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Targeted Oncology
Erschienen in:

Open Access 03.08.2020 | Review Article

Biologic Drug Quality Assurance to Optimize HER2 + Breast Cancer Treatment: Insights from Development of the Trastuzumab Biosimilar SB3

verfasst von: Diana Lüftner, Gary H. Lyman, João Gonçalves, Xavier Pivot, Minji Seo

Erschienen in: Targeted Oncology | Ausgabe 4/2020

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Abstract

SB3 is a biosimilar of trastuzumab that has been approved for use in the treatment of human epidermal growth factor 2-positive breast cancer and human epidermal growth factor 2-positive gastric cancer. Antibody-dependent cellular cytotoxicity is one of several critical quality attributes of trastuzumab. Data from the development of SB3 support the hypothesis of a relationship between antibody-dependent cellular cytotoxicity activity and clinical outcomes in terms of the response rate and long-term survival. Current analytic methods utilizing advanced technology allow the detection of small changes in other quality attributes that influence antibody-dependent cellular cytotoxicity, such as glycosylation and FcγRIIIa binding. Use of such methods to monitor batch-to-batch consistency enables production of trastuzumab biosimilars with consistent quality. Trastuzumab biosimilars such as SB3 therefore have the potential to increase accessibility to trastuzumab-based therapy without compromising efficacy or safety.
Literatur
1.
Loibl S, Gianni L. HER2-positive breast cancer. Lancet. 2017;389:2415–29.CrossRef
2.
Cardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, et al. Early breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up†. Ann Oncol. 2019;30:1194–220.CrossRef
3.
Cardoso F, Senkus E, Costa A, Papadopoulos E, Aapro M, André F, et al. 4th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 4)†. Ann Oncol. 2018;29:1634–57.CrossRef
4.
Denduluri N, Chavez-MacGregor M, Telli ML, Eisen A, Graff SL, Hassett MJ, et al. Selection of optimal adjuvant chemotherapy and targeted therapy for early breast cancer: ASCO clinical practice guideline focused update. J Clin Oncol. 2018;36:2433–43.CrossRef
5.
Giordano SH, Temin S, Chandarlapaty S, Crews JR, Esteva FJ, Kirshner JJ, et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: ASCO clinical practice guideline update. J Clin Oncol. 2018;36:2736–40.CrossRef
6.
7.
Lyman GH, Zon R, Harvey RD. Rationale, opportunities, and reality of biosimilar medications. N Engl J Med. 2018;379:694–5.CrossRef
8.
Nixon NA, Hannouf MB, Verma S. The evolution of biosimilars in oncology, with a focus on trastuzumab. Curr Oncol. 2018;25:S171–9.CrossRef
9.
Bazargani YT, de Boer A, Schellens JHM, Leufkens HGM, Mantel-Teeuwisse AK. Essential medicines for breast cancer in low and middle income countries. BMC Cancer. 2015;15:591.CrossRef
10.
Lammers P, Criscitiello C, Curigliano G, Jacobs I. Barriers to the use of trastuzumab for HER2 + breast cancer and the potential impact of biosimilars: a physician survey in the United States and emerging markets. Pharmaceuticals (Basel). 2014;7:943–53.CrossRef
11.
Jackisch C, Lammers P, Jacobs I. Evolving landscape of human epidermal growth factor receptor 2-positive breast cancer treatment and the future of biosimilars. Breast. 2017;32:199–216.CrossRef
12.
13.
Barbier L, Declerck P, Simoens S, Neven P, Vulto AG, Huys I. The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars. Br J Cancer. 2019;121:199–210.CrossRef
14.
15.
Stebbing J, Mainwaring PN, Curigliano G, Pegram M, Latymer M, Bair AH, et al. Understanding the role of comparative clinical studies in the development of oncology biosimilars. J Clin Oncol. 2020;38:1070–80.CrossRef
16.
Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, et al. American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol. 2018;36:1260–5.CrossRef
17.
Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, et al. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2016;1:e000142.CrossRef
18.
Zelenetz AD, Ahmed I, Braud EL, Cross JD, Davenport-Ennis N, Dickinson BD, et al. NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Cancer Netw. 2011;9(Suppl. 4):S1–22.
19.
Liedtke C, Jackisch C, Thill M, Thomssen C, Müller V, Janni W, et al. Recommendations for the diagnosis and treatment of patients with early breast cancer: update 2018. Breast Care (Basel). 2018;13:196–208.CrossRef
20.
Declerck PJ. Biologicals and biosimilars: a review of the science and its implications. GaBI J. 2012;1:13–6.CrossRef
21.
22.
Pivot X, Aulagner G, Blay JY, Fumoleau P, Kaliski A, Sarkozy F, et al. Challenges in the implementation of trastuzumab biosimilars: an expert panel’s recommendations. Anticancer Drugs. 2015;26:1009–16.CrossRef
23.
24.
25.
26.
Kirchhoff CF, Wang X-ZM, Conlon HD, Anderson S, Ryan AM, Bose A. Biosimilars: key regulatory considerations and similarity assessment tools. Biotechnol Bioeng. 2017;114:2696–705.CrossRef
27.
Pivot X, Pegram M, Cortes J, Lüftner D, Lyman GH, Curigliano G, et al. Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer. Eur J Cancer. 2019;120:1–9.CrossRef
28.
Gonçalves J, Araújo F, Cutolo M, Fonseca JE. Biosimilar monoclonal antibodies: preclinical and clinical development aspects. Clin Exp Rheumatol. 2016;34:698–705.PubMed
29.
Rathore AS. Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol. 2009;27:546–53.CrossRef
30.
Kim S, Song J, Park S, Ham S, Paek K, Kang M, et al. Drifts in ADCC-related quality attributes of Herceptin®: impact on development of a trastuzumab biosimilar. MAbs. 2017;9:704–14.CrossRef
31.
32.
Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs. 2014;28:363–72.CrossRef
33.
Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol. 2011;29:310–2.CrossRef
34.
Vezér B, Buzás Z, Sebeszta M, Zrubka Z. Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents. Curr Med Res Opin. 2016;32:829–34.CrossRef
35.
36.
37.
Clynes RA, Towers TL, Presta LG, Ravetch JV. Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets. Nat Med. 2000;6:443–6.CrossRef
38.
Lee JH, Paek K, Moon JH, Ham S, Song J, Kim S. Biological characterization of SB3, a trastuzumab biosimilar, and the influence of changes in reference product characteristics on the similarity assessment. BioDrugs. 2019;33:411–22.CrossRef
39.
Hudis CA. Trastuzumab: mechanism of action and use in clinical practice. N Engl J Med. 2007;357:39–51.CrossRef
40.
41.
Pivot X, Bondarenko I, Nowecki Z, Dvorkin M, Trishkina E, Ahn J-H, et al. Phase III, randomized, double-blind study comparing the efficacy, safety, and immunogenicity of SB3 (trastuzumab biosimilar) and reference trastuzumab in patients treated with neoadjuvant therapy for human epidermal growth factor receptor 2-positive early breast cancer. J Clin Oncol. 2018;36:968–74.CrossRef
42.
43.
44.
von Minckwitz G, Colleoni M, Kolberg H-C, Morales S, Santi P, Tomasevic Z, et al. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2018;19:987–98.CrossRef
45.
Kolberg H-C, Colleoni M, Santi P, Demetriou GS, Segui-Palmer MA, Fujiwara Y, et al. Totality of scientific evidence in the development of ABP 980, a biosimilar to trastuzumab. Target Oncol. 2019;14:647–56.CrossRef
46.
Martin M. The LILAC trial and the blooming of anticancer biosimilars. Lancet Oncol. 2018;19:861–3.CrossRef
47.
Pivot X, Bondarenko I, Nowecki Z, Dvorkin M, Trishkina E, Ahn J-H, et al. A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: final safety, immunogenicity and survival results. Eur J Cancer. 2018;93:19–27.CrossRef
48.
Pivot X, Curtit E, Lee YJ, Golor G, Gauliard A, Shin D, et al. A randomized phase I pharmacokinetic study comparing biosimilar candidate SB3 and trastuzumab in healthy male subjects. Clin Ther. 2016;38(1665–73):e3.
49.
Jackisch C, Scappaticci FA, Heinzmann D, Bisordi F, Schreitmüller T, von Minckwitz G, et al. Neoadjuvant breast cancer treatment as a sensitive setting for trastuzumab biosimilar development and extrapolation. Future Oncol. 2015;11:61–71.CrossRef
50.
Pivot X, Petit T. Can we establish a hierarchy among trastuzumab biosimilar candidates? Br J Cancer. 2018;119:263–5.CrossRef
51.
52.
Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;384:164–72.CrossRef
53.
Jackisch C, Hegg R, Stroyakovskiy D, Ahn J-S, Melichar B, Chen S-C, et al. HannaH phase III randomised study: association of total pathological complete response with event-free survival in HER2-positive early breast cancer treated with neoadjuvant-adjuvant trastuzumab after 2 years of treatment-free follow-up. Eur J Cancer. 2016;62:62–75.CrossRef
54.
Xie L, Zhang E, Xu Y, Gao W, Wang L, Xie MH, et al. Demonstrating analytical similarity of trastuzumab biosimilar HLX02 to Herceptin® with a panel of sensitive and orthogonal methods including a novel FcγRIIIa affinity chromatography technology. BioDrugs. 2020;34:363–79.CrossRef
Metadaten
Titel
Biologic Drug Quality Assurance to Optimize HER2 + Breast Cancer Treatment: Insights from Development of the Trastuzumab Biosimilar SB3
verfasst von
Diana Lüftner
Gary H. Lyman
João Gonçalves
Xavier Pivot
Minji Seo
Publikationsdatum
03.08.2020
Verlag
Springer International Publishing
Erschienen in
Targeted Oncology / Ausgabe 4/2020
Print ISSN: 1776-2596
Elektronische ISSN: 1776-260X
DOI
https://doi.org/10.1007/s11523-020-00742-w

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