Phase 3 study of bosutinib for the treatment of chronic myeloid leukemia (CML)Pfizer announced results from its Phase 3 study of bosutinib for the treatment of newly diagnosed chronic myeloid leukemia (CML).
This study, known as the Bosutinib Efficacy and safety in chronic myeloid LeukemiA [BELA] study, investigated bosutinib as a first-line treatment in patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). The data showed that a significantly higher proportion of patients with newly diagnosed chronic myeloid leukemia (CML) who were treated with bosutinib (39%) experienced a major molecular response (MMR), a secondary endpoint, compared with patients treated with imatinib (26%) in the intent-to-treat (ITT) population (p=0.002). However, the study did not meet its primary endpoint of superior complete cytogenetic response (CCyR) rate at 1 year versus imatinib (70% vs. 68%, respectively, [p=0.601]), in the ITT population.
Bosutinib is an investigational oral dual Src and Abl kinase inhibitor. It is believed that by dual inhibition of the Src and Abl tyrosine kinases, bosutinib may inhibit signaling in CML cells that allows the cells to grow, survive and reproduce.
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