The FINANCIAL — On December 5, Pfizer Inc. and its partner Avillion LLP 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 U.S. 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, according to Pfizer.
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.