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EfficacyBOSULIF efficacy​​​​​​​EfficacyLinkLinkLinkLinkBFORE studyBYOND studyStudy 200SafetySafety dataDosingBosulif Dosing informationSupport & ResourcesSupport and ResourcesMaterials

Click here for BOSULIF® (bosutinib) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

BFORE studyBFORE: a 5-year, Phase 3 study of BOSULIF in newly diagnosed adult patients with CP Ph+ CML1-4
  • A randomised, 2-arm, open-label, multicenter trial conducted to investigate the efficacy and safety of BOSULIF® (bosutinib) vs imatinib
  • 536 patients were randomised 1:1 to receive 400 mg of BOSULIF or imatinib once daily. Patients were followed for 5 years
  • The primary endpoint was evaluated in a modified intent-to-treat (mITT) population of 487 patients with Ph+ CML harboring b2a2 and/or b3a2 transcripts and baseline BCR-ABL copies >0
Study design: mITT population (1:1)The final 60-month analysis was based on a last patient last visit of April 17, 2020 (June 12, 2020 database lock), 5 years after the last enrolled patient.2Defined as ≥3 years on treatment and BCR-ABL ≤0.01% IS in all consecutive assessments for ≥1 year, and ≥4 years on treatment and BCR-ABL ≤0.01% IS in all consecutive assessments for ≥2 years, respectively.2Early molecular response (EMR): BCR-ABL transcripts ≤10% at 3 months in evaluable patients with >3000 ABL copies.1The BFORE trial represents a clinical spectrum of newly diagnosed patients with CP CML2,3
Scroll left to view table
Patient characteristics in BFORE (ITT population)
Characteristic BOSULIF
n=268		 Imatinib
n=268*
Age, median (range), years 53 (18-84) 53 (19-84)
Male, n (%) 156 (58.2) 155 (57.8)
Sokal risk group, n (%)
Low 95 (35.4) 106 (39.6)
Intermediate 117 (43.7) 105 (39.2)
High 56 (20.9) 57 (21.3)
ECOG PS, n (%)
0 195 (72.8) 194 (72.4)
1 73 (27.2) 74 (27.6)
*3 patients in the imatinib arm did not receive treatment.2Patients with uncontrolled or significant cardiovascular disease, including prolonged QT interval, were excluded by protocol.1Rapid and deep responses1,5,6Newly diagnosed adult Ph+ CML patientsBOSULIF offered vs imatinib1:
  • Superior MMR at 12 months and CCyR by 12 months (48 weeks)
  • More patients achieving early reduction in BCR-ABL transcripts
  • Consistently deeper molecular responses
BOSULIF: Confidence to achieve meaningful clinical outcomes1-6MMR, ≤0.1% BCR-ABL transcripts on the international scale in patients with ≥3000 transcripts assessed at month 3.1Adjusted for geographical region and Sokal score at randomisation.1Statistically significant comparison at the pre-specified significance level; based on CMH test stratified by geographical region and Sokal score at randomisation.1MR4/MR4.5 were defined as ≤0.01/0.0032% BCR-ABL/ABL ratio on international scale (corresponding to ≥4/4.5 log reduction from standardised baseline) with a minimum of 9,800/30,990 ABL transcripts assessed by the central laboratory.1Long-term cardiac/vascular safety data with 5-year follow-up2

*In patients who received ≥1 dose of study drug.

 Please refer to the BOSULIF SmPC for full details of adverse events BOSULIF  Summary of Product Characteristics Durable first-line response after 5 years1,2Long-term efficacy with BOSULIF in newly diagnosed adult CML patientsMMR, ≤0.1% BCR-ABL transcripts on the international scale in patients with ≥3000 ABL transcripts assessed at month 3.Adjusted for Sokal risk group and region at time of random assignment.
MR4, ≤0.01% BCR-ABL transcripts on the international scale.MR4.5, ≤0.0032% BCR-ABL transcripts on the international scale.Long-term AEs were generally manageable2,3​​​​​​​Most common AEs (>20%) with BOSULIF at 5 years in newly diagnosed adult CML patients*Patients who received one or more doses of study drug. Please refer to the BOSULIF SmPC for full details of adverse events BOSULIF Summary of Product Characteristics Explore more BYOND study

A Phase 4 trial in Ph+ CML patients resistant or intolerant to prior therapy.7

 View study Study 200

A long-term analysis in CP, AP, or BP Ph+ CML patients with resistance or intolerance to prior therapy.8-10

 View study ABL=Abelson; AE=adverse event; ALT=alanine aminotransferase; AP=accelerated phase; AST=aspartate aminotransferase; BCR=breakpoint cluster region; BFORE=Bosutinib Trial in First-Line Chronic Myelogenous Leukemia Treatment; BP=blast phase; CCyR=complete cytogenetic response; CI=confidence interval; CML=chronic myelogenous leukemia; CP=chronic phase; ECOG=Eastern Cooperative Oncology Group; EFS=event-free survival; EMR=early molecular response; IS=international scale; ITT=intent-to-treat; MCyR=major cytogenetic response; mITT=modified intent-to-treat; MMR=major molecular response; MR=molecular response; OD=once daily; OHR=overall hematologic response; OR=odds ratio; OS=overall survival; Ph+=Philadelphia chromosome–positive; PS=performance status; SmPC=Summary of Product Characteristics; TEAE=treatment-emergent adverse event; TKI=tyrosine kinase inhibitor.References:BOSULIF (bosutinib) Summary of Product Characteristics.Brummendorf TH, Cortes JE, Milojkovic D, et al; BFORE study investigators. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial. Leukemia. 2022;1-9. doi:10.1038/s41375-022-01589-y.Brummendorf TH, Cortes JE, Milojkovic D, et al BFORE study investigators. Bosutinib versus imatinib for newly diagnosed chronic phase myeloid leukemia final results from the BFORE trial. Leukemia 2022 Supplementary MaterialCortes JE, Gambacorti-Passerini C, Deininger MW, et al. Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia: results from the randomised BFORE trial. J Clin Oncol 2018;36:231–237Clark RE, Gambacorti-Passerini C, Deininger M, et al; the BFORE investigators. Efficacy and safety of first-line bosutinib versus imatinib in the BFORE trial: 18-month follow-up. Presented at the British Society for Haematology (BSH) Annual Meeting, 2018; Oral presentation BSH18-OR-004.Gambacorti-Passerini C, Deininger MW, Mauro MJ, et al. Bosutinib vs imatinib for newly diagnosed chronic myeloid leukemia (CML) in the BFORE trial: 18 month follow-up. Blood. 2017;130:896.Hochhaus A, Gambacorti-Passerini C, Abboud C, et al; BYOND Study Investigators. Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study. Leukemia. 2020;34(8):2125-2137.Cortes JE, Kantarjian HM, Brümmendorf TH, et al. Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome–positive chronic myeloid leukemia patients with resistance or intolerance to imatinib. Blood. 2011;118(17):4567-4576.Cortes JE, Khoury HJ, Kantarjian HM, et al. Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib. Am J Hematol. 2016;91(12):1206-1214.Gambacorti-Passerini C, Kantarjian HM, Kim D-W, et al. Long-term efficacy of bosutinib in patients with advanced leukemia following resistance/intolerance to imatinib and other tyrosine kinase inhibitors. Am J Hematol. 2015;90(9):755-768.Efficacy Safety

The safety profile of BOSULIF is well established and includes long-term, cardiac, and vascular data1

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