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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.

BYOND: a Phase 4 trial of BOSULIF® (bosutinib) in patients with Ph+ CML resistant or intolerant to prior TKIs1,2

A single-arm, open-label, non-randomised study to evaluate the safety and efficacy of BOSULIF in patients with chronic or advanced phase Ph+ CML who have failed prior treatment with TKIs.1,2

Eligibility1,2
  •  
  • Any CML phase; patient must be resistant/intolerant to prior treatment
  • Prior treatment with ≥1 TKI    
  • Adequate hepatic/renal function    
  • 2nd- and 3rd-line patients with CP CML: ECOG PS 0–1
  • 4th-line patients with CP CML and patients with AP/BP CML: ECOG PS 0–3
  •  
  • Primary endpoints1,2
    • Cumulative confirmed* MCyR† by 1 year in patients with CP Ph+ CML treated with 1 or 2 prior TKIs, and 3 prior TKIs
    • Cumulative confirmed* OHR‡ by 1 year in patients with AP/BP CML
  • Patients received up to 4 years of treatment with BOSULIF, except in cases of disease progression or unacceptable toxicity2
  • Patients who discontinued BOSULIF prior to completing 4 years of therapy were followed for survival until they completed 4 years on study2
In two consecutive analyses ≥28 days apart.1Cumulative confirmed MCyR was defined as CCyR (0% Ph+ from ≥20 metaphases or <1% fluorescent in situ hybridization [FISH] positive cells from ≥200 interphase nuclei) or partial cytogenetic response (PCyR; >0%, ≤35% Ph+). To be considered a responder, patients with cytogenetic response at baseline had to maintain response for ≥52 weeks or achieve improvement from baseline. Patients with PCyR at baseline must have attained CCyR on-treatment to be counted as a cytogenetic responder. Patients with at least MMR and an improvement in MR from baseline were counted as confirmed CCyR.2Cumulative confirmed OHR was defined as complete haematologic response (CHR) or return to CP.2Results for the primary endpoints (1 year)
  • CP CML patients1
    • 76.5% (95% CI, 66.9-84.5) of patients treated with 1 or 2 prior TKIs and 62.2% (95% CI, 46.5-76.2) of patients treated with 3 prior TKIs achieved cumulative confirmed MCyR by 1 year 
  • AP CML patients1
    • 75.0% (95% CI, 19.4-99.4) of patients achieved cumulative confirmed OHR by 1 year

Many patients entered the study with a major cytogenetic response2.

  • Overall, the cumulative confirmed MCyR rate by 1 year was 71.5% (95% CI, 63.4–78.7) in the evaluable CP Ph+ CML population2
     
    • 64.6% of patients achieved an improvement in response from baseline
       
    • 6.9% maintained their baseline response for ≥1 year
       
  • 112 (77.8%) patients with CP Ph+ CML had MCyR at baseline2
Efficacy results at study closure, after a minimum follow-up of 3 years, are shown below.1,2Deep molecular responses attainable across all lines of therapy1,2Cumulative molecular response achieved or maintained by 4 years1,2*​​​​​​

71.8% of all ≥2nd-line patients achieved or maintained MMR by 4 years (n=149) 

Evaluable population. MMR: ≤0.1% BCR-ABL ratio on international scale (≥3-log reduction from standardized baseline). MR4: ≤0.01% BCR-ABL ratio on international scale (≥4-log reduction from standardized baseline). MR4.5: ≤0.0032% BCR-ABL ratio on international scale (≥4.5-log reduction from standardized baseline).3 years' minimum follow-up.High rates of cytogenetic response attainable across all lines of therapy1Cumulative cytogenetic response achieved or maintained by 4 years1,2*3 years' minimum follow-up.Deep molecular responses in intolerant and resistant patients2Cumulative molecular response achieved or maintained by 2 years2*

The results shown below are based on a data cut-off of September 2018 (≥1 year after last enrolled patient and ~85% with ≥2-year follow-up)2

Evaluable population. MMR: ≤0.1% BCR/ABL ratio on international scale (≥3-log reduction from standardized baseline). MR4: ≤0.01% BCR-ABL ratio on international scale (≥4-log reduction from standardized baseline). MR4.5: ≤0.0032% BCR-ABL ratio on international scale (≥4.5-log reduction from standardized baseline).Cardiac and vascular safety data​​​​​​​2All Phase 4 study patients (N=163)2

1% of the patient safety population discontinued due to diarrhoea

 Please refer to the BOSULIF SmPC for full details of adverse events BOSULIF Summary of Product Characteristics High rates of cytogenetic response in TKI-intolerant and TKI-resistant patients2Cumulative cytogenetic response rates achieved or maintained by 1 year2*Evaluable population. To be considered a responder, the patient must have maintenance of baseline response while on treatment or an improvement from baseline. Patients with MMR or better are counted as CCyR if a valid cytogenetic assessment is not available on a specific date.Tolerability after dose reduction3BOSULIF dose reductions can improve tolerability, facilitating maintenance or achievement of MMR3*

TEAE rates* before and after dose reduction3

TEAEs occurring in >20% of patients in the overall CP CML population. Excluding patients who dose-reduced to a lower dose of BOSULIF.Efficacy after dose reduction3BOSULIF dose reductions can improve tolerability, facilitating maintenance or achievement of MMR3

MMR before and after dose reduction3

Adapted from Brümmendorf T, et al. 2019.3Excluding patients who dose-reduced to a lower dose of BOSULIF.Explore more BFORE study

A Phase 3 study in patients with newly diagnosed CP Ph+ CML.4

 View study Study 200​​​​​​​

A long-term analysis in CP, AP, or BP Ph+ CML patients with resistance or intolerance to prior therapy.5-7

 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; 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.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.Brummendorf TH, Giles F, Gambacorti-Passerini C, et al. Efficacy and safety following dose reduction of bosutinib in previously treated patients with chronic myeloid leukemia: analysis of the Phase 4 BYOND trial. Presented at the 24th Congress of the European Hematology Association (EHA); June 13-16, 2019; Amsterdam, The Netherlands. Poster PF415.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.Cortes JE, Kantarjian HM, Brümmendorf TH, et al. Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome–postive 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 imatinb 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 Find out more

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