Haematology 2018

Primary endpoint of investigator-assessed PFS

1.0

PFS by investigator

R-chemo (n=601)

G-chemo (n=601)

0.8

Events, n (%)

144 (24.0)

101 (16.8)

Median PFS, months (95% CI)

NE (47.1, NE)

NE (NE, NE)

0.6

Stratified HR (95% CI), p value

0.66 (0.51, 0.85), p=0.0012

0.4

Probability

R-chemo (n=601) G-chemo (n=601) Censored

3-year PFS, % (95% CI)*

73.3 (68.8, 77.2)

80.0 (75.9, 83.6)

0.2

+

0

Median follow-up: 34.5 months

12

18

24

30

36

42

48

54

0

6

Time (months)

601 601 No. of patients at risk R-chemo G-chemo

562 570

505 536

463 502

378 405

266 278

160 168

68 75

10 13

• 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

*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