Efficacy

In a Phase 1/2 trial in adults with CP, AP, or BP Ph+ CML resistant or intolerant to prior therapy
Proven efficacy in patients who have had prior TKI therapy
BOSULIF helped patients achieve a durable response in the 2nd- and 3rd-line settings

2nd-line

BOSULIF helped patients achieve MCyR after treatment with imatinib (n=262 evaluable)1,a
65% of responders had an MCyR lasting at least 18 months
43% of responders had an MCyR lasting at least 54 months
Median duration of MCyR was not reached at the time of analysis1
62% (n=96) of patients who achieved MCyR at any time (n=156) stayed on BOSULIF for at least 5 years2
Treatment with BOSULIF helps keep transformation rates low2,b
95% of patients remained in CP while taking BOSULIF (n=269 out of 284)
– 5% of patients in CP had confirmed disease transformation to AP or BP while taking BOSULIF (n=15 out of 284)
aMedian duration of treatment was 26 months for evaluable patients.1
bTransformation rates for 2nd-line CP patients.1
AP=accelerated phase; BP=blast phase; MCyR=major cytogenetic response; Ph+=Philadelphia chromosome–positive; TKI=tyrosine kinase inhibitor.
References
1.
BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
2.
Data on file. Pfizer Inc, New York, NY.

3rd-line

BOSULIF helped patients achieve MCyR after treatment with imatinib followed by dasatinib or nilotinib (n=112 evaluable)1,a
64% of responders had an MCyR lasting at least 9 months
36% of responders had an MCyR lasting at least 42 months
Median duration of MCyR was not reached at the time of analysis
Treatment with BOSULIF helps keep transformation rates low2,b
96% of patients remained in CP while taking BOSULIF (n=114 out of 119)
– 4% of patients in CP had confirmed disease transformation to AP or BP while taking BOSULIF (n=5 out of 119)
aMedian duration of treatment was 9 months for evaluable patients.1
bTransformation rates for 3rd-line CP patients.1
AP=accelerated phase; BP=blast phase; MCyR=major cytogenetic response; Ph+=Philadelphia chromosome–positive; TKI=tyrosine kinase inhibitor.
References
1.
BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
2.
Data on file. Pfizer Inc, New York, NY.

Advanced-phase

Proven hematologic response rates with BOSULIF (n=132 evaluable)1
Hematologic responses in AP CML by 48 weeks
Hematologic responses in BP CML by 48 weeks
OHR was defined as MHR (CHR + no evidence of leukemia) or RCP. All responses were confirmed after 4 weeks. CHR for AP and BP CML: WBC count ≤ institutional ULN, platelets ≥100,000/mm3 and <450,000/mm3, ANC ≥1.0 x 109/L, no blasts or promyelocytes in peripheral blood, <5% myelocytes + metamyelocytes in bone marrow, <20% basophils in peripheral blood, and no extramedullary involvement. No evidence of leukemia: meets all other criteria for CHR except may have thrombocytopenia (platelets ≥20,000/mm3 and <100,000/mm3) and/or neutropenia (ANC ≥0.5 x 109/L and <1.0 x 109/L). RCP was defined as disappearance of features defining AP or BP but still in CP.1
ANC=absolute neutrophil count; AP=accelerated phase; BP=blast phase; CHR=complete hematologic response; MHR=major hematologic response; OHR=overall hematologic response; Ph+=Philadelphia chromosome–positive; RCP=return to chronic phase; TKI=tyrosine kinase inhibitor; ULN=upper limit of normal; WBC=white blood cell.
Reference
1.
BOSULIF Prescribing Information. New York, NY: Pfizer Inc.