Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular.

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Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial Won Seog Kim, MD, Christian Buske, MD, Michinori Ogura, MD, Wojciech Jurczak, MD, Juan-Manuel Sancho, MD, Edvard Zhavrid, MD, Jin Seok Kim, MD, José-Ángel Hernández-Rivas, MD, Aliaksandr Prokharau, MD, Mariana Vasilica, MD, Rajinish Nagarkar, MD, Dzhelil Osmanov, MD, Larry W Kwak, MD, Sang Joon Lee, PhD, Sung Young Lee, MS, Yun Ju Bae, MS, Dr Bertrand Coiffier, MD The Lancet Haematology Volume 4, Issue 8, Pages e362-e373 (August 2017) DOI: 10.1016/S2352-3026(17)30120-5 Copyright © 2017 Elsevier Ltd Terms and Conditions

Figure 1 Patient disposition of the pharmacokinetic subset and all randomised patients Text above the line shows all randomised patients (all patients in the pharmacokinetic subset, plus additional recruits); text below the line shows the pharmacokinetic subset. Six patients (two patients from the CT-P10 group, four patients from the rituximab group) from a study site that was found to be non-compliant with good clinical practice were excluded from all analyses and study populations and are not included in the patient disposition figure. CVP=cyclophosphamide, vincristine, and prednisone. The Lancet Haematology 2017 4, e362-e373DOI: (10.1016/S2352-3026(17)30120-5) Copyright © 2017 Elsevier Ltd Terms and Conditions

Figure 2 Serum concentration of CT-P10 and rituximab versus time Data are mean (±SD). Analyses are in the pharmacokinetic population (n=121; A, B) and the antibody-negative subset of the pharmacokinetic population (n=111; C, D). Data for cycle four is shown in A and C. The Lancet Haematology 2017 4, e362-e373DOI: (10.1016/S2352-3026(17)30120-5) Copyright © 2017 Elsevier Ltd Terms and Conditions