Harrison CN et al. Proc ASH 2015;Abstract 59.

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Harrison CN et al. Proc ASH 2015;Abstract 59. Long-Term Efficacy and Safety in COMFORT-II, a Phase 3 Study Comparing Ruxolitinib with Best Available Therapy for the Treatment of Myelofibrosis: 5-Year Final Study Results Harrison CN et al. Proc ASH 2015;Abstract 59.

COMFORT-II Trial: Five-Year Follow-Up of Ruxolitinib (RUX) versus Best Available Therapy (BAT) in Myelofibrosis (MF) Five-year follow-up of a multicenter, open-label, randomized (2:1) Phase III study of RUX, a JAK inhibitor, versus BAT, with crossover (CO) N = 219 patients with intermediate 2- or high-risk MF: N = 146 received RUX; N = 73 received BAT (45 crossed over) Study objectives: Five-year efficacy, safety RUX BAT BAT  RUX CO 5 y on study Tx ≥35% SVR 53% (78/146) Not reported 42% (19/45) 67% (34/51) SVR = spleen volume reduction Harrison CN et al. Proc ASH 2015;Abstract 59.

COMFORT-II 5-Year Follow-Up: Conclusions Median overall survival (OS) with RUX versus BAT: Not reached versus 4.1 years (HR = 0.67; p = 0.06) Adjusting for CO to RUX: Median OS with BAT 2.7 years (HR = 0.44) Bone-marrow fibrosis and JAK2 burden were improved with RUX compared to BAT. Longer-term safety was consistent with the 3-year report: Reason for discontinuation, N (%) RUX (n = 146) BAT (n = 73) RUX after CO (n = 45) All combined 107 (73) 28 (38) 34 (76) Adverse events (mainly low platelet counts, anemia) 35 (24) 5 (7) 10 (22) Disease progression 32 (22) 4 (6) 7 (16) Consent withdrawn 10 (7) 9 (12) Other (including stem cell transplant) 16 (11) 6 (13) Five-year follow-up confirms the durability of RUX benefits. RUX treatment is being evaluated for early MF in the Phase III ReTHINK trial. Harrison CN et al. Proc ASH 2015;Abstract 59.