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BOSULIF has been tested in a large number of patients and demonstrates efficacy in a wide range of patient types
Patient cohorts (N = 574* including patients receiving ≥ 1 dose of BOSULIF)
Primary cohort: imatinib resistant
(n-200)
Sub-group: imatinib intolerant
(n=88)
Sub-groups:
IMI-R/I + dasatinib resistant (n=38)
IMI-R/I + dasatinib intolerant (n=50)
IMI-R/I + nilotinib resistant (n=26)
IMI-R/I + nilotinib intolerant (n=5)
Sub-group: Accelerated phase
(n=79)
Sub-group: Blast phase (n=64)
*Includes 24 patients who were Ph+ ALL.3
†Third- and fourth-line subgroups comprise patients with CP CML that were imatinib resistant or imatinib intolerant and ≥ 1 of the following: Dasatinib resistant or dasatinib intolerant, nilotinib resistant, nilotinib intolerant or resistant/intolerant to dasatinib and nilotinib.
Primary endpoint‡: 33% (95% CI, 27–40%) MCyR at 24 weeks in imatinib-resistant patients (n=200)1,5
Results show that the best cumulative response is either attained or maintained.
*Minimum follow-up period was 5 years (CP 2nd-line) or 4 years (CP 3rd-/4th-line and AP/BP).
Criteria used: Resistant mutation; medical history or evidence of prior TKI intolerance.
†Received ≥ 1 BOSULIF dose and had a valid baseline assessment for the corresponding endpoint.
‡In patients with CP imatinib-resistant CML and no previous TKI exposure other than imatinib.
AP, accelerated phase; BP, blast phase; CCyR, complete cytogenetic response; CI, confidence interval; CML, chronic myeloid leukaemia; CP, chronic phase; ELN; European LeukemiaNet, IMI-R/I; imatinib resistant or intolerant, MCyR, major cytogenetic response; TKI, tyrosine kinase inhibitor.
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PP-UNP-GBR-7812. January 2024