Advertisement

Drugs & Therapy Perspectives

, Volume 34, Issue 7, pp 281–287 | Cite as

Dinutuximab beta in high-risk neuroblastoma: a profile of its use

  • Kate McKeage
  • Katherine A. Lyseng-WilliamsonEmail author
Adis Drug Q&A
  • 125 Downloads

Abstract

Dinutuximab beta (Qarziba®), a monoclonal antibody, is indicated to treat high-risk neuroblastoma in patients aged ≥ 12 months in the first-line setting subsequent to front-line treatment with induction chemotherapy, myeloablative therapy and stem cell transplantation (SCT), as well as in the relapsed/refractory setting. It targets disialoganglioside 2, which is highly expressed on neuroblastoma cells. Unlike dinutuximab, which is produced using mouse SP2/0 cells, dinutuximab beta is produced using the more widely used Chinese hamster ovary cells. In both the first-line and relapsed/refractory settings, treatment with dinutuximab beta achieves objective clinical responses in patients with high-risk neuroblastoma. Following standard front-line treatment, survival rates were higher in dinutuximab beta recipients than in historical controls treated in the pre-immunotherapy era. Appropriate measures should be taken to manage toxicities (e.g. neuropathic pain, pyrexia and hypersensitivity reactions) associated with dinutuximab beta treatment. The continuous, 10-day infusion regimen appears to be associated with less toxicity than the once-daily infusion on 5 consecutive days.

Notes

Acknowledgements

The manuscript was reviewed by: P.F. Ambros, Children’s Cancer Research Institute, St. Anna Kinderkrebsforschung, Vienna, Austria; F.H. Felix, Pediatric Cancer Center, Hospital Infantil Albert Sabin, Fortaleza, Brazil; R. Kebudi, Division of Pediatric Hematology-Oncology, Cerrahpaşa Medical Faculty & Oncology Institute, Istanbul, Turkey; H.B. Lindsay, Pediatric Hematology/Oncology, Baylor College of Medicine, Houston, TX, USA; J. Morales, Pharmacy Department, Hospital Dr Luis Calvo Mackenna, Santiago, Chile. During the peer review process, EUSA Pharma (UK) Limited, the marketing-authorization holder of dinutuximab beta, was offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Funding

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

Compliance with ethical standards

Conflict of interest

K McKeage and K.A. Lyseng-Williamson are employees of Adis/Springer, are responsible for the article content and declare no conflicts of interest.

References

  1. 1.
    European Medicines Agency Committee for Medicinal Products for Human Use. Assessment report: dinutuximab beta Apeiron. London: European Medicines Agency; 2017.Google Scholar
  2. 2.
    Dobrenkov K, Cheung N-K. GD2-targeted immunotherapy and radioimmunotherapy. Semin Oncol. 2014;41(5):589–612.CrossRefGoogle Scholar
  3. 3.
    Matthay KK, George RE, Yu AL. Promising therapeutic targets in neuroblastoma. Clin Cancer Res. 2012;18(10):2740–53.CrossRefGoogle Scholar
  4. 4.
    Yang RK, Sondel PM. Anti-GD2 strategy in the treatment of neuroblastoma. Drugs Futur. 2010;35(8):665.CrossRefGoogle Scholar
  5. 5.
    Yu AL, Gilman AL, Ozkaynak MF, et al. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010;363(14):1324–34.CrossRefGoogle Scholar
  6. 6.
    Ladenstein R, Weixler S, Baykan B, et al. Ch14.18 antibody produced in CHO cells in relapsed or refractory Stage 4 neuroblastoma patients: a SIOPEN Phase 1 study. mAbs. 2013;5(5):801–9.CrossRefGoogle Scholar
  7. 7.
    Qarziba® (dinutuximab beta EUSA) 4.5 mg/mL concentrate for solution for infusion: summary of product characteristics. London: European Medicines Agency; 2018.Google Scholar
  8. 8.
    Siebert N, Eger C, Seidel D, et al. Pharmacokinetics and pharmacodynamics of ch14.18/CHO in relapsed/refractory high-risk neuroblastoma patients treated by long-term infusion in combination with IL-2. mAbs. 2016;8(3):604–16.CrossRefGoogle Scholar
  9. 9.
    Lode HN, Valteau-Couanet D, Troschke-Meurer S, et al. Phase II clinical trial with long-term infusion of anti-GD2 antibody ch14.18/CHO in combination with interleukin-2 (IL2) in patients with high risk neuroblastoma [abstract no. 10562]. J Clin Oncol. 2016;34(15 Suppl).CrossRefGoogle Scholar
  10. 10.
    Mueller I, Ehlert K, Endres S, et al. Tolerability, response and outcome of high-risk neuroblastoma patients treated with long-term infusion of anti-GD2 antibody ch14.18/CHO. mAbs. 2018;10(1):55–61.CrossRefGoogle Scholar
  11. 11.
    Ladenstein R, Pötschger U, Valteau Couanet D, et al. Immunotherapy with anti-GD2 antibody ch14.18/CHO ± IL2 within the HR-NBL1/SIOPEN trial improves outcome of high-risk neuroblastoma patients compared to historical controls [abstract]. In: Advances in Neuroblastoma Research Meeting. 2018.Google Scholar
  12. 12.
    Holmes K, Pötschger U, Sarnacki S, et al. The influence of surgical excision on survival in high-risk neuroblastoma revisited after introduction of ch14.18/CHO immunotherapy in the HR-NBL1/SIOPEN trial [abstract]. In: Advances in Neuroblastoma Research Meeting. 2018.CrossRefGoogle Scholar
  13. 13.
    Lode HN, Valteau-Couanet D, Garaventa A, et al. Immunotherapy with ch14.18/CHO in combination with IL2 is active and effective in high-risk relapsed/refractory neuroblastoma patients [abstract no. A032 + poster]. Cancer Immunol Res. 2016;4(1 Suppl).CrossRefGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018
corrected publication June/2018

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations