Table 3.
Overview of the pivotal Phase III clinical trial data for imatinib, dasatinib, and nilotinib in patients with newly diagnosed early chronic phase CML
| Trial | Treatment | No. of patients | Primary endpoint | Follow-up data | ||
|---|---|---|---|---|---|---|
| MMR | PFS | Overall survival | ||||
|
IRIS [13,17,18] |
Imatinib 400 mg qd vs IFN + cytarabine |
Imatinib: 553 IFN: 553 |
PFS at 18 months: Imatinib: 96.7% IFN + cytarabine: 91.5% (P < 0.001) |
6 years / 8 years Imatiniba: 93% / 92% |
6 years / 8 years Imatinib: 88% / 85% |
|
|
ENESTnd [22–25] |
Nilotinib 300 mg bid or Nilotinib 400 mg bid vs Imatinib 400 mg qd |
Nilotinib 300 mg bid: 282 Nilotinib 400 mg bid: 281 Imatinib: 283 |
MMR at 12 months: Nilotinib 300 mg bid: 44% Nilotinib 400 mg bid: 43% Imatinib: 22% (P < 0.001 for both comparisons) |
2 years / 3 years / 4 years Nilotinib 300 mg bid: 71% / 73% / 76% Nilotinib 400 mg bid: 67% / 70% / 73% Imatinib: 44% (P < 0.0001 vs both nilotinib doses) / 53% (P <0.0001 for both comparisons) / 56% (P < 0.0001 vs both nilotinib doses) |
2 years / 3 years / 4 years Nilotinib 300 mg bid: 98.0% / 96.9% / 96.1% Nilotinib 400 mg bid: 97.7% (P<0.05 vs imatinib) / 98.3% (P<0.05 vs imatinib) / 98.3% Imatinib: 95.2% / 94.7% / 94.7% |
2 yearsb / 3 yearsb 4 yearsb Nilotinib 300 mg bid: 97.4% / 95.1% / 94.3% Nilotinib 400 mg bid: 97.8% / 97.0% 96.7% Imatinib: 96.3% / 94.0% / 93.3% |
|
DASISION [26–28] |
Dasatinib 100 mg qd vs Imatinib 400 mg qd |
Dasatinib: 259 Imatinib: 260 |
cCCyR at 12 months: Dasatinib: 77% Imatinib: 66% (P = 0.007) Secondary endpoint: MMR at 12 months: Dasatinib: 46% Imatinib: 28% (P < 0.0001) |
2 years / 3 years Dasatinib: 64% / 68% Imatinib: 46% / 55% |
1 year / 2 years / 3 years Dasatinib: 96% / 93.7% / 93.7% Imatinib:97% / 92.1% / 93.2% |
1 year / 2 years / 3 years Dasatinib: 97% / 95.3% / 91.0% Imatinib: 99% / 95.2% / 90.9% |
a
Free from progression to accelerated phase or blast crisis
(c)CCyR, (confirmed) complete cytogenetic response; CML, chronic myeloid leukemia; DASISION, Dasatinib Versus Imatinib Study in Treatment-Naïve CML Patients; ENESTnd, Evaluating Nilotinib Efficacy and Safety in Clinical Trials – Newly Diagnosed Patients; IFN, interferon; IRIS, International Randomized Study of Interferon and STI571; MMR, major molecular response; PFS, progression-free survival; qd, once daily.