced non-small-cell lung cancer (NSCLC). Clin Lung Cancer. 2016;17(2):119–27.CrossRefGoogle Scholar
  9. 9.
    Yan B, Zhang W, Lu F, et al. Safety of polyethylene glycol recombinant human granulocyte colony-stimulating factor in treating non-small cell lung cancer patients at I b stage. Asian Pac J Trop Med. 2013;6(11):912–5.CrossRefGoogle Scholar
  10. 10.
    Wang T, Wu B, Hu X, et al. A randomized multicenter phase II trial of mecapegfilgrastim single administration versus granulocyte colony-stimulating growth factor on treating chemotherapy-induced neutropenia in breast cancer patients. Ann Transl Med. 2019;7(9):196.CrossRefGoogle Scholar
  11. 11.
    Aapro MS, Bohlius J, Cameron DA, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011;47(1):8–32.CrossRefGoogle Scholar
  12. 12.
    Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the use of WBC growth factors: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2015;33(28):3199–212.CrossRefGoogle Scholar
  13. 13.
    Wang L, Baser O, Kutikova L, et al. The impact of primary prophylaxis with granulocyte colony-stimulating factors on febrile neutropenia during chemotherapy: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer. 2015;23(11):3131–40.CrossRefGoogle Scholar
  14. 14.
    Aapro M, Boccia R, Leonard R, et al. Refining the role of pegfilgrastim (a long-acting G-CSF) for prevention of chemotherapy-induced febrile neutropenia: consensus guidance recommendations. Support Care Cancer. 2017;25(11):3295–304.CrossRefGoogle Scholar
  15. 15.
    Ye X, Zhai Q, Wang Z-Y, et al. Neutropenic complications in Chinese patients with breast cancer in a real-world setting. Int J Clin Exp Pathol. 2017;10(1):651–60.Google Scholar
  16. 16.
    Kyowa Hakko Kirin Co. L. Products: GRAN®/ PEGLASTA® /Neulasta®. Accessed 23 Jul 2019.
  17. 17.
    Jefferies Financial Group. Pharmaceuticals: all about earnings; set to diverge. 2017. Accessed 23 Jul 2019.
  18. 18.
    Ye Q, Jiang H. A comparison of the effect of xinruibai versus filgrastim on hematopoietic reconstruction after allogeneic hematopoietic stem cell transplantation. Ital J Pediatr. 2018;44(1):63.CrossRefGoogle Scholar
  19. 19.
    Shi YK, Chen Q, Zhu YZ, et al. Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study. Anticancer Drugs. 2013;24(6):641–7.Google Scholar
  20. 20.
    Green MD, Koelbl H, Baselga J, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003;14(1):29–35.CrossRefGoogle Scholar
  21. 21.
    Holmes FA, O’Shaughnessy JA, Vukelja S, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002;20(3):727–31.CrossRefGoogle Scholar
  22. 22.
    Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005;23(6):1178–84.CrossRefGoogle Scholar
  23. 23.
    Data on file, Qilu Pharma, 2019.Google Scholar
  24. 24.
    Amgen Inc. Neulasta® (pegfilgrastim) injection, for subcutaneous use: US prescribing information. 2019. Accessed 23 Jul 2019.
  25. 25.
    Xie J, Cao J, Wang JF, et al. Advantages with prophylactic PEG-rhG-CSF versus rhG-CSF in breast cancer patients receiving multiple cycles of myelosuppressive chemotherapy: an open-label, randomized, multicenter phase III study. Breast Cancer Res Treat. 2018;168(2):389–99.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations