Table 2.
Early Molecular Responses with Frontline TKI Therapy and Associated Outcomes
| Clinical Trial | BCR-ABL1 | 3-month Landmark Analysis
|
6-month Landmark Analysis
|
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients, n (%) | PFS | p | OS | p | Patients (%) | PFS | p | OS | p | |||
|
|
|
|||||||||||
| ENESTnd18 (4-year follow-up) | Nilotinib 300 mg BID | ≤ 10% | 234 (91) | 95% | 0.06 | 97% | 0.01 | 250 (97) | 95% | 0.06 | 96% | 0.03 |
| > 10% | 24 (9) | 83% | 87% | 7 (3) | 75% | 75% | ||||||
| Nilotinib 400 mg BID | ≤ 10% | 232 (89) | 97% | 0.04 | 97% | 0.24 | 236 (93) | 97% | <0.01 | 97% | <0.01 | |
| > 10% | 28 (11) | 89% | 93% | 17 (7) | 82% | 82% | ||||||
| Imatinib 400 mg QD | ≤ 10% | 176 (67) | 98% | <0.01 | 99% | <0.01 | 216 (84) | 97% | <0.01 | 98% | <0.01 | |
| > 10% | 43 (16) | 83% | 84% | 40 (16) | 79% | 70% | ||||||
| DASISION60 (3-year follow-up) | Dasatinib 100 mg QD | ≤ 10% | 198 (84) | 93% | <0.01 | 96% | 0.03 | 210 (89) | 94% | <0.01 | 97% | <0.01 |
| > 10% | 37 (16) | 68% | 86% | 26 (11) | 66% | 84% | ||||||
| Imatinib 400 mg QD | ≤ 10% | 154 (64) | 96% | <0.01 | 96% | 0.04 | 197 (83) | 95% | <0.01 | 96% | <0.01 | |
| > 10% | 85 (36) | 75% | 88% | 41 (17) | 65% | 88% | ||||||
TKI, tyrosine kinase inhibitor; n, number; PFS, progression free survival; p, p value; OS, overall survival; BID, twice daily; QD, daily