Bosutinib is a Src / Abl dual tyrosine kinase inhibitor approved for the treatment of newly diagnosed chronic phase (CP) chronic myelogenous leukemia (CML), or resistant or intolerant to previous treatments CML. The study compared data from first-line besutinib and imatinib treatments at ≥24 months of follow-up. BFORE is an ongoing, open-label phase III clinical study with a total of 536 patients enrolled and randomly assigned to receive bursatinib (n = 268) or imatinib (n = 268) in a 1: 1 ratio treatment.
At a follow-up of 12 months, compared with the imatinib group, the bosutinib group showed higher molecular remission (MR) and complete cytogenetic remission (CCyR). And this difference continued to follow up after 24 months. At 24 months of follow-up, the two groups showed a major molecular remission (MMR) difference, but the difference between MR4 and MR4.5 was not significant. Compared with the imatinib group, the time to reach MR and CCyR was shorter in the bosutinib group. Six patients in the bosutinib group and seven patients in the imatinib group were converted to the accelerated / swift phase. At 24 months of follow-up, compared with the imatinib group, the bosutinib group showed a higher major molecular remission (MMR). Studies support the use of bosutinib in the first-line treatment of CP CML patients.