XM02 is superior to placebo and equivalent to Neupogen™ in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy

Table 2 Results of Efficacy Endpoints

Treatment group	XM02	Neupogen™	Placebo/XM02*
Full analysis set [n]	(n = 140)	(n = 136)	72
Mean DSN [days]
Cycle 1	1.1	1.1	3.8
ANCOVA [CI]#	0.028 [-0.261, 0.316]
Cycle 4	0.7	0.7	0.6
Mean ANC nadir [10 ⁹ /L]
Cycle 1	0.7	0.7	0.2
ANCOVA [CI]#	-0.001 [-0.190, 0.189]
Cycle 4	1.0	1.0	1.1
Mean time to ANC recovery [days]
Cycle 1	8.0	7.8	14.0
ANCOVA [CI]#	0.207 [-0.425, 0.838]
Cycle 4	7.6	7.1	7.2
Incidence of FN [%]+
Cycle 1	12.1	12.5	36.1
Across all cycles	20.7	22.1	41.7

Abbreviations: DSN: duration of severe neutropenia; ANC: absolute neutrophil count; FN: febrile neutropenia; ANCOVA: analysis of covariance, CI: confidence interval.
* Patients in this group received placebo in cycle 1 and XM02 afterwards (including in cycle 4).
# ANCOVA estimate and 2-sided 95% confidence interval for difference XM02 – Filgrastim in cycle 1.
+ Observed or protocol defined FN.

ISSN: 1471-2407