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)
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
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)
* 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).
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.
1% of the patient safety population discontinued due to diarrhoea
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.
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