Immunogenicity Assessment of Lipegfilgrastim in Patients with Breast Cancer Receiving Chemotherapy

Table 3

Evaluation of the potential impact of ADA on efficacy among patients with treatment-emergent ADA.

Treatment	Patient	ADA + time point		DSN (days)	ANC AUC	ANC maximum	ANC nadir
Phase II study
Pegfilgrastim	10	D85	Cycle 1	0	160.25	9.60	6.8
			Cycle 2	0	212.95	14.90	7.9
			Cycle 3	0	116.25	8.50	3.6
			Cycle 4	0	91.85	7.50	2.4
Lipegfilgrastim	2	D360	Cycle 1	1	154.24	20.39	0.18
			Cycle 2	1	170.20	21.40	0.0
			Cycle 3	0	225.40	27.64	1.25
			Cycle 4	0	202.26	28.42	1.72
	1	D85	Cycle 1	0	127.80	17.00	0.8
			Cycle 2	0	147.25	9.60	2.2
			Cycle 3	0	121.60	8.30	0.7
			Cycle 4	0	179.55	16.70	1.3
Phase III study
Pegfilgrastim	17	D85	Cycle 1	0	219.88	47.99	0.89
			Cycle 2	0	198.15	13.73	2.2
			Cycle 3	0	302.98	68.32	2.16
			Cycle 4	0	315.63	57.42	4.06
Lipegfilgrastim	13	D360	Cycle 1	2	160.16	26.14	0.25
			Cycle 2	0	257.95	51.92	1.25
			Cycle 3	0	300.24	58.91	1.2
			Cycle 4	0	291.36	68.75	1.45

ADA: antidrug antibody; ANC: absolute neutrophil count; AUC: area under the curve; D85: day 85; D360: day 360; DSN: duration of severe neutropenia.