Pfizer Inc. and its partner Avillion LLP, a drug development company, announced results from the phase 3 BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment) trial demonstrating superiority of Bosulif (bosutinib) over imatinib as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). The study met its primary endpoint of major molecular response (MMR) at 12 months. No new or unexpected safety issues were identified. Bosulif is currently indicated in the U.S. and EU for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy.
“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. The positive outcome of the BFORE study represents a key step in potentially broadening treatment options for patients in the first-line setting,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “This is an important milestone for Pfizer’s emerging hematology portfolio as we work to develop new treatments for patients with acute and chronic hematologic malignancies.”
“This successful partnership between Pfizer and Avillion is good news for CML patients because additional first-line treatment options allow physicians to tailor therapy based on individual patient considerations,” said Allison Jeynes-Ellis, MD, chief executive officer of Avillion. “The outcome of this partnership reinforces our belief in the potential of our innovative business model for the co-development and partnership of late-stage clinical candidates.”
Based on the results of the study, Pfizer will work with the US Food and Drug Administration (FDA) and other regulatory authorities to potentially make Bosulif available for Ph+ CML patients in the first-line setting. Detailed efficacy and safety data from this study will be submitted for a future congress or peer-reviewed journal.
Pfizer and Avillion entered into an exclusive collaborative development agreement in 2014 to conduct the BFORE trial. Under the terms of the agreement, Avillion provided funding and conducted the trial to generate the clinical data that will be used to support potential regulatory filings for marketing authorization of Bosulif as first-line treatment of patients with chronic phase Ph+ CML. If approved for this indication, Avillion will be eligible to receive milestone payments from Pfizer. Pfizer retains all rights to commercialize Bosulif globally.
Pfizer is advancing a broad range of therapies that leverage select pathways and mechanisms of action to address acute and chronic leukemias, myeloproliferative disorders and lymphoma.
BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment) is a multi-center, open-label Phase 3 study designed to assess the effectiveness and safety of Bosulif (bosutinib) as a first-line treatment for patients with chronic phase Ph+ CML. The study enrolled 536 patients at multiple sites in North America, Asia and Europe. Patients were randomized 1:1 to receive Bosulif 400mg or imatinib, a standard of care, for the duration of the study. The primary outcome was to show superiority of bosutinib over imatinib at 12 months by comparing MMR, or the proportion of patients in each arm whose levels of the Bcr-Abl1 kinase have dropped below 0.1%.
Bosulif (bosutinib) is an oral, once-daily, tyrosine kinase inhibitor (TKI), which inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src-family kinases. Bosulif was approved in September 2012 in the US for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy and offers an important treatment option for these patients. In Europe, Bosulif was granted conditional marketing authorization in March 2013 for the treatment of adult patients with Ph+ CML previously treated with one or more TKIs and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. The current approved dose of Bosulif is 500 mg orally once daily with food.
Avillion LLP is a drug development company with an innovative business model focusing on the clinical co-development and regulatory approval of late stage pharmaceutical products.