Heritage: A phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus Herceptin

Rugo, Hope S. and Barve, Abhijit and Waller, Cornelius F. and Hernandez-Bronchud, Miguel and Herson, Jay and Yuan, Jinyu and Manikhas, Alexey and Bondarenko, Igor and Mukhametshina, Guzel and Nemsadze, Gia and Parra, Joseph D. and Tiambeng, Maria Luisa T. Abesamis and Baramidze, Kakhaber and Akewanlop, Charuwan and Vynnychenko, Ihor and Sriuranpong, Virote and Manillapalli, Gopichand and Ray, Sirshendu and Ruiz, Eduardo Patricio Yanez and Pennella, Eduardo J (2016) Heritage: A phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus Herceptin. Journal of Clinical Oncology, Vol 34 (18_sup). P.-LBA503. ISSN 0732-183X (Print) ; 1527-7755 (Electronic) ; 0732-183X (Linking)

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Abstract

Background: Trastuzumab has revolutionized treatment of HER2+ breast cancer. Globally accessible alternatives are a critical need. We evaluated Myl-1401O, a proposed trastuzumab biosimilar, as treatment for HER2+ metastatic breast cancer (MBC), based on physicochemical analyses, nonclinical, pharmacokinetic and pharmacodynamic studies*. Methods: Heritage is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of Myl-1401O vs Herceptin. Eligible patients (pts) had ...

Item Type:	Article
Additional Information:	http://ascopubs.org/doi/abs/10.1200/JCO.2016.34.18_suppl.LBA503 Annals of Oncology, Volume 27, Issue suppl_6, 1 October 2016, LBA16, https://doi.org/10.1093/annonc/mdw435.06 Published: 13 October 2016; European Journal of Cancer.Vol.72. suppl.1. Page S41: http://dx.doi.org/10.1016/S0959-8049(17)30216-2
Subjects:	Oncology Radiology
Divisions:	Departments > Department of Oncology and Medical Radiology
Depositing User:	Елена Шрамко
Date Deposited:	10 Oct 2016 11:24
Last Modified:	20 Sep 2017 08:43
URI:	http://repo.dma.dp.ua/id/eprint/1040

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