Bosutinib was superior to imatinib as first-line therapy for patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP), according to preliminary findings from the BFORE (Bosutinib Trial in First Line Chronic Myelogenous Leukemia Treatment) study.
The international, open-label, phase 3 trial (Clinical Trials.gov identifier: NCT02130557), which enrolled 536 patients with Ph+ CML-CP, met its primary endpoint of major molecular response at 12 months. Investigators observed no new or unexpected safety signals.
For the study, investigators randomly assigned patients 1:1 to receive bosutinib 400 mg orally once daily or imatinib 400 mg orally once daily, the current standard of care, until disease progression, unacceptable toxicity, or for up to 5 years.
“Since its approval, the efficacy and distinct tolerability profile of Bosulif has provided an important treatment option for patients with Ph+ CML who are resistant or intolerant to prior therapy,” Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development, said in a Pfizer news release. “The positive outcome of the BFORE study represents a key step in potentially broadening treatment options for patients in the first-line setting.”
Based on the findings of the study, Pfizer, the developer of bosutinib, will work with the US Food and Drug Administration and other regulatory authorities to potentially make bosutinib available for treatment-naive patients with Ph+ CML-CP.
The investigators plan to submit detailed efficacy and safety data from this study for presentation at a future medical meeting or publication in a peer-reviewed journal.
Bosutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. The approved dose is 500 mg orally once daily with food.
1. Pfizer and Avillion announce positive top-line results for phase 3 BFORE study of Bosulif for first-line treatment of philadelphia chromosome positive chronic myeloid leukemia. Pfizer website. http://press.pfizer.com/press-release/pfizer-and-avillion-announce-positive-top-line-results-phase-3-bfore-study-bosulif-fir. Updated December 5, 2016. Accessed February 8, 2017.