Table 1.

Summary of selected end points from pivotal randomized trials of 2G-TKIs vs imatinib

Outcome*DASISION, %ENESTnd, %BFORE, %
DasatinibImatinibNilotinib, mgImatinibBosutinibImatinib
300400
3-mo BCR-ABL/ABL <10% 84 64 90.6 89.2 69.2 75.2 57.3 
12-mo MMR 46 28 44 43 22 47.2 36.9 
5-y MMR 76 64 77 77 60 — — 
5-y MR4.5 42 33 53.5 52.3 31.4 — — 
5-y sustained MR4.5 NR NR 41 44 26 — — 
Transformation to AP/BP 4.6 7.3 <1 <1 1.6 2.5 
OS 91 90 93.7 96.2 91.7 99.6 97.9 
CML-related deaths 3.5 6.6 2.1 1.4 5.6 NR NR 
PFS 85 86 92.2 95.8 91.0 3.7§ 6.4§ 
Remain on therapy 61 63 59.9 61.9 49.8 78 73.2 
Outcome*DASISION, %ENESTnd, %BFORE, %
DasatinibImatinibNilotinib, mgImatinibBosutinibImatinib
300400
3-mo BCR-ABL/ABL <10% 84 64 90.6 89.2 69.2 75.2 57.3 
12-mo MMR 46 28 44 43 22 47.2 36.9 
5-y MMR 76 64 77 77 60 — — 
5-y MR4.5 42 33 53.5 52.3 31.4 — — 
5-y sustained MR4.5 NR NR 41 44 26 — — 
Transformation to AP/BP 4.6 7.3 <1 <1 1.6 2.5 
OS 91 90 93.7 96.2 91.7 99.6 97.9 
CML-related deaths 3.5 6.6 2.1 1.4 5.6 NR NR 
PFS 85 86 92.2 95.8 91.0 3.7§ 6.4§ 
Remain on therapy 61 63 59.9 61.9 49.8 78 73.2 

AP, accelerated phase; BP, blast phase; MMR, major MR; NR, not reached; PFS, progression-free survival.

*

5-y data presented for DASISION and ENESTnd and 1-y data for BFORE unless otherwise specified.

Twice daily.

At 12 mo.

§

EFS-defining events at 12 mo.

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