Pfizer To Present Clinical Data From Its Hematology Portfolio At The 54th Annual Meeting Of The American Society Of Hematology

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

A secondary analysis from the Bosutinib Efficacy and safety in chronic myeloid Leukemia (BELA) study will be presented (Oral Presentation, Abstract #69, December 9). ¹

Inotuzumab Ozogamicin

Inotuzumab ozogamicin, ^6,7is an investigational ADC comprised of a monoclonal antibody (mAb) targeting CD22 that is linked to a cytotoxic agent. ^10,11Linking an ADC with a cytotoxic agent may allow chemotherapy to directly target the cancer cell ^12,13 and maximize its antitumor effect while minimizing its normal tissue exposure, potentially resulting in an improved therapeutic index. ¹⁴

At ASH, Pfizer will present analyses of Phase 1 data of inotuzumab ozogamicinin in the treatment of ALL and NHL:

• 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

Inotuzumab ozogamicin is currently being evaluated in two Phase 3 studies as part of the INO-VATE trials, which are currently open and enrolling new patients. The first is in combination with rituximab in adult patients with relapsed or refractory CD22-positive aggressive NHL who are not candidates for intensive high-dose chemotherapy. ⁸The second study is in adult patients with relapsed or refractory CD22-positive ALL versus investigator’s choice of chemotherapy. ⁹

BOSULIF (bosutinib) Indication and Important Safety InformationBOSULIF is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.

Contraindication: Hypersensitivity to BOSULIF. Anaphylactic shock occurred in less than 0.2% of treated patients.

Gastrointestinal Toxicity: Diarrhea, nausea, vomiting, and abdominal pain can occur. In the clinical trial, median time to onset for diarrhea was 2 days, median duration was 1 day, and median number of episodes per patient was 3 (range 1-221). Monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and/or fluid replacement. Withhold, dose reduce, or discontinue BOSULIF as necessary.

Myelosuppression: Thrombocytopenia, anemia, and neutropenia can occur. A complete blood count should be performed weekly for the first month and then monthly or as clinically indicated. Withhold, dose reduce, or discontinue BOSULIF as necessary.

Hepatic Toxicity: Twenty percent of patients experienced an increase in either alanine aminotransferase (ALT) or aspartate aminotransferase (AST). Liver-enzyme elevation usually occurs early in treatment. Perform monthly hepatic enzyme tests for the first 3 months and as clinically indicated. In patients with transaminase elevations, monitor liver enzymes more frequently. Drug-induced liver injury has occurred. Withhold, dose reduce, or discontinue BOSULIF as necessary.

Fluid Retention: Fluid retention can occur and may cause pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema. Monitor and manage patients using standards of care. Interrupt, dose reduce, or discontinue BOSULIF as necessary.

Embryofetal Toxicity: BOSULIF may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised of potential hazard to the fetus and to avoid becoming pregnant while receiving BOSULIF.

Adverse Reactions: The most common adverse reactions observed in greater than 20% of patients in the Phase 1/2 safety population (N=546) were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue.

The most common Grade 3/4 adverse reactions and laboratory abnormalities observed in greater than 10% of patients were thrombocytopenia, anemia, and neutropenia.

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