Pfizer Oncology will present updated data in chronic myeloid leukemia (CML) for its oral Abl and Src kinase inhibitor, BOSULIF ®(bosutinib), 12,3,4,5recently approved by the U.S. Food and Drug Administration (FDA), and new data in acute lymphoblastic leukemia (ALL) and non-Hodgkin’s lymphoma (NHL) for inotuzumab ozogamicin, 6,7a CD-22 directed antibody drug conjugate (ADC) that is currently being studied in two Phase 3 trials (INO-VATE trials), 8,9at the upcoming 54 th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, December 8-11.
“The data being presented on Pfizer compounds at ASH provide important new insights into marketed products like BOSULIF (bosutinib), agents in late-stage clinical development like inotuzumab ozogamicin, and our robust hematology pipeline. This is a reflection of Pfizer’s strong commitment to bringing innovative therapies to patients with hematologic cancers,” said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit.
BOSULIF (bosutinib) Tablets
BOSULIF, approved by the FDA in September 2012, is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy. Once-daily BOSULIF was approved with pivotal trial data that included CML patients treated with imatinib followed by a second-generation tyrosine kinase inhibitor (TKI).Despite advances made in recent years for the treatment of CML, additional therapeutic options are still needed for those patients who may never respond to initial treatment, may develop drug-resistant disease, or may not be able to tolerate their therapy. 3,4 At ASH, Pfizer will present several analyses of Study 200, which evaluated BOSULIF in this patient population. Presentations include:
- Bosutinib as Therapy for Chronic Phase Chronic Myeloid Leukemia Following Resistance or Intolerance to Imatinib: 36-month Minimum Follow-up Update (Poster, Abstract #3779, December 10) 4
- Bosutinib as Therapy for Chronic Phase Chronic Myeloid Leukemia Following Failure With Imatinib Plus Dasatinib and/or Nilotinib: 24-month Minimum Follow-up Update(Poster, Abstract #3785, December 10) 5
- Baseline Predictors of Response to Bosutinib in Patients With Chronic Phase Chronic Myeloid Leukemia Following Resistance or Intolerance to Imatinib Plus Dasatinib and/or Nilotinib(Poster, Abstract #2793, December 9) 2
- Assessment of Early Cytogenetic Response as a Predictor of Long-term Clinical Outcomes in a Phase 1/2 Study of Bosutinib in Chronic Phase CML (Poster, Abstract #2798, December 9) 3
- Weekly Inotuzumab Ozogamicin in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (Poster, Abstract #2612, December 9) 7
- An Open-label, Phase 1 Study of R-CVP in Combination with Inotuzumab Ozogamicin in Patients with CD22-positive B-cell Non-Hodgkin’s Lymphoma: Preliminary Safety and Efficacy Data (Poster, Abstract #1633, December 8) 6
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