GADOLIN TRIAL1,2:
•
GAZYVA + bendamustine followed by GAZYVA monotherapy was evaluated vs bendamustine alone in a Phase III, randomized,
controlled trial in follicular lymphoma patients who had no response to or who progressed within 6 months of therapy with a
rituximab-containing regimen
•
Patients in the GAZYVA + bendamustine arm who did not have disease progression (patients with a complete response, partial
response, or stable disease) at the end of the 6 cycles continued receiving GAZYVA monotherapy for 2 years unless disease
progression occurred during the treatment
In follicular lymphoma patients who were refractory to a rituximab-containing regimen
GAZYVA + BENDAMUSTINE FOLLOWED BY GAZYVA MONOTHERAPY
PROVIDED SUPERIOR PFS vs BENDAMUSTINE ALONE1
Primary endpoint: IRC-assessed PFS
52%
Probability of PFS
1.0
0.8
0.6
HR=0.48
95% CI, 0.34-0.68;
P<0.0001; 21.1-month
median follow-up
Median not reached
0.4
GAZYVA + bendamustine
followed by GAZYVA
monotherapy (n=155)
13.8
0.2
0.0
reduction in
the risk of disease
progression or death
0
6
12
Bendamustine (n=166)
18
24
30
36
42
48
1
54
Time (months)
n at risk
GAZYVA + bendamustine
followed by GAZYVA
monotherapy
155
120
79
61
38
20
6
2
Bendamustine
166
122
66
29
17
7
2
1
IRC, independent review committee; HR, hazard ratio; CI, confidence interval.
IMPORTANT SAFETY INFORMATION (CONT’D)
Pregnancy
• There are no data with GAZYVA use in pregnant women to inform a
drug-associated risk. GAZYVA is likely to cause fetal B-cell depletion.
GAZYVA should be used during pregnancy and/or breastfeeding
only if the potential benefit justifies the potential risk to the fetus
and/or infant. Mothers who have been exposed t