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News & Analysis US

Pfizer's Investigational Compound Bosutinib Fails To Meet Primary Endpoint

December 6, 2010, Monday, 10:15 GMT | 05:15 EST | 14:45 IST | 17:15 SGT

(RTTNews) - Pfizer Inc. (PFE) announced that a significantly higher proportion of patients with newly diagnosed chronic myeloid leukemia who were treated with bosutinib experienced a major molecular response or MMR, a secondary endpoint, compared with patients treated with imatinib in the intent-to-treat population.

However, the study failed to meet its primary endpoint of superior complete cytogenetic response or CCyR rate at one year versus imatinib in the ITT population. These results are from a Phase 3 study of the investigational compound bosutinib as a first-line treatment in patients with Philadelphia chromosome positive chronic myeloid leukemia, called the Bosutinib Efficacy and safety in chronic myeloid LeukemiA or BELA study.

The BELA study is a global, open label, multicenter trial of 502 adult patients randomized to receive either bosutinib or imatinib. Also, the company noted that patients responding to bosutinib achieved CCyR faster than those responding to imatinib.