SIGNIFICANTLY SUPERIOR PFS: GAZYVA + CLB IMPROVED MEDIAN PFS BY 11.8 MONTHS
VS RITUXIMAB + CLB IN FIRST-LINE CLL WITH 6 PLANNED CYCLES OF THERAPY1
Proportion progression free
1.0
0.9
58%
0.8
HR=0.42
95% CI, 0.33-0.54
P<0.0001
risk
reduction
0.7
0.6
0.5
0.4
0.3
0.2
14.9
GAZYVA + Clb (n=333)
rituximab + Clb (n=330)
0.1
0.0
0
3
6
9
12
15
26.7
18
21
24
27
30
33
36
39
Time (months)
n at risk
GAZYVA + Clb 333
298
290
268
200
145
119
90
59
35
12
4
1
0
rituximab + Clb 330
310
302
251
157
105
67
44
28
14
6
2
0
0
PFS, progression-free survival; HR, hazard ratio; CI, confidence interval.
• GAZYVA + Clb demonstrated a 58% reduction in the risk of CLL progression or death vs rituximab + Clb (HR=0.42; 95% CI,
0.33-0.54; P<0.0001)
Response rates1
• Complete responsea rates with GAZYVA + Clb were greater than those with rituximab + Clb (28.2% vs 10.3%)
• Overall response rates with GAZYVA + Clb were greater than those with rituximab + Clb (79.6% vs 66.3%)
• GAZYVA + Clb delivered longer median duration of response vs rituximab + Clb (19.6 months vs 9.7 months)
a
Complete response (CR) includes complete response with incomplete marrow recovery (CRi).
Grade 3/4 adverse reactions were: neutropenia (33%), infusion reactions (20%), thrombocytopenia
(10%), anemia (4%), leukopenia (4%), diarrhea (2%), urinary tract infection (1%), pyrexia (<1%), and
nasopharyngitis (<1%)1,2
• The most common adverse reactions (incidence ≥10%) were: infusion reactions (66%), neutropenia (38%), thrombocytopenia (14%),
nausea (12%), anemia (11%), pyrexia (10%), cough (10%), and diarrhea (10%)
IMPORTANT SAFETY INFORMATION (CONT’D)
Infusion Reactions
• GAZYVA can cause severe and life-threatening infusion
• For patients with Grade 1, 2, or 3 infusion reactions: Interrupt
reactions. Two-thirds of patients experienced a reaction to
GAZYVA for Grade 3 reactions until resolution of symptoms.
the first 1000 mg infused of GAZYVA. Infusion reactions can
Interrupt or reduce the rate of the infusion for Grade 1 or 2
also occur with subsequent infusions. Symptoms may include
reactions and manage symptoms
hypotension, tachycardia, dyspnea, and respiratory symptoms
(eg, bronchospasm, larynx and throat irritation, wheezing,
Please see the following pages for additional Important
and laryngeal edema). Other common symptoms include
Safety Information and brief summary of full Prescribing
nausea, vomiting, diarrhea, hypertension, flushing, headache,
Information, including Boxed WARNINGS.
pyrexia, and chills
• Premedicate patients with acetaminophen, an antihistamine,
and a glucocorticoid. Institute medical management for infusion
reactions as needed. Closely monitor patients during the
entire infusion. Infusion reactions within 24 hours of receiving
GAZYVA have occurred
• For patients with any Grade 4 infusion reactions, including but
not limited to anaphylaxis, acute life-threatening respiratory
symptoms, or other life-threatening infusion reaction: Stop the
GAZYVA infusion. Permanently discontinue GAZYVA therapy