NEARLY A 1-YEAR IMPROVEMENT IN MEDIAN PFS
(23.0 MONTHS VS 11.1 MONTHS; HR=0.16; 95% CI, 0.11-0.24; P<0.0001)1
SIGNIFICANTLY SUPERIOR PFS: GAZYVA in combination with Clb
more than doubled median PFS vs Clb monotherapy1
1.0
HR=0.16; 95%
CI, 0.11-0.24;
P<0.0001
0.9
0.8
84%
risk
reduction
0.7
PFS
0.6
0.5
0.4
0.3
11.1
0.2
GAZYVA + chlorambucil (n=238)
Chlorambucil (n=118)
0.1
23.0
0.0
GAZYVA
+ chlorambucil
Chlorambucil
0
No. at risk
3
6
9
12
15
18
21
24
27
Time (months)
238
208
201
146
111
69
39
16
2
0
118
91
76
46
21
6
2
0
0
0
PFS, progression-free survival; Clb, chlorambucil; HR, hazard ratio; CI, confidence interval.
CLL-11 Trial Design1: GAZYVA, in combination with chlorambucil, was evaluated in a Phase III, open-label, multicenter, 3-arm, randomized, parallel-group
comparative study in patients with previously untreated CD20+ chronic lymphocytic leukemia and coexisting medical conditions and/or reduced renal
function. Patients with creatinine clearance <30 mL/min or inadequate liver function were excluded. The primary endpoint was progression-free survival.
Overall response rate and complete response rate were secondary endpoints.
Enhanced response rates1
• GAZYVA + Clb more than doubled response rates vs Clb monotherapy (75.9% vs 32.1%, respectively)
• More than 1 in 4 patients receiving GAZYVA + Clb achieved a complete response (27.8% vs 0.9%, respectively)
The most common adverse reactions (incidence ≥10%) were: infusion reactions (69%), neutropenia (40%),
thrombocytopenia (15%), anemia (12%), pyrexia (10%), cough (10%), and musculoskeletal disorders (17%)1
The most common Grade 3-4 adverse reactions were infusion reactions (21%), neutropenia (34%), and
thrombocytopenia (11%)1
IMPORTANT SAFETY INFORMATION (CONT’D)
Progressive Multifocal Leukoencephalopathy (PML)
• JC virus infection resulting in PML, which can be fatal, was
observed in patients treated with GAZYVA. Consider the
diagnosis of PML in any patient presenting with new onset or
changes to preexisting neurologic manifestations. Evaluation of
PML includes, but is not limited to, consultation with a neurologist,
brain MRI, and lumbar puncture. Discontinue GAZYVA therapy
and consider discontinuation or reduction of any concomitant
chemotherapy or immunosuppressive therapy in patients who
develop PML
with subsequent infusions. Symptoms may include hypotension,
tachycardia, dyspnea, and respiratory symptoms (eg,
bronchospasm, larynx and throat irritation, wheezing, laryngeal
edema). Other common symptoms include nausea, vomiting,
diarrhea, hypertension, flushing, headache, pyrexia, and chills
• Premedicate patients with acetaminophen, 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
Infusion Reactions
• GAZYVA can cause severe and life-threatening infusion reactions.
Two-thirds of patients experienced a reaction to the first
1000 mgs infused of GAZYVA. Infusion reactions can also occur
Please see the following pages for additional Important Safety Information and brief summary
of full Prescribing Information, including Boxed WARNINGS.