ed with one TKI (imatinib), 8 months in patients with CP CML previously treated with imatinib and at least 1 additional TKI, 10 months in patients with AP CML previously treated with at least imatinib, and 3 months in patients with BP CML previously treated with at least imatinib.
The 24 week efficacy results are present in Table 6.
Table 6: Efficacy Results in Patients with Ph+ CP CML with Resistance to or Intolerance to Imatinib Prior Treatment
with Imatinib Only
(N=266 eva luable)
n (%)
at 24 Weeks Prior Treatment with Imatinib and Dasatinib or Nilotinib
(N=108 eva luable)
n (%)
by 24 Weeks
Abbreviations: CI = confidence interval, MCyR = major cytogenetic response
Week 24
MCyR
(95% CI)
90 (33.8)
(28.2, 39.9)
29 (26.9)
(18.8, 36.2)
The minimum follow-up was 23 months for patients with CP CML treated with one prior TKI (imatinib) and 13 months for patients with CP CML treated with imatinib and at least one additional TKI. For the 53.4% of patients with CP CML treated with one prior TKI (imatinib) who achieved a MCyR at any time, the median duration of MCyR was not reached. Among these patients, 52.8 % had a MCyR lasting at least 18 months. For the 32.4% of patients with CP CML treated with imatinib and at least one additional TKI who achieved a MCyR at any time, the median duration of MCyR was not reached. Among these patients, 51.4% had a MCyR lasting at least 9 months. Of the 374 eva luable patients with CP CML, 16 patients had confirmed disease transformation to AP or BP while on treatment with Bosulif.
The 48 week efficacy results in patients with accelerated and blast phases CML previously treated with at least imatinib are summarized in Table 7.
Table 7: Efficacy Results in Patients with Accelerated Phase and Blast Phase CML Previously Treated with at Least Imatinib AP CML
(N=69 eva luable)
n (%) BP CML
(N=60 eva luable)
n (%)
Abbreviations: CI = confidence interval, OHR = overall hematologic response, CHR = complete hematologic response
*
Overall hematologic response (OHR) = major hematologic response (complete hematologic response + no evidence of leukemia) or return to chronic phase (RCP). All responses were confirmed after 4 weeks. Complete hematologic response (CHR) for AP and BP CML: WBC less than or equal to institutional ULN, platelets greater than or equal to 100,000/mm3 and less than 450,000/mm3, absolute neutrophil count (ANC) greater than or equal to 1.0 × 109 /L, no blasts or promyelocytes in peripheral blood, less than 5% myelocytes + metamyelocytes in bone marrow, less than 20% basophils in peripheral blood, and no extramedullary involvement. No evidence of leukemia (NEL): Meets all other criteria for CHR except may have thrombocytopenia (platelets greater than or equal to 20,000/mm3 and less than 100,000/mm3) and/or neutropenia (ANC greater than or equal to 0.5 × 109 /L and less than 1.0 × 109 /L). Return to chronic phase (RCP) =disappearance of features defining accelerated or blast phases but still in chronic phase.
CHR* by Week 48
(95% CI)
21 (30.4)
(19.9, 42.7) 9 (15)
(7.1, 26.6)
OHR* by Week 48 38 (55.1) 17 (28.3)
(95% CI) (42.6, 67.1) (17.5, 41.4)
Abbreviations: CI = confidence interval, OHR = overall hematologic response, CHR = complete hematologic response
*
Overall hematologic response (OHR) = major hematologic response (complete hematologic response + no evidence of leukemia) or return to chronic phase (RCP). All responses were confirmed |
