In CLL-11, for the first-line treatment of typical* patients, in combination with Clb
GAZYVA DEMONSTRATED SUPERIOR PFS vs RITUXIMAB1-4
GAZYVA + CLB DELIVERED A SIGNIFICANT IMPROVEMENT IN MEDIAN PFS COMPARED TO RITUXIMAB
+ CLB IN FIRST-LINE CLL (26.7 MONTHS VS 14.9 MONTHS) WITH 6 PLANNED CYCLES OF THERAPY1
Proportion progression free
1.0
0.9
0.8
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
18
21
24
27
30
33
36
39
Time (months)
n at risk
*
26.7
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.
Based on age and coexisting medical conditions.
CLL-11 efficacy results1
• 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)
NATIONAL COMPREHENSIVE CANCER NETWORK® (NCCN®) STATUS
NCCN
Category
®
1
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) category 1 designation5
• Obinutuzumab (GAZYVA®) + chlorambucil is included in the NCCN Guidelines® with a category 1 designation for
first-line therapy in the following CLL patients without del(17p)*:
– Age ≥70 years
– Younger patients (age <70 years) with significant comorbidities
– Frail patients with significant comorbidities
Note: Category 1 designation is given based upon high-level evidence and uniform NCCN consensus that the intervention is appropriate.
For full definitions of the NCCN Categories of Evidence and Consensus, please refer to the NCCN Guidelines, available online at www.nccn.org.
*
In addition to age and comorbidities, NCCN Guidelines stratify patients based on the mutation status. See NCCN Guidelines for additional information.
IMPORTANT SAFETY INFORMATION
Hepatitis B Virus Reactivation
• Hepatitis B virus (HBV) reactivation, in some cases resulting
•
in fulminant hepatitis, hepatic failure, and death, can occur in
patients treated with anti-CD20 antibodies including GAZYVA.
HBV reactivation has been reported in patients who are
hepatitis B surface antigen (HBsAg) positive and in patients
who are HBsAg negative but are hepatitis B core antibody
(anti-HBc) positive. Reactivation has also occurred in patients
who appear to have resolved hepatitis B infection (ie, HBsAg
negative, anti-HBc positive, and hepatitis B surface antibody
[anti-HBs] positive)
HBV reactivation is defined as an abrupt increase in HBV
replication manifesting as a rapid increase in serum HBV DNA
level, or detection of HBsAg in a person who was previously
HBsAg negative and anti-HBc positive. Reactivation of HBV
•
•
replication is often followed by hepatitis, ie, increase in
transaminase levels and, in severe cases, increase in bilirubin
levels, liver failure, and death
Screen all patients for HBV infection by measuring HBsAg and
anti-HBc before initiating treatment with GAZYVA. For patients
who show evidence of hepatitis B infection (HBsAg positive
[regardless of antibody status] or HBsAg negative but antiHBc positive), consult physicians with expertise in managing
hepatitis B regarding monitoring and consideration for HBV
antiviral therapy
Monitor patients with evidence of current or prior HBV
infection for clinical and laboratory signs of hepatitis or HBV
reactivation during and for several months following treatment
with GAZYVA