1248 / 1631
Primary endpoint of investigator-assessed PFS
*7% difference in 3-year PFS between the two arms was as expected; both arms performed better than protocol assumptions
CI, confidence interval; FL, follicular lymphoma; HR, hazard ratio; NE, not estimable; PD, disease progression; PFS, progression-
free survival
Marcus R, et al. N Engl J Med 2017;377:1331–44
•
GALLIUM met its primary endpoint demonstrating a 34% reduction in the risk or PD/relapse or death for G-chemo vs R-chemo
in FL patients, a statistically significant and clinically meaningful difference
PFS by
investigator
R-chemo
(n=601)
G-chemo
(n=601)
Events, n (%)
144 (24.0)
101 (16.8)
Median PFS,
months (95% CI)
NE
(47.1, NE)
NE
(NE, NE)
Stratified HR
(95% CI), p value
0.66 (0.51, 0.85),
p=0.0012
3-year PFS, %
(95% CI)*
73.3
(68.8, 77.2)
80.0
(75.9, 83.6)
Median follow-up: 34.5 months
505
536
463
502
378
405
266
278
160
168
68
75
10
13
562
570
601
601
No. of patients at risk
R-chemo
G-chemo
R-chemo (n=601)
G-chemo (n=601)
Censored
+
Time (months)
12
18
24
30
36
42
48
54
6
0.8
0.6
0.4
0.2
0
1.0
Probability
0