Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer

British Journal of Cancer
Philip E LammersIra Jacobs

Abstract

This randomised, double-blind study compared pharmacokinetics, efficacy, safety and immunogenicity of PF-05280014 (potential trastuzumab biosimilar) and trastuzumab reference product (Herceptin) sourced from the European Union (trastuzumab-EU) as neoadjuvant treatment for operable human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Patients (N = 226), stratified by primary tumour size and hormone receptor status, were randomised 1:1 to PF-05280014 or trastuzumab-EU (8 mg/kg loading dose; 6 mg/kg thereafter), each with docetaxel and carboplatin, every 3 weeks for six treatment cycles. Primary endpoint was percentage of patients with trough plasma concentration (Ctrough) >20 μg/ml at Cycle 5 (Cycle 6 predose). Efficacy endpoints included pathological complete response and objective response rate. Non-inferiority of PF-05280014 to trastuzumab-EU was declared if the lower limit of the 95% confidence interval for the stratified difference between groups in the percentage of patients with Cycle 5 Ctrough >20 μg/ml was above the prespecified non-inferiority margin of - 12.5%. For PF-05280014 vs trastuzumab-EU patients, respectively, 92.1% vs 93.3% had Cycle 5 Ctrough >20 μg/ml; the lower limit of the 95% confidence...Continue Reading

References

Oct 1, 1993·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·R SeshadriP Kitchen
Oct 21, 2005·The New England Journal of Medicine·Martine J Piccart-GebhartUNKNOWN Herceptin Adjuvant (HERA) Trial Study Team
Oct 21, 2005·The New England Journal of Medicine·Edward H RomondNorman Wolmark
Oct 31, 2009·Biologicals : Journal of the International Association of Biological Standardization·R DobbelaerUNKNOWN World Health Organization
Mar 24, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Michael UntchGunter von Minckwitz
Oct 14, 2011·The New England Journal of Medicine·Dennis SlamonUNKNOWN Breast Cancer International Research Group
Jan 20, 2012·The Lancet Oncology·Michael UntchUNKNOWN Arbeitsgemeinschaft Gynäkologische Onkologie-Breast (AGO-B) Study Group
Oct 9, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Antonio C WolffUNKNOWN College of American Pathologists
Jul 9, 2014·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Susan HurstTeresa A Smolarek
May 20, 2015·Clinical and Molecular Allergy : CMA·Carlo AgostiniEnrico Maggi
Sep 1, 2015·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E SenkusUNKNOWN ESMO Guidelines Committee
Jan 15, 2016·American Journal of Therapeutics·Leah IsakovIra Allen Jacobs
Apr 7, 2016·MAbs·Alicia M VanaReginald Ewesuedo
Jul 28, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·N ChernyA Eniu

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Citations

Jun 9, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Jichun YangFeng Sun
Oct 1, 2019·Journal of Cellular Physiology·Afshin DerakhshaniBehzad Baradaran
Oct 18, 2019·Targeted Oncology·Hans-Christian KolbergVladimir Hanes
Feb 15, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Justin StebbingHope S Rugo
Apr 17, 2020·Expert Review of Anticancer Therapy·Dario Trapani, Giuseppe Curigliano
Jul 14, 2018·British Journal of Cancer·Xavier Pivot, Thierry Petit
Oct 4, 2018·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Julia Paik
Dec 5, 2019·Therapeutic Advances in Medical Oncology·Emily M Miller, Lee S Schwartzberg
Dec 15, 2019·Nature Reviews. Clinical Oncology·Kristina GoutsouliakRachel Schiff
Jul 28, 2020·The Annals of Pharmacotherapy·Dat Ngo, Jason Chen
Apr 14, 2019·Breast Cancer Research and Treatment·Michael Coory, Kate Thornton
Apr 26, 2019·Breast Care·Antonia Busse, Diana Lüftner
Feb 21, 2021·BMC Immunology·Lobna Abdel Aziz KilanyHamdallah Hafez Zedan
Apr 8, 2021·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Binghe XuUNKNOWN HLX02-BC01 Investigators
Apr 20, 2021·Therapeutic Advances in Medical Oncology·Jie ZhangChuangui Song
Jun 8, 2021·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Aqsa SafdarMuhammad Zaman
Jan 25, 2022·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Sarah WeiserEdward R Zartler

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Methods Mentioned

BETA
biopsy
surgical
dissection
surgical resection
enzyme-linked immunosorbent assay

Clinical Trials Mentioned

NCT01989676
NCT02187744

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