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news.Pfizer has reported results from a Phase III study designed to evaluate its investigational compound bosutinib as a first-line treatment in patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
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The global, open label, multicentre trial, the Bosutinib Efficacy and safety in chronic myeloid LeukemiA (BELA) study, enrolled 502 adult patients who were randomised to receive either bosutinib or imatinib.
The primary endpoint of the study was to evaluate the CCyR rate at one year in patients receiving bosutinib versus patients receiving imatinib, while the secondary endpoint was MMR rate at one year.
Pfizer said bosutinib, an investigational oral dual Src and Abl kinase inhibitor, met its secondary endpoint, where significantly higher proportion of patients with myeloid leukaemia who were treated with bosutinib (39%) experienced a major molecular response (MMR), when compared to patients treated with imatinib (26%).
The study, however, did not meet its primary endpoint of superior complete cytogenetic response (CCyR) rate at one year versus imatinib (70% vs 68%, respectively).