Journal of Immunology Research / 2016 / Article / Tab 2

Research Article

Immunogenicity Assessment of Lipegfilgrastim in Patients with Breast Cancer Receiving Chemotherapy

Table 2

ADA titer and binding specificity of ADA-positive samples from lipegfilgrastim-treated patients.

Patient Competitor/titerTime point
BLC2D1C3D1C4D1D85D180D360

Phase II study

1FilgrastimNANANANANegNANA
glycoG-CSFNANANANANegNANA
cPEGNANANANAPosNANA
TiterNANANANA0.6NANA

2FilgrastimNANANANANANANeg
glycoG-CSFNANANANANANANeg
cPEGNANANANANANANeg
TiterNANANANANANA0

3FilgrastimPosPosPosPosPosPosPos
glycoG-CSFPosPosPosPosPosPosPos
cPEGNegNegNegNegNegNegNeg
Titer0000000

4FilgrastimPosPosPosPosNegPosNA
glycoG-CSFNegNegNegPosPosPosNA
cPEGPosPosPosPosPosPosNA
Titer0.30.90.60.60.60.3NA

5FilgrastimNSQNegNANANANegNeg
glycoG-CSFNSQNegNANANANegNeg
cPEGNSQPosNANANAPosPos
TiterNSQ0NANANA00

6FilgrastimNegNANANANANANA
glycoG-CSFNegNANANANANANA
cPEGNegNANANANANANA
Titer0.6NANANANANANA

7FilgrastimPosNANANANANANA
glycoG-CSFNegNANANANANANA
cPEGPosNANANANANANA
Titer1.5NANANANANANA

8FilgrastimPosNANANANANANA
glycoG-CSFNegNANANANANANA
cPEGPosNANANANANANA
Titer0.3NANANANANANA

9FilgrastimPosNANANANANANA
glycoG-CSFNegNANANANANANA
cPEGPosNANANANANANA
Titer0NANANANANANA

Phase III study

13FilgrastimNANANANANAPosPos
glycoG-CSFNANANANANAPosPos
cPEGNANANANANANegNeg
TiterNANANANANA1.22.1

14FilgrastimNegNegNegNegNANANA
glycoG-CSFNegNegNegNegNANANA
cPEGPosPosPosPosNANANA
Titer0.61.20.90.6NANANA

15FilgrastimPosNegNANANANANA
glycoG-CSFPosPosNANANANANA
cPEGNegNegNANANANANA
Titer2.11.8NANANANANA

16FilgrastimPosNANANANANANA
glycoG-CSFNegNANANANANANA
cPEGPosNANANANANANA
Titer0.9NANANANANANA

ADA: antidrug antibody; BL: baseline; C2D1: cycle 2 day 1; C3D1: cycle 3 day 1; C4D1: cycle 4 day 1; cPEG: PEG portion of lipegfilgrastim; D85: day 85; D180: day 180; D360: day 360; glycoG-CSF: glycosylated granulocyte colony-stimulating factor; NA: screened negative sample or confirmed-negative one (not analyzed in characterization assay); Neg: confirmed-negative sample; NSQ: insufficient sample quantity for analysis; Pos: confirmed-positive sample.
Italic font indicates patient with treatment-emergent ADA.

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