1. Lipegfilgras+m
A
new
long-­‐ac,ng
recombinant
human
G-­‐CSF
Joseph
Gligorov
MD,
PhD
ESO
Advanced
Breast
Cancer
Task
Force
APHP-­‐HUEP-­‐Tenon,
Paris
Ins+tut
Universitaire
de
Cancérologie
Université
Pierre
&
Marie
Curie,
Sorbonne
Universités

2. Conflict
of
interest
• Amgen®
• Genomic
Health®
• Eisai®
• Roche-­‐Genentech®
• Nanostring
®
• Novar,s
®
Clinical trials support, advisory boards, speaker

3. • Molecular
structure
:
«
glycoPEGyla+on
technology
»
• Long-­‐ac+ng
human
recombinant
G-­‐CSF
(r-­‐metHuG-­‐CSF)
Lipegfilgrastim

4. GlycoPEGyla+on
Explanation
§ Two enzymes - one-pot reaction
§ Two substrates
• Activated sugar
• Activated sugar linked to PEG
§ The PEGylation site is threonine 134 (THR134)
Filgrastim
(E. coli derived)
Lipegfilgrastim
(glycoPEGylated XM21)
ENZYME 1 ENZYME 2
XM21
S 1
THR134
XM21
THR134
XM21
S 1
S 2
THR134
S 1A1
A1
S 2A2
A2
S 1A1
S 2A2 PEG

5. Clinical
development
Phase I studies
XM22-01-CH PK/PD single dose, bodyweight adjusted dosing
N=53
25/50/100 µg/kg lipegfilgrastim vs
pegfilgrastim
XM22-05-CH PK/PD single dose, fixed dose
N=36
6 mg lipegfilgrastim vs pegfilgrastim
XM22-06
PK at three different injection sites (upper arm,
abdomen, thigh)
N=20
6 mg lipegfilgrastim vs pegfilgrastim
Phase II studie
XM22-02
Dose finding with three different doses of
Lonquex® compared to 6mg pegfilgrastim in
breast cancer patients
N=208
3/4.5/6 mg lipegfilgrastim vs 6mg
pegfilgrastim
phase III studies
XM22-03
Efficacy and safety of 6mg Lonquex® compared
to 6 mg pegfilgrastim in breast cancer patients
N=202
6 mg lipegfilgrastim vs 6mg
pegfilgrastim
XM22-04
Efficacy and safety of 6 mg Lonquex® compared
to placebo in non small cell lung cancer patients
N=373
6 mg lipegfilgrastim vs placebo

6. Phase
I
studies
Healthy
volunteers
1. lipegfilgras,m
25,
50,
100
µg/kg
vs
pegfilgras,m
100
µg/kg:
XM22-­‐01
2. lipegfilgras,m,
6
mg
vs
pegfilgras,m
6
mg:
XM22-­‐05
3. lipegfilgras,m,
6
mg,
3
sites
d’injec,on:
XM22-­‐06

7. 1
ANC
:
absolute
neutrophil
count
XM22-­‐01
XM22-­‐05
Objec+ves
PK/PD
single
dose
25,
50,
100
μg/kg
of
lipegfilgras+m
or
100
μg/kg
pegfilgras+m
bodyweight
adjusted
dosing
(n
=
53)
PK/PD
single
6
mg
fixed
dose
lipegfilgras+m
or
pegfilgras+m
(n
=
36)
Methods
Phase
I
randomised,
single-­‐blind
study
in
healthy
volunteers
Phase
I
randomised,
single-­‐blind
study
in
healthy
volunteers
Primary
endpoint
ANC1
AOBEC
(area
over
baseline
effect
curve)
ANC
AOBEC
Secondary
endpoints
§ PD:
CD34+
AOBEC,
CD
34+
max
,
ANC
max,
§ PK:
AUC,
Cmax,
Tmax,
T
½
terminal
§ Safety
§ PD:
CD34+
AOBEC,
CD
34+
max
,
ANC
max,
§ PK:
AUC,
Cmax,
Tmax,
T
½
terminal
§ Safety
Phase
I
studies

8. 0 24 48 72 96 120 144 168 192 216 240
0
XM22-01-CH
body weight depending dosing
Bioavailability AUC of lipegfilgrastim
56-57% > AUC of pegfilgrastim
(Median ± SD)
XM22-05-CH
fixed dose
100000
200000
300000
400000
500000
600000
Time* [h]
Concentration[pg/ml]
0
0 24 48 72 96 120 144 168 192
100000
200000
300000
400000
500000
600000
Time* [h]
Concentration[pg/ml] 216 240
50 µg/kg lipegfilgrastim (n=15)
100 µg/kg pegfilgrastim
(n=15)
25 µg/kg lipegfilgrastim (n=8)
100 µg/kg lipegfilgrastim (n=15)
6 mg pegfilgrastim, n = 15
6 mg lipegfilgrastim, n = 18
Bioavailability AUC of lipegfilgrastim
63-64% > AUC of pegfilgrastim
(Median ± SD)
Seiberling M, et al. Research report. XM22-01-CH. Mannheim, Germany: BioGenerix, 2009.
Seiberling M, et al. Research report. XM22-05-CH. Mannheim, Germany: BioGenerix, 2009

9. 0
10
20
30
40
50
60
0
10
20
30
40
50
60
XM22-01-CH
body weight depending dosing
XM22-05-CH
fixed dose
96 168 192216 264288 360 384 408
Time*[h]
ANC[neut/nl]
3363122401441207248240 96 168 192 216 264 288 360 384 408
Time*[h]
ANC[neut/nl]
3363122401441207248240
50 µg/kg lipegfilgrastim (n=15)
100 µg/kg pegfilgrastim
(n=15)
25 µg/kg lipegfilgrastim (n=8)
100 µg/kg lipegfilgrastim (n=15)
6 mg pegfilgrastim, n = 15
6 mg lipegfilgrastim, n = 18
With equivalent doses, ANC AUC with lipegfilgrastim >
32% ANC AUC with pegfilgrastim
(Median ± SD)
ANC AUC with lipegfilgrastim > 30% ANC AUC with
pegfilgrastim
(Median ± SD)
Seiberling M, et al. Research report. XM22-01-CH. Mannheim, Germany: BioGenerix, 2009.
Seiberling M, et al. Research report. XM22-05-CH. Mannheim, Germany: BioGenerix, 2009

10. 0 48 96 168192216 240264 288 432 456 480504
20
0
60
80
100
120
140
Time (h)
CD34+[cellcount/ul)
40
24 72 120 144 312 336360 384 408
100 µg/kg lipegfilgrastim (n=15)
100 µg/kg pegfilgrastim (n=15)
25 µg/kg lipegfilgrastim (n=8)
50 µg/kg lipegfilgrastim (n=15)
0 48 96 168192 216240264 288 432 456 480504
20
0
60
80
100
120
140
Time (h)
40
24 72 120 144 312 336 360384 408
CD34+[cellcount/ul)
With equivalent doses: CD34+ 83% and CD34+ max
98% higher with lipegfilgrastim vs pegfilgrastim
(Median)
6 mg pegfilgrastim, (n=18)
6 mg lipegfilgrastim, (n=18)
Seiberling M, et al. Research report. XM22-01-CH. Mannheim, Germany: BioGenerix, 2009.
Seiberling M, et al. Research report. XM22-05-CH. Mannheim, Germany: BioGenerix, 2009
CD34+ 9% and CD34+ max 16% higher with
lipegfilgrastim vs pegfilgrastim (ns)
(Median)
XM22-01-CH
body weight depending dosing
XM22-05-CH
fixed dose

11. 11
XM22-­‐01
n=53
XM-­‐05
n=
36
Lipegfilgras+m
n=38
Pegfilgras+m
n=15
lipegfilgras+m
n=18
Pegfilgras+m
n=18
Any
AE
35
(92,5%)
14
(93,3%)
15
(83,3%)
17
(94,4%)
Gastrointes+nal
7
(18,4%)
1
(6,7%)
3
(16,7%)
3
(16,7%)
Arthralgia
30
(79%)
13
(86,7%)
1
(5,6%)
0
(0%)
Back
pain
4
(10,5%)
0
(0%)
-­‐
-­‐
Headaches
21
(55,2%)
7
(46,7%)
10
(55,6%)
9
(50%)
Bone
pain
1
(2,6%)
2
(13,3%)
12
(66,7%)
15
(83,3%)
• AEs
were
mostly
mild
to
moderate
in
severity
• No
serious
AEs
• No
clinicaly
significant
change
in
biologic
and
vital
signs,
ECG
and
sonographic
examina,on
of
the
spleen
• No
injec,on
site
was
observed
Seiberling M, et al. Research report. XM22-01-CH. Mannheim, Germany: BioGenerix, 2009.
Seiberling M, et al. Research report. XM22-05-CH. Mannheim, Germany: BioGenerix, 2009
Safety
in
studies
XM22-­‐01,
XM22-­‐05
*AE
=
adverse
events

12. Phase
II
study
Breast
cancer
lipegfilgras,m
3mg,
4.5
mg
,
6
mg
vs
pegfilgras,m
6mg

13. § Primary objective:
§ To identify the optimal fixed dose of lipegfilgrastim in breast
cancer patients treated with chemotherapy compared to 6mg
pegfilgrastim
§ Methods:
§ Multinational, multicentre, randomised, double-blind, controlled
study with 4 treatment arms (6 european countries; 37 centres)
§ Patients were stratified according to geographical localisation,
indication of chemotherapy (adjuvant/metastatic) and body
weight
Kaufmann M, et al. Research report XM22-02. Mannheim, Germany: BioGenerix, 2011.
Phase
II
study

14. § Main inclusion criteria:
§ Stage II,III,IV Breast Cancer Cancer treated with 4 cycles of AT
(doxorubicine 60 mg/m2- docetaxel 75 mg/m2) every 3 weeks
§ No previous chemo
§ ANC ≥ 1,5 x 109/L, thrombocytes ≥ 100 x 109/L
§ ECOG* ≤ 2
§ Normal heart, kidney and liver function
§ Main exclusion criteria:
§ Previous G-CSF exposure
§ Anti infectious treatment (antibiotics) ≤ 72 hours before chemo initiation
§ Radiotherapy ≤ 4 weeks before study inclusion
§ Previous bone marrow transplantation
*ECOG= Eastern Cooperative Oncology Group
Phase
II
study

15. Doxorubicin
60
mg/m2
+
Docetaxel
75
mg/m2
(
n=208)
lipegfilgrastim 3.0 mg (n=53)
lipegfilgrastim 4.5 mg (n=51)
lipegfilgrastim 6.0 mg (n=50)
pegfilgrastim 6.0 mg
(n=54)
Primary
breast
cancer
patients
(N=229)
Randomization
Next chemo
cycle if ANC
≥1.5 x 109/L
and platelet
count
≥100 x 109/LOne chemotherapy cycle
= 21 days
rGCS-­‐F
therapy
Chemotherapy
Run-­‐in
Cycle
1
Cycle
2
Cycle
3
Cycle
4
Follow-­‐up
D1 D22 D43 D64
D85
End of study D180
Ab test
D360
Ab test
D2 D23 D44 D65
Ab=antibody test; D=day; chemo=chemotherapy.
Haematological and biochemical parameters measured on Day 15 of each cycle
Multinational, multicenter, randomized, double blind
Data on file
Buchner, A. et all JCO, 29:2011 (Suppl; abstr 9080)
Phase
II
study

16.
§ Primary
Endpoint:
Dura,on
of
Severe
Neutropenia
(DSN)
in
the
first
cycle
of
chemotherapy
in
the
respec,ve
arms
§ Secondary
Endpoint
§
Incidence
of
Febrile
Neutropenia
in
cycles
1,
2,
3,
and
4
and
across
all
cycles.
Febrile
§
DSN
in
cycles
2,
3,
and
4.
§ The
following
secondary
efficacy
endpoints
were
evaluated
in
cycles
1,
2,
3,
and
4:
§ Depth
of
ANC
nadir.
§
Time
to
ANC
recovery
(
ANC
≥2.0
x
109/L).
§ Incidence
of
grade
4
neutropenia
(ANC
<
0.5
x
109/L).
§ Safety
Data on file
Buchner, A. et all JCO, 29:2011 (Suppl; abstr 9080)
Severe Neutropenia =grade 4 neutropenia (ANC < 0.5 x 109/L).
Very Severe Neutropenia (ANC < 0.1 x 109/L)
Febrile Neutropenia was defined as axillary body temperature of > 38.5°C for more than 1 h and ANC <0.5 x 109/L, both measured on the same day L)
Phase
II
study

17. No significant difference between groups
4 groupes aux caractéristiques démographiques et médicales
comparables (en ITT et en PP)
Pegfilgrastim
N=54
lipegfilgrastim 3
mg, N=53
lipegfilgrastim
4,5 mg, N=51
lipegfilgrastim
6 mg, N=50
Total
N=208
Age (years)
Median ± SD
≤ 64 years, %
49,5 ±11,1
92,6%
53,1 ±9,2
86,8%
52,8 ± 10,1
88,2%
51,4 ± 9,8
90%
51,7 ±10,1
89,4%
Weight
≤ 60 kg
60 à 75 kg
> 75 kg
25,9%
33,3%
40,7%
22,6%
45,3%
32,1%
25,5%
39,2%
35,3%
26,0%
38,0%
36,0%
25,0%
38,9%
36,1%
CT indication
Adjuvant
Métastatic
79,6%
20,4%
81,1%
18,9%
86,3%
13,7%
82,0%
18,0%
82,2%
17,8%
Disease stage
High-risk stage II
Stage III
Stage IV
40,7%
42,6%
16,7%
39,6%
43,4%
17,0%
37,3%
51,0%
11,8%
36,0%
48,0%
16,0%
38,5%
46,2%
15,4%
ECOG status
0
1
2
61,1%
38,9%
0%
64,1%
34,0%
1,9%
51,0%
43,1%
5,9%
56,0%
42,0%
2,0%
58,2%
39,4%
2,4%
Patients caracteristics

18. Duration of Severe Neutropenia in cycle 1 (ITT population)
pegfilgrastim
6mg
Lonquex®
3mg
Lonquex®
4.5mg
Lonquex®
6mg
N valid,
Mean ± standard
deviation (median)
Minimum
to maximum
54
0.9±1.0 (1.0)
0.0 to 3.0
53
1.1±1.1 (1.0)
0.0 to 4.0
51
0.8±1.0 (1.0)
0.0 to 4.0
50
0.8±1.1 (0.0)
0.0 to 3.0
No statistically significant difference between treatment arms
Same results in PP population and within sub-groups analysis..
Phase
II
study

19. § Conclusion :
§ Non-inferiority of lipegfilgrastim 6 mg vs pegfilgrastim 6 mg was
demonstrated on DSN in cycle 1
§ Significantly more patients without severe neutropenia in the lipegfilgrastim
group vs pegfilgrastim group, in cycles 2, 3 and 4
§ Time to ANC recovery (ANC ≥ 2 x 10 9/L) significantly shorter with
lipegfilgrastim than pegfilgrastim 6 mg, in each cycle
§ Safety profile similar to pegfilgrastim 6 mg
Phase
II
study

20. Phase
III
study
XM22-­‐03
Lipegfilgras,m
6mg
vs
pegfilgras,m
6
mg
Breast
cancer
Bondarenko I, et al. BMC Cancer. 2013: 2013;13(1): 386.

21. § Primary Objective :
§ Demonstration of non-inferiority of Lonquex® versus
pegfilgrastim in patients treated for breast cancer
(doxorubicine-docétaxel)
Non inferiority hypothesis demonstrated if :
Δ DSN (lipegfilgrastim –pegfilgrastim) < 1 day
§ Design:
§ Multinational, multicenter, randomized, double-blind, phase III
study
Phase
III
study,
XM22-­‐03

22. Doxorubicin
60
mg/m2
+
Docetaxel
75
mg/m2
(Pooled
n=202)
Lipegfilgrastim 6 mg (n=101)
pegfilgrastim 6.0 mg
(n=101)
Ab=antibody test; D=day; CTX=chemotherapy;
ANC=absolute neutrophil count.
Primary
breast
cancer
patients
(n=218)
Randomization
Next CTX
cycle if ANC
≥1.5 x 109/L
and platelet
count
≥100 x 109/L
One chemotherapy cycle = 21 days
Multinational, multicenter, randomized, double-blind, phase III study
rGCS-­‐F
therapy
Chemotherapy
Run-­‐in
Cycle
1
Cycle
2
Cycle
3
Cycle
4
Follow-­‐up
D1 D22 D43 D64
D85
End of
study
D180
Ab test
D360
Ab test
D2 D23 D44 D65
Bondarenko, I. et all JCO, 30, 2012 (Suppl; abstr 19587)
Bondarenko et al,Jcancer Research and Clin Oncology , 2012, Submitted
Phase
III
study,
XM22-­‐03

23. § Primary Endpoint: Duration of Severe Neutropenia (DSN) in the first cycle of
chemotherapy.
§ Secondary Endpoints:
§ Efficacy parameters
§ Incidence of Febrile Neutropenia in cycles 1-4
§ Duration of Severe Neutropenia in cycle 2-4
§ Depth of ANC nadir in each cycle
§ Time to ANC recovery (ANC ≥ 2.0 109/L)
§ Incidence of severe neutropenia
§ Safety parameters
Bondarenko, I. et all JCO, 30, 2012 (Suppl; abstr 19587)
• Severe Neutropenia/Grade 4 (NCI) :ANC < 0.5X109/L
• Febrile neutropenia (FN): Severe Neutropenia + Axyllary temperature > 38.5° C for at least one hour +/-(documented
neutropenic sepsis
and /or documented of serious or life threatening infection)
Phase
III
study,
XM22-­‐03

24. Patients caracteristics : similar in both groups
Pegfilgras+m
6
mg
N=101
Lipegfilgras+m
6
mg
N=101
Age
Median
±
SD
(years)
≤
64,
n
(%)
65
à
74,
n
(%)
51.1
±
9.4
94
(93.1)
7
(6.9)
49.9
±
10.1
94
(93.1)
7
(6.9)
Body
weight
Median
±
SD
(kg)
≤
60,
n
(%)
>60
à
≤75,
n
(%)
>75,
n
(%)
73.2
±
14.6
16
(15.8)
49
(48.5)
36
(35.6)
73.9
±
17.1
22
(21.8)
40
(39.6)
39
(38.6)
Indica+on
for
CT,
n
(%)
Adjuvant
Métasta,c
74
(73.3)
27
(26.7)
75
(74.3)
26
(25.7)
ECOG
status
0
1
2
47
(46.5)
54
(53.5)
0
(-­‐)
45
(44.6)
56
(55.4)
0
(-­‐)
Stage
High-­‐risk
stage
II
III
IV
36
(35,6)
45
(44,6)
20
(19,8)
39
(38,6)
48
(47,5)
14
(13,9)
Bondarenko I, et al. BMC Cancer. 2013: 2013;13(1): 386.
Phase
III
study,
XM22-­‐03

25. Tumor and treatment caracteristics similar in both arms
Variable
Pegfilgras+m
6
mg
N=101
(%)
Lipegfilgras+m
6
mg
N=101
(%)
Months
since
diagnosis
Mean
±
SD
Median
Varia,ons
6,1
±
26,6
1
0
à
185
5,3
±16,7
2
0
à
130
Surgery
59
(59,4)
50
(49,5)
Time
since
surgery
(months)
Mean
±
SD
9,1
±
34,1
6,7
±
15,5
Type
of
surgery
Conserva,ve
Mastectomy
Axillary
dissec,on
7
(6,9)
55
(54,5)
46
(45,5)
4
(4)
46
(45,5)
44
(43,6)
Bondarenko I, et al. BMC Cancer. 2013: 2013;13(1): 386.
Phase
III
study,
XM22-­‐03

26. Primary endpoint : DSN in cycle 1
Non-inferiority of Lipegfilgrastim 6 mg vs Pegfilgrastim 6 mg demonstrated
(Δ DSN < 1 jour)
Results confirmed in sub-groups analysis by country, indication for CT and body weight
Lipegfilgrastim
6mg
Pegfilgrastim
6 mg
Δ Lipegfilgrastim-
pegfilgrastim (IC95)
p
PP population
DSN median ± SD
LS Mean (95% CI)
0,7 ± 0,9 jours
0
0,8 ±0,9 jours
1
- 0,218 jours
(-0,498 à 0,062)
0,1260
Bondarenko I, et al. BMC Cancer. 2013: 2013;13(1): 386.
Phase
III
study,
XM22-­‐03

27. Secondary endpoints (PP population)
Pegfilgras+m
6mg
Lipegfilgras+m
6mg
p
DSN
Cycle
2
Cycle
3
Cycle
4
0,3
±
0,6
0,2
±
0,4
0,2
±
0,5
0,1
±
0,5
0,1
±
0,3
0,2
±
0,6
0,1287
0,6227
0,922
Incidence
of
FN
Cycle
1
Cycles
1
to
4
3,2%
3,2%
0,0%
0,0%
NS
Incidence
of
SN
Cycle
1
Cycle
2
Cycles
1
à
4
51,1%
21,5%
58,5%
43,6%
8,5%
50,0%
0,341
0,013*
0,269
Bondarenko I, et al. BMC Cancer. 2013: 2013;13(1): 386.
Phase
III
study,
XM22-­‐03

28. Neutropenia in cycles 1-4 (PP population)
Nadir comparable in cycle 1 in both treatment groups
ANC values to nadir significantly higher in cycles 2 and 3 in the lipegfilgrastim group
Pegfilgrastim 6 mg
(N=94) [NCx109/L]
Lipegfilgrastim 6 mg
(N=94) [NCx109/L]
p
Nadir (109/L)
Cycle 1
Cycle 2
Cycle 3
Cycle 4
1,0 ± 1,3
2,0 ± 1,6
2,0 1,5
2,3 1,8
1,2 ± 1,3
2,6 ± 2,1
2,5 ± 1,6
2,7 ± 1,7
0,254
0,019
0,035
0,112
ANC recovery*
Cycle 1
Cycle 2
Cycle 3
Cycle 4
1,6 ± 1,2
0,8 ± 1,0
0,8 ± 1,0
0,7 ± 0,9
1,3 ± 1,0
0,5 ± 0,7
0,4 ± 0,7
0,4 ± 0,7
0,062
0,076
0,021
0,076
*Time to ANC recovery ≥1,5x109 /L after nadir (days)
Bondarenko I, et al. BMC Cancer. 2013: 2013;13(1): 386.
Phase
III
study,
XM22-­‐03

29. Time to ANC recovery (≥ 2x 109/L after ANC < 2x 109/L ) in cycles 1-4 (PP
population)
Cycle
pegfilgras+m
6mg
N=94
Lipegfilgras+m
6mg
N=94
p
1
7.4±3.6
5.9±3.4
0.003*
2
5.3±4.6
3.6±4.1
0.008*
3
5.1±4.3
3.9±4.8
0.033*
4
4.3±4.7
3.3±4.1
0.223
Course of ANC in cycle 1
Bondarenko I, et al. BMC Cancer. 2013: 2013;13(1): 386.
Phase
III
study,
XM22-­‐03

30. 30
Quality
of
life
• Global
decreasing
of
the
score
during
the
treatment
phase
• No
sta,s,cal
difference
among
the
2
arms
according
to
QLQ-­‐C30
nor
QLQ-­‐BR23
scales
Mean variations of EORTC QLQ-BR23 scoring scales between inclusion and end of the study
Phase
III
study,
XM22-­‐03

31. Safety
Safety profile similar in both treatment groups
a : 1 neutropenia and 1 paroxysmal tachycardia
b : epistaxis
c : FN stage 3 and enterocolitis
Phase
III
study,
XM22-­‐03
pegfilgras+m
6mg
N=101
lipegfilgras+m
6mg
N01=1
Category
of
TEAE
N
(%)
N
(%)
Any
TEAE
99
(98.0)
100
(99.0)
Drug
related
TEAE=TEADR
26
(25.7)
28
(27.7)
Serious
TEAE
7
(6.9)
3
(3.0)
Serious
TEADR
1
(1.0)
1
(1.0)
Severe
TEAE
35
(34.7)
26
(25.7)
Severe
TEADR
2
(2.0)
a
1
(1.0)
b
Discon,nued
due
to
TEAE
2
(2.0)
3
(3.0)
Discon,nued
due
to
TEADR
1
(1.0)
0
(0)
Death
0
(0)
1
(1.0)
c

32. Comparable safety profile
Phase
III
study,
XM22-­‐03
Most
frequent
side
effects
occurring
in
≥
3
%
pa+ents
(ITT
popula+on)
Side
effects
Pegfilgras+m
6
mg
(N=101)
Lonquex®
6
mg
(N=101)
N
(%)
N
(%)
Bone
pain
10
(9.9)
13
(12.9)
Myalgia
5(5.0)
7
(6.9)
Erythema
3(3.0)
6
(5.9)
Arthralgia
0
(-­‐)
3
(3.0)
Nausea
3
(3.0)
2
(2.0)

33. Conclusions :
§ Non inferiority of lipegfilgrastim 6 mg vs pegfilgrastim 6 mg demonstrated on
DSN in cycle 1
§ Secondary endpoints : significant differences in favor of lipegfilgrastim on following
endpoints :
§ Lower incidence of severe neutropenia in cycle 2
§ Lower depth of neutropenia in cycles 2 and 3
§ Time to ANC recovery ≥ 2 x109/L shorter in cycles 1, 2 and 3
§ Comparable safety profiles
Phase
III
study,
XM22-­‐03

34. Conclusion
Lipegfilgras+m:
• Molecular
structure
:
«
glycoPEGyla,on
technology
»
• Long-­‐ac,ng
human
recombinant
G-­‐CSF
(r-­‐metHuG-­‐
CSF)
• Efficacy
and
safety
profile
comparable
to
pegfilgras,m

35. THANKS