New data from Pfizer's hematology portfolio to be presented at 53rd ASH annual meeting

Pfizer Oncology will present data on a number of investigational compounds from its hematology portfolio, including new data from bosutinib in chronic myeloid leukemia (CML), inotuzumab in non-Hodgkin lymphoma (NHL), as well as the first presentation of clinical data for PF-04449913, which inhibits Smoothened (SMO), a key component of the Hedgehog pathway. In addition, ongoing investigator-initiated research on gemtuzumab ozogamicin (Mylotarg) will be presented in the plenary session. These data will be presented at the upcoming 53rd Annual Meeting of the American Society of Hematology (ASH) in San Diego, December 10-13.

"Pfizer is committed to the evaluation and development of innovative therapies for hematologic malignancies," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit. "In addition to important results from company-initiated trials, we also support investigator-initiated research of compounds within our portfolio. The positive data to be presented at this meeting on gemtuzumab ozogamicin add to our understanding of this compound and the potential role of antibody-drug conjugates in hematologic malignancies. We are working closely with investigators to better understand the findings from this study and will work with regulatory authorities to determine next steps, as appropriate."

Advancing a Robust Late-Stage Portfolio: Bosutinib and Inotuzumab

Key investigational compounds bosutinib and inotuzumab, both with ongoing Phase 3 trials, will be featured in presentations at the upcoming meeting.

Analyses of data evaluating bosutinib, an investigational oral dual Src and Abl kinase inhibitor, as a single-agent in both newly diagnosed and previously treated patients with CML will be presented, including:

• Bosutinib Versus Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia - BELA Trial: 24-month Follow-up (Oral presentation, Abstract #455, December 12)
• Activity of Bosutinib by Baseline and Emergent Mutation Status in Philadelphia Chromosome-Positive Leukemia Patients with Resistance or Intolerance to Other Tyrosine Kinase Inhibitors (Study 200) (Oral presentation, Abstract #110, December 11)
• In addition, multiple poster presentations for bosutinib in newly diagnosed and previously treated patients with CML have been accepted for presentation.

Additionally, Phase 1 and 2 data will be presented on inotuzumab, an investigational antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on approximately 90 percent of B-cell malignancies, linked to a cytotoxic agent. Inotuzumab is currently being evaluated in a Phase 3 study in combination with rituximab in patients with relapsed or refractory CD22-positive aggressive NHL who are not candidates for intensive high-dose chemotherapy.

• Anti-CD22 Immunoconjugate Inotuzumab Ozogamicin + Rituximab Followed by Stem Cell Transplantation in Relapsed/Refractory DLBCL Patients: Safety and Efficacy (Study 2005) (Poster, Abstract #2718, December 11)
• An Open-label, Phase I Study of R-CVP in Combination with Inotuzumab Ozogamicin in Patients with Relapsed/Refractory CD22-positive B-cell Non-Hodgkin Lymphoma (Study 1105) (Poster, Abstract #3715, December 12)

New Pathways, New Promise in the Early-Stage Pipeline

For the first time, Pfizer will present clinical data for PF-04449913, an oral inhibitor of SMO, one of the key components of the Hedgehog signaling pathway. The study evaluates the effectiveness of PF-04449913 across multiple hematologic cancers, including CML, acute myeloid leukemia (AML), myelodysplatic syndrome, and myelofibrosis.

• Phase 1 Dose-escalation Study of PF-04449913, an Oral Hedgehog Inhibitor, in Patients with Select Hematologic Malignancies (Oral presentation, Abstract #424, December 12)

Abnormal activation of the Hedgehog pathway has been linked to multiple human cancers. Recent data suggest that disruption of the hedgehog pathway or inhibition of its activity may provide a new strategy for the treatment of hematologic disorders, including multiple myeloma, lymphoma, and myeloid malignancies.

Partnering to Gain a Better Understanding of our Cancer Therapies

Data on a range of investigator-initiated research will also be presented, including data on gemtuzumab ozogamicin to be featured in the Plenary Scientific Session:

• Fractionated doses of Gemtuzumab Ozogamicin combined to standard chemotherapy improve event-free and overall survival in newly diagnosed de novo AML patients aged 50-70 years old: A prospective randomized Phase 3 trial from the Acute Leukemia French Association (ALFA) (Sylvie Castaigne, Hôpital André Mignot; Plenary presentation, Abstract #6, December 11)