Phase II results for nilotinib and dasatinib across all phases of chronic myeloid leukemia (CML).
| Drug . | Disease State . | N . | Hematologic Response (%) . | CHR (%) . | Any Cytogenetic Response (%) . | Minor CyR (%) . | MCR (%) . | CCR (%) . | Median F/U (mos) . | Ref. . |
|---|---|---|---|---|---|---|---|---|---|---|
| *Nilotinib response in Ph+ ALL was recorded as “complete response” (= hematologic recovery + < 5% marrow blasts); | ||||||||||
| Abbreviations: ALL, acute lymphoblastic leukemia; AP, accelerated phase; CCR, complete cytogenetic response; CP, chronic phase; LBC, lymphoid blast crisis; MBC, myeloid blast crisis; MCR, major cytogenetic response; NR, not reported. | ||||||||||
| Nilotinib (AMN107) | ||||||||||
| Imatinib refractory / intolerant CP CML | 81 | NR | 69 | 68 | 11 | 46 | 32 | 6 | 36 | |
| Imatinib refractory / intolerant AP CML | 25 | 40 | 16 | 56 | 8 | 28 | 16 | 5.5 | 37 | |
| Imatinib refractory / intolerant MBC CML | 13 | 8 | NR | NR | NR | 16 | 8 | 2.5 | 38 | |
| Imatinib refractory / intolerant LBC CML | 6 | NR | 17 | NR | NR | 50 | 33 | 2.5 | 38 | |
| Imatinib refractory / intolerant Ph+ ALL | 15 | 27* | NR | NR | NR | NR | NR | 2.3 | 38 | |
| Sprycel (Dasatinib) | ||||||||||
| Imatinib refractory / intolerant CP CML | 387 | NR | 90 | NR | NR | 51 | 40 | 8 | 32 | |
| Imatinib refractory / intolerant AP CML | 174 | 59 | 34 | 39 | 5 | 34 | 25 | 7 | 33 | |
| Imatinib refractory / intolerant MBC CML | 109 | 49 | 25 | 44 | 13 | 31 | 25 | 3.5 | 34 | |
| Imatinib refractory / intolerant LBC CML | 48 | 39 | 29 | NR | NR | 44 | 38 | 2.3 | 35 | |
| Imatinib refractory / intolerant Ph+ ALL | 46 | 48 | 33 | NR | NR | 46 | 44 | 2.7 | 35 | |
| Drug . | Disease State . | N . | Hematologic Response (%) . | CHR (%) . | Any Cytogenetic Response (%) . | Minor CyR (%) . | MCR (%) . | CCR (%) . | Median F/U (mos) . | Ref. . |
|---|---|---|---|---|---|---|---|---|---|---|
| *Nilotinib response in Ph+ ALL was recorded as “complete response” (= hematologic recovery + < 5% marrow blasts); | ||||||||||
| Abbreviations: ALL, acute lymphoblastic leukemia; AP, accelerated phase; CCR, complete cytogenetic response; CP, chronic phase; LBC, lymphoid blast crisis; MBC, myeloid blast crisis; MCR, major cytogenetic response; NR, not reported. | ||||||||||
| Nilotinib (AMN107) | ||||||||||
| Imatinib refractory / intolerant CP CML | 81 | NR | 69 | 68 | 11 | 46 | 32 | 6 | 36 | |
| Imatinib refractory / intolerant AP CML | 25 | 40 | 16 | 56 | 8 | 28 | 16 | 5.5 | 37 | |
| Imatinib refractory / intolerant MBC CML | 13 | 8 | NR | NR | NR | 16 | 8 | 2.5 | 38 | |
| Imatinib refractory / intolerant LBC CML | 6 | NR | 17 | NR | NR | 50 | 33 | 2.5 | 38 | |
| Imatinib refractory / intolerant Ph+ ALL | 15 | 27* | NR | NR | NR | NR | NR | 2.3 | 38 | |
| Sprycel (Dasatinib) | ||||||||||
| Imatinib refractory / intolerant CP CML | 387 | NR | 90 | NR | NR | 51 | 40 | 8 | 32 | |
| Imatinib refractory / intolerant AP CML | 174 | 59 | 34 | 39 | 5 | 34 | 25 | 7 | 33 | |
| Imatinib refractory / intolerant MBC CML | 109 | 49 | 25 | 44 | 13 | 31 | 25 | 3.5 | 34 | |
| Imatinib refractory / intolerant LBC CML | 48 | 39 | 29 | NR | NR | 44 | 38 | 2.3 | 35 | |
| Imatinib refractory / intolerant Ph+ ALL | 46 | 48 | 33 | NR | NR | 46 | 44 | 2.7 | 35 | |