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EfficacyEfficacyBosulif EfficacyBFORE StudyBFORE 5-year dataBYOND StudyStudy 200Study 200 extensionSafetyDosingSupport & ResourcesSupport & ResourcesResource overviewGuidelinesNew challenges videoVideosMaterials

The content of this website has been produced in line with the BOSULIF® (bosutinib) Summary of Product Characteristics for Great Britain and Northern Ireland. For BOSULIF® (bosutinib) Prescribing Information Click here. Adverse event reporting information can be found at the bottom of the page.

BYOND Study: Post-Authorisation Study Design​​​​​​​1BYOND: a phase IV trial of BOSULIF in patients with Ph+ CML who have failed prior treatment with TKIs

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.

• BYOND was designed to fulfil the post-authorisation commitment to the European Medicines Agency to provide additional safety and efficacy data for BOSULIF in patients with CML after failure of prior TKI treatment, including imatinib and/or dasatinib and/or nilotinib, or in those who are
otherwise ineligible for treatment with other TKIs
• The results shown are based on a data cut-off of September 2018
(≥1 year after last enrolled patient and ~85% with ≥2-year follow-up)

Full analysis set: (N=163)

Eligibility

Any CML phase; patient must be resistant/intolerant
to prior treatment
• Prior treatment with ≥1 TKI
• Adequate hepatic/renal function
• 2nd- and 3rd-line therapy for patients with CP CML: ECOG PS 0–1
• 4th-line therapy in patients with CP CML and patients with AP/BP CML: ECOG PS 0–3

• Patients received up to 4 years of treatment with BOSULIF, except in cases of disease progression, or unacceptable toxicity
• Patients who discontinued BOSULIF prior to completing 4 years of therapy were followed for survival until they completed 4 years on study

Deep molecular responses attainable across all lines of therapy1

Cumulative molecular response attained or maintained by 2 years1*

71.1% of all patients in ≥2nd-line subgroup achieved or maintained MMR by 2 years (n=149)

71.1% of all >2nd-line patients achieve or maintained MMR by 2 years (n=149)

Cumulative molecular response attained by 2 years​​​​​​​1*

* Evaluable population. MMR (MR3): ≤0.1% BCR-ABL1 ratio on international scale (≥3-log reduction from standardised baseline). MR4: ≤0.01% BCR-ABL1 ratio on international scale (≥4-log reduction from standardised baseline). MR4.5: ≤0.0032% BCR-ABL1 ratio on international scale (≥4.5-log reduction from standardised baseline).

Deep molecular responses in patients with intolerance and resistance1

Cumulative molecular response attained or maintained by 2 years1*

Cumulative molecular response attained by 2 years1*

Over 80% of intolerant patients who had not attained MMR at baseline were able to attain MMR or deeper response levels by 2 years on BOSULIF (n=31)

Example

* Evaluable population. MMR (MR3): ≤0.1% BCR-ABL1 ratio on international scale (≥3-log reduction from standardised baseline). MR4: ≤0.01% BCR-ABL1 ratio on international scale (≥4-log reduction from standardised baseline). MR4.5: ≤0.0032% BCR-ABL1 ratio on international scale (≥4.5-log reduction from standardised baseline).
​​​​​​​†Excluding patients without the respective baseline response. 

No new safety signals in second-line therapy and onwards1

All phase IV study patients (n=163)1

1% of the patient safety population discontinued due to diarrhoea

Any grade AEs reported for >20% of patients (%)Grade 3/4 AEs reported for >5% of patients (%) Please refer to the BOSULIF SmPC for full details of adverse events
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ABL, Abelson;​​​​​​​ AP, accelerated phase; BCR, breakpoint cluster region;​​​​​​​BP, blast phase; CML, chronic myelogenous leukaemia; CP, chronic phase; ECOG PS, Eastern Cooperative Oncology Group performance status; MMR, major molecular response; MR, molecular response; Ph+/-, Philadelphia chromosome-positive/negative; TKI, tyrosine kinase inhibitor.  

References:Hochhaus A, et al. Leukemia 2020;34:2125–2137.
PP-BOS-GBR-1640. June 2021
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