BFORE study design

BFORE: An ongoing Phase 3 study of BOSULIF in newly diagnosed adult patients with CP Ph+ CML1
A randomized, 2-arm, open-label, multicenter trial conducted to investigate the efficacy and safety of BOSULIF vs imatinib1
• 536 patients were randomized to receive 400 mg of BOSULIF or 400 mg of imatinib once daily
The primary endpoint was evaluated in a modified intent-to-treat (mITT) population of patients with Ph+ CML (n=487)

Study design

Study design: mITT population (1:1)1
MMR at 12 months was defined as ≤0.1% BCR-ABL ratio on the International Scale (corresponding to a ≥3-log reduction from standardized baseline) with a minimum of 3000 ABL transcripts as assessed by the central laboratory. CCyR was defined as the absence of Ph+ metaphases in chromosome banding analysis of ≥20 metaphases derived from bone marrow aspirate, or MMR if an adequate cytogenetic assessment was unavailable. MR4 was defined as ≤0.01% BCR-ABL1 transcripts on the International Scale with ≥9800 ABL1 assessed; MR4.5 was defined as ≤0.0032% BCR-ABL1 transcripts on the International Scale with ≥30,990 ABL1 assessed.1,2
AP=accelerated phase; BFORE=Bosutinib Trial in First-Line Chronic Myelogenous Leukemia Treatment; BP=blast phase; CCyR=complete cytogenetic response; ECOG PS=Eastern Cooperative Oncology Group Performance Status; EFS=event-free survival; MMR=major molecular response; MR=molecular response; OS=overall survival; Ph+=Philadelphia chromosome–positive. 

Patient characteristics

BOSULIF was studied in a population representing a clinical spectrum of patients with CP CML2
BFORE included patients with comorbidities and across all Sokal risk groups2

aNOTE: Data are n (%) unless noted otherwise. mITT population includes Ph+ patients with typical (e13a2 and/or e14a2) BCR-ABL1 transcript types.
bData missing for 1 patient in the imatinib arm.
cPer case report form collected at screening if the patient had history of coronary disease.
dPatients with uncontrolled or significant cardiovascular disease, including prolonged QT interval, were excluded by protocol.1
In the BOSULIF arm, 11.4% of patients had a history of cardiac diseasec and 6.1% had a history of cardiac procedures.2,d
BFORE=Bosutinib Trial in First-Line Chronic Myelogenous Leukemia Treatment; ECOG PS=Eastern Cooperative Oncology Group Performance Status; Ph+=Philadelphia chromosome–positive.
References
1.
BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
2.
Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia: results from the randomized BFORE trial. J Clin Oncol. 2018;36(3):231-237.