718 / 1631
OS
1. Marcus R, et al. N Engl J Med 2017;377:1331–44
2. Hiddemann W, et al. ICML presentation 2017
Primary analysis
1
(31 January 2016 cut-off)
•
OS analysis supportive of the primary endpoint (investigator-assessed PFS)
•
From the updated analysis, OS still relatively immature. More deaths for any reason in R vs G arm (52 [8.7%] vs 43 [7.2%])
•
GALLIUM not powered to detect differences in OS between treatment arms
HR, 0.75 (95% CI: 0.49, 1.17
)
; p=0.21
3 year OS: 92.1% vs 94.0% (R vs G)
81 events; 46 vs 35 (R vs G)
1.0
12 18 24 30 36 42 48 54
6
60
0.8
0.6
0.4
0.2
0
0
Probability
Time (months)
566
573
549
563
527
549
399
416
265
271
160
161
2
588
584
601
601
58
55
R-chemo (n=601)
G-chemo (n=601)
Censored
+
No. of patients at risk
Updated analysis
2
(10 September 2016 cut-off)
HR, 0.82 (95% CI: 0.54, 1.22
)
; p=0.32
3 year OS: 92.2% vs 93.9% (R vs G)
95 events; 52 vs 43 (R vs G)
1.0
12 18 24 30 36 42 48 54
6
60
0.8
0.6
0.4
0.2
0
0
Probability
Time (months)
566
573
549
563
533
551
424
438
286
286
178
179
4
3
588
584
601
601
69
72
R-chemo (n=601)
G-chemo (n=601)
Censored
+
No. of patients at risk
522
541