Haematology 2018

OS

Primary analysis 1 (31 January 2016 cut-off)

Updated analysis 2 (10 September 2016 cut-off)

1.0

1.0

0.8

0.8

0.6

0.6

0.4

0.4

Probability

Probability

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

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

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)

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)

0.2

0.2

Censored +

Censored +

0

0

12 18 24 30 36 42 48 54

12 18 24 30 36 42 48 54

0

6

60

0

6

60

Time (months)

Time (months)

No. of patients at risk

No. of patients at risk

601 601

588 584

566 573

549 563

527 549

399 416

265 271

160 161

58 55

2

601 601

588 584

566 573

549 563

533 551

522 541

424 438

286 286

178 179

69 72

4 3

• 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

1. Marcus R, et al. N Engl J Med 2017;377:1331–44 2. Hiddemann W, et al. ICML presentation 2017